chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Impaired work ability, Insomnia, Lymphadenopathy, Mobility decreased
Clinical narrative: unable to sleep on my left side; prevented me from doing my regular chores; couldn't move it as much; Sore back; low grade fever of 99.7; swollen lymph nodes; Sore arm; tingling on the face started about an hour; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore back), PARAESTHESIA (tingling on the face started about an hour), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores) and MOBILITY DECREASED (couldn't move it as much) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Aug-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PARAESTHESIA (tingling on the face started about an hour). On 28-Aug-2021, the patient experienced MYALGIA (Sore arm). On 29-Aug-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On an unknown date, the patient experienced BACK PAIN (Sore back), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores), MOBILITY DECREASED (couldn't move it as much) and PYREXIA (low grade fever of 99.7). On 27-Aug-2021, PARAESTHESIA (tingling on the face started about an hour) had resolved. On 04-Sep-2021, LYMPHADENOPATHY (swollen lymph nodes) had resolved with sequelae. At the time of the report, BACK PAIN (Sore back), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores), MOBILITY DECREASED (couldn't move it as much), MYALGIA (Sore arm) and PYREXIA (low grade fever of 99.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Nasal swab for COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received and updated event, lab data and patient demographics information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: unable to sleep on my left side; prevented me from doing my regular chores; couldn't move it as much; Sore back; low grade fever of 99.7; swollen lymph nodes; Sore arm; tingling on the face started about an hour; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore back), PARAESTHESIA (tingling on the face started about an hour), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores) and MOBILITY DECREASED (couldn't move it as much) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Aug-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PARAESTHESIA (tingling on the face started about an hour). On 28-Aug-2021, the patient experienced MYALGIA (Sore arm). On 29-Aug-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On an unknown date, the patient experienced BACK PAIN (Sore back), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores), MOBILITY DECREASED (couldn't move it as much) and PYREXIA (low grade fever of 99.7). On 27-Aug-2021, PARAESTHESIA (tingling on the face started about an hour) had resolved. On 04-Sep-2021, LYMPHADENOPATHY (swollen lymph nodes) had resolved with sequelae. At the time of the report, BACK PAIN (Sore back), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores), MOBILITY DECREASED (couldn't move it as much), MYALGIA (Sore arm) and PYREXIA (low grade fever of 99.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Nasal swab for COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received and updated event, lab data and patient demographics information.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to 14 year old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059F71A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: kind of warm; It was slightly raised, kind of warm, and itchy; rash around the site of injection; It was slightly raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (kind of warm), VACCINATION SITE PRURITUS (It was slightly raised, kind of warm, and itchy), VACCINATION SITE RASH (rash around the site of injection) and VACCINATION SITE SWELLING (It was slightly raised) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced VACCINATION SITE WARMTH (kind of warm), VACCINATION SITE PRURITUS (It was slightly raised, kind of warm, and itchy), VACCINATION SITE RASH (rash around the site of injection) and VACCINATION SITE SWELLING (It was slightly raised). On 31-Aug-2021, VACCINATION SITE WARMTH (kind of warm), VACCINATION SITE PRURITUS (It was slightly raised, kind of warm, and itchy), VACCINATION SITE RASH (rash around the site of injection) and VACCINATION SITE SWELLING (It was slightly raised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient watched the events for the next few days, and by 31-Aug-2021 it was looking fine. There was just a little left in the skin, but it was smooth and not itchy. No treatment information reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness; she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness) and FATIGUE (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced MYALGIA (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness) and FATIGUE (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness). At the time of the report, MYALGIA (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness) and FATIGUE (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-304259 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Missed the second shot 6 months ago; patient got sick after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient got sick after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed the second shot 6 months ago) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ILLNESS (patient got sick after first vaccine). In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second shot 6 months ago). In February 2021, PRODUCT DOSE OMISSION ISSUE (Missed the second shot 6 months ago) had resolved. At the time of the report, ILLNESS (patient got sick after first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication was reported. No treatment history was reported. second vaccine  appointment  was scheduled for the end of February but patient was sick, too sick to get the second vaccine.  Second shot was only available at the same  location where patient got first vaccine. Patient reports that missed second vaccine appointment.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up contains event of sickness added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chest discomfort, Cough
