chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations
Clinical narrative: arm soreness; pounding heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PALPITATIONS (pounding heart beat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (ALLERGIC TO TAMOXIFEN AND LIDOCAINE.). Concomitant products included ROSUVASTATIN for Cholesterol, ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and CALCIUM for Supplementation therapy.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and PALPITATIONS (pounding heart beat). At the time of the report, PAIN IN EXTREMITY (arm soreness) and PALPITATIONS (pounding heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) in a 31-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 042L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Jun-2020 and the estimated date of delivery was 29-Mar-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) had resolved.            Concomitant and treatment medications were not reported. Patient delivered 3 live, full-term birth babies. Lab data includes ultrasound 2020 normal, blood screen 2020 normal and glucose tolerance nove 2020 normal. 20 Jul 2020, the pregnancy test was positive.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site streaking
Clinical narrative: hurt a little bit; big red slash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (big red slash) and PAIN (hurt a little bit) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE STREAKING (big red slash). On an unknown date, the patient experienced PAIN (hurt a little bit). The patient was treated with CLINDAMYCIN at a dose of 150 milligram. At the time of the report, VACCINATION SITE STREAKING (big red slash) and PAIN (hurt a little bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included regular medications.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Illness, Insomnia, Pain in extremity
Clinical narrative: felt very tired; sick; could not sleep; Arm hurt; felt aweful; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt very tired), ILLNESS (sick), INSOMNIA (could not sleep), PAIN IN EXTREMITY (Arm hurt) and FEELING ABNORMAL (felt aweful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Previously administered products included for an unreported indication: DECADRON A.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (felt very tired), ILLNESS (sick), INSOMNIA (could not sleep), PAIN IN EXTREMITY (Arm hurt) and FEELING ABNORMAL (felt aweful). On 04-Feb-2021, FATIGUE (felt very tired), ILLNESS (sick), INSOMNIA (could not sleep), PAIN IN EXTREMITY (Arm hurt) and FEELING ABNORMAL (felt aweful) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Diarrhea; stomach cramps; low-grade fever; Headache; Felt minor aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), PYREXIA (low-grade fever), PAIN (Felt minor aches and pains) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), PYREXIA (low-grade fever) and PAIN (Felt minor aches and pains). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PYREXIA (low-grade fever) outcome was unknown and PAIN (Felt minor aches and pains) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Onychomadesis
Clinical narrative: experienced severe abdominal pain; severe back pain after receiving the Moderna COVID-19 vaccin; toenail fell off as well; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN (experienced severe abdominal pain), BACK PAIN (severe back pain after receiving the Moderna COVID-19 vaccin) and ONYCHOMADESIS (toenail fell off as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (experienced severe abdominal pain), BACK PAIN (severe back pain after receiving the Moderna COVID-19 vaccin) and ONYCHOMADESIS (toenail fell off as well). At the time of the report, ABDOMINAL PAIN (experienced severe abdominal pain), BACK PAIN (severe back pain after receiving the Moderna COVID-19 vaccin) and ONYCHOMADESIS (toenail fell off as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema
Clinical narrative: Erythema; Erythema around IS, that spread al the arm, until today; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Erythema) and INJECTION SITE ERYTHEMA (Erythema around IS, that spread al the arm, until today) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ERYTHEMA (Erythema) and INJECTION SITE ERYTHEMA (Erythema around IS, that spread al the arm, until today). At the time of the report, ERYTHEMA (Erythema) and INJECTION SITE ERYTHEMA (Erythema around IS, that spread al the arm, until today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Numbness of her foot fingers; Soreness of injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness of her foot fingers) and VACCINATION SITE PAIN (Soreness of injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, SIMVASTATIN and LORATADINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness of her foot fingers) and VACCINATION SITE PAIN (Soreness of injection site). At the time of the report, HYPOAESTHESIA (Numbness of her foot fingers) and VACCINATION SITE PAIN (Soreness of injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was provided as cold clean cloth for soreness in the injection site as advised by CDC.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Presyncope, Vaccination site pain
