chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Received Moderna Covid 19 Bivalent booster as a primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-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 02-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series) 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 (Received Moderna Covid 19 Bivalent booster as a primary series).    No concomitant medication were reported. Pharmacist stated that on they accidentally provided Moderna Covid19 Bivalent vaccine as a primary series instead of a booster. No treatment information was provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-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 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary 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 Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medication was reported.   No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Immunisation reaction, Influenza like illness, Mobility decreased
Clinical narrative: Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction; arm was so sore/ Leg pain; could not lift it; flu like symptoms; could not get out of bed; general aches; nausea; general fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction), PAIN IN EXTREMITY (arm was so sore/ Leg pain), MOBILITY DECREASED (could not lift it), INFLUENZA LIKE ILLNESS (flu like symptoms) and BEDRIDDEN (could not get out of bed) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction), PAIN IN EXTREMITY (arm was so sore/ Leg pain), MOBILITY DECREASED (could not lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (could not get out of bed), MYALGIA (general aches), NAUSEA (nausea) and FATIGUE (general fatigue). At the time of the report, IMMUNISATION REACTION (Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction), PAIN IN EXTREMITY (arm was so sore/ Leg pain), MOBILITY DECREASED (could not lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (could not get out of bed), MYALGIA (general aches), NAUSEA (nausea) and FATIGUE (general fatigue) outcome was unknown.            No concomitant drug were reported.   Patient experienced the side effects from Moderna vaccine but a milder version. Patient has not had any problem with any of them except last one. Patient has not taken any medication.   This case was linked to US-MODERNATX, INC.-MOD-2022-666600 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666600:Wife case
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction; arm was so sore/ Leg pain; could not lift it; flu like symptoms; could not get out of bed; general aches; nausea; general fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction), PAIN IN EXTREMITY (arm was so sore/ Leg pain), MOBILITY DECREASED (could not lift it), INFLUENZA LIKE ILLNESS (flu like symptoms) and BEDRIDDEN (could not get out of bed) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction), PAIN IN EXTREMITY (arm was so sore/ Leg pain), MOBILITY DECREASED (could not lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (could not get out of bed), MYALGIA (general aches), NAUSEA (nausea) and FATIGUE (general fatigue). At the time of the report, IMMUNISATION REACTION (Caller's husband is experiencing the same side effects from the Moderna vaccine but a milder version, really bad reaction), PAIN IN EXTREMITY (arm was so sore/ Leg pain), MOBILITY DECREASED (could not lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (could not get out of bed), MYALGIA (general aches), NAUSEA (nausea) and FATIGUE (general fatigue) outcome was unknown.            No concomitant drug were reported.   Patient experienced the side effects from Moderna vaccine but a milder version. Patient has not had any problem with any of them except last one. Patient has not taken any medication.   This case was linked to US-MODERNATX, INC.-MOD-2022-666600 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666600:Wife case
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; 2nd primary dose given on day 21; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose given on day 21) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose given on day 21). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose given on day 21) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Patient was Pediatric.  No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Psoriasis
Clinical narrative: Not doing well medically; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not doing well medically) and PSORIASIS (Psoriasis) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination, USTEKINUMAB (STELARA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. On an unknown date, received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient experienced MALAISE (Not doing well medically) and PSORIASIS (Psoriasis). At the time of the report, MALAISE (Not doing well medically) and PSORIASIS (Psoriasis) outcome was unknown.            The data for Moderna Covid 19 Vaccine was reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event of Not doing well medically and Psoriasis unknown onset with Humira was Not Provided.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Moderna Bivalent vaccine have been used to administer a second dose to a patient instead of monovalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent vaccine have been used to administer a second dose to a patient instead of monovalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent vaccine have been used to administer a second dose to a patient instead of monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent vaccine have been used to administer a second dose to a patient instead of monovalent) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent vaccine have been used to administer a second dose to a patient instead of monovalent).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 13.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; A 13-year-old patient has received 0.25mL vaccine instead of 0.5mL vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (A 13-year-old patient has received 0.25mL vaccine instead of 0.5mL vaccine) and NO ADVERSE EVENT (No adverse event) in a 13-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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) .25 milliliter. On 29-Oct-2022, the patient experienced UNDERDOSE (A 13-year-old patient has received 0.25mL vaccine instead of 0.5mL vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (A 13-year-old patient has received 0.25mL vaccine instead of 0.5mL vaccine) 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 UNDERDOSE (A 13-year-old patient has received 0.25mL vaccine instead of 0.5mL vaccine).    No concomitant medications was reported. No treatment drug details was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERTENSION (top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051022A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer CIVID-19 Vaccine (previous doses). Past adverse reactions to the above products included No adverse event with Pfizer CIVID-19 Vaccine. Concurrent medical conditions included Diabetes.    On 25-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 26-Oct-2022, the patient experienced HYPERTENSION (top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.). At the time of the report, HYPERTENSION (top part of blood pressure was high,it was 222 and when we got home it was 229/72 and has been high since.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, Blood pressure measurement: All was good. On 26-Oct-2022, Blood pressure measurement: 222 blood pressure was high and 229/72 has been high since..         Concomitant medications details were not reported by the reporter. On Wednesday, 26Oct2022, after the vaccination patient met with neurologist and top part of blood pressure was high, it was 222 and when patient and his wife got home it was 229/72 and has been high since. On 24-OCT-2022, Patient had A1C blood test and it was good. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666723:Same reporter (Wife Case)
