chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a patient of an unknown age and 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 IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) 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 did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2023: Live non-significant follow up received.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: fatigue; dizziness; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIZZINESS (dizziness) and MYALGIA (muscle soreness) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 22-Sep-2023, the patient experienced FATIGUE (fatigue), DIZZINESS (dizziness) and MYALGIA (muscle soreness). At the time of the report, FATIGUE (fatigue), DIZZINESS (dizziness) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported.  The patient did not experience any additional symptoms/events. No treatment medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Injection site scab
Clinical narrative: Scabs forming at the injection site; Covid 19; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE SCAB (Scabs forming at the injection site) and COVID-19 (Covid 19) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Penicillin allergy, Seasonal allergy and Drug allergy (Decongestants).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (Covid 19). In March 2022, the patient experienced INJECTION SITE SCAB (Scabs forming at the injection site). At the time of the report, INJECTION SITE SCAB (Scabs forming at the injection site) and COVID-19 (Covid 19) had not resolved.            No concomitant medication was reported.  Scabs occurred every 5-6 months, where the scabs form and within 7-10 days, heal themselves. Patient said that it's very prominent at the injection sites and that he can see the 3 injection sites when the scabs start to form, as that is where they start to form. The issue has been ongoing since MAR2022 and occurred every 5-6 months. The most recent one started happening in AUG-2023 and was lasting the longest, for about 6 weeks now. It has occurred at 4-5 times since the booster shot. He stated that he has pictures that he can share where the scabs forming at the injection sites.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid 19) in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    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 COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) 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.   No concomitant medications were reported. Patient also tested positive for COVID-19 after being on an airplane 6 months after he received Moderna. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741662 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741662:Son case
Sex: M
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Lymphoma. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1), Moderna COVID-19 vaccine (Dose 6), Moderna COVID-19 vaccine (Dose 5), Moderna COVID-19 vaccine (Dose 3), Moderna COVID-19 vaccine (Dose 2) and Moderna COVID-19 vaccine (Dose 4); for Product used for unknown indication: Janssen vaccine (2 out of 2) and Janssen vaccine (1 out of 2). Past adverse reactions to the above products included No adverse event with Janssen vaccine, Janssen vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    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 COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received a monoclonal antibody treatment.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blister, Expired product administered
Clinical narrative: blister; Expiration date was in 25JUN2023, dose administered on 17AUG2023; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (blister) and EXPIRED PRODUCT ADMINISTERED (Expiration date was in 25JUN2023, dose administered on 17AUG2023) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2023, 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 17-Aug-2023, the patient experienced BLISTER (blister) and EXPIRED PRODUCT ADMINISTERED (Expiration date was in 25JUN2023, dose administered on 17AUG2023). At the time of the report, BLISTER (blister) had not resolved and EXPIRED PRODUCT ADMINISTERED (Expiration date was in 25JUN2023, dose administered on 17AUG2023) 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.   It was reported that patient received historical drug as Pneumonia 20. Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 16-AUG-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter.