Clinical narrative: Felt like Fainting; Headache; Pain on the Injection Site; A spontaneous report was received from other health care professional concerning a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, pain on the injection site and felt like fainting.  The patient's medical history was not provided by the reporter. Concomitant medications not reported.  On 05-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On the same day, patient experienced events, headache, pain on the injection site and felt like fainting.   The treatment information was not reported.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, headache, pain on the injection site and felt like fainting were resolved on 06-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: spinning while lying on right side; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (spinning while lying on right side) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo (in her mid 20s which she takes medication for) and Dizziness.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VERTIGO (spinning while lying on right side). At the time of the report, VERTIGO (spinning while lying on right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on treatment for dizziness.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aching muscle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aching muscle) 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aching muscle). At the time of the report, MYALGIA (Aching muscle) outcome was unknown.            Concomitant product information was not reported. Treatment information was not reported. Patient wanted to know to take Acetaminophen, Ibuprofen or Naproxen for the aching pain.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05-MAY-2021 and it contains updated AE contact information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Little nausea; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) and NAUSEA (Little nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 03-Feb-2021, the patient experienced NAUSEA (Little nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore) and NAUSEA (Little nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: m arm at about 2-3 inches below the injection site is swelling; arm at about 2-3 inches below the injection site is warm to touch; arm at about 2-3 inches below the injection site is painful; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE SWELLING (m arm at about 2-3 inches below the injection site is swelling), INJECTION SITE WARMTH (arm at about 2-3 inches below the injection site is warm to touch) and INJECTION SITE PAIN (arm at about 2-3 inches below the injection site is painful) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE SWELLING (m arm at about 2-3 inches below the injection site is swelling), INJECTION SITE WARMTH (arm at about 2-3 inches below the injection site is warm to touch) and INJECTION SITE PAIN (arm at about 2-3 inches below the injection site is painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (m arm at about 2-3 inches below the injection site is swelling), INJECTION SITE WARMTH (arm at about 2-3 inches below the injection site is warm to touch) and INJECTION SITE PAIN (arm at about 2-3 inches below the injection site is painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: Pains in both  legs; Both legs are cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pains in both  legs) and PERIPHERAL COLDNESS (Both legs are cold) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L2DA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-Jan-2001, High cholesterol since 01-Jan-2009, Dry eyes since 01-Jan-2013 and Drug allergy (patient is allergic to codeine). Concomitant products included SIMVASTATIN from 01-Jan-2009 to an unknown date for Blood cholesterol, AMLODIPINE BESYLATE from 01-Jan-2001 to an unknown date, ATENOLOL from 01-Jan-2001 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Jan-2002 to an unknown date and LOSARTAN from 01-Jan-2002 to an unknown date for Blood pressure high, CICLOSPORIN (RESTASIS) for Dry eyes, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600+D3), VITAMIN D3 and CENTRUM SILVER +50 for an unknown indication.    On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (Pains in both  legs) and PERIPHERAL COLDNESS (Both legs are cold). The patient was treated with IBUPROFEN at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pains in both  legs) and PERIPHERAL COLDNESS (Both legs are cold) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-255678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: follow up received and it contains information about patient demographics, and allergies, medical history and dose 2 information added and concomitant and treatment mediations were updated and events outcome were added.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: she started feeling light headed aer a 1 h walk; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she started feeling light headed aer a 1 h walk) and FATIGUE (general fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (general fatigue). On 06-Feb-2021 at 12:50 PM, the patient experienced DIZZINESS (she started feeling light headed aer a 1 h walk). At the time of the report, DIZZINESS (she started feeling light headed aer a 1 h walk) and FATIGUE (general fatigue) outcome was unknown.            Concomitant medications were not provided. treatment medications was not reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Vaccination site induration, Vaccination site rash
