chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: No adverse event; Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3833D) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.) 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 assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.).    No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743073 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743073:Bivalent dose
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: unable to function and have to miss work or schedule appointment; Extreme body aches; Fever 100 or higher; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to function and have to miss work or schedule appointment), MYALGIA (Extreme body aches) and PYREXIA (Fever 100 or higher) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (twice).    On an unknown date, the patient received fourth 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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to function and have to miss work or schedule appointment), MYALGIA (Extreme body aches) and PYREXIA (Fever 100 or higher). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to function and have to miss work or schedule appointment), MYALGIA (Extreme body aches) and PYREXIA (Fever 100 or higher) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever 100 or higher.     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 reported. Patient had received dose 1-3 of Moderna monovalent vaccine. Batch numbers reported were 011M20A, 026A21A, 012F21A.  Overall health of patient was excellent. Starting about 8-10 hours after the shot, patient was sick for 1.5 - 2.0 days. Fever 100 or higher, extreme body aches (this was the worst part), unable to function and had to miss work or schedule appointment at the beginning of the weekend. So, patient was prepared to be sick. Patient had covid twice, and the recollection that having covid was not as miserable as having the shot. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-030948 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2023: Batch number was added. Product coding was updated. On 28-Sep-2023: Additional reference number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030948:Monovalent
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; shivers; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (shivers) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced PAIN (body aches), CHILLS (shivers) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (shivers) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's other vaccination details included two doses of Jansen, in which First Primary Janssen dose was taken on 17-Mar-2021 and 2nd Primary Janssen dose was taken on   28-Oct-2021. Other Moderna covid-19 vaccination details were as follows: patient received third dose of as first Monovalent Booster dose on 17-Jun-2022 with batch number 058A22A, fourth dose as Bivalent Booster dose on 16-Oct-2022, fifth dose as Bivalent Booster on 27-May-2023. Patient's husband received Spikevax vaccination at the same time.  Patient's arm was reported as fine. Patient had satisfaction with Moderna vaccination in the past.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742491 (E2B Linked Report). This case was linked to MOD-2023-742557, MOD-2023-742579 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742491:Husband's master Case
Sex: F
Vaccine: UNK
Symptoms: Rash, Vaccination site swelling
Clinical narrative: rash; swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) and VACCINATION SITE SWELLING (swelling at injection site) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    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 RASH (rash) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (rash) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's all previous doses were Moderna vaccines. Patient received previous booster dose, 6 months ago. A week ago, patient developed rash and swelling at injection site. Patient queried if treatment medication can be continued. Patient stated that she will rethink regarding future Covid vaccine injections due to constituent of PEG 2000 in vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-743520 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2023: Live non- Significant follow up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743520:Monovalent case
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Gait inability, Hypersomnia
Clinical narrative: still a little tired; feeling really weak; it was hard for her to walk; She stayed asleep from 1:15 PM until the next morning; really dizzy, like she had no control over her body; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (feeling really weak), GAIT INABILITY (it was hard for her to walk), HYPERSOMNIA (She stayed asleep from 1:15 PM until the next morning), DIZZINESS (really dizzy, like she had no control over her body) and FATIGUE (still a little tired) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine (flu shot) on 22-Sep-2023. