chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Night sweats, Pyrexia, Vaccination complication
Clinical narrative: After receiving 2nd dose, he had night sweats.; strong reaction to both doses; chills (lasted a couple of days); fever (lasted a couple of days); 1st dose on 28Jan2021 and 2nd dose on 05Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (After receiving 2nd dose, he had night sweats.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021), VACCINATION COMPLICATION (strong reaction to both doses), CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021). 05-Mar-2021, the patient experienced CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)). On an unknown date, the patient experienced NIGHT SWEATS (After receiving 2nd dose, he had night sweats.) and VACCINATION COMPLICATION (strong reaction to both doses). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)) had resolved. At the time of the report, NIGHT SWEATS (After receiving 2nd dose, he had night sweats.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021) had resolved and VACCINATION COMPLICATION (strong reaction to both doses) outcome was unknown.      Concomitant medications included BP medicine. Treatment medications included Anti-histamines along with above mentioned medications.  The caller reported he had a strong reaction to both Moderna COVID-19 injections. The caller stated the first Moderna COVID-19 dose (28Jan2021) "knocked me out" and "bothered me".   This case was linked to MOD-2021-324078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Significant follow up due to event has been updated
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysuria, Hyperhidrosis, Myalgia
Clinical narrative: Testicular pain; Pain with urination; sweating; Hives; Macular rash on his back; Dizziness; vomiting; chills; muscle aches/sores on his arms; fever; severe pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives) and RASH MACULAR (Macular rash on his back) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 059721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-324016 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Testicular pain, Urticaria, Vaccination site pain
Clinical narrative: Testicular pain; Pain with urination; sweating; Hives; Macular rash on his back; Dizziness; vomiting; chills; muscle aches/sores on his arms; fever; severe pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives) and RASH MACULAR (Macular rash on his back) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 059721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-324016 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Testicular pain; Pain with urination; sweating; Hives; Macular rash on his back; Dizziness; vomiting; chills; muscle aches/sores on his arms; fever; severe pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives) and RASH MACULAR (Macular rash on his back) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 059721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-324016 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus (both ears)/buzzing sound/hazy/constant (both ears); This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (on left arm requiring physical therapy) in January 2021. Concurrent medical conditions included Hypothyroidism, Arthritis, Drug allergy (Becomes nauseated if she takes Codeine and Erythromycin) and Allergy to antibiotic. Concomitant products included LEVOTHYROXINE, CELECOXIB (CELEBREX) and RALOXIFENE for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)). At the time of the report, TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Approximately one month after the second dose, the patient noticed tinnitus in both ears. The patient described the tinnitus as a buzzing sound, and was hazy, and tinnitus was constant in both ears. No treatment medications were reported.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna Covid-19 vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided.,.     On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up document contains updated reporter contact details
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his right arm was sore a little; This case was received via FDA VAERS on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his right arm was sore a little) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (his right arm was sore a little). At the time of the report, PAIN IN EXTREMITY (his right arm was sore a little) 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   This case was linked to MOD-2021-324345 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Agitation, Asthenia, Chest pain, Headache, Inflammation
Clinical narrative: Vaccination adverse reaction; Weakness; chest pain; chest inflammation; agitation; legs pain; sometimes weak; Muscle aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation) and AGITATION (agitation) in a  patient of an unknown age and gender 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 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 VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination complication
Clinical narrative: Vaccination adverse reaction; Weakness; chest pain; chest inflammation; agitation; legs pain; sometimes weak; Muscle aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation) and AGITATION (agitation) in a  patient of an unknown age and gender 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 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 VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: most people are getting side effects after getting the vaccine; 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 VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine) 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 VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided. No concomitant medication was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash, Rash pruritic
Clinical narrative: Chills; Rash itches; Rash all over her body including her face that itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itches), RASH (Rash all over her body including her face that itches) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced RASH PRURITIC (Rash itches) and RASH (Rash all over her body including her face that itches). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, RASH PRURITIC (Rash itches), RASH (Rash all over her body including her face that itches) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided. Treatment medications were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Incorrect route of product administration
Clinical narrative: Was worried that she will not develop antibodies; Vaccinator gave it to her under the skin and not in her muscle; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Was worried that she will not develop antibodies) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intradermal) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle). On an unknown date, the patient experienced ANXIETY (Was worried that she will not develop antibodies). On 16-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle) had resolved. At the time of the report, ANXIETY (Was worried that she will not develop antibodies) outcome was unknown.            No Concomitant medication were reported. No Treatment medications were reported.  The patient got second dose on 16-Sep-2021, however, the patient did not felt any injection at all. The patient had no soreness in arm, not even a tiny bit, not even anything that looks like a needle had been there, no bruising. The patient was positive the vaccinator gave it under the skin and not in muscle. The patient was worried that antibodies would not be developed.  The patient states that her HCP is new, and had an appointment coming up on 28-Sep-2021.   This case was linked to MOD-2021-322930 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Oral pain, Pain, Swelling, Underdose
Clinical narrative: pain; swelling; tummy aches; sore mouth; redness at the injection site; low dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a patient of an unknown age and gender 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 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 PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth), VACCINATION SITE ERYTHEMA (redness at the injection site) and UNDERDOSE (low dose of Moderna vaccine). At the time of the report, PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown and UNDERDOSE (low dose of Moderna vaccine) 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.   No concomitant medication were reported No treatment medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: pain; swelling; tummy aches; sore mouth; redness at the injection site; low dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a patient of an unknown age and gender 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 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 PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth), VACCINATION SITE ERYTHEMA (redness at the injection site) and UNDERDOSE (low dose of Moderna vaccine). At the time of the report, PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown and UNDERDOSE (low dose of Moderna vaccine) 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.   No concomitant medication were reported No treatment medication were reported
