chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: I just had the pain in my arm and that was it and actually I took both at the same time.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I just had the pain in my arm and that was it and actually I took both at the same time.) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I just had the pain in my arm and that was it and actually I took both at the same time.). At the time of the report, PAIN IN EXTREMITY (I just had the pain in my arm and that was it and actually I took both at the same time.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that reporter had the Moderna (Unspecified Vaccine) now and reporter did not have anything. reporter just had the pain in arm and that was it and actually reporter took both at the same time. Reporter took the Flu (Unspecified Flu shot) and the Moderna, but reporter had the Moderna and never had the Pfizer.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-751870 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751870:Reporter elder case
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: the plunger on the syringe gets stuck midway into injection; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (the plunger on the syringe gets stuck midway into injection) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection 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 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (the plunger on the syringe gets stuck midway into injection) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (the plunger on the syringe gets stuck midway into injection) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the plunger on the syringe gets stuck midway into injection).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the plunger on the syringe gets stuck midway into injection).    This case refers to patient 2 out of 3 patients reported.  Concomitant medication use information was not provided by reporter.  It was reported that the reporter just had a 3rd patient were the plunger on the syringe gets stuck midway into injection.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.  The Spikevax syringe device was malfunctioned and the type was CIRM.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-748306 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748306:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: the syringes where the plunger get stuck midway into injection; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection 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 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the syringes where the plunger get stuck midway into injection).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the syringes where the plunger get stuck midway into injection).    Concomitant medication use information was not provided by reporter.  It was reported that the just had a 3rd patient were the plunger on the syringe gets stuck midway into injection.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.  The Spikevax syringe device was malfunctioned and the type was CIRM.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-748306 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748306:Patient 1
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: My wife and I got our shot at CVS 10 days ago. We both got extremely ill for 24 hours; What was the reason modernatx caused us so much pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (My wife and I got our shot at pharmacy 10 days ago. We both got extremely ill for 24 hours) and PAIN (What was the reason moderna caused us so much pain) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    In November 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced ILLNESS (My wife and I got our shot at pharmacy 10 days ago. We both got extremely ill for 24 hours) and PAIN (What was the reason moderna caused us so much pain). In November 2023, ILLNESS (My wife and I got our shot at pharmacy 10 days ago. We both got extremely ill for 24 hours) had resolved. At the time of the report, PAIN (What was the reason moderna caused us so much pain) outcome was unknown.            No concomitant medications were reported. Reporter stated that he had Pfizer shot in the past and didn't get sick from them. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: got extremely ill for 24 hours; What was the reason modernatx caused us so much pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (got extremely ill for 24 hours) and PAIN (What was the reason modernatx caused us so much pain) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    In November 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced ILLNESS (got extremely ill for 24 hours) and PAIN (What was the reason modernatx caused us so much pain). In November 2023, ILLNESS (got extremely ill for 24 hours) had resolved. At the time of the report, PAIN (What was the reason modernatx caused us so much pain) outcome was unknown.            No concomitant medications were reported. Reporter stated that his wife had Pfizer shot in the past and didn't get sick from them. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-752086 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752086:Same reporter, husband case
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This person also had a sore throat after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (This person also had a sore throat after receiving the vaccine.) in a patient of an unknown age and gender 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 OROPHARYNGEAL PAIN (This person also had a sore throat after receiving the vaccine.). At the time of the report, OROPHARYNGEAL PAIN (This person also had a sore throat after receiving the vaccine.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Osteoporosis, Transferrin saturation