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: arm was sore; swollen lymph node on the right side of neck; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (swollen lymph node on the right side of neck) 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 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Sep-2023, the patient experienced PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (swollen lymph node on the right side of neck). At the time of the report, PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (swollen lymph node on the right side of neck) 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 did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever gets to 103 to 104.     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.  Her sisters fever gets to 103 to 104 when she got the vaccines. Sister had mostly Pfizer but may had one Moderna. She had covid more than once.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: She believes half of the vaccine ran down her arm and clothes; When the HCP did the injection, they were a problem with the needle; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes), SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle) and NO ADVERSE EVENT (No adverse event) in a 66-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 vaccination: Covid-19 vaccine (Dose 1, lot number: EL8982) on 29-Jan-2021, Covid-19 vaccine (Dose 2, lot number: EL9267) on 20-Feb-2021, Covid-19 vaccine (Dose 3 and lot number: 33030BD) on 02-Dec-2021; for Vaccination: Flu shot on 19-Sep-2023. Past adverse reactions to the above products included No adverse event with Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine and Flu shot.    On 25-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes), SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes), SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle) 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 (She believes half of the vaccine ran down her arm and clothes) and SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle).    Concomitant medication was not provided. Patient stated that when the HCP did the injection, they were a problem with the needle and half of the vaccine ran down her arm and clothes. The HCP that administered the vaccine stated it was just a little bit and not to worry about it. Patient thoughts she might have gotten a quarter of the vaccine. Patient stated she might not be covered since half the vaccine ran down her arm. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, No adverse event, Therapeutic response unexpected
Clinical narrative: he and his local oncologist have noticed that after getting the Moderna vaccine, his lab works numbers get better; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (he and his local oncologist have noticed that after getting the Moderna vaccine, his lab works numbers get better) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 028A21A, 037F21A, 083J21A and 058A22-2A) for COVID-19 prophylaxis.     The patient's past medical history included Ulcerative proctitis. Concurrent medical conditions included Immunocompromised since 2015, Smoldering myeloma since 2017 and MGUS since 2015. Concomitant products included ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) for Bone marrow disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (he and his local oncologist have noticed that after getting the Moderna vaccine, his lab works numbers get better) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (he and his local oncologist have noticed that after getting the Moderna vaccine, his lab works numbers get better) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2017, Biopsy bone marrow: diagnosed smoldering MM (multiple myeloma).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (he and his local oncologist have noticed that after getting the Moderna vaccine, his lab works numbers get better).    Patient received Moderna Covid-19 vaccine, Bivalent on 12-Sep-2022, lot number AS7144B (dose 6) and on 19-May-2023, lot number 016H22A (dose 7). Patient had blood works every 3 months. He specifically mentioned that it was reducing the bad proteins. They noticed this one month after of being given the vaccine. Treatment information was not reported.
Sex: F
Vaccine: UNK
Symptoms: Malaise
Clinical narrative: she had received 5 doses of the Moderna COVID-19 vaccines and got sick last Spring.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she had received 5 doses of the Moderna COVID-19 vaccines and got sick last Spring.) in an elderly 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 an unknown date, the patient experienced ILLNESS (she had received 5 doses of the Moderna COVID-19 vaccines and got sick last Spring.). At the time of the report, ILLNESS (she had received 5 doses of the Moderna COVID-19 vaccines and got sick last Spring.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient went to vaccination cnetre and all ran out of vaccine, she was sick and don't want to take pfizer. She had received 5 doses of the Moderna COVID-19 vaccines and got sick last Spring. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: subconjunctival hemorrhage in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage in the left eye) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient was healthy.     On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage in the left eye) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage in the left eye) outcome was unknown.        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.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Company comment: This spontaneous case concerns an elderly female patient (unknown age), with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Conjunctival haemorrhage. The event occurred approximately 2 days after a dose of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula; no information about prior immunisation schedule was provided. The report stated that the patient experienced subconjunctival hemorrhage in the left eye. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741885:Different patient same reporter (Neighbours case)
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia
Clinical narrative: pneumonia, SOB (Shortness of breath), chills, fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia, SOB (Shortness of breath), chills, fever) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1: Lot number 011J20A) on 09-Jan-2021, Spikevax (Dose 2: Lot number 028L20A) on 06-Feb-2021, Spikevax (Dose 3: Lot number 058E21A) on 20-Aug-2021 and Spikevax (Dose 4: Lot number 107T065Y-21A) on 04-Jul-2022. Past adverse reactions to the above products included No adverse event with Spikevax, Spikevax, Spikevax and Spikevax.    In October 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 05-Mar-2023, the patient experienced PNEUMONIA (pneumonia, SOB (Shortness of breath), chills, fever) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PNEUMONIA (pneumonia, SOB (Shortness of breath), chills, fever) 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 medication information was provided. The patient took things at home including ibuprofen, breathing in steam, rest, and a lot of water. She did not take any prescribed medications for her symptoms. The patient had chest X-ray at local emergency room. On SEP-2023 the patient had been scheduled to receive a flu vaccine  Company comment: This spontaneous case concerns 73-years old female patient, with no medical history information provided, who experienced unexpected serious (medically significant) event of pneumonia. The event occurred approx. 5 months after fifth dose of Spikevax bivalent BA.4/BA.5. As reported, patient's symptoms included chills, fever, and SOB (shortness of breath). The patient took things at home including ibuprofen, breathing in steam, rest, and a lot of water. The patient did not take any prescribed medications for her symptoms. The patient had chest X-ray at local emergency room (no results provided). Considering the reported information, non suggestive temporal association, nature of event (infectious nature) and lack of biological plausibility for such event to be caused by Spikevax vaccine, the event of pneumonia is assessed as not related per Company assessment. The benefit-risk relationship of the Spikevax bivalent BA.4/BA.5 is not affected by this report.