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: having a problem breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having a problem breathing) 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 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having a problem breathing). At the time of the report, DYSPNOEA (having a problem breathing) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of urticaria (systemic hives and welts) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced urticaria (systemic hives and welts). At the time of the report, urticaria (systemic hives and welts) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-325440 (patient link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: son who is 16 received the first shot of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna) in a 16-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 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 (son who is 16 received the first shot of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna) had resolved.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; 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 TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 product was provided by the reporter. No treatment medication was provided. She stated that when they received the vaccine, she looked at them and they looked frozen so she placed them in the freezer.  HCP stated that it was brought to her attention that the data logger was not set properly and thus it was not alarming when the temp got below -15C.  The data logger was set to alarm if it went above 7C, it was set for refrigerator.  HCP stated that looking back at the temp data logger, the highest temperature the freezer reached is -11C for a period of approximately 3 hours. The vials remain in the freezer quarantined. 4 doses were administered since receipt of vaccine, two on 16Sep2021 and two on 09Sep2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Gait disturbance, Gingivitis
Clinical narrative: dizzy; gum infection; vertigo; was not able to walk for about four hours after the shot; feeling so weak; body ache all over; swollen lymph nodes on the right side by the upper neck under her chin; Second dose 19 days after the first; high temperature for 2 days/light temperature for 3 to 4 days at least; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot) and ASTHENIA (feeling so weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 19 days after the first). On an unknown date, the patient experienced DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot), ASTHENIA (feeling so weak), PAIN (body ache all over), LYMPHADENOPATHY (swollen lymph nodes on the right side by the upper neck under her chin) and PYREXIA (high temperature for 2 days/light temperature for 3 to 4 days at least). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) for Gum infection, at a dose of 500 mg. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 19 days after the first) had resolved. At the time of the report, DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot), ASTHENIA (feeling so weak), PAIN (body ache all over) and LYMPHADENOPATHY (swollen lymph nodes on the right side by the upper neck under her chin) outcome was unknown and PYREXIA (high temperature for 2 days/light temperature for 3 to 4 days at least) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High body temperature for 2 days.         This case was linked to MOD-2021-325583 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Pain, Pyrexia, Vertigo
Clinical narrative: dizzy; gum infection; vertigo; was not able to walk for about four hours after the shot; feeling so weak; body ache all over; swollen lymph nodes on the right side by the upper neck under her chin; Second dose 19 days after the first; high temperature for 2 days/light temperature for 3 to 4 days at least; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot) and ASTHENIA (feeling so weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 19 days after the first). On an unknown date, the patient experienced DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot), ASTHENIA (feeling so weak), PAIN (body ache all over), LYMPHADENOPATHY (swollen lymph nodes on the right side by the upper neck under her chin) and PYREXIA (high temperature for 2 days/light temperature for 3 to 4 days at least). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) for Gum infection, at a dose of 500 mg. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 19 days after the first) had resolved. At the time of the report, DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot), ASTHENIA (feeling so weak), PAIN (body ache all over) and LYMPHADENOPATHY (swollen lymph nodes on the right side by the upper neck under her chin) outcome was unknown and PYREXIA (high temperature for 2 days/light temperature for 3 to 4 days at least) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High body temperature for 2 days.         This case was linked to MOD-2021-325583 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Influenza like illness, Vaccination site erythema
Clinical narrative: Felt real bad; Where I got the shot is all red; (Where I got the shot) is hot now; like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu). At the time of the report, FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu) outcome was unknown.      No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered to patients after the 30 days use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.  Nurse stated that patient received the 1st dose of the Moderna COVID 19 vaccine on 20SEPT2021 between 8:10-9:10am. The dose was administered to patients after the 30 days use by date.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Additional information received and Anatomical location was added
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: had temperature; chills for 2 days; pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PYREXIA (had temperature) and CHILLS (chills for 2 days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm). On 11-Aug-2021, the patient experienced PYREXIA (had temperature) and CHILLS (chills for 2 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Aug-2021, PYREXIA (had temperature) and CHILLS (chills for 2 days) had resolved. On 14-Aug-2021, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.  10-15 min after she started feeling pain in the arm, the next day she had temperature and chills for 2 days and pain in the arm until the forth day; took 2 tylenols at the time.   This case was linked to MOD-2021-315286 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: still in a fog; right arm pit the glands feel full of liquid, glands are still swollen under my arm.; arm hurts at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089A21A, 31A21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Nov-2020.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache). At the time of the report, FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No relevant treatment medication were provided.  Patient was home quarantined. Patient got better. Her taste and smell returned about 3 weeks later. Patient was reported to massage her right arm pit very gently once a day in the warm shower which she said helped her.  Patient reported that the she had swollen glands under the arm after the booster dose which was not there after the first two vaccinations.   This case was linked to MOD-2021-281964, MOD-2021-282508 (Patient Link).; Sender's Comments: This report concerns a 67 year old female patient with past medical history of COVID-19 who experienced non-serious unexpected events of abnormal feeling (reported as still in a fog), lymphadenopathy and non-serious expected events of headache, vaccination site pain. The events occurred after an unknown duration following vaccination with the third dose of mRNA-1273. The patient reports having received all the 3 doses of mRNA-1273, but had not experienced similar adverse effects with the previous 2 doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Entire week of not being able to work for being sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Entire week of not being able to work for being sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ILLNESS (Entire week of not being able to work for being sick). At the time of the report, ILLNESS (Entire week of not being able to work for being sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  The patient got the first round of the Moderna COVID vaccine a week ago.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A - 025B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-326632.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A - 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Reporter did not allow further contact