chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the left arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028821A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in the left arm). At the time of the report, MYALGIA (pain in the left arm) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-110046 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Moderna COVID-19 Vaccine second dose, more than 42 days have passed since first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 PRODUCT DOSE OMISSION ISSUE (Missed Moderna COVID-19 Vaccine second dose, more than 42 days have passed since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Moderna COVID-19 Vaccine second dose, more than 42 days have passed since first dose) 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 products were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Pregnant patient received the second vaccine dose; Chills; achy; headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the second vaccine dose), CHILLS (Chills), MYALGIA (achy) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (in Jan 2020 ) in January 2020, Celiac disease, Depression and ADD. Concurrent medical conditions included Allergy to antibiotic (allergy to clindamycin), Gluten sensitive enteropathy (celiac), Grass allergy and Anxiety. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 10-Jan-2020 to an unknown date for ADD, BUPROPION from 04-Jan-2020 to an unknown date for Depression and Anxiety, VITAMIN A NOS, PYRIDOXINE HYDROCHLORIDE (B6), CYANOCOBALAMIN (B12-VITAMIIN), VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], VITAMIN E NOS, FOLIC ACID (FOLATE), MAGNESIUM, NIACIN, FISH OIL (OMEGA 3 [FISH OIL]) and CALCIUM for an unknown indication, ZINC.   On 01-Apr-2021 at 9:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was in 2021 and the estimated date of delivery was 01-Nov-2021. On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the second vaccine dose), CHILLS (Chills), MYALGIA (achy) and HEADACHE (headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the second vaccine dose) had resolved. On 01-May-2021, CHILLS (Chills), MYALGIA (achy) and HEADACHE (headache) had resolved.            All chromosomal test was performed with no significant findings. No treatment drugs were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oxygen saturation decreased, Sneezing
Clinical narrative: low oxygen; cough; sneezing; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (low oxygen), COUGH (cough), SNEEZING (sneezing) and FATIGUE (fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (cough), SNEEZING (sneezing) and FATIGUE (fatigue). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (low oxygen). At the time of the report, OXYGEN SATURATION DECREASED (low oxygen), COUGH (cough), SNEEZING (sneezing) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-109930 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109930:husband
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: itching all stemming; weakness; dizziness; difficulty in breathing; sore throat; fast heartbeats at the night; headache; legs feel very heavy/feels like walking on something that is very heavy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DYSPNOEA (difficulty in breathing), OROPHARYNGEAL PAIN (sore throat), HEART RATE INCREASED (fast heartbeats at the night) and PRURITUS (itching all stemming) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROPINIROLE for Restless leg syndrome, QUETIAPINE FUMARATE (SEROQUEL), PRAZOSIN, CLONAZEPAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and VALACICLOVIR HYDROCHLORIDE (PRO-VALACYCLOVIR) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache), HEART RATE INCREASED (fast heartbeats at the night) and PERIPHERAL SWELLING (legs feel very heavy/feels like walking on something that is very heavy). On an unknown date, the patient experienced DYSPNOEA (difficulty in breathing), OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching all stemming), ASTHENIA (weakness) and DIZZINESS (dizziness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form and LAVENDER OIL for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache) and OROPHARYNGEAL PAIN (sore throat) had not resolved and DYSPNOEA (difficulty in breathing), HEART RATE INCREASED (fast heartbeats at the night), PRURITUS (itching all stemming), ASTHENIA (weakness), DIZZINESS (dizziness) and PERIPHERAL SWELLING (legs feel very heavy/feels like walking on something that is very heavy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-JUN-2021, no new information
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Pruritus
