chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site vesicles, Vaccination site warmth
Clinical narrative: Injection site warm; lnjection site little bumps almost like blisters; Injection site itchy; Area where she got the vaccine was sensitive; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE VESICLES (lnjection site little bumps almost like blisters), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Area where she got the vaccine was sensitive) and VACCINATION SITE SWELLING (Injection site swollen) in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE VESICLES (lnjection site little bumps almost like blisters), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Area where she got the vaccine was sensitive) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE VESICLES (lnjection site little bumps almost like blisters), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Area where she got the vaccine was sensitive) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       No treatment  information was provided.  Concomitant medication included thyroid medication (unspecified).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: On and off headache that sometimes radiates at the back or in the front; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (On and off headache that sometimes radiates at the back or in the front) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (On and off headache that sometimes radiates at the back or in the front). At the time of the report, HEADACHE (On and off headache that sometimes radiates at the back or in the front) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fatigue/tired; Headache; Chills; Fever; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/tired), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 008BT1A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced FATIGUE (Fatigue/tired), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, FATIGUE (Fatigue/tired), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain
Clinical narrative: Full body twitches; That are painful; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Full body twitches) and PAIN (That are painful) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included GABAPENTIN, HYDROCORTISONE, LEFLUNOMIDE (FLUDART), CELECOXIB (CELEBREX), MONTELUKAST SODIUM (SINGULAIR), POTASSIUM, RANOLAZINE, DULOXETINE, ACARBOSE and OMEPRAZOLE for an unknown indication.    On 24-Mar-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 MUSCLE TWITCHING (Full body twitches) and PAIN (That are painful). At the time of the report, MUSCLE TWITCHING (Full body twitches) and PAIN (That are painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included Methyl Carbinol and Piperamide for unknown indication. No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis
Clinical narrative: Dizziness; Nosebleed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and EPISTAXIS (Nosebleed) in a 32-year-old female patient who received mRNA-1273 (batch no. 04SA21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTAMIDE (PROFAMID) for Blood pressure abnormal.    On 01-May-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIZZINESS (Dizziness) and EPISTAXIS (Nosebleed). At the time of the report, DIZZINESS (Dizziness) and EPISTAXIS (Nosebleed) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment. No treatment details were not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vaccination site pain
Clinical narrative: the Moderna vaccine has cured my Type II diabetes; some arm soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some arm soreness at injection site) and THERAPEUTIC RESPONSE UNEXPECTED (the Moderna vaccine has cured my Type II diabetes) in a 64-year-old female patient who received mRNA-1273 (batch nos. 047A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (some arm soreness at injection site). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (the Moderna vaccine has cured my Type II diabetes). On 26-Mar-2021, VACCINATION SITE PAIN (some arm soreness at injection site) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (the Moderna vaccine has cured my Type II diabetes) outcome was unknown.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   treatment information not provided.   This case was linked to MOD-2021-101376 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick). At the time of the report, ILLNESS (felt sick) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable. Symptom text:  Patient reported that when she saw her Doctor her Doctor told her that  he had received both doses of his Moderna Covid-19 vaccine and that the Doctor felt sick after each dose. I am reporting this as a limited Adverse Event and the manufacturer of the vaccine is unknown.  Other Patient specific and product specific vaccine information is unknown at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-103953 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103953:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Lost feeling in both legs; Little dizziness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Lost feeling in both legs) and DIZZINESS (Little dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and GABAPENTIN for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HYPOAESTHESIA (Lost feeling in both legs) and DIZZINESS (Little dizziness). On 23-Apr-2021, HYPOAESTHESIA (Lost feeling in both legs) and DIZZINESS (Little dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pyrexia, Rash, Rash pruritic, Swelling face
Clinical narrative: Burning sensation on rash; Face swollen; Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash; Fever; Rash became itchier; This spontaneous case was reported by a non-health professional and describes the occurrence of BURNING SENSATION (Burning sensation on rash), RASH PRURITIC (Rash became itchier), SWELLING FACE (Face swollen), RASH (Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced RASH PRURITIC (Rash became itchier), RASH (Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash) and PYREXIA (Fever). On 01-May-2021, the patient experienced BURNING SENSATION (Burning sensation on rash) and SWELLING FACE (Face swollen). At the time of the report, BURNING SENSATION (Burning sensation on rash), RASH PRURITIC (Rash became itchier) and SWELLING FACE (Face swollen) outcome was unknown, RASH (Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash) had not resolved and PYREXIA (Fever) had resolved.            The patient was not taking any concomitant medications. The patient has not sought medical attention and no treatment information was provided.   This case was linked to MOD-2021-100584 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Tendonitis
