chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the bivalent booster as a first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose).    No concomitant medications were reported.  No treatment medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: excruciating pain in her left arm, right between her shoulder and elbow; she was not even able to rise her arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in her left arm, right between her shoulder and elbow) and MOBILITY DECREASED (she was not even able to rise her arms) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21B, 050A22A, 002A21A and 030M20A) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.  The patient's past medical history included Pacemaker insertion (cardiac) (heart issues (pacemaker), No recent change in status, since 5 years ago). Concurrent medical conditions included Arthritis (since a long time ago, No recent change in status), Restless leg syndrome (in her 20's, No recent change in status), Raynaud's disease (since 20 years ago, No recent change in status), Blood pressure high (since 20 years ago, No recent change in status), Colitis (since 4 years ago, No recent change in status), Narcolepsy (since 3 years ago, No recent change in status), Allergic sinusitis (sinus allergies) and Heart disease, unspecified (Heart issues, No recent change in status, since 5 years ago).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain in her left arm, right between her shoulder and elbow) and MOBILITY DECREASED (she was not even able to rise her arms). At the time of the report, PAIN IN EXTREMITY (excruciating pain in her left arm, right between her shoulder and elbow) and MOBILITY DECREASED (she was not even able to rise her arms) had not resolved.            Patient mentioned after 1st and 2nd dose did not experienced any symptoms but shortly after 1st booster started experiencing such an excruciating pain in the left arm, right between the shoulder and elbow, patient was not even able to rise the arms and doctor advised to go to physical therapy but it had gotten worse instead of improving. Patient mentioned had arthritis but doctors made studies and mentioned that pain had nothing to do with the disease and it was maybe due to the vaccine. Pain was still ongoing. Patient was under a lot of regular medications but did not wanted to provide names. No treatment had been given for the symptoms.  The patient did not experience a similar event in the past. The events caused patient to seek medical care.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Illness
Clinical narrative: Had COVID 4 times; Sick; Feeling bad/felt like profanity; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID 4 times), ILLNESS (Sick) and FEELING ABNORMAL (Feeling bad/felt like profanity) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (Feeling bad/felt like profanity). On an unknown date, the patient experienced COVID-19 (Had COVID 4 times) and ILLNESS (Sick). In November 2021, FEELING ABNORMAL (Feeling bad/felt like profanity) had resolved. At the time of the report, COVID-19 (Had COVID 4 times) and ILLNESS (Sick) outcome was unknown.            Concomitant medication list was not provided. The reporter stated that they were shooting people up with profanity drugs that don't work. The first two that the reporter got had not really worked. The reporter got the first one, felt like profanity for two weeks, then felt fine for two weeks, and then went and got the second one, felt like profanity for two weeks. Reporter also asked how get in contact with the legal department and was gonna sue. Complaint title was lack of efficacy. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up was received on 17-Oct-2022. QE-022683, QE-022708 numbers was added.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced PAIN IN EXTREMITY (Pain in her arm). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) had not resolved.            It was reported as unknown if patient was under any concomitant or regular medication, or under any treatment for her symptom. No concomitant medication was not reported. No treatment medication was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: mild left arm soreness; mild left arm redness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (mild left arm soreness) and VACCINATION SITE ERYTHEMA (mild left arm redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030L20AH) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (mild left arm soreness) and VACCINATION SITE ERYTHEMA (mild left arm redness). At the time of the report, VACCINATION SITE PAIN (mild left arm soreness) and VACCINATION SITE ERYTHEMA (mild left arm redness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was reported by a physician (patient's husband).  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-660549, MOD-2022-660557, MOD-2022-660560, MOD-2022-660563 (Patient Link).
