chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: neck pain that is shooting down the arm; muscle ache, muscle pain; Headache; fatigue; weakness; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NECK PAIN (neck pain that is shooting down the arm), PAIN IN EXTREMITY (Arm Pain), MYALGIA (muscle ache, muscle pain) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARBAMAZEPINE, GABAPENTIN, LAMOTRIGINE, METOPROLOL, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 03-Mar-2021, the patient experienced ASTHENIA (weakness), HEADACHE (Headache) and FATIGUE (fatigue). On an unknown date, the patient experienced NECK PAIN (neck pain that is shooting down the arm) and MYALGIA (muscle ache, muscle pain). On 05-Feb-2021, PAIN IN EXTREMITY (Arm Pain) had resolved. On 04-Mar-2021, ASTHENIA (weakness) and HEADACHE (Headache) had resolved. At the time of the report, NECK PAIN (neck pain that is shooting down the arm), MYALGIA (muscle ache, muscle pain) and FATIGUE (fatigue) had resolved.            Treatment information was also not reported. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Not applicable) was Not applicable.   This case was linked to MOD-2021-272911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: significant FU- AE outcome updated to resolved.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Dose 1 on 12/29/2021; dose 2 on 1/24/2022 and dose 3 on 2/12/2022. Patient should not have received a third dose. Questionable if patient actually received dose on 1/24/2022.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Headache, Pain, Pain in extremity
Clinical narrative: Headache, vomiting, diarrhea, low-grade fever, chills, body ache,  arm pain and itching.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: Headache, vomiting, diarrhea, low-grade fever, chills, body ache,  arm pain and itching.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Barium swallow, Computerised tomogram, Dyspnoea, Laboratory test
Clinical narrative: Positional Dyspnea
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb mass, SARS-CoV-2 antibody test
Clinical narrative: Knots within the palms of our left hands; joint pain in all my fingers; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Knots within the palms of our left hands) and ARTHRALGIA (joint pain in all my fingers) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-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 LIMB MASS (Knots within the palms of our left hands) and ARTHRALGIA (joint pain in all my fingers). At the time of the report, LIMB MASS (Knots within the palms of our left hands) and ARTHRALGIA (joint pain in all my fingers) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medication reported. No treatment information was provided.  Within a week, there were knots within the palms of left hands. The patient states that they are going up his fingers. The patient reports that he has joint pain in all his fingers but he doesn't have arthritis. He states it was weird that they were both positive for COVID when they received their first vaccination. They tested positive on 29Dec2020.   This case was linked to MOD-2021-272986 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Lip disorder, Lip swelling
Clinical narrative: Approximately one month after receiving the Pfizer booster, I developed an allergic reaction to tomato-based foods and any spicy foods. My lips swelled and the corners of my mouth reddened.  The inside of my lips felt raw. This allergic reaction continues. I must now be careful of the type of food I eat. I made one visit to my doctor in January.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Peripheral swelling, Pneumonia, Swelling
Clinical narrative: Pneumonia after first shot. Second shot caused unexplained swelling in various parts of body to include neck, hands and feet.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Pneumonia after first shot. Second shot caused unexplained swelling in various parts of body to include neck, hands and feet.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after Janssen vaccine; breakthrough case admission
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after Janssen vaccine; breakthrough case admission
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after Janssen vaccine; breakthrough case admission
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Simple cold; Lost sense of taste; Lost sense of smell; Had mild COVID case after vaccination for five days/ got Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Simple cold), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and COVID-19 (Had mild COVID case after vaccination for five days/ got Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced COVID-19 (Had mild COVID case after vaccination for five days/ got Covid-19). On an unknown date, the patient experienced NASOPHARYNGITIS (Simple cold), AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell). At the time of the report, NASOPHARYNGITIS (Simple cold), AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell) outcome was unknown and COVID-19 (Had mild COVID case after vaccination for five days/ got Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arm where the vaccine was given.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Insomnia, Pain in extremity, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: Painful & sore arm, Tinnitus, Ear ringing, Clogged ears, Vertigo, Hives, Insomnia.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vertigo
Clinical narrative: Painful & sore arm, Tinnitus, Ear ringing, Clogged ears, Vertigo, Hives, Insomnia.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Syncope
Clinical narrative: Post injection patient experienced cold sweats and fainted. EMS contacted and physicians came to give medical attention. Patient transported to the emergency department.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after Janssen vaccine; breakthrough case admission
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Fibrin D dimer normal, Heavy menstrual bleeding, Muscle spasms, Stress
Clinical narrative: On the following Saturday 4-5 days after my shot, I started spotting which is not normal for me. I was feeling crampy the 10th and 11th. Then the following week, I was feeling really crampy, I started my period. I was bleeding heavy, it felt like when your water breaks. I thought I was having a miscarriage, I thought maybe my husband vasectomy did not take. I was sitting on the toilet bleeding profusely. I called my doctor, I was scared because I have never bled like this my entire life. My doctor monitored me. I was passing blood clots, never got bigger than a quarter. That type of bleeding continued for 3 days. My stress was through the roof. The burden of COVID landed on women. I had to wear adult diapers at night because of non-stop bleeding. My suggested taking iron and kept monitoring. My period did eventually die down. My cramping was more intense after the shot as well. I do not know if my period was scheduled and or knocked me into my period.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vaginal haemorrhage