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction, Loss of personal independence in daily activities, Malaise
Clinical narrative: felt ill/Felt very sick; Very adverse reaction; Cannot do daily activities.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt ill/Felt very sick), IMMUNISATION REACTION (Very adverse reaction) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot do daily activities.) in a patient of an unknown age and gender 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 at 4:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) Booster dose. On an unknown date, the patient experienced MALAISE (felt ill/Felt very sick), IMMUNISATION REACTION (Very adverse reaction) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot do daily activities.). At the time of the report, MALAISE (felt ill/Felt very sick) and IMMUNISATION REACTION (Very adverse reaction) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot do daily activities.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient got the moderna booster friday 4:00 PM PST on Friday and had felt ill since. Very adverse reaction. Could not did daily activities. Felt very sick. The patient was normally a very healthy person.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: fatigue; low grade fever up to 99.5; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PYREXIA (low grade fever up to 99.5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FATIGUE (fatigue) and PYREXIA (low grade fever up to 99.5). At the time of the report, FATIGUE (fatigue) and PYREXIA (low grade fever up to 99.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  A HCP friend of the patient said that they were intending to receive the Spikevax vaccine and instead received a bivalent vaccine. The patient received a second shot. He had a mild reaction for an afternoon following the second dose. He was having fatigue and a low grade fever up to 99.5. Probably would have taken Tylenol with those symptoms if he took anything but did not remember.   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: On 25-Sep-2023: Live Follow-up contains, patient DOB, Initial and events outcome updated.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: tenderness; axillary swelling; chills; arthralgia; myalgia; headache; nausea; vomiting; fatigue; Swelling at the injection site; pain at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia) and MYALGIA (myalgia) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy and Penicillin allergy (Penicillin reactions in the past).    On 24-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Sep-2023, the patient experienced TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient never experienced any side effects with her last doses. She was staying hydrated and stayed in bed. She started experiencing side effects on the night of 24-Sep-2023 and early in the morning of 25-Sep-2023.  Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Myalgia, Nausea, Oedema peripheral, Tenderness
Clinical narrative: tenderness; axillary swelling; chills; arthralgia; myalgia; headache; nausea; vomiting; fatigue; Swelling at the injection site; pain at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia) and MYALGIA (myalgia) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy and Penicillin allergy (Penicillin reactions in the past).    On 24-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Sep-2023, the patient experienced TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient never experienced any side effects with her last doses. She was staying hydrated and stayed in bed. She started experiencing side effects on the night of 24-Sep-2023 and early in the morning of 25-Sep-2023.  Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: tenderness; axillary swelling; chills; arthralgia; myalgia; headache; nausea; vomiting; fatigue; Swelling at the injection site; pain at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia) and MYALGIA (myalgia) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy and Penicillin allergy (Penicillin reactions in the past).    On 24-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Sep-2023, the patient experienced TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient never experienced any side effects with her last doses. She was staying hydrated and stayed in bed. She started experiencing side effects on the night of 24-Sep-2023 and early in the morning of 25-Sep-2023.  Treatment information was not reported.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C; This spontaneous safety report, with Case Number: 2023SA191135 (Inquiry Number: 01662682, Parent Inquiry: 01662646), was received by a partner on 19-JUN-2023 and forwarded on 22-JUN-2023, from a HCP.   This case was considered non-valid due to no patient identifiers were provided (temperature excursion only).  Due to the nature of the event, the causality between the event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C 1600: 10.7C" and Vaxelis was not applicable.  Further information is expected.  NON-SIGNIFICANT follow-up information was received on 21-JUN-2023 by the partner and forwarded on 22-JUN-2023, from a HCP. The case is maintained as non-serious and non-valid.  Due to the nature of the event, the causality between the reported event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C 1600: 10.7C" and Vaxelis was not applicable.  