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered).    No concomitant product reported by reporter. Patient received Moderna COVID-19 vaccine with Blue Capped Purple-Bordered (Ages 6-11 years Monovalent) instead of Blue Capped Gray-Bordered (Ages 6 and older BIVALENT) doses. No treatment medication reported by reporter.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine).    No concomitant product use was reported.   On 14-Oct-2022, a dosing error occurred with a couple of patients. Doses of Blue capped purple-bordered (Ages 6-11 MONOVALENT) given instead of Blue capped gray-bordered (Ages 6 and older BIVALENT) booster doses.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659880:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Illness, Immunisation reaction, Influenza
Clinical narrative: Total Blowout flu; Bedridden for three days; Sick; Serious diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Total Blowout flu), IMMUNISATION REACTION (Bedridden for three days), ILLNESS (Sick), DIARRHOEA (Serious diarrhea) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Total Blowout flu), IMMUNISATION REACTION (Bedridden for three days), ILLNESS (Sick), DIARRHOEA (Serious diarrhea) and CHILLS (Chills). At the time of the report, INFLUENZA (Total Blowout flu), IMMUNISATION REACTION (Bedridden for three days), ILLNESS (Sick), DIARRHOEA (Serious diarrhea) and CHILLS (Chills) outcome was unknown.            No concomitant medication information was provided.  It was reported that after vaccination, as week later the side effects were horrendous. It was reported that the patient did not like Pfizer, patient preferred Moderna.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: was positive for Covid-19 in June 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (was positive for Covid-19 in June 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In January 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (was positive for Covid-19 in June 2022). At the time of the report, COVID-19 (was positive for Covid-19 in June 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant information were reported by the reporter.  No treatment information were reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.; Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.).    Concomitant medications details were not reported by the reporter. Patient received first Primary Series dose of the Moderna vaccine on 22-FEB-2022,  lot number 083521A  expiration date 2-MAY-2022. Patient received the vaccine in left arm,  no adverse events were reported. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster).    This case contains information on 2nd of 6th adult patients as described by the reporter.   No concomitant medications were reported. It was reported that 6 Adult patients were received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial (Lot no AR6965B & Expiration Date unknown).  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow-up received : Narrative updated and initial version was captured to 17OCT2022. On 17-Oct-2022: Live follow-up received and narrative updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing loss; This spontaneous case was reported by a nurse and describes the occurrence of DEAFNESS (Hearing loss) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Adenocarcinoma (Lobectomy for adenocarcinoma) in 2017.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Within a few weeks of first shot with Moderna vaccine, patient had some hearing loss. Some of the patient's friends experienced the same thing.  Company Comment: This spontaneous case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of deafness. The event occurred unknown number of days after receiving the first dose of the mRNA-1273 original vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that within a few weeks after vaccination, the patient had some hearing loss. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.   This case was linked to MOD-2022-660854 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of deafness. The event occurred unknown number of days after receiving the first dose of the mRNA-1273 original vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that within a few weeks after vaccination, the patient had some hearing loss. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Deep vein thrombosis, Fibrin D dimer increased, Ultrasound Doppler abnormal
Clinical narrative: Moderna Bivalent Vaccine and flu vaccin 10/2/2022 Patient on Yaz oral contraceptive for years Presents with DVT
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Deep vein thrombosis
Clinical narrative: Moderna Bivalent Vaccine and flu vaccin 10/2/2022 Patient on Yaz oral contraceptive for years Presents with DVT
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Cardiac disorder, Cerebral disorder, Myalgia
Clinical narrative: brain problems; cardiac problems; Bone pain; Muscle pain; Joint pain; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL DISORDER (brain problems), CARDIAC DISORDER (cardiac problems), BONE PAIN (Bone pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL DISORDER (brain problems), CARDIAC DISORDER (cardiac problems), BONE PAIN (Bone pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, CEREBRAL DISORDER (brain problems), CARDIAC DISORDER (cardiac problems), BONE PAIN (Bone pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.            Concomitant medication was not reported. Patient still having adverse reactions to that shot (almost a year). Doctors don't know anything or refused to see the patient, the cardiac Doctor said that patient was one of the lucky one, they had saw people who was dead from it. Patient almost ready to try Ivermectin (the horse med).  Treatment drug was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Patient's lips went numb; Felt strange; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Patient's lips went numb) and FEELING ABNORMAL (Felt strange) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Patient's lips went numb) and FEELING ABNORMAL (Felt strange). At the time of the report, HYPOAESTHESIA ORAL (Patient's lips went numb) and FEELING ABNORMAL (Felt strange) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 03-Oct-2022, it was reported that a patient started treatment on an unspecified date with Moderna COVID-19 Vaccine at dose 1 for an unspecified indication. It was reported the patient's lips went numb and felt strange.   Treatment information was not provided.   Reporter did not allow further contact
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: COVID vaccine that was given to the patient ended up being expired.
