chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, UNK
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Lump on her arm that started right after her second dose of the vaccine; It is just a little red dot.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Lump on her arm that started right after her second dose of the vaccine) and VACCINATION SITE ERYTHEMA (It is just a little red dot.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), pfizer (Dose 3) and pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, pfizer and pfizer.   On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Lump on her arm that started right after her second dose of the vaccine) and VACCINATION SITE ERYTHEMA (It is just a little red dot.). At the time of the report, VACCINATION SITE MASS (Lump on her arm that started right after her second dose of the vaccine) had not resolved and VACCINATION SITE ERYTHEMA (It is just a little red dot.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Dose number 3 was Moderna which was taken on 16 Sep 2022 with lot number AS7145B. Bump was lower on her arm. It was not hard but squishy on her left arm. No treatment medication reported.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 27-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In July 2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient received Moderna vaccinations. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741650 (E2B Linked Report).   Reporter did not allow further contact.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741650:Husband case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Hot flush, Nervous system disorder, Pain, Vaccination site pain
Clinical narrative: Felt like all of my nerves were reacting when touched; Had shooting pain in injection arm, random pains throughout body; chills; hot flashes; Had shooting pain in injection arm/random pains throughout body; I have had cramping (not on period); This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes), PAIN (Had shooting pain in injection arm/random pains throughout body), ABDOMINAL PAIN (I have had cramping (not on period)), NERVOUS SYSTEM DISORDER (Felt like all of my nerves were reacting when touched) and VACCINATION SITE PAIN (Had shooting pain in injection arm, random pains throughout body) in a 37-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030371) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endometriosis.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 21-Sep-2023, the patient experienced HOT FLUSH (hot flashes), PAIN (Had shooting pain in injection arm/random pains throughout body), ABDOMINAL PAIN (I have had cramping (not on period)), VACCINATION SITE PAIN (Had shooting pain in injection arm, random pains throughout body) and CHILLS (chills). On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Felt like all of my nerves were reacting when touched). At the time of the report, HOT FLUSH (hot flashes) had not resolved, PAIN (Had shooting pain in injection arm/random pains throughout body), ABDOMINAL PAIN (I have had cramping (not on period)), VACCINATION SITE PAIN (Had shooting pain in injection arm, random pains throughout body) and CHILLS (chills) was resolving and NERVOUS SYSTEM DISORDER (Felt like all of my nerves were reacting when touched) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient  hot flashes continued 23-Sep-2023 It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Polyuria
Clinical narrative: extreme increases in urine/woke up to void 7 times/During the day had to void approximately each hour; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (extreme increases in urine/woke up to void 7 times/During the day had to void approximately each hour) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 203e23a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POLYURIA (extreme increases in urine/woke up to void 7 times/During the day had to void approximately each hour). At the time of the report, POLYURIA (extreme increases in urine/woke up to void 7 times/During the day had to void approximately each hour) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741814 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741814:Same reporter, same product, different patient (spouse)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Somnolence
Clinical narrative: sleep most of the day after vaccine and all night; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleep most of the day after vaccine and all night), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030371) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Sep-2023, the patient experienced SOMNOLENCE (sleep most of the day after vaccine and all night), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). On 22-Sep-2023, SOMNOLENCE (sleep most of the day after vaccine and all night), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. These adverse reactions have been same after each shot. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Nerve pain in legs. Terrible nerve pain in arm overall; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (Nerve pain in legs. Terrible nerve pain in arm overall) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced NEURALGIA (Nerve pain in legs. Terrible nerve pain in arm overall). At the time of the report, NEURALGIA (Nerve pain in legs. Terrible nerve pain in arm overall) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately; No adverse event; dose was administered after the excursion happened; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately), POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205F232A) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 22-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately), POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion during 8 hours approximately) and POOR QUALITY PRODUCT ADMINISTERED (dose was administered after the excursion happened).    Some refrigerated pre-filled syringes of Spikevax Vaccine experienced a temperature excursion for 8 hours approximately. Maximum temperature reached was 57°F. This was the first and only excursion. 1 dose was administered on 22 Sep 2023 after the excursion happened, but no adverse events were reported.  Treatment medication not reported.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Discomfort, Erythema, Fatigue, Incorrect dose administered
