chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: terribly itching rash with large, red bumps after first dose; Patient he had a rash developed and after his second dose he also had the rash develop again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again) and VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose). At the time of the report, VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again) and VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dry mouth, Increased upper airway secretion, Pain in extremity, Paraesthesia oral
Clinical narrative: tremendous dryness in mouth; thickness in throat; arm hurting; tingling in lips; Frightened; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anxiety (frightened), dry mouth (tremendous dryness in mouth),  increased upper airway secretion (thickness in throat), pain in extremity (arm hurting) and paresthesia oral ( tingling in lips).  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced tingling in lips, thickness in throat and arm hurting that went away in about 45min to 1 hour. On an unknown date, the patient experienced the tremendous dryness in mouth and was frightened.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, tingling lips and thickness in the throat was resolved on 4 Mar 2021. The outcome of the other events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Arm started itching; it was really hard at injection site; it was really hot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm started itching), INJECTION SITE REACTION (it was really hard at injection site) and INJECTION SITE WARMTH (it was really hot at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient had breast cancer on left side and right side patient also has lymph node after surgery.) Concomitant products included EXEMESTANE for Breast cancer, ATORVASTATIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Mar-2021, the patient experienced PRURITUS (Arm started itching), INJECTION SITE REACTION (it was really hard at injection site) and INJECTION SITE WARMTH (it was really hot at injection site).    Treatment included Tylenol(Acetaminophen) was noted.  At the time of the report, PRURITUS (Arm started itching), INJECTION SITE REACTION (it was really hard at injection site) and INJECTION SITE WARMTH (it was really hot at injection site) outcome were unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Don't have much energy; Pain in the injection site; Muscle pains on their back; Muscle pains on their legs; Muscle pains on their arms; Headaches; They're tired; Have fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms) and HEADACHE (Headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy). At the time of the report, INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Don't have much energy; Pain in the injection site; Muscle pains on their back; Muscle pains on their legs; Muscle pains on their arms; Headaches; They're tired; Have fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms) and HEADACHE (Headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy). At the time of the report, INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Palpitations, Tooth extraction
Clinical narrative: Heart racing; tooth extraction; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia, Heart rate abnormal (reported on 06-Nov-2019 that heart rate was in the 40s on an unknown date), Dizziness (reported on 06-Nov-2019 that he was experiencing some dizziness on an unknown date), Heart rate increased (reported by the patient on 24-Jun-2020; again reported on 30-Jun-2020 that he had been having episodes of the fast heart rate around every 3-4 weeks where it gets up to around 128 to 135 and lasts for about 3-4 minutes; again reported periodic heart rate increased by patient on 14-Jan-2021), Fatigue (reported by the patient on 24-Jun-2020), White blood cell count decreased (reported by the patient on 24-Jun-2020), Glare (reported on 30-Jun-2020) and Difficulty focusing eyes (reported on 30-Jun-2020). Concomitant products included METOPROLOL SUCCINATE, LEVOTHYROXINE SODIUM and ATORVASTATIN CALCIUM for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient experienced PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date for Heart racing and Tooth extraction, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his heart rate was in the 130s and normally he runs in the 50-60s. He thought his heart racing was due to having large meals.   Reporter did not allow further contact
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Vision blurred, Visual impairment
Clinical narrative: Vision is blurring/Can't watch television; Can't read; Everything at distance is double vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 492021) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision). At the time of the report, VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision) outcome was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site mass, Injection site pain
Clinical narrative: Muscles twitching; arm felt like bowling ball where injection given; Muscles sore/body aches; Tender [where injection given]; Extremely tired; Severe chills; Shaking uncontrollably; Profuse sweating; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given) and CHILLS (Severe chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (ACE Inhibitors), Hypertension and Depression. Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE for an unknown indication.   On 29-Jan-2021 at 10:30 AM, 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) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 3:00 AM, the patient experienced TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating) and CHILLS (Severe chills). On 30-Jan-2021 at 7:00 AM, the patient experienced MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired). On 30-Jan-2021 at 7:00 AM, CHILLS (Severe chills) had resolved. At the time of the report, TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Tremor