Clinical narrative: anemia; osteoporosis; This spontaneous case was reported by a patient and describes the occurrence of ANAEMIA (anemia) and OSTEOPOROSIS (osteoporosis) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (anemia) and OSTEOPOROSIS (osteoporosis). At the time of the report, ANAEMIA (anemia) and OSTEOPOROSIS (osteoporosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Transferrin saturation: 4.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The patient was either 75 or 77 years old. No concomitant medication was reported. After the patient's first COVID-19 vaccine the patient developed anemia. Saturation of Iron was 4. Very low to the point the doctor was concerned which starting to reach normal level after 3 years. the patient had also been diagnosed with severe osteoporosis. The patient had muscle pain and joint pain.  No treatment medication was reported.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Lip swelling
Clinical narrative: Swollen upper lip; The doctor thinks it is a fungal infection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LIP SWELLING (Swollen upper lip) and FUNGAL INFECTION (The doctor thinks it is a fungal infection) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3921B) for COVID-19 prophylaxis.     The patient's past medical history included Triple negative breast cancer on 01-Jun-2023 and Chemotherapy on 19-Oct-2023. Previously administered products included for Product used for unknown indication: FLU vaccine on 13-Oct-2023. Past adverse reactions to the above products included No adverse event with FLU vaccine. Concurrent medical conditions included Hypothyroidism.    On 07-Nov-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced LIP SWELLING (Swollen upper lip) and FUNGAL INFECTION (The doctor thinks it is a fungal infection). At the time of the report, LIP SWELLING (Swollen upper lip) and FUNGAL INFECTION (The doctor thinks it is a fungal infection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered FUNGAL INFECTION (The doctor thinks it is a fungal infection) to be not related. No further causality assessment was provided for LIP SWELLING (Swollen upper lip).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-752209 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of effect. COVID infection; Lack of effect. COVID infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Lack of effect. COVID infection) and VACCINATION FAILURE (Lack of effect. COVID infection) in a 46-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Nov-2023, the patient experienced COVID-19 (Lack of effect. COVID infection) and VACCINATION FAILURE (Lack of effect. COVID infection). At the time of the report, COVID-19 (Lack of effect. COVID infection) and VACCINATION FAILURE (Lack of effect. COVID infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by other health care professional, concerning a 46-year-old male patient, with no medical history reported, who experienced the unexpected and non-serious event of COVID-19, which occurred approximately 1 month and a half after an unspecified dose of SPIKEVAX 2023-2024 vaccine. Vaccination failure was also reported. SARS-CoV-2 test was performed, with positive result. No information disclosed about treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in an adult male 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 dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.        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. Treatment information was not provided.  The HCP explained that 3 months after his father got injured from the vaccine, the son of doctor 2, who was young and healthy, decided to get the vaccine despite his dad having cardiac issues and then he had a heart attack that day and died five days later. Company Comment: This is a spontaneous case concerning an adult male patient with no reported medical history, who experienced the serious (due to medically significant) Fatal, unexpected, AESI event of myocardial infarction, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-751774 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2023: Live significant follow-up received, contains event and death information added, narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751774:Different patient same product (doctor OB/GYN); Reported Cause(s) of Death: heart attack
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: caller mentioned the patient had an immediate cardiac reaction after the vaccine requiring hospitalization; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC DISORDER (caller mentioned the patient had an immediate cardiac reaction after the vaccine requiring hospitalization) in a 62-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 dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (caller mentioned the patient had an immediate cardiac reaction after the vaccine requiring hospitalization) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (caller mentioned the patient had an immediate cardiac reaction after the vaccine requiring hospitalization) had not 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.   Concomitant and treatment medications were not reported.  The patient had an immediate cardiac reaction after the vaccine requiring hospitalization and was forced to retire as a pediatrician, and she was still having health issues.  Company comment: This spontaneous case concerns a 62-year-old female patient, with no medical history reported, who experienced the unexpected, serious (hospitalization) event of cardiac disorder in context of SPIKEVAX 2023-2024 dose administration, which unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to event and vaccination date dates unknown, however, it was reported that the event happened immediately after vaccination. The course of events was reported as an immediate cardiac reaction after the vaccine requiring hospitalization. The patient was forced to retire as a pediatrician and was still having health issues. No further clinical information or details on medical history, concomitant medications, clinical course with type of cardiac reaction with hospitalization details, etiologic and diagnostic work up, treatment were provided for medical review. Event outcome was not recovered at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-751774.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2023: Live significant follow-up received: Patient details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751774:Different patient same product (doctor OB/GYN)