Clinical narrative: Rash on left arm about the size of 3 x 5 at injection site; redness; Itchiness; soreness; feels warmer than other body areas; hardness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas) and VACCINATION SITE INDURATION (hardness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas) and VACCINATION SITE INDURATION (hardness). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on left arm about the size of 3 x 5 at injection site). The patient was treated with BENADRYL COMPLEX ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE RASH (Rash on left arm about the size of 3 x 5 at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included Benadryl triamcinolone cream topically.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Rash on left arm about the size of 3 x 5 at injection site; redness; Itchiness; soreness; feels warmer than other body areas; hardness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas) and VACCINATION SITE INDURATION (hardness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas) and VACCINATION SITE INDURATION (hardness). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on left arm about the size of 3 x 5 at injection site). The patient was treated with BENADRYL COMPLEX ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE RASH (Rash on left arm about the size of 3 x 5 at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included Benadryl triamcinolone cream topically.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Heart rate increased
Clinical narrative: rapid heart beat; shortness of breath; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat), DYSPNOEA (shortness of breath), CHILLS (chills) and HEADACHE (headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ENALAPRIL MALEATE (VASOPRIL [ENALAPRIL MALEATE]), AMLODIPINE BESILATE (NORVASC), ISOSORBIDE MONONITRATE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LEVOTHYROXINE and LORAZEPAM for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heart beat), DYSPNOEA (shortness of breath), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FOSINOPRIL SODIUM (VASOPRIL [FOSINOPRIL SODIUM]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat), DYSPNOEA (shortness of breath), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication reported was eye drops.  Company Comment: 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptom's; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom's) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom's). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom's) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm Pain - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown. Not Provided          Action taken with mRNA-1273 related to the event was not applicable. Concomitant medication details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Tachycardia
Clinical narrative: shortness of breath; little bit of fast heartbeat; feels strange, like feels warm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), TACHYCARDIA (little bit of fast heartbeat) and FEELING HOT (feels strange, like feels warm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney disorder since an unknown date and Heart disease, unspecified since an unknown date.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), TACHYCARDIA (little bit of fast heartbeat) and FEELING HOT (feels strange, like feels warm). At the time of the report, DYSPNOEA (shortness of breath), TACHYCARDIA (little bit of fast heartbeat) and FEELING HOT (feels strange, like feels warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information  was provided ,  no concomitant medication were reported.; 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: Vaccination complication
Clinical narrative: Patient expressed to MS a higher intensity of adverse events during her second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient expressed to MS a higher intensity of adverse events during her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient expressed to MS a higher intensity of adverse events during her second dose). At the time of the report, VACCINATION COMPLICATION (Patient expressed to MS a higher intensity of adverse events during her second dose) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2021: Followup received on 22-APR-2021 and contains NNI.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Presyncope, Taste disorder
Clinical narrative: felt like she was going to faint; Taste in the back of throat; eyes were so red; A spontaneous report was received from 69-year-old female patient who experienced events such as felt like she was going to faint'/ near syncope, taste in the back of throat/taste abnormality and eyes were so red/ ocular hyperaemia after receiving Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant product use was reported.  On 02 Feb 2021, the patient received first of the two planned dose of m-RNA-1273 (lot number: unknown) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection.  Five minutes following vaccination, she experienced a taste in the back of her throat, her eyes were so red, She also felt like she was going to faint. She felt like her throat was sticking to itself. She did not receive any treatment for the same.  Action taken with mRNA-1273 in the response to the events felt like she was going to faint', taste in the back of throat and eyes were so red was not known.  The outcome of the events felt like she was going to faint', taste in the back of throat and eyes were so red were considered as resolved in about 2 hours from the time it started.; Reporter'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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Malaise