Clinical narrative: Muscles twitching; arm felt like bowling ball where injection given; Muscles sore/body aches; Tender [where injection given]; Extremely tired; Severe chills; Shaking uncontrollably; Profuse sweating; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given) and CHILLS (Severe chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (ACE Inhibitors), Hypertension and Depression. Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE for an unknown indication.   On 29-Jan-2021 at 10:30 AM, 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) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 3:00 AM, the patient experienced TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating) and CHILLS (Severe chills). On 30-Jan-2021 at 7:00 AM, the patient experienced MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired). On 30-Jan-2021 at 7:00 AM, CHILLS (Severe chills) had resolved. At the time of the report, TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the second dose window; A spontaneous report was received from a female patient concerning herself who received Modern's COVID-19 vaccine (mRNA-1273) and missed the second dose window.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Jan 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and at an unknown anatomical location for prophylaxis of COVID-19 infection.   On an unknown date, the patient missed the second dose appointment and was again scheduled to get the second dose on 08 Mar 2021.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome and causality are not applicable.; Reporter's Comments: This report refers to a case of missed d second dose for mRNA-1273, with no associated AEs. Causality for this medication error is not applicable
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival disorder, Sensation of foreign body
Clinical narrative: Bumps; Lump; This spontaneous case was reported by a patient and describes the occurrence of GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LL20A) for an unknown indication.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump). At the time of the report, GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump) outcome was unknown.            Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: Waiting to receive second dose of the vaccine as partially vaccinated; A 17 year old received 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old received 1st dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (Waiting to receive second dose of the vaccine as partially vaccinated) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old received 1st dose of the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Waiting to receive second dose of the vaccine as partially vaccinated). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old received 1st dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (Waiting to receive second dose of the vaccine as partially vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported In the follow up it was reported that patient was partially vaccinated and not experienced any severe adverse reaction.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Partial vaccination event  reported; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 015M20A) with no associated AEs reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: entire left armpit and triceps are tender; swollen; not feeling too well; fatigued; fever of 100.5 degrees F; arm soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.5 degrees F), VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen) and FATIGUE (fatigued) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney cancer. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 100.5 degrees F) and VACCINATION SITE PAIN (arm soreness on the injection site). On 04-Mar-2021, the patient experienced TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well). On 04-Mar-2021, PYREXIA (fever of 100.5 degrees F) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: fever of 100.5 F.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: entire left armpit and triceps are tender; swollen; not feeling too well; fatigued; fever of 100.5 degrees F; arm soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.5 degrees F), VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen) and FATIGUE (fatigued) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney cancer. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 100.5 degrees F) and VACCINATION SITE PAIN (arm soreness on the injection site). On 04-Mar-2021, the patient experienced TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well). On 04-Mar-2021, PYREXIA (fever of 100.5 degrees F) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: fever of 100.5 F.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm; body ache; fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, body ache/myalgia, fever/pyrexia.  The patient's medical history was not provided. Concomitant medications reported were Tylenol for drug use for unknown indication.  On 7 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 7 Mar 2021, the patient experienced sore arm/pain in extremity, body ache/myalgia, fever/pyrexia.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  on an unknown date the outcome of sore arm/pain in extremity, body ache/myalgia, fever/pyrexia was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Parosmia, Rash