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Pyrexia
Clinical narrative: today has a temp of 99.5, joint aches, chills, and weakness; today has a temp of 99.5, joint aches, chills, and weakness.; today has a temp of 99.5, joint aches, chills, and weakness; today has a temp of 99.5, joint aches, chills, and weakness; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (today has a temp of 99.5, joint aches, chills, and weakness), ARTHRALGIA (today has a temp of 99.5, joint aches, chills, and weakness.), CHILLS (today has a temp of 99.5, joint aches, chills, and weakness) and PYREXIA (today has a temp of 99.5, joint aches, chills, and weakness) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Biontech COVID-19 vaccine (Dose 1) on 18-Jan-2021, Pfizer Biontech COVID-19 vaccine (Dose 2) on 06-Feb-2021, Pfizer Biontech COVID-19 vaccine (Dose 3) on 23-Aug-2021, Pfizer Biontech COVID-19 vaccine (Dose 4) on 01-Mar-2022, Pfizer Biontech COVID-19 vaccine (Dose 5) on 29-Sep-2022 and Flu. Past adverse reactions to the above products included No adverse event with Flu, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine. Concurrent medical conditions included Kidney disorder.    On 29-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Nov-2023, the patient experienced ASTHENIA (today has a temp of 99.5, joint aches, chills, and weakness), ARTHRALGIA (today has a temp of 99.5, joint aches, chills, and weakness.), CHILLS (today has a temp of 99.5, joint aches, chills, and weakness) and PYREXIA (today has a temp of 99.5, joint aches, chills, and weakness). At the time of the report, ASTHENIA (today has a temp of 99.5, joint aches, chills, and weakness), ARTHRALGIA (today has a temp of 99.5, joint aches, chills, and weakness.), CHILLS (today has a temp of 99.5, joint aches, chills, and weakness) and PYREXIA (today has a temp of 99.5, joint aches, chills, and weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Dyspepsia, Hypothyroidism
Clinical narrative: hypothyroidism; Hashimotos; Digestive issues; This spontaneous case was reported by a patient and describes the occurrence of HYPOTHYROIDISM (hypothyroidism) and AUTOIMMUNE THYROIDITIS (Hashimotos) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 045C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPOTHYROIDISM (hypothyroidism) (seriousness criterion medically significant), AUTOIMMUNE THYROIDITIS (Hashimotos) (seriousness criterion medically significant) and DYSPEPSIA (Digestive issues). At the time of the report, HYPOTHYROIDISM (hypothyroidism), AUTOIMMUNE THYROIDITIS (Hashimotos) and DYSPEPSIA (Digestive issues) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient got two shots. They have had health problems ever since they got the vaccines. Caller has Hashimotos, hypothyroidism, digestive issues. Hashimotos was an autoimmune disease and it's destroyed his immune system. Caller says it was about a month later after their second dose, they had their usual 6 month check ups and they had all kinds of new stuff. Company comment: This spontaneous case concerns a 73-year-old male patient, with no medical history reported, who experienced the unexpected, serious (medically significant) events of autoimmune thyroiditis (AESI) and hypothyroidism after receiving the dose of mRNA-1273 vaccine which was described as 2nd dose in Covid-19 vaccination schedule. Latency cannot be calculated due to events onset dates unknown. 1st dose of Covid vaccination schedule was performed with mRNA-1273 with interval between 1st and 2nd dose of 27 days apart. It was reported that events were diagnosed app. a month after the second dose during the usual biannual health check-up. No further details regarding clinical course, etiologic and diagnostic work-up and treatment are available for the review. Events outcome was not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rash pruritic
Clinical narrative: random Itchy and raised areas on different body parts/ random outbreak and Itchy-rash; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (random Itchy and raised areas on different body parts/ random outbreak and Itchy-rash) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccines (previously had Pfizer COVID-19 vaccines and last Pfizer shot was in 2021.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccines. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced RASH PRURITIC (random Itchy and raised areas on different body parts/ random outbreak and Itchy-rash). At the time of the report, RASH PRURITIC (random Itchy and raised areas on different body parts/ random outbreak and Itchy-rash) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that one week later, patient started having random Itchy and raised areas on different body parts. The itchy, raised area were on the hips and body. They were random on arm, lower feet. Sometimes back and on the reporting week it was on patient's breast area. They were kind of raised. Patient was waiting for the dermatologist to review all the little scabs she got from itching and stuff. Patient was concerned about the random outbreak and Itchy-rash. Patient had not used any type of medication to alleviate itchy raised area until the time of report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Sinus pain, Toothache