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 27-Sep-2023, the patient experienced ASTHENIA (feeling really weak), GAIT INABILITY (it was hard for her to walk), HYPERSOMNIA (She stayed asleep from 1:15 PM until the next morning) and DIZZINESS (really dizzy, like she had no control over her body). On 28-Sep-2023, the patient experienced FATIGUE (still a little tired). At the time of the report, ASTHENIA (feeling really weak), GAIT INABILITY (it was hard for her to walk), HYPERSOMNIA (She stayed asleep from 1:15 PM until the next morning) and DIZZINESS (really dizzy, like she had no control over her body) was resolving and FATIGUE (still a little tired) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient stated that, she had received many Moderna COVID-19 vaccines and boosters (details unspecified).  On 27-Sep-2023, around 1, patient started feeling really week, really dizzy, like she had no control over her body, and it was hard for her to walk. She made her way to her bedroom and fell asleep. She stayed asleep from 1:15 PM until the next morning. On the reportind day, she was feeling fine, but was still a little tired. She never had an issue with any previous doses.  No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 immunisation: PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 29-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved 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 assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy).    Treatment medications were not reported. Company Comment: This is a spontaneous case concerning a 25-year-old female patient with no reported medical history, who received the fourth dose of mRNA-1273.815 (Spikevax 2023-2024) during pregnancy (39 weeks pregnant). Maternal exposure during pregnancy was considered in this case and no adverse events were reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (Spikevax 2023-2024) is not affected by this report.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Immunisation reaction
Clinical narrative: she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient has some allergies and issues with blood pressure. Medications: 1 pill of Levothyroxine, Metoprolol and 1 pill for her eyes.  The patient's past medical history included Blood pressure fluctuation (issues with blood pressure). Previously administered products included for Drug use for unknown indication: Levothyroxine and Metoprolol; for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Levothyroxine, Metoprolol, Pfizer and Pfizer. Concurrent medical conditions included Allergy (Patient had some allergies.).    On 28-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 50 microgram. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced IMMUNISATION REACTION (she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible). On 29-Sep-2023, IMMUNISATION REACTION (she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. She had one pill for her eyes as past medication. No treatment medication reported.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    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 POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) 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 POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze).    No concomitant medications were reported. It was reported as unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patients have not reported other side effects.  No treatment medications were reported.  This case contains information for the 01 of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743068, US-MODERNATX, INC.-MOD-2023-743074, US-MODERNATX, INC.-MOD-2023-743085, US-MODERNATX, INC.-MOD-2023-743075, US-MODERNATX, INC.-MOD-2023-743079, US-MODERNATX, INC.-MOD-2023-743084, US-MODERNATX, INC.-MOD-2023-743083, US-MODERNATX, INC.-MOD-2023-743082, US-MODERNATX, INC.-MOD-2023-743080 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743068:Patient 2 US-MODERNATX, INC.-MOD-2023-743079:Patient 5 US-MODERNATX, INC.-MOD-2023-743083:Patient 8 US-MODERNATX, INC.-MOD-2023-743085:Patient 10 US-MODERNATX, INC.-MOD-2023-743082:Patient 7 US-MODERNATX, INC.-MOD-2023-743074:Patient 3 US-MODERNATX, INC.-MOD-2023-743075:Patient 4 US-MODERNATX, INC.-MOD-2023-743080:Patient 6 US-MODERNATX, INC.-MOD-2023-743084:Patient 9
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: chills fever; only sore arm from injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (chills fever) and VACCINATION SITE PAIN (only sore arm from injection site) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2023 at 10:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 30-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE PAIN (only sore arm from injection site). On 30-Sep-2023 at 1:00 AM, the patient experienced PYREXIA (chills fever). On 30-Sep-2023 at 7:00 AM, PYREXIA (chills fever) had resolved. At the time of the report, VACCINATION SITE PAIN (only sore arm from injection site) outcome was unknown.            No concomitant medications were reported. No treatment medications were provided. It was unknown if the patient experienced any additional symptoms/events.