chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Low grade fever; Left arm is swollen/Puffy arm; Soreness in arm; Headache; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Low grade fever), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Left arm is swollen/Puffy arm) 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 medical history reported.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Soreness in arm). On 07-Jan-2021, the patient experienced PYREXIA (Low grade fever) and PERIPHERAL SWELLING (Left arm is swollen/Puffy arm). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Low grade fever), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Left arm is swollen/Puffy arm) 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 relevant concomitant medications were reported.  Treatment for the events was ibuprofen.  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: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nausea, fatigue (fatigue/tiredness) and pyrexia (low-grade fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No reported medical history. On Jan 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 3, 2021, patient experienced nausea and fatigue (fatigue/tiredness). On Jan 7, 2021, patient experienced pyrexia (low-grade fever). At the time of the report, nausea, fatigue (fatigue/tiredness) and pyrexia (low-grade fever): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The concomitant medications reported included blood thinner and other unspecified medications. The treatment information not provided. Reporter's comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gingival blister
Clinical narrative: blisters on side of fingers and palm; blisters inside my lips; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters on side of fingers and palm) and GINGIVAL BLISTER (blisters inside my lips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced BLISTER (blisters on side of fingers and palm) and GINGIVAL BLISTER (blisters inside my lips). At the time of the report, BLISTER (blisters on side of fingers and palm) and GINGIVAL BLISTER (blisters inside my lips) 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.   Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: splitting headache all day; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (splitting headache all day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (splitting headache all day). On 09-Jan-2021, HEADACHE (splitting headache all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Further information has been requested; 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. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) 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 Nasal congestion.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 10-Jan-2021, NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: High blood sugar that went from 120 to 160; This spontaneous case was reported by a consumer and describes the occurrence of   in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025002X) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood glucose increased: 120-160 (High) Blood sugar that went from 120 to 160.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The event was consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.; Reporter's Comments: The event was consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: it was itchy; it had a lump; arm soreness; it was red; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE MASS (it had a lump) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Previously administered products included for Tooth ache: Tylenol since an unknown date. Concomitant products included SIMVASTATIN, CARVEDILOL, AMLODIPINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (it was red). On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (it was itchy) and VACCINATION SITE MASS (it had a lump). On 17-Jan-2021, VACCINATION SITE MASS (it had a lump) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness) had resolved and VACCINATION SITE PRURITUS (it was itchy) and VACCINATION SITE ERYTHEMA (it was red) 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.   Treatment for the event included ice for 20 minutes.  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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.; 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: Pain in extremity
Clinical narrative: My arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm sore) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm sore). At the time of the report, PAIN IN EXTREMITY (My arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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'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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: red area around the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (red area around the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red area around the injection site). At the time of the report, INJECTION SITE ERYTHEMA (red area around the injection site) 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.   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.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching on back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PRURITUS (Itching on back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of UNK dosage form. At the time of the report, PRURITUS (Itching on back) 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 medication was not 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Taste disorder
Clinical narrative: taste abnormality; soar throat; numb throat; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (taste abnormality), OROPHARYNGEAL PAIN (soar throat) and OROPHARYNGEAL DISCOMFORT (numb throat) 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 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 TASTE DISORDER (taste abnormality), OROPHARYNGEAL PAIN (soar throat) and OROPHARYNGEAL DISCOMFORT (numb throat). At the time of the report, TASTE DISORDER (taste abnormality), OROPHARYNGEAL PAIN (soar throat) and OROPHARYNGEAL DISCOMFORT (numb throat) 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.   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.; 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 on 29-Dec-2020.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced COVID-19 (Diagnosed with Covid). At the time of the report, COVID-19 (Diagnosed with Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Company Comment: 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'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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body ache; Fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EL1283) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Jan-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021 at 11:00 PM, the patient experienced PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.; 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Heart rate