Clinical narrative: Approximately 5 minutes after taking the shot I experienced a feeling of being unwell; Several minutes afterwards I experienced a severe toothache; Advised by Denist that most likely sinus pain; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Approximately 5 minutes after taking the shot I experienced a feeling of being unwell), TOOTHACHE (Several minutes afterwards I experienced a severe toothache) and SINUS PAIN (Advised by Denist that most likely sinus pain) in an 80-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Nov-2023, the patient experienced MALAISE (Approximately 5 minutes after taking the shot I experienced a feeling of being unwell), TOOTHACHE (Several minutes afterwards I experienced a severe toothache) and SINUS PAIN (Advised by Denist that most likely sinus pain). At the time of the report, MALAISE (Approximately 5 minutes after taking the shot I experienced a feeling of being unwell), TOOTHACHE (Several minutes afterwards I experienced a severe toothache) and SINUS PAIN (Advised by Denist that most likely sinus pain) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered MALAISE (Approximately 5 minutes after taking the shot I experienced a feeling of being unwell), TOOTHACHE (Several minutes afterwards I experienced a severe toothache) and SINUS PAIN (Advised by Denist that most likely sinus pain) to be related.    No concomitant medications were reported. Several minutes afterwards patient experienced a severe toothache which took about 4 hours to moderate and since it was Friday late on holiday weekend, Next morning pain was torable and remained so until visited dentist on Monday. The dentist was advised that most likely sinus pain and treated with over counter mess and recovering nicely. Hard to believe that this not related to Spikevax shot given how quickly it appeared after the shot was administered. patient also had no history of sinus issues. It was unknown if the patient experienced any additional symptoms/events. No treatment medication details were provided.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold; COVID-19 twice, he tested positive; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 twice, he tested positive) and NASOPHARYNGITIS (cold) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1, lot number 013L20A) on 14-Jan-2021, MODERNA COVID-19 VACCINE (Dose 2, lot number 010M20A) on 11-Feb-2021, MODERNA COVID-19 VACCINE (Dose 3, lot number 062E21A) on 01-Sep-2021, MODERNA COVID-19 VACCINE (Dose 4, lot number 002M21A) on 30-Mar-2022, MODERNA COVID-19 VACCINE (Dose 5 and lot number AS7144B) on 07-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 04-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In May 2023, the patient experienced COVID-19 (COVID-19 twice, he tested positive). In November 2023, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, COVID-19 (COVID-19 twice, he tested positive) and NASOPHARYNGITIS (cold) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2023, SARS-CoV-2 test: Positive.     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 got COVID-19 twice, the first time he got it approximately 1 week after getting the last Moderna COVID-19 shot, and he had mild symptoms. The second time he got COVID-19, he tested positive on 8 NOV2023 and had also mild symptoms. Currently he only feels periodically like having a col.  Treatment medication was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: confusion; trouble breathing; head and body aches; chills; low fever/fever 103.1 degrees; 36 hrs after nausea; head and body aches; Tired; This spontaneous case was reported by a patient and describes the occurrence of CONFUSIONAL STATE (confusion), DYSPNOEA (trouble breathing), PAIN (head and body aches), CHILLS (chills) and PYREXIA (low fever/fever 103.1 degrees) in a 75-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.     Patient had strong reactions to every vaccine that was received, but not just Covid. This was the worst ever.  The patient's past medical history included Vaccination adverse reaction, Lupus erythematosus systemic (Went into remission in 60`s.) and Joint replacement (Four major joints were replaced at the age of 59.). Concurrent medical conditions included COPD, Renal disorder, Immune disorder (NOS), Osteoarthritis and Rheumatoid arthritis.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Nov-2023, the patient experienced CONFUSIONAL STATE (confusion), DYSPNOEA (trouble breathing), PAIN (head and body aches), NAUSEA (36 hrs after nausea) and HEADACHE (head and body aches). 16-Nov-2023, the patient experienced CHILLS (chills), PYREXIA (low fever/fever 103.1 degrees) and FATIGUE (Tired). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; OXYCODONE for Pain, at a dose of 5 milligram and DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) at a dose of 150 milligram. At the time of the report, CONFUSIONAL STATE (confusion), DYSPNOEA (trouble breathing), PAIN (head and body aches), CHILLS (chills), PYREXIA (low fever/fever 103.1 degrees), NAUSEA (36 hrs after nausea), HEADACHE (head and body aches) and FATIGUE (Tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.1 degrees.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that 12 hrs after dose patient was tired, chills low fever; 36 hrs after nausea, head and body aches, fever 103.1 degrees, trouble breathing, confusion: next 10 hrs in ER at local hospital, fever reduced taking Zofran for nausea and using oxygen to help breathing This continued for 3 more days. Fever down still achy, tired, nausea and headache. The patient did not experience any additional symptoms/events. Ibuprofen was given at ER and patient was usually taking an antidepressant of Pristiq.