Clinical narrative: itching all stemming; weakness; dizziness; difficulty in breathing; sore throat; fast heartbeats at the night; headache; legs feel very heavy/feels like walking on something that is very heavy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DYSPNOEA (difficulty in breathing), OROPHARYNGEAL PAIN (sore throat), HEART RATE INCREASED (fast heartbeats at the night) and PRURITUS (itching all stemming) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROPINIROLE for Restless leg syndrome, QUETIAPINE FUMARATE (SEROQUEL), PRAZOSIN, CLONAZEPAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and VALACICLOVIR HYDROCHLORIDE (PRO-VALACYCLOVIR) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache), HEART RATE INCREASED (fast heartbeats at the night) and PERIPHERAL SWELLING (legs feel very heavy/feels like walking on something that is very heavy). On an unknown date, the patient experienced DYSPNOEA (difficulty in breathing), OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching all stemming), ASTHENIA (weakness) and DIZZINESS (dizziness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form and LAVENDER OIL for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache) and OROPHARYNGEAL PAIN (sore throat) had not resolved and DYSPNOEA (difficulty in breathing), HEART RATE INCREASED (fast heartbeats at the night), PRURITUS (itching all stemming), ASTHENIA (weakness), DIZZINESS (dizziness) and PERIPHERAL SWELLING (legs feel very heavy/feels like walking on something that is very heavy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-JUN-2021, no new information
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site erythema, Vaccination site induration, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: small ball at the injection site; ¨it is very itchy and I can't stand it ¨; Could not move it; It was painful; Received the 2nd dose on day number 44 after the 1st dose; Swollen arm ( left arm); painfull at injection site; was red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE PAIN (painfull at injection site), VACCINATION SITE ERYTHEMA (was red at injection site) and VACCINATION SITE INDURATION (small ball at the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE PAIN (painfull at injection site), VACCINATION SITE ERYTHEMA (was red at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move it) and VACCINATION SITE PAIN (It was painful). On 01-May-2021, the patient experienced VACCINATION SITE INDURATION (small ball at the injection site) and VACCINATION SITE PRURITUS (¨it is very itchy and I can't stand it ¨). On 02-May-2021, VACCINATION SITE PAIN (painfull at injection site) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE ERYTHEMA (was red at injection site), VACCINATION SITE INDURATION (small ball at the injection site), VACCINATION SITE PRURITUS (¨it is very itchy and I can't stand it ¨), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move it) and VACCINATION SITE PAIN (It was painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not provided. the Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: small ball at the injection site; ¨it is very itchy and I can't stand it ¨; Could not move it; It was painful; Received the 2nd dose on day number 44 after the 1st dose; Swollen arm ( left arm); painfull at injection site; was red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE PAIN (painfull at injection site), VACCINATION SITE ERYTHEMA (was red at injection site) and VACCINATION SITE INDURATION (small ball at the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE PAIN (painfull at injection site), VACCINATION SITE ERYTHEMA (was red at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move it) and VACCINATION SITE PAIN (It was painful). On 01-May-2021, the patient experienced VACCINATION SITE INDURATION (small ball at the injection site) and VACCINATION SITE PRURITUS (¨it is very itchy and I can't stand it ¨). On 02-May-2021, VACCINATION SITE PAIN (painfull at injection site) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE ERYTHEMA (was red at injection site), VACCINATION SITE INDURATION (small ball at the injection site), VACCINATION SITE PRURITUS (¨it is very itchy and I can't stand it ¨), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move it) and VACCINATION SITE PAIN (It was painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not provided. the Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: feeling short of breath; Mild dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (feeling short of breath) and DIZZINESS (Mild dizziness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (feeling short of breath) and DIZZINESS (Mild dizziness). At the time of the report, DYSPNOEA (feeling short of breath) and DIZZINESS (Mild dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: rash on her arms shoulders, chest, and upper back; arm swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her arms shoulders, chest, and upper back) and VACCINATION SITE SWELLING (arm swelling at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm swelling at the injection site). On an unknown date, the patient experienced RASH (rash on her arms shoulders, chest, and upper back). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) for Rash, at an unspecified dose and frequency. On 18-Feb-2021, VACCINATION SITE SWELLING (arm swelling at the injection site) had resolved. At the time of the report, RASH (rash on her arms shoulders, chest, and upper back) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received contains no new information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Night sweats, Pyrexia