Clinical narrative: Can't lift arm/ put arm backward; can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm; can't lay on arm; Tendonitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Can't lift arm/ put arm backward), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm), PAIN IN EXTREMITY (can't lay on arm) and TENDONITIS (Tendonitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Can't lift arm/ put arm backward), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm), PAIN IN EXTREMITY (can't lay on arm) and TENDONITIS (Tendonitis). At the time of the report, MOBILITY DECREASED (Can't lift arm/ put arm backward), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm), PAIN IN EXTREMITY (can't lay on arm) and TENDONITIS (Tendonitis) had not resolved.            No concomitant medications were provided. The patient was given the diagnosis of Tendonitis by the HCP.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue, SARS-CoV-2 test
Clinical narrative: COVID-19 Positive after first dose; Tested COVID-19 positive so did not receive the vaccine second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Positive after first dose) and INTENTIONAL PRODUCT USE ISSUE (Tested COVID-19 positive so did not receive the vaccine second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (COVID-19 Positive after first dose) and INTENTIONAL PRODUCT USE ISSUE (Tested COVID-19 positive so did not receive the vaccine second dose). On 24-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Tested COVID-19 positive so did not receive the vaccine second dose) had resolved. At the time of the report, COVID-19 (COVID-19 Positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 test: inconclusive (Positive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided. 21Apr2021 and had not received the vaccine.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: severe headache; body aches; This spontaneous case was reported by an other and describes the occurrence of HEADACHE (severe headache) and MYALGIA (body aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache) and MYALGIA (body aches). At the time of the report, HEADACHE (severe headache) and MYALGIA (body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Could not raise arm; Arm soreness; Body malaise; Chills; Low grade fever 99.3F; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise), MUSCULAR WEAKNESS (Could not raise arm), PYREXIA (Low grade fever 99.3F) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (developed positive antibodies) in September 2020.   On 23-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 23-Mar-2021, the patient experienced PYREXIA (Low grade fever 99.3F). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise) and CHILLS (Chills). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Could not raise arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 24-Apr-2021, PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise), PYREXIA (Low grade fever 99.3F) and CHILLS (Chills) had resolved. At the time of the report, MUSCULAR WEAKNESS (Could not raise arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99.3 degree f (Low) Low grade fever 99.3 degree F On 24-MAR-2021 recovered.. On 28-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient Quest diagnostics re-ran sample and confirmed it was negative for viral load and therefore the PCR test was false positive. he put off the colonoscopy due to false positive . Terrible arm pain/severe arm pain ,AE Preferred Contact Updated, AE details updated were given as events   This case was linked to MOD-2021-100770 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-Up received on 14-JUN-2021 and new AE event updated On 27-Jul-2021: Follow up received on 27 JUL 2021 included no new information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Could not raise arm; Arm soreness; Body malaise; Chills; Low grade fever 99.3F; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise), MUSCULAR WEAKNESS (Could not raise arm), PYREXIA (Low grade fever 99.3F) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (developed positive antibodies) in September 2020.   On 23-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 23-Mar-2021, the patient experienced PYREXIA (Low grade fever 99.3F). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise) and CHILLS (Chills). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Could not raise arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 24-Apr-2021, PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise), PYREXIA (Low grade fever 99.3F) and CHILLS (Chills) had resolved. At the time of the report, MUSCULAR WEAKNESS (Could not raise arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99.3 degree f (Low) Low grade fever 99.3 degree F On 24-MAR-2021 recovered.. On 28-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient Quest diagnostics re-ran sample and confirmed it was negative for viral load and therefore the PCR test was false positive. he put off the colonoscopy due to false positive . Terrible arm pain/severe arm pain ,AE Preferred Contact Updated, AE details updated were given as events   This case was linked to MOD-2021-100770 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-Up received on 14-JUN-2021 and new AE event updated On 27-Jul-2021: Follow up received on 27 JUL 2021 included no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at the injection site that is size of baseball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site that is size of baseball) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Apr-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 VACCINATION SITE ERYTHEMA (Redness at the injection site that is size of baseball). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site erythema, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site that is size of baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Myalgia
Clinical narrative: lightheadedness; vaccination site was inflammed; injection site was tender/ injection site was painful with pain scale of 6; fever with temperature of 100.2F and 103.2F; Body aches; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds, Allergy to animal dander and Pollen allergy. Concomitant products included OLOPATADINE and OLOPATADINE for Allergy, MULTIVITAMINS [VITAMINS NOS], L-THYROXIN [LEVOTHYROXINE], SIMVASTATIN, PREGABALIN and FLUTICASONE FUROATE (FLONASE SENSIMIST ALLERGY RELIEF) for an unknown indication.    On 30-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100.2 (High) Fever with temperature of 100.2 F then at around 5:30 P.M it was 103.2 F. On 01-May-2021, Body temperature: fever was down to 100.8f (High) fever was down to 100.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant also include an allergy pill (unspecified). The patient applied ice pack for 20 minutes on affected arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site inflammation, Vaccination site pain