Clinical narrative: On the following Saturday 4-5 days after my shot, I started spotting which is not normal for me. I was feeling crampy the 10th and 11th. Then the following week, I was feeling really crampy, I started my period. I was bleeding heavy, it felt like when your water breaks. I thought I was having a miscarriage, I thought maybe my husband vasectomy did not take. I was sitting on the toilet bleeding profusely. I called my doctor, I was scared because I have never bled like this my entire life. My doctor monitored me. I was passing blood clots, never got bigger than a quarter. That type of bleeding continued for 3 days. My stress was through the roof. The burden of COVID landed on women. I had to wear adult diapers at night because of non-stop bleeding. My suggested taking iron and kept monitoring. My period did eventually die down. My cramping was more intense after the shot as well. I do not know if my period was scheduled and or knocked me into my period.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Erythema, Pruritus, Rash
Clinical narrative: Chronic spontaneous Urticaria- itching began within 24 hours, resulting in 3 large patches and several smaller patches on my right breast, right arm, and neck/chest.  I have taken Benadryl and avoided inflammatory foods and beverages, symptoms are improved but return if I stop taking Benadryl and avoiding food and drink that did not cause any issues for me prior to this booster dose.  I have not sought medical care, as others who experienced this same condition recommended topical cream and Benadryl, and this improved symptoms significantly, but it seems temporarily, as I have now experienced a return of red itchy skin  on my face and neck twice when I have tried to stop taking Benadryl.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm very sore after Covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm very sore after Covid vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm very sore after Covid vaccine). At the time of the report, PAIN IN EXTREMITY (arm very sore after Covid vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown.       NO Concomitant and treatment drugs were given by reporter.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal
Clinical narrative: Unable to maintain control of blood sugars since vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness over the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness over the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness over the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received contains no new information.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medication was reported no concomitant drugs are reported   This case was linked to MOD-2021-272958 (Patient Link).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was not provided.  No Treatment information was provided.   This case was linked to MOD-2021-272806, MOD-2021-272957.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received and contains no significant information.Reporter's Contact details were updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: her right arm started hurting; can't move her arm and Cant raise her arm higher than her elbow height; gradual but it has gotten worse over the last week; her arm is so sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her right arm started hurting), MOBILITY DECREASED (can't move her arm and Cant raise her arm higher than her elbow height), CONDITION AGGRAVATED (gradual but it has gotten worse over the last week) and MYALGIA (her arm is so sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (her right arm started hurting), MOBILITY DECREASED (can't move her arm and Cant raise her arm higher than her elbow height), CONDITION AGGRAVATED (gradual but it has gotten worse over the last week) and MYALGIA (her arm is so sore). The patient was treated with LIDOCAINE for Adverse event, at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her right arm started hurting), MOBILITY DECREASED (can't move her arm and Cant raise her arm higher than her elbow height), CONDITION AGGRAVATED (gradual but it has gotten worse over the last week) and MYALGIA (her arm is so sore) had not resolved.            Concomitant Medications were not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This spontaneous case was reported by an other health care professional and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B218) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) 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.   Concomitant medications were not reported.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-272959 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Therapeutic response unexpected, Vaccination site swelling
Clinical narrative: Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.; lightheaded; big knot on arm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.), DIZZINESS (lightheaded) and VACCINATION SITE SWELLING (big knot on arm near the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.), DIZZINESS (lightheaded) and VACCINATION SITE SWELLING (big knot on arm near the injection site). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Opened up her sinuses where she could smell better/rash flare up to a medication which stopped after the vaccine.) outcome was unknown and DIZZINESS (lightheaded) and VACCINATION SITE SWELLING (big knot on arm near the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-272991 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received contains Non-significant information. HCP contact details updated
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pain in the arm; redness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (redness in the arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 091D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (redness in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (redness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment medications were provided.   This case was linked to MOD-2021-272996 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Consumer received the first dose "2-3 months ago" has not received 2nd dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer received the first dose "2-3 months ago" has not received 2nd dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer received the first dose "2-3 months ago" has not received 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer received the first dose "2-3 months ago" has not received 2nd dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, SARS-CoV-2 test