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 5) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included EKG (Have to get EKG done every 4 weeks) since an unknown date. Concurrent medical conditions included Sulfonamide allergy, Diabetes and High risk pregnancy. Concomitant products included INSULIN for Diabetes.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Jun-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 15-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Heart rate: increased (High) Accelerated heart rate, 99 resting and above 150beats per min.     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 medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with the event of Increased Heart Rate. 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.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Headache, Herpes zoster, Pain in extremity
Clinical narrative: Scalp burning; suspected shingles in my scalp; redness in one area on the left side; Slight headache; Minor arm pain; Shooting pain in the left ear; This spontaneous case was reported by a nurse and describes the occurrence of EAR PAIN (Shooting pain in the left ear), PAIN IN EXTREMITY (Minor arm pain), SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp) and ERYTHEMA (redness in one area on the left side) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2020, the patient experienced EAR PAIN (Shooting pain in the left ear). On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Minor arm pain) and HEADACHE (Slight headache). On 06-Jan-2021, the patient experienced SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp) and ERYTHEMA (redness in one area on the left side). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 gram three times a day. At the time of the report, EAR PAIN (Shooting pain in the left ear), PAIN IN EXTREMITY (Minor arm pain), SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp), ERYTHEMA (redness in one area on the left side) and HEADACHE (Slight headache) outcome was unknown.        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.   no concomitant medication provided   Reporter did not allow further contact; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Scalp burning; suspected shingles in my scalp; redness in one area on the left side; Slight headache; Minor arm pain; Shooting pain in the left ear; This spontaneous case was reported by a nurse and describes the occurrence of EAR PAIN (Shooting pain in the left ear), PAIN IN EXTREMITY (Minor arm pain), SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp) and ERYTHEMA (redness in one area on the left side) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2020, the patient experienced EAR PAIN (Shooting pain in the left ear). On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Minor arm pain) and HEADACHE (Slight headache). On 06-Jan-2021, the patient experienced SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp) and ERYTHEMA (redness in one area on the left side). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 gram three times a day. At the time of the report, EAR PAIN (Shooting pain in the left ear), PAIN IN EXTREMITY (Minor arm pain), SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp), ERYTHEMA (redness in one area on the left side) and HEADACHE (Slight headache) outcome was unknown.        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.   no concomitant medication provided   Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: Rash on her chest; Mild headache; A spontaneous report was received from a consumer concerning a female patient of unknown age who experienced a headache and rash on chest/rash.    The patient's medical history included viral infections and allergic reaction to flu vaccine. Concomitant product use was not provided by the reporter.   On 08JAN2021, prior to the onset of the symptoms, the patient received their unspecified dose of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Beginning on 09JAN2021, the patient experienced a headache.  On 10JAN2021 the patient developed a rash on her chest.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, headache and rash on chest were unknown.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis; A spontaneous report was received from a physician, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 Vaccine and developed arthritis.  The patient's medical history included history of being Covid positive. Concomitant product use was not provided by the reporter.   On an unspecified date, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscular for COVID-19 infection prophylaxis.  On an unreported date, that physician stated that his colleague (infectious disease doctor) reported him about a patient, who received vaccine and developed arthritis after the shot. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, arthritis was considered to be unknown.; Reporter's Comments: This case concerns a patient, who experienced event of arthritis. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Vaccination site erythema, Vaccination site induration, Vaccination site rash
Clinical narrative: Hardness under the skin has started to move towards the inside of her arm; Swollen hard lump under the skin the size of her palm; Spots of redness.; Rash on top of the hardness; Little lightheadedness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Little lightheadedness), CONDITION AGGRAVATED (Hardness under the skin has started to move towards the inside of her arm), VACCINATION SITE INDURATION (Swollen hard lump under the skin the size of her palm), VACCINATION SITE ERYTHEMA (Spots of redness.) and VACCINATION SITE RASH (Rash on top of the hardness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure. Concomitant products included RIVAROXABAN (XARELTO) and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIZZINESS (Little lightheadedness). On 13-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Swollen hard lump under the skin the size of her palm), VACCINATION SITE ERYTHEMA (Spots of redness.) and VACCINATION SITE RASH (Rash on top of the hardness). On 15-Jan-2021, the patient experienced CONDITION AGGRAVATED (Hardness under the skin has started to move towards the inside of her arm). The patient was treated with CEPHALEXIN [CEFALEXIN] for Vaccination site induration, at a dose of 500 mg. At the time of the report, DIZZINESS (Little lightheadedness), CONDITION AGGRAVATED (Hardness under the skin has started to move towards the inside of her arm), VACCINATION SITE ERYTHEMA (Spots of redness.) and VACCINATION SITE RASH (Rash on top of the hardness) outcome was unknown and VACCINATION SITE INDURATION (Swollen hard lump under the skin the size of her palm) had not 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.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Urticaria