Clinical narrative: lethargy; night sweats; fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), NIGHT SWEATS (night sweats) and PYREXIA (fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced LETHARGY (lethargy), NIGHT SWEATS (night sweats) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 08-Apr-2021, LETHARGY (lethargy), NIGHT SWEATS (night sweats) and PYREXIA (fever) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.   This case was linked to MOD-2021-110063 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine like headache; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine like headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MIGRAINE (Migraine like headache). At the time of the report, MIGRAINE (Migraine like headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Feeling hot, Swelling, Urticaria
Clinical narrative: a bruise" next to her left elbow; reported "a bruise"next to her left elbow and she described that"looks like a blood clot"; left arm is hot; swelling between neck and shoulder (left side); "huge left arm"; pain between her neck and shoulder (left side); further down from the injection site "huge welt"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (left arm is hot), SWELLING (swelling between neck and shoulder (left side)), CONTUSION (a bruise" next to her left elbow), CONTUSION (reported "a bruise"next to her left elbow and she described that"looks like a blood clot") and URTICARIA (further down from the injection site "huge welt") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (further down from the injection site "huge welt"). On 05-May-2021, the patient experienced FEELING HOT (left arm is hot) and VACCINATION SITE SWELLING ("huge left arm"). 05-May-2021, the patient experienced SWELLING (swelling between neck and shoulder (left side)) and ARTHRALGIA (pain between her neck and shoulder (left side)). On 06-May-2021, the patient experienced CONTUSION (a bruise" next to her left elbow) and CONTUSION (reported "a bruise"next to her left elbow and she described that"looks like a blood clot"). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site swelling and Swelling, at a dose of 500 milligram. At the time of the report, FEELING HOT (left arm is hot), SWELLING (swelling between neck and shoulder (left side)), CONTUSION (a bruise" next to her left elbow), CONTUSION (reported "a bruise"next to her left elbow and she described that"looks like a blood clot"), URTICARIA (further down from the injection site "huge welt"), VACCINATION SITE SWELLING ("huge left arm") and ARTHRALGIA (pain between her neck and shoulder (left side)) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-110472 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110472:Case for daughter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: a bruise" next to her left elbow; reported "a bruise"next to her left elbow and she described that"looks like a blood clot"; left arm is hot; swelling between neck and shoulder (left side); "huge left arm"; pain between her neck and shoulder (left side); further down from the injection site "huge welt"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (left arm is hot), SWELLING (swelling between neck and shoulder (left side)), CONTUSION (a bruise" next to her left elbow), CONTUSION (reported "a bruise"next to her left elbow and she described that"looks like a blood clot") and URTICARIA (further down from the injection site "huge welt") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (further down from the injection site "huge welt"). On 05-May-2021, the patient experienced FEELING HOT (left arm is hot) and VACCINATION SITE SWELLING ("huge left arm"). 05-May-2021, the patient experienced SWELLING (swelling between neck and shoulder (left side)) and ARTHRALGIA (pain between her neck and shoulder (left side)). On 06-May-2021, the patient experienced CONTUSION (a bruise" next to her left elbow) and CONTUSION (reported "a bruise"next to her left elbow and she described that"looks like a blood clot"). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site swelling and Swelling, at a dose of 500 milligram. At the time of the report, FEELING HOT (left arm is hot), SWELLING (swelling between neck and shoulder (left side)), CONTUSION (a bruise" next to her left elbow), CONTUSION (reported "a bruise"next to her left elbow and she described that"looks like a blood clot"), URTICARIA (further down from the injection site "huge welt"), VACCINATION SITE SWELLING ("huge left arm") and ARTHRALGIA (pain between her neck and shoulder (left side)) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-110472 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110472:Case for daughter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Injection site was sore; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was sore) and FATIGUE (A little tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Gabapentin), Drug allergy (Phenergan), Depression, Anxiety and Pain.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection site was sore) and FATIGUE (A little tired). At the time of the report, VACCINATION SITE PAIN (Injection site was sore) and FATIGUE (A little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Anti-depressant medications, Anti-anxiety medications and  Pain medications. Treatment information was not provided.   This case was linked to MOD-2021-110073 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea, Fatigue, Headache