Clinical narrative: Coughing; Tightness in chest; Exhaustion; COVID-19; Lack of drug effect; Lost hearing; Sinus infection / Head congestion; Allergy attack; Sneezing; Blowing her nose al the time; Really bad ear pain; Pain in her teeth; Lost sense of taste; Lost sense of smell; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Lost hearing) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and INSOMNIA (Insomnia). On 27-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 29-Aug-2021, the patient experienced COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest) and FATIGUE (Exhaustion). At the time of the report, DEAFNESS (Lost hearing), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell), INSOMNIA (Insomnia), COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Drug ineffective, Ear pain, Fatigue, Hypersensitivity
Clinical narrative: Coughing; Tightness in chest; Exhaustion; COVID-19; Lack of drug effect; Lost hearing; Sinus infection / Head congestion; Allergy attack; Sneezing; Blowing her nose al the time; Really bad ear pain; Pain in her teeth; Lost sense of taste; Lost sense of smell; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Lost hearing) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and INSOMNIA (Insomnia). On 27-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 29-Aug-2021, the patient experienced COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest) and FATIGUE (Exhaustion). At the time of the report, DEAFNESS (Lost hearing), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell), INSOMNIA (Insomnia), COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rhinorrhoea, SARS-CoV-2 test, Sinusitis, Sneezing
Clinical narrative: Coughing; Tightness in chest; Exhaustion; COVID-19; Lack of drug effect; Lost hearing; Sinus infection / Head congestion; Allergy attack; Sneezing; Blowing her nose al the time; Really bad ear pain; Pain in her teeth; Lost sense of taste; Lost sense of smell; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Lost hearing) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and INSOMNIA (Insomnia). On 27-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 29-Aug-2021, the patient experienced COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest) and FATIGUE (Exhaustion). At the time of the report, DEAFNESS (Lost hearing), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell), INSOMNIA (Insomnia), COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Coughing; Tightness in chest; Exhaustion; COVID-19; Lack of drug effect; Lost hearing; Sinus infection / Head congestion; Allergy attack; Sneezing; Blowing her nose al the time; Really bad ear pain; Pain in her teeth; Lost sense of taste; Lost sense of smell; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Lost hearing) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and INSOMNIA (Insomnia). On 27-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 29-Aug-2021, the patient experienced COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest) and FATIGUE (Exhaustion). At the time of the report, DEAFNESS (Lost hearing), SINUSITIS (Sinus infection / Head congestion), HYPERSENSITIVITY (Allergy attack), SNEEZING (Sneezing), RHINORRHOEA (Blowing her nose al the time), EAR PAIN (Really bad ear pain), TOOTHACHE (Pain in her teeth), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell), INSOMNIA (Insomnia), COUGH (Coughing), CHEST DISCOMFORT (Tightness in chest), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: She woke up at 3:00AM and was really wheezy; Trouble catching breath; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (She woke up at 3:00AM and was really wheezy) and DYSPNOEA (Trouble catching breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021 at 5:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021 at 3:00 AM, the patient experienced WHEEZING (She woke up at 3:00AM and was really wheezy) and DYSPNOEA (Trouble catching breath). On 30-Aug-2021, WHEEZING (She woke up at 3:00AM and was really wheezy) and DYSPNOEA (Trouble catching breath) had resolved.            No concomitant medications were mentioned. The events  cleared up completely in 15 to 20 minutes No treatment details were reported.   This case was linked to MOD-2021-304211 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     no medical history was provided.    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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.            concomitant medications were not reported. treatment medications were not reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received 1mL dose instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 01-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL). At the time of the report, ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch; Hurts underneath also; Swollen; Hurting at the injection site; Shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), PAIN (Hurts underneath also), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Hurting at the injection site) and ARTHRALGIA (Shoulder hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), PAIN (Hurts underneath also), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Hurting at the injection site) and ARTHRALGIA (Shoulder hurt). