chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Pruritus, Rash erythematous, Urticaria
Clinical narrative: 20 weeks pregnant after 2nd dose; Hives all over her body after 2nd dose; Red rash all over her body after 2nd dose / Quit antihistamine rash comes back; Itchy all over her body after 2nd dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back), PRURITUS (Itchy all over her body after 2nd dose) and MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011J209) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Dec-2021. On 12-Feb-2021, the patient experienced URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back) and PRURITUS (Itchy all over her body after 2nd dose). On 25-Aug-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, Hives and Pruritus, at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form. On 25-Aug-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose) had resolved. At the time of the report, URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back) and PRURITUS (Itchy all over her body after 2nd dose) outcome was unknown.            Concomitant medication details were not reported by the reporter.   Patient stated that as long as she took Zyrtec the rash goes away, but when she stops taking Zyrtec the rash came back. The doctor also prescribed one week Steroid Medrol dose pack which she finished taking. Patient  was thinking about getting a booster shot. The LMP of the patient was reported as 08-MAR-2021.; 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.  This is a case of maternal exposure before pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Spinal stenosis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 SITE PAIN (Arm hurt). At the time of the report, VACCINATION SITE PAIN (Arm hurt) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-296540, MOD-2021-022507 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: left injection site arm sore; left injection site arm red; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MECLOZINE HYDROCHLORIDE (BONINE) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2021-296560 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Vaccination site pain
Clinical narrative: Sore arm; 1st dose Pfizer- 2nd dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    Concurrent medical conditions included Autism.   On 28-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna). On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 25-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        No concomitant medications reported. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site erythema, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Fatigue; Sore arm; knot at the injection site.; red knot  at the injection site.; swollen at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (knot at the injection site.), VACCINATION SITE ERYTHEMA (red knot  at the injection site.), VACCINATION SITE SWELLING (swollen at the injection site.), FATIGUE (Fatigue) and MYALGIA (Sore arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History was provided.  Concomitant products included ETONOGESTREL (NEXPLANON) for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE NODULE (knot at the injection site.), VACCINATION SITE ERYTHEMA (red knot  at the injection site.) and VACCINATION SITE SWELLING (swollen at the injection site.). On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (Sore arm). At the time of the report, VACCINATION SITE NODULE (knot at the injection site.), VACCINATION SITE ERYTHEMA (red knot  at the injection site.), VACCINATION SITE SWELLING (swollen at the injection site.), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Birth control orally and now injectable (Nexplanon) No Treatment Medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: upper arm has a large red rash about 3"; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (upper arm has a large red rash about 3") 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (upper arm has a large red rash about 3"). At the time of the report, RASH ERYTHEMATOUS (upper arm has a large red rash about 3") outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Headache, Illness
Clinical narrative: Got covid-19, not as severe; Was a little sick; Stomach problems; Whoopping headache/massive headache/constant headache/headache all day for days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid-19, not as severe), ILLNESS (Was a little sick), ABDOMINAL DISCOMFORT (Stomach problems) and HEADACHE (Whoopping headache/massive headache/constant headache/headache all day for days) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had covid-19 two and a half weeks ago).    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 COVID-19 (Got covid-19, not as severe), ILLNESS (Was a little sick), ABDOMINAL DISCOMFORT (Stomach problems) and HEADACHE (Whoopping headache/massive headache/constant headache/headache all day for days). At the time of the report, COVID-19 (Got covid-19, not as severe), ILLNESS (Was a little sick), ABDOMINAL DISCOMFORT (Stomach problems) and HEADACHE (Whoopping headache/massive headache/constant headache/headache all day for days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   This case was linked to MOD-2021-297301 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Hypoaesthesia oral, Paraesthesia oral, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face), HYPOAESTHESIA ORAL (Numbness on lips) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 14-Dec-2020.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face) and HYPOAESTHESIA ORAL (Numbness on lips). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 06-Jan-2021, FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face) and HYPOAESTHESIA ORAL (Numbness on lips) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered) had resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. The symptoms went away in 1-2 hours post their onset.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Cold sweat, Dyspnoea