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: confusion; trouble breathing; head and body aches; chills; low fever/fever 103.1 degrees; 36 hrs after nausea; head and body aches; Tired; This spontaneous case was reported by a patient and describes the occurrence of CONFUSIONAL STATE (confusion), DYSPNOEA (trouble breathing), PAIN (head and body aches), CHILLS (chills) and PYREXIA (low fever/fever 103.1 degrees) in a 75-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.     Patient had strong reactions to every vaccine that was received, but not just Covid. This was the worst ever.  The patient's past medical history included Vaccination adverse reaction, Lupus erythematosus systemic (Went into remission in 60`s.) and Joint replacement (Four major joints were replaced at the age of 59.). Concurrent medical conditions included COPD, Renal disorder, Immune disorder (NOS), Osteoarthritis and Rheumatoid arthritis.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Nov-2023, the patient experienced CONFUSIONAL STATE (confusion), DYSPNOEA (trouble breathing), PAIN (head and body aches), NAUSEA (36 hrs after nausea) and HEADACHE (head and body aches). 16-Nov-2023, the patient experienced CHILLS (chills), PYREXIA (low fever/fever 103.1 degrees) and FATIGUE (Tired). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; OXYCODONE for Pain, at a dose of 5 milligram and DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) at a dose of 150 milligram. At the time of the report, CONFUSIONAL STATE (confusion), DYSPNOEA (trouble breathing), PAIN (head and body aches), CHILLS (chills), PYREXIA (low fever/fever 103.1 degrees), NAUSEA (36 hrs after nausea), HEADACHE (head and body aches) and FATIGUE (Tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.1 degrees.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that 12 hrs after dose patient was tired, chills low fever; 36 hrs after nausea, head and body aches, fever 103.1 degrees, trouble breathing, confusion: next 10 hrs in ER at local hospital, fever reduced taking Zofran for nausea and using oxygen to help breathing This continued for 3 more days. Fever down still achy, tired, nausea and headache. The patient did not experience any additional symptoms/events. Ibuprofen was given at ER and patient was usually taking an antidepressant of Pristiq.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia
Clinical narrative: dhiarrea; body aches; headache; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (dhiarrea), MYALGIA (body aches) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 01-Dec-2023, the patient experienced DIARRHOEA (dhiarrea), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, DIARRHOEA (dhiarrea), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            It was unknown that patient experienced any additional symptoms/events.  No concomitant medication was reported.  No treatment medication was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "PBC" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "lymphoma remission", start date: Jul2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 14Nov2023 to 18Nov2023. Clinical course: Patient had no known allergies. Patient reported that retesting was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300418584 Same patient, different drug, different event;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid (indication: Covid-19 Treatment); Paxlovid (indication: Covid-19 Treatment); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Paxlovid (indication: Covid-19 Treatment)". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid on 28Nov2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: it became Covid/caught Covid last week; it became Covid/caught Covid last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing), notes: He has had Covid twice before: Jan2021; "Covid-19", start date: Jun2021 (unspecified if ongoing), notes: He has had Covid twice before: Jun2021. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "it became Covid/caught Covid last week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2021) Positive, notes: He has had Covid twice before: Jan2021; (Jun2021) Positive, notes: He has had Covid twice before: Jun2021. Therapeutic measures (paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated he has had two vaccines and two boosters, mostly Pfizer vaccines. Last dose might have been Moderna but he was not certain. He did not had the most recent dose of the Pfizer Covid 19 vaccine due to having a head cold before it became Covid. He believes he must have caught Covid last week. He had Covid twice before: Jan2021 and Jun2021. His symptoms were most severe the first time, not as severe the second time, and were mild this time. He took Paxlovid twice before as well with the infections in Jan and June of 2021.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300419121 Same reporter, Patient / Different AE, product;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Day 9 antigen test negative/Vaccination failure; Day 9 antigen test negative/COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Nov2023, outcome "recovered" (Nov2023), described as "Day 9 antigen test negative/COVID-19"; VACCINATION FAILURE (medically significant) with onset Nov2023, outcome "recovered" (Nov2023), described as "Day 9 antigen test negative/Vaccination failure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 18Nov2023 to 22Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300419159 same patient/drug, different dose/events;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vaccination w Pfizer caught COVID 6 days then rebound/Drug ineffective; Vaccination w Pfizer caught COVID 6 days then rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "Vaccination w Pfizer caught COVID 6 days then rebound"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", described as "Vaccination w Pfizer caught COVID 6 days then rebound/Drug ineffective". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300419230 Same patient different product and events;