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Asthenia, Fatigue, Headache, Nausea, Product administered to patient of inappropriate age
Clinical narrative: Pfizer COVID-19 Bivalent Booster 12+ dose given to child under 12. Side effects began 12 hours later - fever, headache, fatigue, weakness, nausea - and mainly resolved around 48 hours later.
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Pfizer COVID-19 Bivalent Booster 12+ dose given to child under 12. Side effects began 12 hours later - fever, headache, fatigue, weakness, nausea - and mainly resolved around 48 hours later.
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Pfizer COVID-19 Bivalent Booster 12+ dose given to child under 12. Side effects began 12 hours later - fever, headache, fatigue, weakness, nausea - and mainly resolved around 48 hours later.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pfizer COVID-19 Bivalent Booster 12+ dose given to child under 12. Child experienced headache and fatigue 36-48 hours after vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 030M20A, 037C21A and 005M21A) for COVID-19 vaccination.     Concurrent medical conditions included Exposure to poison ivy (Poison ivy), Latex allergy and Adhesive tape allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and TRAZODONE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: (Negative) Negative.  The patient was ready to get new booster. The patient got COVID-19 for her daughter, son-in-law and granddaughter who came from a trip.  The height was 152.4 cm 95 feet).  The patient had no history relating to mentioned AE and both acute and chronic illness.   This case was linked to MOD-2022-660892, MOD-2022-660889 (Patient Link).
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Pain, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Arm pain that moved to shoulder. I currently still have should pain, especially with movement. Was send at Dr. office for treatment on 10/4/22. Was prescribed Naproxen 500mg. It didn't work. As I started I still have the shoulder pain. I have  SIRVA.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Nausea, Pain, Pyrexia
Clinical narrative: Fever, trembling, stomach ache, nausea, severe body ache, loss of appetite.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Fever, trembling, stomach ache, nausea, severe body ache, loss of appetite.
Age: 38.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: 10 days after second Moderna boaster, itchy hives appear on neck, ear, back, arm, legs, buttocks. Similar to Dermatographia, but not raised skin. Took Zyrtec and helped all day, when worn out a night, used cortizone cream.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Dermatitis atopic, Food allergy, Hypersensitivity, Immunisation reaction
Clinical narrative: Patient reports adverse reaction to Moderna Covid vaccine with significant persistent rash lasting several months for which patient had to go to the emergency treatment two times in April and May. Pt stated that symptoms began 10 days after vaccination. She eventually had to lose her job due to stress from the adverse reaction. Pt also has had to quit various foods as she continued to get exacerbation of skin conditions. Food allergy testing negative.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Rash, Skin disorder, Stress
Clinical narrative: Patient reports adverse reaction to Moderna Covid vaccine with significant persistent rash lasting several months for which patient had to go to the emergency treatment two times in April and May. Pt stated that symptoms began 10 days after vaccination. She eventually had to lose her job due to stress from the adverse reaction. Pt also has had to quit various foods as she continued to get exacerbation of skin conditions. Food allergy testing negative.