Clinical narrative: lightheadedness; vaccination site was inflammed; injection site was tender/ injection site was painful with pain scale of 6; fever with temperature of 100.2F and 103.2F; Body aches; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds, Allergy to animal dander and Pollen allergy. Concomitant products included OLOPATADINE and OLOPATADINE for Allergy, MULTIVITAMINS [VITAMINS NOS], L-THYROXIN [LEVOTHYROXINE], SIMVASTATIN, PREGABALIN and FLUTICASONE FUROATE (FLONASE SENSIMIST ALLERGY RELIEF) for an unknown indication.    On 30-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100.2 (High) Fever with temperature of 100.2 F then at around 5:30 P.M it was 103.2 F. On 01-May-2021, Body temperature: fever was down to 100.8f (High) fever was down to 100.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant also include an allergy pill (unspecified). The patient applied ice pack for 20 minutes on affected arm.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Hypersomnia, Vaccination site pain
Clinical narrative: massive excruciating headache from eyes to the back of her head; chills; burning sensation in her veins; slept all day; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in her veins), HYPERSOMNIA (slept all day), VACCINATION SITE PAIN (pain in the arm), CHILLS (chills) and HEADACHE (massive excruciating headache from eyes to the back of her head) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain in the arm). On 30-Apr-2021, the patient experienced BURNING SENSATION (burning sensation in her veins), HYPERSOMNIA (slept all day) and CHILLS (chills). On 01-May-2021, the patient experienced HEADACHE (massive excruciating headache from eyes to the back of her head). The patient was treated with PARACETAMOL (TYLENOL) from 29-Apr-2021 to 30-Apr-2021 for Pain, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation in her veins), HYPERSOMNIA (slept all day), VACCINATION SITE PAIN (pain in the arm), CHILLS (chills) and HEADACHE (massive excruciating headache from eyes to the back of her head) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported     This case was linked to MOD-2021-100457 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of erythematous rash (red bumps on arm) in a 26-year-old female patient who received mRNA-1273 for COVID-19 vaccination. No medical history reported. On Apr 23, 2021, patient received dose of mRNA-1273, intramuscular; 1 dosage form. On Apr 30, 2021, patient experienced erythematous rash (red bumps on arm). At the time of the report, erythematous rash (red bumps on arm) outcome: unknown. The action taken with mRNA-1273, intramuscular: unknown. No concomitant medication or treatment information reported/provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Medication error, SARS-CoV-2 antibody test
Clinical narrative: nurse employed "pinched her arm at the injection site, felt like the needle didn't enter her muscle,; itching around injection site; This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (nurse employed "pinched her arm at the injection site, felt like the needle didn't enter her muscle,) and INJECTION SITE PRURITUS (itching around injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary hypertension.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching around injection site). On 09-Feb-2021, the patient experienced MEDICATION ERROR (nurse employed "pinched her arm at the injection site, felt like the needle didn't enter her muscle,). At the time of the report, MEDICATION ERROR (nurse employed "pinched her arm at the injection site, felt like the needle didn't enter her muscle,) and INJECTION SITE PRURITUS (itching around injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) No antibodies on test.         Concomitant medications were not provided.  Treatment medications was not given.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Disorientation, Dizziness, Dyspnoea exertional, Electrocardiogram
Clinical narrative: Disoriented; Ringing in my ears; Numbing of my lips; Numbing of my left cheek/Numbing of my left hand; Chest pains; High blood pressure; Lightheadedness worse; Fatigue; Migraine on the left side of my head; shortness of Breath after running; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN, HYPERTENSION, MIGRAINE, DISORIENTATION, and TINNITUS in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA EXERTIONAL (shortness of Breath after running). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine on the left side of my head). On 27-Mar-2021, the patient experienced CHEST PAIN, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA, DIZZINESS, and FATIGUE. On 27-Mar-2021, MIGRAINE had resolved. On 09-Apr-2021, CHEST PAIN had resolved. At the time of the report, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA (Numbing of my left cheek/Numbing of my left hand), DYSPNOEA EXERTIONAL, and FATIGUE outcome was unknown and DIZZINESS (Lightheadedness worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC-MOD-2021-100429.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: New lab test EKG and heart test were reported. Sender's Comments: Based on current available information and the temporal association between product use and the start date of events a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypertension, Hypoaesthesia, Hypoaesthesia oral, Migraine