Clinical narrative: left arm was burning, it was red; discomfort; vaccine leaked; underdose; It did not go into the deltoid muscle. It was given much lower.; fatigue; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort), PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23F) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE ((dose 1) (Lot# 025L20A) first primary monovalent dose) on 28-Jan-2021, MODERNA COVID-19 VACCINE ((dose 2) (Lot# 011A21A) 2nd primary monovalent dose) on 25-Feb-2021, MODERNA COVID-19 VACCINE ((dose 3) (Lot# 035C21A) booster dose) on 02-Sep-2021, spikevax ((dose 4)  (Lot# 005M21A) booster dose) on 15-Apr-2022, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 ((dose 5) (Lot# 055B22B) bivalent booster) on 14-Oct-2022 and SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 ((dose 6) (Lot# AS7180B)  bivalent booster) on 15-May-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 and spikevax.    On 18-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Sep-2023, the patient experienced BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort), PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort) and FATIGUE (fatigue) had not resolved and PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. It was reported that the patient received the 7th dose in the wrong site. It did not go into the deltoid muscle. It was given much lower. Some went under the skin and some to surrounding tissue. The patient also felt that the skin at injection site left arm was burning, it was red. Also felt discomfort and the patient believes that the vaccine leaked. The patient was feeling fatigue.  No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Product administered at inappropriate site, Product leakage
Clinical narrative: left arm was burning, it was red; discomfort; vaccine leaked; underdose; It did not go into the deltoid muscle. It was given much lower.; fatigue; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort), PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23F) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE ((dose 1) (Lot# 025L20A) first primary monovalent dose) on 28-Jan-2021, MODERNA COVID-19 VACCINE ((dose 2) (Lot# 011A21A) 2nd primary monovalent dose) on 25-Feb-2021, MODERNA COVID-19 VACCINE ((dose 3) (Lot# 035C21A) booster dose) on 02-Sep-2021, spikevax ((dose 4)  (Lot# 005M21A) booster dose) on 15-Apr-2022, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 ((dose 5) (Lot# 055B22B) bivalent booster) on 14-Oct-2022 and SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 ((dose 6) (Lot# AS7180B)  bivalent booster) on 15-May-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 and spikevax.    On 18-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Sep-2023, the patient experienced BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort), PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort) and FATIGUE (fatigue) had not resolved and PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. It was reported that the patient received the 7th dose in the wrong site. It did not go into the deltoid muscle. It was given much lower. Some went under the skin and some to surrounding tissue. The patient also felt that the skin at injection site left arm was burning, it was red. Also felt discomfort and the patient believes that the vaccine leaked. The patient was feeling fatigue.  No treatment medication was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.). At the time of the report, HYPOAESTHESIA (Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient had the 2 original Moderna shots and 3 boosters. He had the bivalent last October. He was about to take the new one. Patient knew that the bivalent vaccine was different. He was eft handed, so took shot in right arm. His arm went dead for 5 minutes and could had cut it off and wouldn't have known. The sensation came back shortly, but he was very scared during that time.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-020830, US-MODERNATX, INC.-MOD-2021-362014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020830:Dose 1 US-MODERNATX, INC.-MOD-2021-362014:Dose 2
Sex: F
Vaccine: UNK
Symptoms: Cough, Lethargy, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: cough; stuffy nose; lethargy; sneezing; sore throat; Cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (sore throat) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (Cold). At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: over 170.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  She stated this morning she woke up with a severe cough, stuffy nose, lethargy, she was sneezing, and had a sore throat. She had received both primary series and a booster dose.  She had sore throat, sneezing, stuffy nose, feel wiped out, no energy. She went to the gym and she exposed to a lot of people and she did not know if the equipment was clean. Her symptoms seem to be a cold but more severe, she did not know exactly what was going on or what she should do. They stated she had CHF and had episode of heart rate over 170.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2023: On 26-Sep-2023: Live follow-up contains, medical history and new event cold added.