SIGNIFICANT FOLLOW-UP INFORMATION was received on 22-JUN-2023 from the physician.  The case is maintained as non-serious and valid as patient identifiers were provided and no adverse event following vaccination was reported.  Due to the nature of the event, the causality between the reported event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C 1600: 10.7C" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004930 and MCM-004931.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C; This non-serious spontaneous safety report was received by company on 22-JUN-2023 from a physician.   It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004924 and MCM-004931.  No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C; This non-serious, spontaneous safety report was received on 22-JUN-2023 from a physician.  It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004924 and MCM-004930.  Further information is not expected.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices; First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices; First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices; This spontaneous safety report, was received by the partner on 22-JUN-2023 and forwarded to company on 22-JUN-2023. Additional information was received by the partner on 23-JUN-2023 and forwarded to company on 26-JUN-2023 from a nurse.  This case was originally considered non-valid due to no patient identifiers but is now a valid case due to gender being provided.  Due to the nature of the event, the causality between the event "First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices" and Vaxelis was not applicable.   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administered Vaxelis to an 11-year-old patient; This non-serious spontaneous safety report, with GPV Case Number: 2023SA204243, was received by partner, on 26-JUN-2023 and forwarded to company on 05-JUL-2023 from other health professional.  The causal relationship between Vaxelis and the reported event "Administered Vaxelis to an 11-year-old patient" was assessed as not applicable due to the nature of the event.  Further information is expected.  FOLLOW UP INFORMATION WAS RECEIVED ON 20-JUL-2023, directly sent to company by a certified medical assistant.  The causal relationship between Vaxelis and the reported event "Administered Vaxelis to an 11-year-old patient" was assessed as not applicable due to the nature of the event.  The date of first dose of Vaxelis was provided on 21-Jun-23, batch number# U7535AA and route as intramuscular.  Medical history of autism spectrum disorder and generalized anxiety disorder was provided.  The reason for the event administered Vaxelis to an 11-year old was provided as wrong vaccine was given.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, MMR
Symptoms: Wrong product administered
Clinical narrative: Patient was accidentally administered with VAXELIS today even though he did not need it; This spontaneous safety report, with reference number 2023SA208212 (Inquiry number 01683246), was received by a partner on 07-JUL-2023 and forwarded to company on 10-JUL-2023, from a HCP.   The causal relationship between Vaxelis and the reported event "Patient was accidentally administered with VAXELIS today even though he did not need it" 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 02-AUG-2023 and forwarded to company on the same day, from a physician. This case is maintained as non-serious.  The causal relationship between VAXELIS and the reported event of "Patient was accidentally administered with VAXELIS today even though he did not need it" is not applicable."  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Skin warm, Urticaria
Clinical narrative: He had hives and was very warm to the touch; He had hives and was very warm to the touch; This spontaneous safety report, with reference number 2023SA216537 was received by the partner on 14-JUL-2023 and forwarded on 17-JUL-2023, from a health professional.  A four-month-old neonate had an immediate reaction to Vaxelis. He experienced hives and was very warm to the touch.  Due to the short latency period between time of vaccination and occurrence of the event, the causality between the event "He had hives and was very warm to the touch" and Vaxelis was assessed as related.  Further information is expected.  Follow-up information was received on 01-AUG-2023, from an HCP. This case is maintained as non-serious.  The patient was given Benadryl as treatment for the reported event.  The reporter assessed the causal relationship between Vaxelis and the reported event "He had hives and was very warm to the touch" as related.  No further information is expected, given that reporter replied to all our queries.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Inadvertent administration of Vaxelis after temperature excursion; This spontaneous safety report, with reference number 02430531 (Interaction Number), was received by a partner on 19-JUL-2023 and forwarded to agency on 19-JUL-2023 and 20-JUL-2023, from a healthcare professional on behalf of a physician.  A ten-month-old neonate experienced an inadvertent administration of Vaxelis after a temperature excursion. No symptoms were reported.   Excursion details were reported as 65.2 F for 9 hours 45 minutes, 32.4 F for 42 hours 45 minutes. Batch number: U7217AA with expiration date:12-NOV-2024.  