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), PAIN (Hurts underneath also), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Hurting at the injection site) outcome was unknown and ARTHRALGIA (Shoulder hurt) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were taken by the patient. No treatment medications were taken by the patient.  The patient initially stated booster shot but then stated that she received her 3rd dose. The patient stated that this did not happen with the other shots.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: really bad pain in her right leg /barely any pain in her left leg/pain in the foot; Pain in the ankle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad pain in her right leg /barely any pain in her left leg/pain in the foot) and ARTHRALGIA (Pain in the ankle) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (really bad pain in her right leg /barely any pain in her left leg/pain in the foot) and ARTHRALGIA (Pain in the ankle). At the time of the report, PAIN IN EXTREMITY (really bad pain in her right leg /barely any pain in her left leg/pain in the foot) and ARTHRALGIA (Pain in the ankle) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-304308 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Urticarial vasculitis
Clinical narrative: Post-vaccine associated urticarial vasculitis; This literature-study case was reported in a literature article and describes the occurrence of URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) (seriousness criterion medically significant). At the time of the report, URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) The biopsy specimen demonstrates an inflammatory process within the dermis, exhibiting urticarial-like features. In particular, there is a mixed infiltrate that is interstitial and perivascular composed of lymphocytes, monocytes, and neutrophils along with a few eosinophils with concomitant dermal edema. Inflammatory cells migrate through the vessel wall without fibrin deposition, although nevertheless there is focal leukocytoclasia and red cell extravasation, a constellation of findings consistent with urticarial vasculitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) to be possibly related.    Patient developed urticarial reaction process after receiving the COVID-19 Moderna vaccine.  Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start of the event after vaccination, a causal relationship cannot be excluded   This case was linked to MOD-2021-304252, MOD-2021-304413, MOD-2021-304414 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received by safety on 02-Sep-2021 included an Email received from a team and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event after vaccination, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Choking, Productive cough
Clinical narrative: Bubbly chunks causing me to choke often on my own mucous; Irritating persistent cough, Cough emitting little bubbly chunks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Bubbly chunks causing me to choke often on my own mucous) in a  patient of an unknown age and gender 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 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 CHOKING (Bubbly chunks causing me to choke often on my own mucous) (seriousness criterion medically significant) and PRODUCTIVE COUGH (Irritating persistent cough, Cough emitting little bubbly chunks). At the time of the report, CHOKING (Bubbly chunks causing me to choke often on my own mucous) and PRODUCTIVE COUGH (Irritating persistent cough, Cough emitting little bubbly chunks) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication was reported.  Ever since patient got first injection patient had an irritating persistent cough emitting little bubbly chunks causing the patient to choke often on own mucous.   Treatment medication was not provided by the reporter.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pyrexia
Clinical narrative: Next morning, she felt horribly sick/terribly ill after booster of Moderna; She had chills; She had nausea; She had fever; She had headaches.; She was vomiting.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever) and HEADACHE (She had headaches.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received third 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever), HEADACHE (She had headaches.) and VOMITING (She was vomiting.). At the time of the report, ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever), HEADACHE (She had headaches.) and VOMITING (She was vomiting.) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Include significant information include consent denied by the reporter and new event terribly ill after booster dose is mentioned in events tab.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Next morning, she felt horribly sick/terribly ill after booster of Moderna; She had chills; She had nausea; She had fever; She had headaches.; She was vomiting.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever) and HEADACHE (She had headaches.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received third 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever), HEADACHE (She had headaches.) and VOMITING (She was vomiting.). At the time of the report, ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever), HEADACHE (She had headaches.) and VOMITING (She was vomiting.) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Include significant information include consent denied by the reporter and new event terribly ill after booster dose is mentioned in events tab.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Loss of taste sensation; Loss of smell sensation; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste sensation) and ANOSMIA (Loss of smell sensation) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, 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 experienced AGEUSIA (Loss of taste sensation) and ANOSMIA (Loss of smell sensation). At the time of the report, AGEUSIA (Loss of taste sensation) and ANOSMIA (Loss of smell sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive COVID test after getting both doses of vaccine..         Additional information includes for lab data where patient had reported that he got tested positive for COVID test after getting both doses of vaccine.  Concomitant product use was not provided. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: chills; high fever; really severe vomiting; massive headache; injection site pain; fatigue/she still feels fatigued; muscle pain; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting), HEADACHE (massive headache) and VACCINATION SITE PAIN (injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 026B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS and Arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting), HEADACHE (massive headache), VACCINATION SITE PAIN (injection site pain), FATIGUE (fatigue/she still feels fatigued), MYALGIA (muscle pain) and NAUSEA (nauseous). On 01-Sep-2021, CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting) and VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, HEADACHE (massive headache), FATIGUE (fatigue/she still feels fatigued), MYALGIA (muscle pain) and NAUSEA (nauseous) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for her blood pressure, thyroid, arthritis.  Patient gets infusions and is immunosuppressed.  Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: chills; high fever; really severe vomiting; massive headache; injection site pain; fatigue/she still feels fatigued; muscle pain; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting), HEADACHE (massive headache) and VACCINATION SITE PAIN (injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 026B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS and Arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting), HEADACHE (massive headache), VACCINATION SITE PAIN (injection site pain), FATIGUE (fatigue/she still feels fatigued), MYALGIA (muscle pain) and NAUSEA (nauseous). On 01-Sep-2021, CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting) and VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, HEADACHE (massive headache), FATIGUE (fatigue/she still feels fatigued), MYALGIA (muscle pain) and NAUSEA (nauseous) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for her blood pressure, thyroid, arthritis.  Patient gets infusions and is immunosuppressed.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Passed out once; thrown up twice; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out once) in a patient of an unknown age and gender 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 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out once) (seriousness criterion medically significant) and VOMITING (thrown up twice). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out once) and VOMITING (thrown up twice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Some adverse event reported; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some adverse event reported) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some adverse event reported). At the time of the report, VACCINATION COMPLICATION (Some adverse event reported) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myocardial infarction, Paralysis, Peripheral swelling
Clinical narrative: either had a heart attack or going to have one; Left arm was red from the shoulder all the way down to the elbow; left arm was swollen real big; Paralyzed/she couldn't move; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (either had a heart attack or going to have one), PARALYSIS (Paralyzed/she couldn't move), ERYTHEMA (Left arm was red from the shoulder all the way down to the elbow) and PERIPHERAL SWELLING (left arm was swollen real big) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced PARALYSIS (Paralyzed/she couldn't move) (seriousness criteria hospitalization and medically significant). On 29-Aug-2021, the patient experienced ERYTHEMA (Left arm was red from the shoulder all the way down to the elbow) (seriousness criterion hospitalization) and PERIPHERAL SWELLING (left arm was swollen real big) (seriousness criterion hospitalization). On 01-Sep-2021, the patient experienced MYOCARDIAL INFARCTION (either had a heart attack or going to have one) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (either had a heart attack or going to have one), PARALYSIS (Paralyzed/she couldn't move), ERYTHEMA (Left arm was red from the shoulder all the way down to the elbow) and PERIPHERAL SWELLING (left arm was swollen real big) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment included ice on swollen arm.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events (myocardial infarction, paralysis, peripheral swelling, erythema), a causal relationship cannot be excluded.; 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 (myocardial infarction, paralysis, peripheral swelling, erythema), a causal relationship cannot be excluded.