Clinical narrative: Knots within the palms of their left hands; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Knots within the palms of their left hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-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 LIMB MASS (Knots within the palms of their left hands). At the time of the report, LIMB MASS (Knots within the palms of their left hands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-272927 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Diarrhea; Headache; Vomiting; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Reporter's contact information, Patient gender and age,Vaccine start date, events start date and new event added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Headache; Vomiting; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Reporter's contact information, Patient gender and age,Vaccine start date, events start date and new event added.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depression, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: more than 36 days after the first dose without receiving the second dose; temporary depression; (rash) itches; bad rash all over my body/ rash look like welts; Fever; Body aches; Chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose), DEPRESSION (temporary depression), RASH PRURITIC ((rash) itches), RASH (bad rash all over my body/ rash look like welts) and PYREXIA (Fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 033C21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced RASH (bad rash all over my body/ rash look like welts), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose), DEPRESSION (temporary depression) and RASH PRURITIC ((rash) itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 01-Aug-2021, PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose) had resolved, DEPRESSION (temporary depression) outcome was unknown and RASH PRURITIC ((rash) itches) and RASH (bad rash all over my body/ rash look like welts) had not resolved.            This case was linked to MOD-2021-272984 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: more than 36 days after the first dose without receiving the second dose; temporary depression; (rash) itches; bad rash all over my body/ rash look like welts; Fever; Body aches; Chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose), DEPRESSION (temporary depression), RASH PRURITIC ((rash) itches), RASH (bad rash all over my body/ rash look like welts) and PYREXIA (Fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 033C21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced RASH (bad rash all over my body/ rash look like welts), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose), DEPRESSION (temporary depression) and RASH PRURITIC ((rash) itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 01-Aug-2021, PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose) had resolved, DEPRESSION (temporary depression) outcome was unknown and RASH PRURITIC ((rash) itches) and RASH (bad rash all over my body/ rash look like welts) had not resolved.            This case was linked to MOD-2021-272984 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under 18 years of age; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received their first shot of the Moderna Vaccine but never received their second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot) had 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.   concomitants medication information was not provided.  Treatment information was not given.   This case was linked to MOD-2021-274272 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest crushing
Clinical narrative: heart hurts; chest feels bruised; This spontaneous case was reported by a consumer and describes the occurrence of CHEST CRUSHING (chest feels bruised) and CARDIAC DISCOMFORT (heart hurts) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced CHEST CRUSHING (chest feels bruised). On an unknown date, the patient experienced CARDIAC DISCOMFORT (heart hurts). At the time of the report, CHEST CRUSHING (chest feels bruised) and CARDIAC DISCOMFORT (heart hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter. No treatment details were provided by reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red spit below injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red spit below injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red spit below injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red spit below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Stuffy nose; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose) and OROPHARYNGEAL PAIN (Sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, NASAL CONGESTION (Stuffy nose) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were reported.  Treatment medications were reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very fatigued. not acting like himself; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very fatigued. not acting like himself) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very fatigued. not acting like himself). At the time of the report, FATIGUE (Very fatigued. not acting like himself) outcome was unknown.            No concomitant medication listed.   No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: sharp stabbing pain on the left side of my chest with deep breaths; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (sharp stabbing pain on the left side of my chest with deep breaths) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAINFUL RESPIRATION (sharp stabbing pain on the left side of my chest with deep breaths). At the time of the report, PAINFUL RESPIRATION (sharp stabbing pain on the left side of my chest with deep breaths) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not reported. No lab data has been provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Dysstasia, Eye pain, Eye swelling
Clinical narrative: she had to slide her feet; my head pounded; I've been getting tired more easily; such pain behind my eyes/when I blinked, they hurt terribly; my eyes felt swollen; there was pressure/ felt pressure in my brain; I could hardly eat; I couldn't stand up; I was incontinent; left side of the chest hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (such pain behind my eyes/when I blinked, they hurt terribly), EYE SWELLING (my eyes felt swollen), HEAD DISCOMFORT (there was pressure/ felt pressure in my brain), DECREASED APPETITE (I could hardly eat) and DYSSTASIA (I couldn't stand up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 LEVOTHYROXINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EYE PAIN (such pain behind my eyes/when I blinked, they hurt terribly), EYE SWELLING (my eyes felt swollen), HEAD DISCOMFORT (there was pressure/ felt pressure in my brain), DECREASED APPETITE (I could hardly eat), DYSSTASIA (I couldn't stand up), INCONTINENCE (I was incontinent), CHEST PAIN (left side of the chest hurt really bad), HEADACHE (my head pounded) and FATIGUE (I've been getting tired more easily). On an unknown date, the patient experienced GAIT DISTURBANCE (she had to slide her feet). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pain, at a dose of 1 dosage form. At the time of the report, EYE PAIN (such pain behind my eyes/when I blinked, they hurt terribly), EYE SWELLING (my eyes felt swollen), HEAD DISCOMFORT (there was pressure/ felt pressure in my brain), DECREASED APPETITE (I could hardly eat), DYSSTASIA (I couldn't stand up), INCONTINENCE (I was incontinent), CHEST PAIN (left side of the chest hurt really bad), GAIT DISTURBANCE (she had to slide her feet), HEADACHE (my head pounded) and FATIGUE (I've been getting tired more easily) outcome was unknown.