Clinical narrative: Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose; Trouble breathing; Headache; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose), DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B214 and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Adenocarcinoma (Right lung) since 28-Feb-2019, Drug allergy and Lung cancer (worsened) since 28-Feb-2019. Concomitant products included CALCIUM from 09-Jan-2018 to an unknown date for Bone density abnormal, ASPIRIN [ACETYLSALICYLIC ACID] from 07-Jan-2020 to an unknown date for Heart disease, unspecified, OSIMERTINIB MESILATE (TAGRISSO) from 06-Jan-2020 to an unknown date for Immunodeficiency secondary to oncology chemotherapy.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose), DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea). At the time of the report, TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose) had not resolved and DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Positron emission tomogram: extensive numerous pulmonary nodules (abnormal) Extensive numerous pulmonary nodules ranging in size from 6mm to 2.5cm with significant hypermetabolic activity and SUV of 8.2. On 26-Apr-2021, Blood test: 13.7 (abnormal) Cancer antigen at 13.7(double the previous number). On 28-Apr-2021, Chest X-ray: diffuse metastasis in both lungs (abnormal) Diffuse metastasis in both lungs.         Concomitant medication reported also included Poly-MVA indication of use cancer by oral route route of administration daily. It was reported that patient had to use inhaler daily about 30 days.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received included updated lab data details (PET scan shows more and larger nodules) and outcome of event tumour marker increased updated from unknown to not resolved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Positron emission tomogram, Tumour marker increased
Clinical narrative: Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose; Trouble breathing; Headache; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose), DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B214 and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Adenocarcinoma (Right lung) since 28-Feb-2019, Drug allergy and Lung cancer (worsened) since 28-Feb-2019. Concomitant products included CALCIUM from 09-Jan-2018 to an unknown date for Bone density abnormal, ASPIRIN [ACETYLSALICYLIC ACID] from 07-Jan-2020 to an unknown date for Heart disease, unspecified, OSIMERTINIB MESILATE (TAGRISSO) from 06-Jan-2020 to an unknown date for Immunodeficiency secondary to oncology chemotherapy.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose), DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea). At the time of the report, TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose) had not resolved and DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Positron emission tomogram: extensive numerous pulmonary nodules (abnormal) Extensive numerous pulmonary nodules ranging in size from 6mm to 2.5cm with significant hypermetabolic activity and SUV of 8.2. On 26-Apr-2021, Blood test: 13.7 (abnormal) Cancer antigen at 13.7(double the previous number). On 28-Apr-2021, Chest X-ray: diffuse metastasis in both lungs (abnormal) Diffuse metastasis in both lungs.         Concomitant medication reported also included Poly-MVA indication of use cancer by oral route route of administration daily. It was reported that patient had to use inhaler daily about 30 days.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received included updated lab data details (PET scan shows more and larger nodules) and outcome of event tumour marker increased updated from unknown to not resolved.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bedridden, Body temperature, Dizziness, Headache
Clinical narrative: Both hands were shaky, and still are; Have been in bed for a week almost; Feel like the equilibrium is off; Started getting really really sick; Felt dizzy and that kind of things; Skin felt like what they call shingles; The whole body was just sensitive; Fever of 104°F; Complete body aches; Head aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things) and TREMOR (Both hands were shaky, and still are) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), PYREXIA (Fever of 104°F), MYALGIA (Complete body aches) and HEADACHE (Head aches). On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things) and BALANCE DISORDER (Feel like the equilibrium is off). On an unknown date, the patient experienced TREMOR (Both hands were shaky, and still are) and BEDRIDDEN (Have been in bed for a week almost). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of 800 mg and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea and Flu like symptoms, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things), BEDRIDDEN (Have been in bed for a week almost), BALANCE DISORDER (Feel like the equilibrium is off), PYREXIA (Fever of 104°F), MYALGIA (Complete body aches) and HEADACHE (Head aches) outcome was unknown and TREMOR (Both hands were shaky, and still are) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 104 (High) Fever of 104 degree F..         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported.   This case was linked to MOD-2021-109985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant follow up received and mentions that patient does not have mail address.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Myalgia, Pyrexia, Sensitive skin