Clinical narrative: Disoriented; Ringing in my ears; Numbing of my lips; Numbing of my left cheek/Numbing of my left hand; Chest pains; High blood pressure; Lightheadedness worse; Fatigue; Migraine on the left side of my head; shortness of Breath after running; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN, HYPERTENSION, MIGRAINE, DISORIENTATION, and TINNITUS in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA EXERTIONAL (shortness of Breath after running). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine on the left side of my head). On 27-Mar-2021, the patient experienced CHEST PAIN, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA, DIZZINESS, and FATIGUE. On 27-Mar-2021, MIGRAINE had resolved. On 09-Apr-2021, CHEST PAIN had resolved. At the time of the report, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA (Numbing of my left cheek/Numbing of my left hand), DYSPNOEA EXERTIONAL, and FATIGUE outcome was unknown and DIZZINESS (Lightheadedness worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC-MOD-2021-100429.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: New lab test EKG and heart test were reported. Sender's Comments: Based on current available information and the temporal association between product use and the start date of events a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Disoriented; Ringing in my ears; Numbing of my lips; Numbing of my left cheek/Numbing of my left hand; Chest pains; High blood pressure; Lightheadedness worse; Fatigue; Migraine on the left side of my head; shortness of Breath after running; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN, HYPERTENSION, MIGRAINE, DISORIENTATION, and TINNITUS in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA EXERTIONAL (shortness of Breath after running). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine on the left side of my head). On 27-Mar-2021, the patient experienced CHEST PAIN, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA, DIZZINESS, and FATIGUE. On 27-Mar-2021, MIGRAINE had resolved. On 09-Apr-2021, CHEST PAIN had resolved. At the time of the report, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA (Numbing of my left cheek/Numbing of my left hand), DYSPNOEA EXERTIONAL, and FATIGUE outcome was unknown and DIZZINESS (Lightheadedness worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC-MOD-2021-100429.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: New lab test EKG and heart test were reported. Sender's Comments: Based on current available information and the temporal association between product use and the start date of events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Migraine, Mobility decreased, Myalgia
Clinical narrative: she had really bad pain in her arm to the point where she couldn't lift her arm; couldn't lift her arm; also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday; Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight; everything on the left side hurts; bad migraine; dizziness; nausea; Generalized soreness and pain on the left side of her body; muscle pain; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (she had really bad pain in her arm to the point where she couldn't lift her arm), MOBILITY DECREASED (couldn't lift her arm), RASH ERYTHEMATOUS (also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday), CHEST PAIN (Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight) and PAIN (everything on the left side hurts) in a female patient of an unknown age who received mRNA-1273 (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she had really bad pain in her arm to the point where she couldn't lift her arm), MOBILITY DECREASED (couldn't lift her arm), RASH ERYTHEMATOUS (also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday), CHEST PAIN (Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight), PAIN (everything on the left side hurts), MIGRAINE (bad migraine), DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (Generalized soreness and pain on the left side of her body) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (she had really bad pain in her arm to the point where she couldn't lift her arm), MOBILITY DECREASED (couldn't lift her arm), RASH ERYTHEMATOUS (also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday), CHEST PAIN (Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight), PAIN (everything on the left side hurts), MIGRAINE (bad migraine), DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (Generalized soreness and pain on the left side of her body) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Unknown Route) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Rash erythematous
Clinical narrative: she had really bad pain in her arm to the point where she couldn't lift her arm; couldn't lift her arm; also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday; Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight; everything on the left side hurts; bad migraine; dizziness; nausea; Generalized soreness and pain on the left side of her body; muscle pain; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (she had really bad pain in her arm to the point where she couldn't lift her arm), MOBILITY DECREASED (couldn't lift her arm), RASH ERYTHEMATOUS (also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday), CHEST PAIN (Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight) and PAIN (everything on the left side hurts) in a female patient of an unknown age who received mRNA-1273 (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she had really bad pain in her arm to the point where she couldn't lift her arm), MOBILITY DECREASED (couldn't lift her arm), RASH ERYTHEMATOUS (also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday), CHEST PAIN (Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight), PAIN (everything on the left side hurts), MIGRAINE (bad migraine), DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (Generalized soreness and pain on the left side of her body) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (she had really bad pain in her arm to the point where she couldn't lift her arm), MOBILITY DECREASED (couldn't lift her arm), RASH ERYTHEMATOUS (also has a rash, raised and red, slowly spreading instead of getting smaller, surface area has been getting bigger since Thursday), CHEST PAIN (Left sided chest pain, sharp muscle pain in the chest, heart is really sharp and tight), PAIN (everything on the left side hurts), MIGRAINE (bad migraine), DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (Generalized soreness and pain on the left side of her body) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Unknown Route) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mental disorder
Clinical narrative: Placed in a mental institution; Will miss second dose and for 30 days she will be in mental institution; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (Placed in a mental institution) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will miss second dose and for 30 days she will be in mental institution) 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 01-Apr-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 MENTAL DISORDER (Placed in a mental institution) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will miss second dose and for 30 days she will be in mental institution). At the time of the report, MENTAL DISORDER (Placed in a mental institution) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will miss second dose and for 30 days she will be in mental institution) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Treatment information was not provided