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis after temperature excursion)" was assessed as not applicable due to the nature of the event.  Companion Case: MCM-005056  Further information is expected.  Significant follow-up information was received by agency on 03-AUG-2023, from a HCP. The case is maintained as non-serious  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis after temperature excursion" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms. No additional AE. Time frame:65.2F for 9 hrs 45 mins,32.4F for 42 hrs 45 mins; This non-serious spontaneous safety report, with reference number, was received by a partner on 19-JUL-2023 and forwarded to agency on the same day and significant additional information was received by a partner on 19-JUL-2023 and forwarded to agency on 20-JUL-2023, from a HCP  The causal relationship between Vaxelis and the reported event "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms. No additional AE. Time frame:65.2F for 9 hrs 45 mins,32.4F for 42 hrs 45 mins." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Inadvertent administration of Vaxelis and Rotateq after TE/ 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes;; This non-serious spontaneous safety report, with reference number, was received by a partner on 19-JUL-2023 and forwarded to agency on the same day, from a non-HCP. Additional information was received by a partner on 19-JUL-2023 and forwarded to agency on 20-JUL-2023 by a HCP.  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis and Rotateq after TE/ 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes" was assessed as not applicable due to the nature of the event.  Further information is expected
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms reported. No additional AE. Time frame: 65.2F for 9 Hours 45 Minutes , 32.4F for 42 Hours 45 minutes; This spontaneous safety report, with reference number 02430544, was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023 and also significant additional information was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023, from a HCP.   The causal relationship between Vaxelis and the reported event "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms reported. No additional AE. Time frame: 65.2F for 9 Hours 45 Minutes, 32.4F for 42 Hours 45 minutes" was assessed as not applicable due to the nature of the event.  Further information is expected.  FOLLOW-UP information was received on 03-AUG-2023, from a physician. This case is maintained as non-serious.  The reporter confirmed that the patient did not experience an adverse event following the administration of Vaxelis after temperature excursion.  The causal relationship between VAXELIS and the reported event of "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms reported. No additional AE. Time frame: 65.2F for 9 Hours 45 Minutes, 32.4F for 42 Hours 45 minutes" remained as not applicable due to the nature of the event.  Companion Cases: MCM-005053, MCM-005054, MCM-005056, MCM-005057, MCM-005058.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Inadvertent administration of Vaxelis and Rotateq after temperature excursion; This non-serious spontaneous safety report, with reference number 02430542, was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023, from a non-HCP.  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis and Rotateq after temperature excursions" 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 03-APR-2023 and forwarded on the same day, from a physician. This case is maintained as non-serious.  The causal relationship between VAXELIS and the reported event of "Inadvertent administration of Vaxelis and Rotateq after temperature excursion" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Inadvertent administration of Vaxelis and Roteteq after TE; This spontaneous safety report, was received by the partner on 19-JUL-2023 and forwarded to company on 19-JUL-2023 and 20-JUL-2023, from a health professional on behalf of a physician.  A nine-month-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 Roteteq after TE3" and Vaxelis was not applicable.  Companion Cases: MCM-005053, MCM-005054, MCM-005055, MCM-005056, MCM-005057.  No additional information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: VAXELIS administered to a patient post excursion. Refrigerator malfunction Max/Low Temperature reached: 28 F; This spontaneous safety report, with reference number 2023SA220996, was received by a partner on 19-JUL-2023 and forwarded to company on 20-JUL-2023, from an other-HCP.  The causal relationship between Vaxelis and the reported event "VAXELIS administered to a patient post excursion. Refrigerator malfunction Max/Low Temperature reached: 28 F." 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: Vaccines administered before Temperature Excursion; This non-serious spontaneous safety report, with reference number 02430543, was received by a partner on 19-JUL-2023 and forwarded to company on 20-JUL-2023, from a non-HCP. Additional information was received by a partner on 19-JUL-2023 and forwarded to company on 20-JUL-2023 from a HCP.  The causal relationship between Vaxelis and the reported event "Vaccines administered before Temperature Excursion" was assessed as not applicable due to the nature of the event.  No further information is expected given that Vaxelis was administered before TE.