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Eye swelling, Fatigue, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling underneath the eye on the same side the shot was administered (right side); Aching on the right side leg; Redness by the injection area; General tiredness and fatigue; Swelling by the injection area; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling underneath the eye on the same side the shot was administered (right side)), PAIN IN EXTREMITY (Aching on the right side leg), INJECTION SITE ERYTHEMA (Redness by the injection area), FATIGUE (General tiredness and fatigue) and VACCINATION SITE SWELLING (Swelling by the injection area) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023, the patient experienced EYE SWELLING (Swelling underneath the eye on the same side the shot was administered (right side)), PAIN IN EXTREMITY (Aching on the right side leg), INJECTION SITE ERYTHEMA (Redness by the injection area), FATIGUE (General tiredness and fatigue) and VACCINATION SITE SWELLING (Swelling by the injection area). At the time of the report, EYE SWELLING (Swelling underneath the eye on the same side the shot was administered (right side)), PAIN IN EXTREMITY (Aching on the right side leg), INJECTION SITE ERYTHEMA (Redness by the injection area), FATIGUE (General tiredness and fatigue) and VACCINATION SITE SWELLING (Swelling by the injection area) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Soreness in his left injection site arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Soreness in his left injection site arm) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received 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 VACCINATION SITE PAIN (Soreness in his left injection site arm). At the time of the report, VACCINATION SITE PAIN (Soreness in his left injection site arm) 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.   No concomitant drug was reported.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743491 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743491:2023-2024 dose
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administration error, Underdose
Clinical narrative: Some of the vaccine, medicines spurt it out did not get the full dose; Some of the vaccine, medicines spurt it out did not get the full dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose), PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    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 ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose), PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose), PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose) 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 ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose) and PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose).    Concomitant medication was not provided. Treatment information was not reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Vaccination site erythema
Clinical narrative: It was swollen, had tenderness; I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.; Felt a bit tired; It was swollen, had tenderness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (It was swollen, had tenderness), INJECTION SITE SWELLING (It was swollen, had tenderness), VACCINATION SITE ERYTHEMA (I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.) and FATIGUE (Felt a bit tired) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 30-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (It was swollen, had tenderness). On an unknown date, the patient experienced INJECTION SITE SWELLING (It was swollen, had tenderness). an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.). an unknown date, the patient experienced FATIGUE (Felt a bit tired). The patient was treated with ZINC OXIDE at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (It was swollen, had tenderness) and INJECTION SITE SWELLING (It was swollen, had tenderness) had not resolved and VACCINATION SITE ERYTHEMA (I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.) and FATIGUE (Felt a bit tired) outcome was unknown.            Concomitant medication was not provided. Two days after administration on her left arm, patient got a red large circular spot measuring about 4-4.5 inches diameter on arm. It was swollen and had tenderness. Close to the injection site it was a deep red color. Patient also felt a bit tired. She used over the counter cream to bring down the swelling. Sudo cream (zinc oxide) was currently being used. It was slowly going away.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Discomfort, Pain, Pruritus, Rash
Clinical narrative: pain; rash was painful for 3 days; a shingle like burning, itching, at the lower abdominal area; shingle like burning; mild discomfort; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (a shingle like burning, itching, at the lower abdominal area), BURNING SENSATION (shingle like burning), DISCOMFORT (mild discomfort), PAIN (pain) and RASH (rash was painful for 3 days) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had no COID-19 diagnosis.  The patient's past medical history included Central serous chorioretinopathy (Central series retinopathy, diagnosed before any of the COVID-19 vaccine.), Arrhythmia (diagnosed before any of the COVID-19 vaccine.) and Retinal ischaemia (Retinal transient ischaemic attack.  diagnosed after March 2022). Previously administered products included for Product used for unknown indication: Flu shot (a week prior the Spikevax shot and patient had the flu shot.). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Cystitis interstitial (diagnosed before any of the COVID-19 vaccine.) and Irritable bowel (diagnosed before any of the COVID-19 vaccine.).    