Clinical narrative: Could not sleep; Hives which became progressive; Arms and leg itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives which became progressive), PRURITUS (Arms and leg itching) and INSOMNIA (Could not sleep) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE from 08-Jan-2017 to an unknown date and LISINOPRIL from 08-Jan-2017 to an unknown date for Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced URTICARIA (Hives which became progressive). 06-Jan-2021, the patient experienced PRURITUS (Arms and leg itching). On 08-Jan-2021, the patient experienced INSOMNIA (Could not sleep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 14-Jan-2021, URTICARIA (Hives which became progressive) was resolving. At the time of the report, PRURITUS (Arms and leg itching) and INSOMNIA (Could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient woke up around 4 am with arms and legs itching and noticed hives. These hives gradually became worse over the next 48 hours despite taking oral diphenhydramine for every 4 hours. These hives also began spreading to stomach, face, and ears. 48 hours later could not sleep and called a doctor and asked whether he would prescribed a solumedrol dose pack because she would otherwise end up in the Emergency room (ER). Doctor then collaborated with an ER physician who prescribed oral prednisone. 30mg the first day, 25mg the 2nd day, 20mg the 3rd day, 15mg the 4th day, 10mg the 3rd day, 5mg the 6th day. Around day 3 of taking these steroids hives became much better.  Company Comment - 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.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07-Apr-2021 included therapy start date , anatomical location, concomitant medication, onset date for event, additional events (Arms and leg itching and could not sleep) and outcome of the event was updated.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site pruritus
Clinical narrative: the skin of the arm is red; itchiness at the site injection; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (the skin of the arm is red) and VACCINATION SITE PRURITUS (itchiness at the site injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the site injection). On 08-Jan-2021, the patient experienced ERYTHEMA (the skin of the arm is red). On 31-Dec-2020, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ERYTHEMA (the skin of the arm is red) and VACCINATION SITE PRURITUS (itchiness at the site injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported included Medication for thyroids, Medication for Cholesterol. Treatment for the events included Cortisol cream (started on 07-JAN-2021). Symptoms ongoing but skin is less red  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19vaccine) for COVID-19 immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On Jan 14, 2021, patient experienced maternal exposure during pregnancy. On Jan 14, 2021, maternal exposure during pregnancy resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided. Sender's comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy spells; A spontaneous report was received from a patient of unknown age and gender (Health care professional) concerning patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and dizzy spells/dizziness.  The patient's medical history was unknown. No concomitant medications was reported.    On an unknown date (Monday), the patient received their first of two planned doses of mRNA-1273 via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On an unknown date, after receiving the first dose of vaccine, the patient experienced dizzy spells.  Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event dizziness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Muscular weakness
Clinical narrative: spasms and weakness in the upper arm; weakness in the upper arm; A spontaneous report was received from a consumer (United States) who was a patient who received Moderna's COVID-19 Vaccine, and who experienced spasms (muscle spasms) and weakness in the upper arm (muscular weakness).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received their Moderna vaccine on an undisclosed date.  They reported having a reaction and stated that they were having spasms and weakness in the upper arm and wished to know if that was normal.  No additional information was provided.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, spasms and weakness in the upper arm, was not provided.   The outcome of the events, spasms and weakness in the upper arm, was not reported.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red and hot to touch; red and hot to touch; pretty large swelling on arm, 9x9 cm; COVID-19; really bad itching on injection site; headache; A spontaneous report was received from a healthcare facility staff member who was a 32-year-old, female patient who received Moderna's COVID-19 Vaccine, and  who experienced a pretty large swelling on arm 9x9 cm (vaccination site swelling), headache, really bad itching on injection site (vaccination site pruritus), redness started to grow and red and hot to the touch (vaccination site warmth and vaccination site erythema).  The patient's medical history included a positive COVID-19 diagnosis on 10-Jan-2021. Concomitant product use was not provided by the reporter.    On 29-Dec-2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 29-Dec-2020. She reported that approximately 30 minutes after receiving the vaccination, she had a headache that lasted the rest of that day and into the next. The following Wednesday, 06-Jan-2021, she developed itching on the injection site and a few days later, on an undisclosed date, the redness started to grow. She stated that the site was red, hot to the touch and swollen.  The next morning, 07-Jan-2021, she reported that although the site was not as red, it was still swollen 9x9 cm.    Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events, a pretty large swelling on arm 9x9 cm, headache, really bad itching on injection site, redness started to grow and red and hot to the touch, was not provided.   The event, headache, was considered recovered/resolved.  The outcome of the events, a pretty large swelling on arm 9x9 cm, really bad itching on injection site, redness started to grow and red and hot to the touch, was not reported.; 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. However , the mRNA-1273 does not contain a virus capable of causing infection and the occurrence of Covid-19 positive test after vaccination is unlikely related to mRNA-1273.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: red and hot to touch; red and hot to touch; pretty large swelling on arm, 9x9 cm; COVID-19; really bad itching on injection site; headache; A spontaneous report was received from a healthcare facility staff member who was a 32-year-old, female patient who received Moderna's COVID-19 Vaccine, and  who experienced a pretty large swelling on arm 9x9 cm (vaccination site swelling), headache, really bad itching on injection site (vaccination site pruritus), redness started to grow and red and hot to the touch (vaccination site warmth and vaccination site erythema).  The patient's medical history included a positive COVID-19 diagnosis on 10-Jan-2021. Concomitant product use was not provided by the reporter.    On 29-Dec-2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 29-Dec-2020. She reported that approximately 30 minutes after receiving the vaccination, she had a headache that lasted the rest of that day and into the next. The following Wednesday, 06-Jan-2021, she developed itching on the injection site and a few days later, on an undisclosed date, the redness started to grow. She stated that the site was red, hot to the touch and swollen.  The next morning, 07-Jan-2021, she reported that although the site was not as red, it was still swollen 9x9 cm.    Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events, a pretty large swelling on arm 9x9 cm, headache, really bad itching on injection site, redness started to grow and red and hot to the touch, was not provided.   The event, headache, was considered recovered/resolved.  The outcome of the events, a pretty large swelling on arm 9x9 cm, really bad itching on injection site, redness started to grow and red and hot to the touch, was not reported.; 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. However , the mRNA-1273 does not contain a virus capable of causing infection and the occurrence of Covid-19 positive test after vaccination is unlikely related to mRNA-1273.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Redness is spreading down her arm and up across her back/At her injection site was a 3 inch raised red circle; Hive type stuff across her back; Arm  became swollen; Arm  became hot to the touch; Right arm was also itchy/Itchiness is spreading down her arm and up across her back; Arm soreness in the vaccination arm; A spontaneous report was received from a boyfriend concerning a 27-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness in the vaccination arm/ Pain in extremity, at her injection site was a 3 inch raised red circle/ redness spreading down her arm and up across her back/ Injection site erythema, arm became swollen/ Peripheral swelling, arm became hot to the touch, right arm was also itchy, itchiness spreading down her arm/ Pruritus and hives type stuff across her back/ Urticaria.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving her vaccination, the patient experienced one day of arm soreness in the vaccination arm, which resolved after one day.  On 09 Jan 2021, the patient noticed a 3 inch raised red circle at her injection site. Her became swollen, hot to the touch and was also itchy.  On 10 Jan 2021, the redness and itchiness spread down her arm and up across her back. There also appeared to be hive type stuff across her back. The patient called her HCP who recommended taking 25-50 mg of diphenhydramine every 6 hours, which the patient had been doing.   Action taken with mRNA-1273 in response to the events was not reported.   The event, arm soreness in the vaccination arm, was resolved on 01 Jan 2021. The events, at her injection site was a 3 inch raised red circle, arm became swollen, arm became hot to the touch, right arm was also itchy, redness spreading down her arm and up across her back, itchiness spreading down her arm and up across her back, and hive type stuff across her back was unknown at the time of this report.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Redness is spreading down her arm and up across her back/At her injection site was a 3 inch raised red circle; Hive type stuff across her back; Arm  became swollen; Arm  became hot to the touch; Right arm was also itchy/Itchiness is spreading down her arm and up across her back; Arm soreness in the vaccination arm; A spontaneous report was received from a boyfriend concerning a 27-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness in the vaccination arm/ Pain in extremity, at her injection site was a 3 inch raised red circle/ redness spreading down her arm and up across her back/ Injection site erythema, arm became swollen/ Peripheral swelling, arm became hot to the touch, right arm was also itchy, itchiness spreading down her arm/ Pruritus and hives type stuff across her back/ Urticaria.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving her vaccination, the patient experienced one day of arm soreness in the vaccination arm, which resolved after one day.  On 09 Jan 2021, the patient noticed a 3 inch raised red circle at her injection site. Her became swollen, hot to the touch and was also itchy.  On 10 Jan 2021, the redness and itchiness spread down her arm and up across her back. There also appeared to be hive type stuff across her back. The patient called her HCP who recommended taking 25-50 mg of diphenhydramine every 6 hours, which the patient had been doing.   Action taken with mRNA-1273 in response to the events was not reported.   The event, arm soreness in the vaccination arm, was resolved on 01 Jan 2021. The events, at her injection site was a 3 inch raised red circle, arm became swollen, arm became hot to the touch, right arm was also itchy, redness spreading down her arm and up across her back, itchiness spreading down her arm and up across her back, and hive type stuff across her back was unknown at the time of this report.; 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.