Clinical narrative: Both hands were shaky, and still are; Have been in bed for a week almost; Feel like the equilibrium is off; Started getting really really sick; Felt dizzy and that kind of things; Skin felt like what they call shingles; The whole body was just sensitive; Fever of 104°F; Complete body aches; Head aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things) and TREMOR (Both hands were shaky, and still are) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), PYREXIA (Fever of 104°F), MYALGIA (Complete body aches) and HEADACHE (Head aches). On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things) and BALANCE DISORDER (Feel like the equilibrium is off). On an unknown date, the patient experienced TREMOR (Both hands were shaky, and still are) and BEDRIDDEN (Have been in bed for a week almost). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of 800 mg and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea and Flu like symptoms, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things), BEDRIDDEN (Have been in bed for a week almost), BALANCE DISORDER (Feel like the equilibrium is off), PYREXIA (Fever of 104°F), MYALGIA (Complete body aches) and HEADACHE (Head aches) outcome was unknown and TREMOR (Both hands were shaky, and still are) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 104 (High) Fever of 104 degree F..         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported.   This case was linked to MOD-2021-109985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant follow up received and mentions that patient does not have mail address.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Both hands were shaky, and still are; Have been in bed for a week almost; Feel like the equilibrium is off; Started getting really really sick; Felt dizzy and that kind of things; Skin felt like what they call shingles; The whole body was just sensitive; Fever of 104°F; Complete body aches; Head aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things) and TREMOR (Both hands were shaky, and still are) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), PYREXIA (Fever of 104°F), MYALGIA (Complete body aches) and HEADACHE (Head aches). On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things) and BALANCE DISORDER (Feel like the equilibrium is off). On an unknown date, the patient experienced TREMOR (Both hands were shaky, and still are) and BEDRIDDEN (Have been in bed for a week almost). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of 800 mg and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea and Flu like symptoms, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Skin felt like what they call shingles), SENSITIVE SKIN (The whole body was just sensitive), ILLNESS (Started getting really really sick), DIZZINESS (Felt dizzy and that kind of things), BEDRIDDEN (Have been in bed for a week almost), BALANCE DISORDER (Feel like the equilibrium is off), PYREXIA (Fever of 104°F), MYALGIA (Complete body aches) and HEADACHE (Head aches) outcome was unknown and TREMOR (Both hands were shaky, and still are) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 104 (High) Fever of 104 degree F..         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported.   This case was linked to MOD-2021-109985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant follow up received and mentions that patient does not have mail address.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Confusional state, Headache, Myalgia
Clinical narrative: nausea; vomiting; body aches; stomach ache; weakness; confusion; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches), ABDOMINAL PAIN UPPER (stomach ache) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Headache). On 01-May-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (weakness), CONFUSIONAL STATE (confusion) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (weakness), CONFUSIONAL STATE (confusion), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details was Tylenol every 4-6 hours pertained to the events experienced.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; body aches; stomach ache; weakness; confusion; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches), ABDOMINAL PAIN UPPER (stomach ache) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Headache). On 01-May-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (weakness), CONFUSIONAL STATE (confusion) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (weakness), CONFUSIONAL STATE (confusion), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details was Tylenol every 4-6 hours pertained to the events experienced.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: started having menstrual cycle every 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (started having menstrual cycle every 2 weeks) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Feb-2021, the patient experienced POLYMENORRHOEA (started having menstrual cycle every 2 weeks). At the time of the report, POLYMENORRHOEA (started having menstrual cycle every 2 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was Advil