On 24-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRURITUS (a shingle like burning, itching, at the lower abdominal area), BURNING SENSATION (shingle like burning) and DISCOMFORT (mild discomfort). On an unknown date, the patient experienced PAIN (pain) and RASH (rash was painful for 3 days). At the time of the report, PRURITUS (a shingle like burning, itching, at the lower abdominal area) and BURNING SENSATION (shingle like burning) outcome was unknown, DISCOMFORT (mild discomfort) and PAIN (pain) had resolved and RASH (rash was painful for 3 days) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient received 6th dose a week ago on Sunday. Post vaccination morning patient developed a rash, a shingle like burning, itching, at the lower abdominal area, there were found 3 spots. Patient visited a dermatologist and dermatologist thought it might be related to the vaccine and maybe a mild case of Shingles. Dermatologist prescribed antiviral treatment medication, but patient chose not to take it. It has been reported that rash was painful for 3 days. Patient took treatment medication steroid ointment as per prescription strength, but it did not help much to patient.  Patient did not have information on previous doses, but all were Moderna vaccines. And patient mentioned that on 26-Apr-2023, received Moderna Bivalent dose.   This case was linked to US-MODERNATX, INC.-MOD-2023-743144 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743144:2nd dose (MODERNA COVID-19 VACCINE)
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosea; This spontaneous case was reported by a patient and describes the occurrence of PITYRIASIS ROSEA (pityriasis rosea) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had no COID-19 diagnosis.  The patient's past medical history included Central serous retinopathy (Central series retinopathy, diagnosed before any of the COVID-19 vaccine.), Arrhythmia (diagnosed before any of the COVID-19 vaccine.) and Ischemia retinal (Retinal transient ischaemic attack, diagnosed after March 2022). Concurrent medical conditions included Cystitis interstitial (diagnosed before any of the COVID-19 vaccine.) and Irritable bowel (diagnosed before any of the COVID-19 vaccine.).    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 PITYRIASIS ROSEA (pityriasis rosea). At the time of the report, PITYRIASIS ROSEA (pityriasis rosea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had rash at the very beginning after the second dose. Patient did not have information on previous doses, but all were Moderna vaccines. And patient mentioned that on 26-Apr-2023, received Moderna Bivalent dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743176 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743176:6th dose (SPIKEVAX 2023-2024)
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Feeling hot, Illness, Impaired work ability
Clinical narrative: Sick in bed; exhaustion; nausea; severe body pain/terrible body pain; chills; hot last night so he may have had a fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick in bed), MYALGIA (severe body pain/terrible body pain), CHILLS (chills), PYREXIA (hot last night so he may have had a fever) and FATIGUE (exhaustion) in a 69-year-old male 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.     The patient's past medical history included COVID-19 (Had COVID last summer).    On 30-Sep-2023 at 5:00 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced MYALGIA (severe body pain/terrible body pain), CHILLS (chills) and PYREXIA (hot last night so he may have had a fever). On an unknown date, the patient experienced ILLNESS (Sick in bed), FATIGUE (exhaustion) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick in bed), MYALGIA (severe body pain/terrible body pain) and CHILLS (chills) had not resolved and PYREXIA (hot last night so he may have had a fever), FATIGUE (exhaustion) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient woke up on early Sunday with chills and terrible body pain. All day on the previous day and on the day of reporting patient still experienced it. Patient was hot last night so patient might had a fever. Patient had to miss work on the day of reporting. Patient hadn't had any previous reactions aside for sore arm for his previous vaccinations.   This case was linked to MOD-2023-743178 (Patient Link).
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Sick in bed; exhaustion; nausea; severe body pain/terrible body pain; chills; hot last night so he may have had a fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick in bed), MYALGIA (severe body pain/terrible body pain), CHILLS (chills), PYREXIA (hot last night so he may have had a fever) and FATIGUE (exhaustion) in a 69-year-old male 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.     The patient's past medical history included COVID-19 (Had COVID last summer).    On 30-Sep-2023 at 5:00 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced MYALGIA (severe body pain/terrible body pain), CHILLS (chills) and PYREXIA (hot last night so he may have had a fever). On an unknown date, the patient experienced ILLNESS (Sick in bed), FATIGUE (exhaustion) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick in bed), MYALGIA (severe body pain/terrible body pain) and CHILLS (chills) had not resolved and PYREXIA (hot last night so he may have had a fever), FATIGUE (exhaustion) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient woke up on early Sunday with chills and terrible body pain. All day on the previous day and on the day of reporting patient still experienced it. Patient was hot last night so patient might had a fever. Patient had to miss work on the day of reporting. Patient hadn't had any previous reactions aside for sore arm for his previous vaccinations.   This case was linked to MOD-2023-743178 (Patient Link).