Sex: F
Vaccine: UNK
Symptoms: Sneezing
Clinical narrative: cough; stuffy nose; lethargy; sneezing; sore throat; Cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (sore throat) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (Cold). At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), LETHARGY (lethargy), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: over 170.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  She stated this morning she woke up with a severe cough, stuffy nose, lethargy, she was sneezing, and had a sore throat. She had received both primary series and a booster dose.  She had sore throat, sneezing, stuffy nose, feel wiped out, no energy. She went to the gym and she exposed to a lot of people and she did not know if the equipment was clean. Her symptoms seem to be a cold but more severe, she did not know exactly what was going on or what she should do. They stated she had CHF and had episode of heart rate over 170.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2023: On 26-Sep-2023: Live follow-up contains, medical history and new event cold added.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Feeling abnormal, Tremor
Clinical narrative: Everything on my body just started shaking, almost like I had Parkinson's, from my head, arms, and legs started shaking; just lost everything, she can't explain the feeling; Tired; Very weak; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Everything on my body just started shaking, almost like I had Parkinson's, from my head, arms, and legs started shaking), ASTHENIA (Very weak), FEELING ABNORMAL (just lost everything, she can't explain the feeling) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu; for Blood pressure high: Losartan. Past adverse reactions to the above products included No adverse event with Flu; and No adverse reaction with Losartan. Concurrent medical conditions included Sulfonamide allergy, Allergic reaction to analgesics (morphine), Drug allergy (demerol) and Blood pressure high. Concomitant products included SPIRONOLACTONE for Blood pressure high.    On 24-Sep-2023 at 11:30 AM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Sep-2023, the patient experienced ASTHENIA (Very weak) and FATIGUE (Tired). On 24-Sep-2023 at 6:00 PM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TREMOR (Everything on my body just started shaking, almost like I had Parkinson's, from my head, arms, and legs started shaking) and FEELING ABNORMAL (just lost everything, she can't explain the feeling). At the time of the report, TREMOR (Everything on my body just started shaking, almost like I had Parkinson's, from my head, arms, and legs started shaking), ASTHENIA (Very weak) and FATIGUE (Tired) was resolving and FEELING ABNORMAL (just lost everything, she can't explain the feeling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2023, Blood test: Normal. On 24-Sep-2023, Chest X-ray: Normal. On 24-Sep-2023, Computerised tomogram head: Normal. On 24-Sep-2023, Electrocardiogram: Normal.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 16-Jan-2021, patient received 1st dose lot number 013L20A. On 13-Feb-2021, patient received 2nd dose lot number 010M20A. On 24-Oct-2021, patient received 3rd dose. On 23-Apr-2022, patient received 4th dose lot number 056M21A. On 19-Sep-2022, patient received 5th dose lot number AS7143C. Patient did not have any problems with her previous vaccinations.  Following 6th dose, at 6pm, patient just "just lost everything", she cannot explain the feeling, everything on her body just started shaking, almost like Parkinson's- from head, arms, and legs started shaking. Patient was brought to the emergency room where she stayed for 4 hours. She was given fluids. She was sent home still very weak and tired. On the day of reporting, she was feeling much better.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Illness
Clinical narrative: she got very ill for 3 days / She says she was very very sick.; Throwing up and sweating like she got a terrible flu.; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; fever; rash; nausea and vomiting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 076B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A-03) for COVID-19 prophylaxis.    The patient's past medical history included COVID-19 (Positive COVID-19 diagnosis 2 years ago after her booster vaccine she thinks.).   On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 11-Feb-2023, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash) and VOMITING (nausea and vomiting). At the time of the report, ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash) and VOMITING (nausea and vomiting) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient started off with the Moderna vaccines and never had problems with it. Just for the one Moderna booster patient was very ill for 3 days. Patient said that she was very very sick. Throwing up and sweating like got a terrible flu. Patient switched to Pfizer thought it would be better, but patient had a horrible reaction to theirs as well. Patient got sick for 2-3 days and couldn't get out of bed.   Patient was unsure what dose in the series it was but stated it was her booster.  Treatment Medication use information was not provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: she got very ill for 3 days / She says she was very very sick.; Throwing up and sweating like she got a terrible flu.; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; fever; rash; nausea and vomiting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 076B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A-03) for COVID-19 prophylaxis.    