Clinical narrative: sore arm; Quite  sick; dizzy/woozy but doesn't fall down; diarrhea; complaint of general weakness; nauseated; feeling tired the night of vaccination; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea) and ASTHENIA (complaint of general weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea), ASTHENIA (complaint of general weakness), NAUSEA (nauseated) and FATIGUE (feeling tired the night of vaccination). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea), ASTHENIA (complaint of general weakness), NAUSEA (nauseated) and FATIGUE (feeling tired the night of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-JUN-2021, added patient details.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: sore arm; Quite  sick; dizzy/woozy but doesn't fall down; diarrhea; complaint of general weakness; nauseated; feeling tired the night of vaccination; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea) and ASTHENIA (complaint of general weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea), ASTHENIA (complaint of general weakness), NAUSEA (nauseated) and FATIGUE (feeling tired the night of vaccination). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea), ASTHENIA (complaint of general weakness), NAUSEA (nauseated) and FATIGUE (feeling tired the night of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-JUN-2021, added patient details.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: her entire under arm is swollen; breast is swollen; swelling of lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her entire under arm is swollen), BREAST SWELLING (breast is swollen) and LYMPHADENOPATHY (swelling of lymph node) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (her entire under arm is swollen), BREAST SWELLING (breast is swollen) and LYMPHADENOPATHY (swelling of lymph node). At the time of the report, PERIPHERAL SWELLING (her entire under arm is swollen), BREAST SWELLING (breast is swollen) and LYMPHADENOPATHY (swelling of lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Arm soreness; vomiting; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in May 2020. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), Symbistatin and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine.   This case was linked to US-MODERNATX, INC.-MOD-2021-068391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068391:Patient's wife (First dose case)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Arm soreness; vomiting; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in May 2020. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), Symbistatin and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine.   This case was linked to US-MODERNATX, INC.-MOD-2021-068391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068391:Patient's wife (First dose case)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise, Rash erythematous, Rash macular, Rash pruritic, Vaccination site haemorrhage
Clinical narrative: bubbly rash; itchy rash; red rash; delayed large pink rash at injection site (COVID Arm); injection site bleeding; injection site bruise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (injection site bleeding), ADMINISTRATION SITE BRUISE (injection site bruise), RASH MACULAR (bubbly rash), RASH PRURITIC (itchy rash) and RASH ERYTHEMATOUS (red rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (injection site bleeding) and ADMINISTRATION SITE BRUISE (injection site bruise). On 20-Feb-2021, the patient experienced VACCINATION SITE RASH (delayed large pink rash at injection site (COVID Arm)). On an unknown date, the patient experienced RASH MACULAR (bubbly rash), RASH PRURITIC (itchy rash) and RASH ERYTHEMATOUS (red rash). At the time of the report, VACCINATION SITE HAEMORRHAGE (injection site bleeding), ADMINISTRATION SITE BRUISE (injection site bruise), RASH MACULAR (bubbly rash), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE RASH (delayed large pink rash at injection site (COVID Arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: bubbly rash; itchy rash; red rash; delayed large pink rash at injection site (COVID Arm); injection site bleeding; injection site bruise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (injection site bleeding), ADMINISTRATION SITE BRUISE (injection site bruise), RASH MACULAR (bubbly rash), RASH PRURITIC (itchy rash) and RASH ERYTHEMATOUS (red rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (injection site bleeding) and ADMINISTRATION SITE BRUISE (injection site bruise). On 20-Feb-2021, the patient experienced VACCINATION SITE RASH (delayed large pink rash at injection site (COVID Arm)). On an unknown date, the patient experienced RASH MACULAR (bubbly rash), RASH PRURITIC (itchy rash) and RASH ERYTHEMATOUS (red rash). At the time of the report, VACCINATION SITE HAEMORRHAGE (injection site bleeding), ADMINISTRATION SITE BRUISE (injection site bruise), RASH MACULAR (bubbly rash), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE RASH (delayed large pink rash at injection site (COVID Arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain, Pyrexia
Clinical narrative: redness in her arm that went down to her elbows and her arm felt "fevered."; fever, chills, and her arm was sore; fever, chills, and her arm was sore; fever, chills, and her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (fever, chills, and her arm was sore), ERYTHEMA (redness in her arm that went down to her elbows and her arm felt "fevered."), PYREXIA (fever, chills, and her arm was sore) and CHILLS (fever, chills, and her arm was sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 20-Feb-2021, the patient experienced PAIN (fever, chills, and her arm was sore), PYREXIA (fever, chills, and her arm was sore) and CHILLS (fever, chills, and her arm was sore). On 24-Feb-2021, the patient experienced ERYTHEMA (redness in her arm that went down to her elbows and her arm felt "fevered."). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (fever, chills, and her arm was sore), ERYTHEMA (redness in her arm that went down to her elbows and her arm felt "fevered."), PYREXIA (fever, chills, and her arm was sore) and CHILLS (fever, chills, and her arm was sore) outcome was unknown.            Action taken with mRNA-1273 was not applicable. Concomitant medication were not reported by the reported.