Clinical narrative: Non itchy rash; Weird rubber smell; Chills; Verysore arm; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness), RASH (Non itchy rash) and PAROSMIA (Weird rubber smell) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 03L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness) and PAROSMIA (Weird rubber smell). On 05-Mar-2021, the patient experienced RASH (Non itchy rash). On 03-Mar-2021, PAROSMIA (Weird rubber smell) had resolved. At the time of the report, PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness) and RASH (Non itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness
Clinical narrative: Light headedness; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Latex allergy (blisters , hives, loss of voice), Fragrance sensitivity (loss of voice , tingling tongue), Allergy to chemicals (loss of voice, heart rate increased, tingling tongue, pain in jaws) and Allergy to vaccine (pneumonia vaccine causes Fever of 103. Chills. Aching. Weakness. Swelling. Not able to get into any clothes. ) on 31-Oct-2018. Concomitant products included AMLODIPINE for Hypertension.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 02-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) HIGH.         This case was linked to MOD-2021-173466 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADEDD MEDICAL HISTORY AND SECOND DOSE INFORMATIONS
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site discolouration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Itchy; Hot to touch; Vaccination site discoloration; Rash; Hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.).    On 26-Feb-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 RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch). At the time of the report, RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, headache was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Injection site swelling, Injection site warmth
Clinical narrative: Not self; Warm to touch at the site of the injection; Mild swelling at the site of the injection; Fatigue; Tiredness; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self.  The patient's medical history was not provided. Concomitant medications reported were apixaban, metoprolol for drug use for unknown indication.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the events mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self.Consent granted for safety to follow up  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035984 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter did not remember reporting adverse event for her sister. States that she does not have time to discuss as she was at work at the time of the call. Declined to provide email address or complete ADR form but states "everyone's doing fine".; 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. US-MODERNATX, INC.-MOD-2021-035984:2nd dose case
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site haemorrhage
Clinical narrative: While getting second dose noticed that a blood stream was going down the arm; Not receiving the full dose; A spontaneous report was received from a consumer concerning a 79-years-old, male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood stream was going down patient's arm /vaccination site haemorrhage, not receiving the full dose/ accidental underdose.  The patient's medical history was not provided. Concomitant medications included were ezetimibe, simvastatin and metformin.  On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 030L20A) in the left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 026A10A) in the left arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, while getting the second dose the patient noticed that a blood stream was going down his arm and was worried that the blood was mixed with the vaccine and not receiving the full dose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of the events, blood stream was going down patient's arm and not receiving the full dose was resolved on 03 Mar 2021.; Reporter's Comments: This report refers to a case of vaccine underdose for mRNA-1273, lot# 026A10A  with associated AE of vaccination site bleeding. 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Hypertension, Tongue discomfort
Clinical narrative: Little short of breath; tongue burning "felt like bunch of hot peppers"; Face flushing; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers"), FLUSHING (Face flushing) and DYSPNOEA (Little short of breath) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy multiple, Asthma and Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), LANSOPRAZOLE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 ALKALOID), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers") and FLUSHING (Face flushing). On 03-Mar-2021, the patient experienced DYSPNOEA (Little short of breath). On 02-Mar-2021, TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers") and FLUSHING (Face flushing) was resolving. On 03-Mar-2021, DYSPNOEA (Little short of breath) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Hypertension (high-Unknown): (High) high blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient stated that she received her first dose of Moderna Covid-19 vaccine on 02March2021 on left arm. The patient notes that she has "a lot of allergies and I am also on medicine for a-fib". The patient states that she received her vaccine in her doctor's office where she started experiencing high blood pressure, tongue burning "felt like bunch of hot peppers" face flushing. The patient states that her symptoms are little bit ongoing. The patient also states that on 03March2021 she felt little short of breath and states that my asthma medicine did not help. The patients states that she end up staying at the doctor's office for an hour. The patient is asking if she should get second dose of vaccine. The patient agreed to follow up with safety. No treatment provided