Age: 23.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: Large red localized reaction an inch below vaccination site. Has continued to grow in size even after taking a Benadryl and Advil.   Reaction looks somewhat like cellulitis.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: He started having discomfort on the left chest, around the heart area; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (He started having discomfort on the left chest, around the heart area) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 042L20A, 065F21A and 045L21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (10 years ago, Taking Inhalers) and Blood pressure high (diagnosed about 25 years ago under control with HBP medicine.). Concomitant products included CHLORTALIDONE (CHLORTHALIDONE), LISINOPRIL, TERAZOSIN, BISOPROLOL, SPIRONOLACTONE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and CICLESONIDE (ALVESCO) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHEST DISCOMFORT (He started having discomfort on the left chest, around the heart area). At the time of the report, CHEST DISCOMFORT (He started having discomfort on the left chest, around the heart area) outcome was unknown.            It was reported that patient started having discomfort on the left chest, around the heart area. Doctor did not find anything. The doctor reduced his blood pressure medications. He stated that his COPD and Blood pressure did not get any better or worst after vaccination.    This case was linked to MOD-2022-660909 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 012N20A and 012L20A) for COVID-19 vaccination.     Patient did not have any allergies.  Concurrent medical conditions included Blood pressure high. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         Patient was taking unspecified high blood pressure pill medication.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (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.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient birth year was reported.  No concomitant product use was reported.   Reporter stated that got the Covid for son-in-law who came from a trip. The patient was vaccinated but reporter was not sure whether it was Moderna or Pfizer that the patient got.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660892, US-MODERNATX, INC.-MOD-2022-660893, US-MODERNATX, INC.-MOD-2022-660877. Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660892:Daughter case US-MODERNATX, INC.-MOD-2022-660893:Granddaughter case US-MODERNATX, INC.-MOD-2022-660877:Reporters case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy
Clinical narrative: Covid-19; Pregnant when given the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when given the vaccine) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (Covid-19) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when given the vaccine). At the time of the report, COVID-19 (Covid-19) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when given the vaccine) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Relevant concomitant and treatment medications were not reported.  Company Comment:  This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected, non-serious  event of Maternal exposure during pregnancy (reported as Pregnant when given the vaccine) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency for the event could not be determined as both the dates of vaccine administration and onset date of event were not disclosed.  Last menstrual period, estimated date of delivery, pregnancy test, and ultrasound dating of gestational age were not reported.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-660893, US-MODERNATX, INC.-MOD-2022-660889, US-MODERNATX, INC.-MOD-2022-660877 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected, non-serious  event of Maternal exposure during pregnancy (reported as Pregnant when given the vaccine) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency for the event could not be determined as both the dates of vaccine administration and onset date of event were not disclosed.  Last menstrual period, estimated date of delivery, pregnancy test, and ultrasound dating of gestational age were not reported.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: Covid-19; Patient had 6 days of fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) and PYREXIA (Patient had 6 days of fever) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19) and PYREXIA (Patient had 6 days of fever). At the time of the report, COVID-19 (Covid-19) outcome was unknown and PYREXIA (Patient had 6 days of fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.   Reporter stated that she got the Covid for the patient who came from a trip. Patient was vaccinated however the reporter was not sure whether it was Moderna or Pfizer  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660892, US-MODERNATX, INC.-MOD-2022-660889 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660892:daughter case US-MODERNATX, INC.-MOD-2022-660889:son-in-lawcase
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient was generally very healthy.  Concurrent medical conditions included High cholesterol (High cholesterol). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, ROSUVASTATIN for High cholesterol.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 29-Apr-2022 for COVID-19, at a dose of 3 pills twice a day. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive. On 16-Oct-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the first booster of Moderna vaccine and second booster of Pfizer anti-COVID vaccine.  The patient tested positive for COVID-19 for the second time and was previously treated with Paxlovid, a miracle drug as described by the patient and needed to receive a second course of Paxlovid therapy.  The patient had COVID-19 following a family funeral. The patient tested positive on Sunday and tried calling in to get prescription for another course of Paxlovid and was then told that the patient could not be prescribed Paxlovid for the second time.  The reporter could not find anything online for the reason why Paxlovid could not be prescribed more than once. The reporter was then going to question the pharmacist about this.  The reporter and the patient both planned on getting the new bivalent vaccine booster at the end of this month or beginning of next month when getting flu shots.   This case was linked to US-MODERNATX, INC.-MOD-2022-660899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660899:same reporter, wife case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: no adverse event; Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator; Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (no adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. o13B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator). On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator).    Concomitant products were not reported.  It was reported that on 14-Oct-2022, the temperature went for vial up to 8.2C for 1 minute. There has not been a previous excursion. The vial was moved from Freezer to the refrigerator on 13-Oct-2022. The patient received 1 Booster Dose on Monday 17-Oct-2022 and the vial was discarded within 12 hours after first puncture. Storage condition at the time of excursion was reported as refrigerated. Vial size was 2.5ml. The maximum temperature reached was 8.2c. Visual inspection of the vial was normal.    No treatment medicine was reported.