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Patient was tired the next day; sore left arm, not as bad as the first two shots; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots) and FATIGUE (Patient was tired the next day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 008B21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots). On 29-Oct-2021, the patient experienced FATIGUE (Patient was tired the next day). At the time of the report, VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots) and FATIGUE (Patient was tired the next day) outcome was unknown.      Concomitant medications included unspecified High cholesterol medications.  No treatment medications were reported.   This case was linked to MOD-2022-666798, MOD-2022-666783 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Patient was tired the next day; sore left arm, not as bad as the first two shots; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots) and FATIGUE (Patient was tired the next day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 008B21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots). On 29-Oct-2021, the patient experienced FATIGUE (Patient was tired the next day). At the time of the report, VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots) and FATIGUE (Patient was tired the next day) outcome was unknown.      Concomitant medications included unspecified High cholesterol medications.  No treatment medications were reported.   This case was linked to MOD-2022-666798, MOD-2022-666783 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: achy for a day or two / achy; left arm was sore / sore left arm; tired / felt tired; some chills / had some chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (achy for a day or two / achy), VACCINATION SITE PAIN (left arm was sore / sore left arm), FATIGUE (tired / felt tired) and CHILLS (some chills / had some chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (achy for a day or two / achy), VACCINATION SITE PAIN (left arm was sore / sore left arm), FATIGUE (tired / felt tired) and CHILLS (some chills / had some chills). At the time of the report, MYALGIA (achy for a day or two / achy), VACCINATION SITE PAIN (left arm was sore / sore left arm), FATIGUE (tired / felt tired) and CHILLS (some chills / had some chills) outcome was unknown.            Concomitant medications reported included unspecified High blood cholesterol treatment medications. After first dose patient reported Adverse Reactions of achy for a day or two, along with sore left arm, tiredness and chills. After second dose patient reported Adverse Reactions of achy, along with sore left arm, tiredness and chills. No treatment medications were reported.   This case was linked to MOD-2022-666783, MOD-2022-666790 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: achy for a day or two / achy; left arm was sore / sore left arm; tired / felt tired; some chills / had some chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (achy for a day or two / achy), VACCINATION SITE PAIN (left arm was sore / sore left arm), FATIGUE (tired / felt tired) and CHILLS (some chills / had some chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (achy for a day or two / achy), VACCINATION SITE PAIN (left arm was sore / sore left arm), FATIGUE (tired / felt tired) and CHILLS (some chills / had some chills). At the time of the report, MYALGIA (achy for a day or two / achy), VACCINATION SITE PAIN (left arm was sore / sore left arm), FATIGUE (tired / felt tired) and CHILLS (some chills / had some chills) outcome was unknown.            Concomitant medications reported included unspecified High blood cholesterol treatment medications. After first dose patient reported Adverse Reactions of achy for a day or two, along with sore left arm, tiredness and chills. After second dose patient reported Adverse Reactions of achy, along with sore left arm, tiredness and chills. No treatment medications were reported.   This case was linked to MOD-2022-666783, MOD-2022-666790 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: The patient only received about 75 percent of the injection; Injecting the Moderna bivalent booster the needle leaked out; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The patient only received about 75 percent of the injection), DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (The patient only received about 75 percent of the injection), DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient only received about 75 percent of the injection), DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out) 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 UNDERDOSE (The patient only received about 75 percent of the injection) and DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out).    The concomitant and treatment medication was not reported.  When injecting the Moderna bivalent booster the needle leaked out and the patient only received about 75 percent of the injection.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (allergic reaction) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (allergic reaction). At the time of the report, IMMUNISATION REACTION (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  Patient was getting a Pfizer bivalent booster and reported that patient had a two different version one that use a potassium chloride route. It was also reported that patient had an allergic reaction with Moderna Covid-19 vaccine previous shots due to the presence of tromethamine.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient was not immunocompromised.     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, the patient experienced CHRONIC SPONTANEOUS URTICARIA (developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Reporter stated that it was not specified if the third dose was a full third dose or the first booster dose. Reporter wanted to know if the patient can take the bivalent booster dose. No treatment drug was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Tremor