Clinical narrative: back pain; a bad thing; not being able to work; cold sweats; pressure on his chest and back; feeling like she couldn't breath; numbness in her hands; pain in feet; headaches; severe body aches; arm pain; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats) and CHEST DISCOMFORT (pressure on his chest and back) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-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 BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet), HEADACHE (headaches), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee). At the time of the report, BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee) outcome was unknown and HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet) and HEADACHE (headaches) had not resolved.            Concomitant medications were not provided.  Treatment information was not reported.  The patient reported that her HCP (Healthcare Provider) thought she had symptoms of COVID-19, but her tests came back negative with no reported date. The patient's bloodwork was normal as well.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Myalgia, Pain in extremity
Clinical narrative: back pain; a bad thing; not being able to work; cold sweats; pressure on his chest and back; feeling like she couldn't breath; numbness in her hands; pain in feet; headaches; severe body aches; arm pain; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats) and CHEST DISCOMFORT (pressure on his chest and back) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-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 BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet), HEADACHE (headaches), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee). At the time of the report, BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee) outcome was unknown and HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet) and HEADACHE (headaches) had not resolved.            Concomitant medications were not provided.  Treatment information was not reported.  The patient reported that her HCP (Healthcare Provider) thought she had symptoms of COVID-19, but her tests came back negative with no reported date. The patient's bloodwork was normal as well.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: back pain; a bad thing; not being able to work; cold sweats; pressure on his chest and back; feeling like she couldn't breath; numbness in her hands; pain in feet; headaches; severe body aches; arm pain; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats) and CHEST DISCOMFORT (pressure on his chest and back) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-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 BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet), HEADACHE (headaches), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee). At the time of the report, BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee) outcome was unknown and HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet) and HEADACHE (headaches) had not resolved.            Concomitant medications were not provided.  Treatment information was not reported.  The patient reported that her HCP (Healthcare Provider) thought she had symptoms of COVID-19, but her tests came back negative with no reported date. The patient's bloodwork was normal as well.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Muscle disorder, Myalgia, Rash
Clinical narrative: Ever since have the shot I'm feeling worse/Each day seems to be getting worse; Burning feeling on the bottom of the right foot/ and burning in my muscle; Something is happening to the muscle that never happened before; Muscle pain/Aching in my muscle; Shooting pain into my brain; Rash on my bottom; Burning feeling on the bottom of the right foot/ and burning in my muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle) and HEADACHE (Shooting pain into my brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine.    On 30-Jul-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 COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle). At the time of the report, VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatment information was provided.  The patient stated that she is scare to death and high risk patient.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Ever since have the shot I'm feeling worse/Each day seems to be getting worse; Burning feeling on the bottom of the right foot/ and burning in my muscle; Something is happening to the muscle that never happened before; Muscle pain/Aching in my muscle; Shooting pain into my brain; Rash on my bottom; Burning feeling on the bottom of the right foot/ and burning in my muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle) and HEADACHE (Shooting pain into my brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine.    On 30-Jul-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 COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle). At the time of the report, VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatment information was provided.  The patient stated that she is scare to death and high risk patient.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Pain in extremity
Clinical narrative: Sore arm; Faster heart rate that came and went periodically; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The medical history information was not provided by the reporter.  Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Heart rate: irregular (abnormal) Faster heart rate that came and went periodically.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Patient reported experiencing the symptoms beginning a day and a half ago after the first dose.  Patient did not take any medication for symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received on 27-Aug-2021, Updated patient's date of birth, age, vaccine start date and vaccine facility information.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect after he got the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect after he got the dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect after he got the dose). At the time of the report, VACCINATION COMPLICATION (Side effect after he got the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) 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 August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Contracted COVID). At the time of the report, COVID-19 (Contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Temperature 101 degrees Farenheight/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature) 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, the patient experienced BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature). At the time of the report, BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (abnormal) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Chronic fatigue). At the time of the report, FATIGUE (Chronic fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided by the reporter.  Treatment medication include muscle relaxant prescribed by a HCP.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: coughing; congestion; , sneezing; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HEADACHE (headache) and COUGH (coughing). 18-Aug-2021, the patient experienced NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever). On 26-Aug-2021, HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test positive: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.     This case was linked to MOD-2021-296717 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: coughing; congestion; , sneezing; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HEADACHE (headache) and COUGH (coughing). 18-Aug-2021, the patient experienced NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever). On 26-Aug-2021, HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test positive: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.     This case was linked to MOD-2021-296717 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Decreased appetite, Movement disorder, Vomiting