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Pain
Clinical narrative: chills; body pain; didn't feel good; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), PAIN (body pain) and FEELING ABNORMAL (didn't feel good) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (last summer).    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced CHILLS (chills), PAIN (body pain) and FEELING ABNORMAL (didn't feel good). In September 2023, CHILLS (chills) and PAIN (body pain) had resolved. On 23-Sep-2023, FEELING ABNORMAL (didn't feel good) had resolved.        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.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2023-743153 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Urticaria
Clinical narrative: urticaria; rashes; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (urticaria) and RASH (rashes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product EPINEPHRINE (EPIPEN JR) for an unknown indication.    The patient's past medical history included COVID-19 on 02-Oct-2020. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Urticaria, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient started EPINEPHRINE (EPIPEN JR) (unknown route) at an unspecified dose. On 01-Oct-2021, the patient experienced URTICARIA (urticaria) and RASH (rashes). At the time of the report, URTICARIA (urticaria) and RASH (rashes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered URTICARIA (urticaria) and RASH (rashes) to be related.    Co-Suspect product included steroids. It has been reported that rashes began under eye of patient. Patient was treated with treatment medication steroids and the symptom was not resolved. Further symptom returned each time for patient.  Each time it turned as worse, and it eventually turned into urticaria. Patient visited allergist and for this underwent multiple rounds of allergy testing. Patient also visited ENT physician. It has ended up ruling this to likely be caused by Moderna vaccine. Patient had multiple rounds of not only allergy testing but also blood testing done to rule out other conditions and causes. Currently patient was taking six different antihistamines a day. It's more than two years later and patient still battling this. Treatment information was not provided.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.     On 30-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Since vaccination yesterday, she has a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Since vaccination yesterday, she has a headache) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (Since vaccination yesterday, she has a headache). At the time of the report, HEADACHE (Since vaccination yesterday, she has a headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient queried that if patient could take treatment medication Tylenol after vaccination.   Reporter did not allow further contact
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 1-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5509B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml) 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 assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml).    Concomitant medication was not provided. HCP stated that they received a shipment of single dose vials of Moderna COVID-19 Vaccine for 6 months to 11 years and on 02-OCT they used 1 vial to administer 1 dose to a patient. After 1st dose was withdrawn from the vial and administered to the patient (without AEs reported), the HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml. HCP mentioned this was the only vial they have been thawed so far, and they still have 9 vials from the same shipment in the freezer, and the caller stated that the rest of the vials seemed to have the same volume than the first one, but she was not sure since the rest of the vials are not thawed yet. Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Slight fever achy after first shot; Slight fever achy after first shot; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Slight fever achy after first shot) and PYREXIA (Slight fever achy after first shot) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (She has caught Covid twice.).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight fever achy after first shot) and PYREXIA (Slight fever achy after first shot). At the time of the report, PAIN (Slight fever achy after first shot) outcome was unknown and PYREXIA (Slight fever achy after first shot) 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.   Concomitant medication was not provided. Patient reported that she has had all of her Moderna shots, and she had caught Covid twice. She blames this on the medications they gave her for Covid-19 and not the Moderna Covid-19 vaccine. Patient had to leave the telephone call and could not provide much information about her previous Moderna Covid-19 vaccines however she reported slight fever achy after first shot they said that this was what one usually gets.   Treatment information was not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site for about 48 hours; low grade fever; mild chills; mild fatigue for a few hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site for about 48 hours), PYREXIA (low grade fever), CHILLS (mild chills) and FATIGUE (mild fatigue for a few hours) in a 40-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with COVID-19) on 15-Jul-2022. Concomitant products included ACETAMINOPHEN for an unknown indication.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 29-Sep-2023, the patient experienced VACCINATION SITE PAIN (Pain at the injection site for about 48 hours), PYREXIA (low grade fever), CHILLS (mild chills) and FATIGUE (mild fatigue for a few hours). On 30-Sep-2023, VACCINATION SITE PAIN (Pain at the injection site for about 48 hours), PYREXIA (low grade fever), CHILLS (mild chills) and FATIGUE (mild fatigue for a few hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient did not experience any additional symptoms/events.  No treatment information was provided.
Sex: M
Vaccine: FLUX, RSV
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.