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine vial which has black particles in it; A spontaneous report from a vaccine administrator/reporter/pharmacist concerning Moderna's COVID-19 vaccine (mRNA-1273) (lot# 036A21A) (PC number: 7154) vial that had black particles and administered 2 doses before noticing the change.  No details were provided about the patients.   No events were reported.  Action taken, outcome and causality are not applicable.; Reporter's Comments: This report refers to a case of poor quality product administered for mRNA-1273, lot # 036A21A with no associated AEs. Causality for this medication error is not applicable
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Speech disorder, Tremor
Clinical narrative: Shaking violently; Pain in legs; Effected speech; Feeling off; Extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech), MALAISE (Feeling off) and FATIGUE (Extremely fatigued) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL (ZYLOPRIM), RABEPRAZOLE, ROSUVASTATIN, APIXABAN (ELIQUIS), LISINOPRIL, METOPROLOL, METFORMIN, HYDROCHLOROTHIAZIDE, MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech), MALAISE (Feeling off) and FATIGUE (Extremely fatigued). On 03-Mar-2021, TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech) and MALAISE (Feeling off) had resolved. On 04-Mar-2021, FATIGUE (Extremely fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. The patient's symptoms lasted an hour and a half but the patient was extremely fatigued for rest of the day.   This case was linked to MOD21-046829 (E2B Linked Report).; Sender's Comments:  MOD21-046829:patient's wife case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test, Fatigue, Illness, Pyrexia
Clinical narrative: tested positive of COVID-19; very ill; tired; Fever; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive of COVID-19), RHINORRHOEA (Runny nose), ILLNESS (very ill), PYREXIA (Fever) and FATIGUE (tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Fever). On 16-Feb-2021, the patient experienced ILLNESS (very ill) and FATIGUE (tired). On 17-Feb-2021, the patient experienced COVID-19 (tested positive of COVID-19). At the time of the report, COVID-19 (tested positive of COVID-19), RHINORRHOEA (Runny nose), ILLNESS (very ill), PYREXIA (Fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Coronavirus test: (Positive) Tested COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medications was reported. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: tested positive of COVID-19; very ill; tired; Fever; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive of COVID-19), RHINORRHOEA (Runny nose), ILLNESS (very ill), PYREXIA (Fever) and FATIGUE (tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Fever). On 16-Feb-2021, the patient experienced ILLNESS (very ill) and FATIGUE (tired). On 17-Feb-2021, the patient experienced COVID-19 (tested positive of COVID-19). At the time of the report, COVID-19 (tested positive of COVID-19), RHINORRHOEA (Runny nose), ILLNESS (very ill), PYREXIA (Fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Coronavirus test: (Positive) Tested COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medications was reported. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: patient saw some vaccine drip on her arm, about the size of a quarter; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient saw some vaccine drip on her arm, about the size of a quarter) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (patient saw some vaccine drip on her arm, about the size of a quarter). On 02-Mar-2021, PRODUCT ADMINISTRATION ERROR (patient saw some vaccine drip on her arm, about the size of a quarter) 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.   concomitant medications are not provided. No treatment information was provided.; Sender's Comments: This report refers to a case of accidental underdose  and product administration error for mRNA-1273 (lot/batch: 027A21A) with no associated AEs reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Palpitations
Clinical narrative: heart was beating "real fast" could "feel it in her chest"; feeling lousy; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was beating "real fast" could "feel it in her chest") and FEELING ABNORMAL (feeling lousy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (She had received the flu vaccine in past years.). Concurrent medical conditions included Asthma and Hypertension.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced PALPITATIONS (heart was beating "real fast" could "feel it in her chest") and FEELING ABNORMAL (feeling lousy). At the time of the report, PALPITATIONS (heart was beating "real fast" could "feel it in her chest") was resolving and FEELING ABNORMAL (feeling lousy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 88-90 88-90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red patch below her deltoid; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red patch below her deltoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH MACULAR (red patch below her deltoid). At the time of the report, RASH MACULAR (red patch below her deltoid) outcome was unknown.            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.   Reporter did not allow further contact; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: "huge round circle" rash swollen and dense; arm sore; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (arm sore) and VACCINATION SITE RASH ("huge round circle" rash swollen and dense) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 20-Feb-2021, the patient experienced VACCINATION SITE RASH ("huge round circle" rash swollen and dense). At the time of the report, VACCINATION SITE PAIN (arm sore) and VACCINATION SITE RASH ("huge round circle" rash swollen and dense) 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 treatment information was provided.