The patient's past medical history included COVID-19 (Positive COVID-19 diagnosis 2 years ago after her booster vaccine she thinks.).   On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 11-Feb-2023, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash) and VOMITING (nausea and vomiting). At the time of the report, ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash) and VOMITING (nausea and vomiting) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient started off with the Moderna vaccines and never had problems with it. Just for the one Moderna booster patient was very ill for 3 days. Patient said that she was very very sick. Throwing up and sweating like got a terrible flu. Patient switched to Pfizer thought it would be better, but patient had a horrible reaction to theirs as well. Patient got sick for 2-3 days and couldn't get out of bed.   Patient was unsure what dose in the series it was but stated it was her booster.  Treatment Medication use information was not provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: she got very ill for 3 days / She says she was very very sick.; Throwing up and sweating like she got a terrible flu.; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; fever; rash; nausea and vomiting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 076B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A-03) for COVID-19 prophylaxis.    The patient's past medical history included COVID-19 (Positive COVID-19 diagnosis 2 years ago after her booster vaccine she thinks.).   On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 11-Feb-2023, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash) and VOMITING (nausea and vomiting). At the time of the report, ILLNESS (she got very ill for 3 days / She says she was very very sick.), INFLUENZA (Throwing up and sweating like she got a terrible flu.), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash) and VOMITING (nausea and vomiting) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient started off with the Moderna vaccines and never had problems with it. Just for the one Moderna booster patient was very ill for 3 days. Patient said that she was very very sick. Throwing up and sweating like got a terrible flu. Patient switched to Pfizer thought it would be better, but patient had a horrible reaction to theirs as well. Patient got sick for 2-3 days and couldn't get out of bed.   Patient was unsure what dose in the series it was but stated it was her booster.  Treatment Medication use information was not provided by reporter.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia
Clinical narrative: Body ache; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) and PYREXIA (pyrexia) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. C0S9860 and AS7180B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (lasted 6 days, very mild, no symptoms) on 15-Apr-2022.   On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache) and PYREXIA (pyrexia). At the time of the report, PAIN (Body ache) and PYREXIA (pyrexia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. With all the subsequent booster shots, patient had body aches. When he had gotten fever previously, it came with the other symptoms. Reporter said that some of the lot numbers might be incorrect as he was unable to read what was written in the card. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742282:New varient 2023-24
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Caller, calling on behalf of a physician, stated that a patient received Vaxelis at 5 years of age and that the dosing intervals were correct; Male patient born on 16 July 2017, who had not previously received any doses of the vaccines contained in Vaxelis, was administered Vaxelis on a catch-up schedule for three doses on the following dates: 30 Aug 2021, 10 Nov 2021, and 25 Aug 2022.; This non-serious spontaneous safety report, with case Number 2023SA202003 (Inquiry Number 01674630), was received by partner, on 30JUN2023 and forwarded on 03JUL2023 from a healthcare professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. "Caller, calling on behalf of a physician, stated that a patient received Vaxelis at 5 years of age and that the dosing intervals were correct and, male patient born on 16 July 2017, who had not previously received any doses of the vaccines contained in Vaxelis, was administered Vaxelis on a catch-up schedule for three doses on the following dates: 30 Aug 2021, 10 Nov 2021, and 25 Aug 2022."  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Device data issue