Clinical narrative: brain bleeds; did not each much because did not feel hungry; She couldn't move; was throwing up all bile; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain bleeds), DECREASED APPETITE (did not each much because did not feel hungry), MOVEMENT DISORDER (She couldn't move) and VOMITING (was throwing up all bile) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain bleeds) (seriousness criteria hospitalization, disability, medically significant and life threatening), DECREASED APPETITE (did not each much because did not feel hungry) (seriousness criteria hospitalization, disability and life threatening), MOVEMENT DISORDER (She couldn't move) (seriousness criteria hospitalization, disability and life threatening) and VOMITING (was throwing up all bile) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, CEREBRAL HAEMORRHAGE (brain bleeds), DECREASED APPETITE (did not each much because did not feel hungry), MOVEMENT DISORDER (She couldn't move) and VOMITING (was throwing up all bile) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: myalgia; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (myalgia) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and GABAPENTIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NAUSEA (nausea). On 09-Feb-2021, the patient experienced MYALGIA (myalgia). On 09-Jan-2021, NAUSEA (nausea) outcome was unknown. On 10-Feb-2021, MYALGIA (myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment was not specified.   This case was linked to MOD-2021-297337 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Pyrexia, Sleep paralysis
Clinical narrative: Sleep Paralysis with Lucid dreaming; when he sleeps he has difficulty breathing; fatigue; mild fever; Horrible but bearable sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Sleep paralysis.    On 28-Jul-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 SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm). At the time of the report, SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient says he has similar symptoms when he had Covid, its like he is having Covid again. Concomitant medication were not provided Treatment information was not provided   This case was linked to MOD-2021-297642 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness
Clinical narrative: got sick after both shots; explosive diarrhea after the first shot for about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after both shots) and DIARRHOEA (explosive diarrhea after the first shot for about 5 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick after both shots) and DIARRHOEA (explosive diarrhea after the first shot for about 5 days). At the time of the report, ILLNESS (got sick after both shots) outcome was unknown and DIARRHOEA (explosive diarrhea after the first shot for about 5 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported. The treatment medication was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Pain in extremity, Palpitations
Clinical narrative: Heart flutters; Heart palpitations; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart flutters) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced CARDIAC FLUTTER (Heart flutters) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations). At the time of the report, CARDIAC FLUTTER (Heart flutters), PAIN IN EXTREMITY (Sore arm) and PALPITATIONS (Heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Patient was asking if she should  get her 2nd shot on Aug 31st.  Patient has an appointment with a new primary care physician on 4Sep2021 and wants to know if she can extend the shot after that. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Extra dose administered; given an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired dose) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A, 010M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired dose). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (given an expired dose) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported by reporter Treatment information was not provided by reporter
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site). At the time of the report, VACCINATION SITE PRURITUS (first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided. No Treatment medication was reported.   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; A bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Digestion impaired, Depression, Irritable, Hair loss and Memory loss. Concurrent medical conditions included Oil allergy and Reaction to sulfites (Allergic to sulfite or histamine allergy.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication was not reported.  It was reported that patient is taking allergic injections.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: Was not a booster, but it was 3rd shot; Second dose on 17-FEB-2021 and third dose on 23-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Was not a booster, but it was 3rd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0PF2D21A, 023M20A and 032L2(Z)1A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer (It became aggressive this last fall (2020) before receiving the Moderna vaccine.) since 2017.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, 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 experienced OFF LABEL USE (Was not a booster, but it was 3rd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021). At the time of the report, OFF LABEL USE (Was not a booster, but it was 3rd shot) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that he recently had a hormone shot to keep the cancer from growing.  Treatment information was not provided.