Clinical narrative: A HCP called to report a data logger discrepancy in which he was not able to report what temperature doses of administered VAXELIS and VAXNUEVANCE were maintained at. No additional AE information was able to be provided; This non-serious spontaneous safety report, with reference number, was received by a partner on 18-JUL-2023 and forwarded to agency on 19-JUL-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "A HCP called to report a data logger discrepancy in which he was not able to report what temperature doses of administered VAXELIS and VAXNUEVANCE were maintained at. No additional AE information was able to be provided." was assessed as not applicable due to the nature of the event.  Further information is expected.  Significant Follow-up information was received by the partner on 31-JUL-2023 and forwarded to agency on 01-AUG-2023, from a HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event "A HCP called to report a data logger discrepancy in which he was not able to report what temperature doses of administered VAXELIS and VAXNUEVANCE were maintained at. No additional AE information was able to be provided." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported AE for inadvertent administration of VAXELIS and ROTATEQ after TE. No symptoms reported. No additional AE/PQC.; This spontaneous safety report, with reference number, was received by the partner on 19-JUL-2023 and forwarded to agency on 19-JUL-2023 and 20-JUL-2023, from a health professional on behalf of a physician s.  A 8 week old neonate experienced an inadvertent administration of Vaxelis and Rotateq after TE (temperature excursion) No symptoms were reported. No additional adverse event/product quality complaint.   Due to the nature of the event, the causality between the events "Inadvertent administration of Vaxelis and Rotateq after TE" and Vaxelis was not applicable.  Companion Cases: MCM-005053, MCM-005054, MCM-005055, MCM-005056, MCM-005058.  FOLLOW UP INFORMATION as received by the partner on 10-AUG-2023 and forwarded to agency on the same day:   This case is maintained as non-serious. Patient's first dose of Vaxelis was administered on 01-MAY-2023.  Due to the nature of the event, the causality between the events "Inadvertent administration of Vaxelis and Rotateq after TE" and Vaxelis was not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Unevaluable event
Clinical narrative: Caller states a 6 year old patient was administered Vaxelis in order to get the patient caught up on vaccinations.; This non-serious spontaneous safety report, with Case Number: 2023SA223339 (Inquiry Number: 01699146), was received by partner, on 20-JUL-2023 and forwarded on 21-JUL-2023 from other health professional.  The causal relationship between Vaxelis and the reported event "Caller states a 6-year-old patient was administered Vaxelis in order to get the patient caught up on vaccinations" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: product use in unapproved population; She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered.; This spontaneous safety report, with reference number 2023SA240457(Inquiry # 01716117, Parent Inquiry # 01715866) was received by the partner on 03-AUG-2023 and forwarded on 07-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.   Companion Case: MCM-005127  Further information is expected.  Non-Significant Follow-up information was received by the partner on 03-AUG-2023 and forwarded on 08-AUG-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.  Further information is expected.  Non-Significant Follow-up information was received by the partner on 03-AUG-2023 and forwarded on 08-AUG-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.  Further information is expected.  Non-Significant Follow-up information was received by the partner on 04-AUG-2023 and forwarded on 08-AUG-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Product administered after a temperature excursion; This spontaneous safety report, with reference number was received by the partner on 18-AUG-2023 and forwarded to agency on 22-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "Product administered after a temperature excursion." and Vaxelis was not applicable.   Companion Case: MCM-005192.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Fridge temperature excursion 06/20/23; 6hrs 34min; 06/20/23/second excursion on 07/03/23; 41 hrs; 07/05/23; This spontaneous safety report, with reference number 02430701 (Interaction # 02429417) was received by the partner on 18-AUG-2023 and forwarded on 22-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "Fridge temperature excursion 06/20/23; 6hrs 34min; 06/20/23/second excursion on 07/03/23; 41 hrs; 07/05/23" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Dyskinesia
Clinical narrative: the patient had abnormal limb movements after they received their first dose of VAXELIS. The customer said the parents of the patient took the patient to the hospital, but the patient was not admitted to the hospital. T; This spontaneous safety report, with reference number 02464343 (Interaction # 02464340) was received by the partner on 01-SEP-2023 and forwarded on 04-SEP-2023, from a health professional.  Due to the nature of the event, the causality between the event " the patient had abnormal limb movements after they received their first dose of VAXELIS. The customer said the parents of the patient took the patient to the hospital, but the patient was not admitted to the hospital" and Vaxelis was related.   Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: patient received both VAXELIS and Engerix-B yesterday and wants to know if the manufacturer has any recommendation; This non-serious spontaneous safety report, with reference number 2023SA282138 (Inquiry# 01767327), was received by the partner on 14-SEP-2023 and forwarded on 15-SEP-2023, from a health professional.     Due to the nature of the event, the causality between the event "patient received both VAXELIS and Engerix-B yesterday and wants to know if the manufacturer has any recommendation" Vaxelis was not applicable.  Further information is expected.