Clinical narrative: freezing cold; shakiness/Like if the body was fighting something; Shivering; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (freezing cold), TREMOR (shakiness/Like if the body was fighting something) and CHILLS (Shivering) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder. Concomitant products included SACUBITRIL, VALSARTAN (ENTRESTO) and CARVEDILOL for Heart disorder.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (freezing cold), TREMOR (shakiness/Like if the body was fighting something) and CHILLS (Shivering). At the time of the report, NASOPHARYNGITIS (freezing cold), TREMOR (shakiness/Like if the body was fighting something) and CHILLS (Shivering) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   This case was linked to MOD-2022-667345 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna bivalent administered after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date).    The vial was initially stored in the refrigerator on 25-Sep-2022. The vials were from unbroken cartons. The doses were administered after a beyond use date of 25-Oct-2022.  The vial had undergone no temperature excursions. The concomitant and treatment medication was not reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received Moderna Covid 19 vaccine after the expiration date; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A and 0A242A1) for COVID-19 vaccination.     Patient did not tested positive for COVID-19.  Concurrent medical conditions included Food allergy (Dairy), Dust allergy and Allergy to animals.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 vaccine after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Musculoskeletal discomfort
Clinical narrative: doctor's husband had the same problem; except he got it on his neck; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (doctor's husband had the same problem) and MUSCULOSKELETAL DISCOMFORT (except he got it on his neck) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (doctor's husband had the same problem) and MUSCULOSKELETAL DISCOMFORT (except he got it on his neck). At the time of the report, IMMUNISATION REACTION (doctor's husband had the same problem) and MUSCULOSKELETAL DISCOMFORT (except he got it on his neck) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   No concomitant medications were reported. Caller's wife stated that her doctor's husband had the same problems as her except he got his on his neck. No additional details were provided. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-667377 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-667377
Sex: F
Vaccine: PNC20
Symptoms: Magnetic resonance imaging, Vaccination site cellulitis, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: thinks she has cellulitis in right arm; redness; swelling; fever in the arm; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 26Oct2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2606, Expiration Date: 31Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (intervention required, medically significant), outcome "unknown", described as "thinks she has cellulitis in right arm"; VACCINATION SITE ERYTHEMA (intervention required), outcome "unknown", described as "redness"; VACCINATION SITE SWELLING (intervention required), outcome "unknown"; VACCINATION SITE WARMTH (intervention required), outcome "unknown", described as "fever in the arm". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown Results, notes: will be getting an MRI done today for that. Therapeutic measures were taken as a result of cellulitis. Clinical course: (NDC number of Prevnar 20: 00005200010). The caller called about a lady's reaction to Prevnar 20, thought it was just a reaction then the patient went to the doctors office in the morning since the reaction got worse and thought she had cellulitis in her arm. This was reported in the morning. The doctor thought it may have been creating a boil or cysts and will be getting an MRI done for that. Doctor put her on antibiotic as treatment.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of vaccination site cellulitis with redness, swelling and warmth cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have any known allergies. The patient did not receive any other medication in 2weeks. The patient received Paxlovid as COVID 19 treatment from 11Oct2022 to 16Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: rosemary" (unspecified if ongoing), notes: known allergies: rosemary; "known allergies: soy" (unspecified if ongoing), notes: known allergies: soy; "osteoporosis" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex,; Percocet, reaction(s): "known allergies: Percocet", notes: known allergies: Percocet; Erythromycin, reaction(s): "known allergies: erythromycin", notes: known allergies: erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid antiviral treatment was given for COVID 19, (lot GF1137) from 25Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted Covid; Contracted Covid; 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 male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted Covid". Clinical course: patient had the first PFizer COVID 19 booster in Nov2021 and contracted COVID about 4 months ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Condition aggravated, Gait disturbance, Headache
Clinical narrative: pain/jabbing/pain all over her body. Like a knife all over her body; low-grade fever; chills; tremors; couldn't walk; loss of balance; headache; neck pain; it was more severe; couldn't get up; not even to go to the bathroom; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer, previously experienced some reactions with the previous doses), for COVID-19 Immunization, reaction(s): "reactions with the previous doses". The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "couldn't get up; not even to go to the bathroom"; GAIT DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "couldn't walk"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown", described as "it was more severe"; BALANCE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "loss of balance"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "low-grade fever"; NECK PAIN (non-serious) with onset 2022, outcome "unknown"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "pain/jabbing/pain all over her body. Like a knife all over her body"; TREMOR (non-serious) with onset 2022, outcome "unknown", described as "tremors".  Additional information:-As per transferring agent caller would like to know if the reactions she reported are unusual. She had previously experienced some reactions with the previous doses, but now it was more severe. Caller confirms the previous information. Patient got the booster dose on Thursday. She couldn't get up, not even to the bathroom Patient was very active person, she can't go to the bathroom because she didn't moved around. It's not the first time it happened to the patient many times, but this time it was more severe. her friends, her husband, her family had suffered it but they didn't react like that. Caller would like to know if her symptoms were usual. AE - E-transfer to agent that it may possibly duplicated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Neck pain, Pain, Pyrexia, Tremor
Clinical narrative: pain/jabbing/pain all over her body. Like a knife all over her body; low-grade fever; chills; tremors; couldn't walk; loss of balance; headache; neck pain; it was more severe; couldn't get up; not even to go to the bathroom; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer, previously experienced some reactions with the previous doses), for COVID-19 Immunization, reaction(s): "reactions with the previous doses". The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "couldn't get up; not even to go to the bathroom"; GAIT DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "couldn't walk"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown", described as "it was more severe"; BALANCE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "loss of balance"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "low-grade fever"; NECK PAIN (non-serious) with onset 2022, outcome "unknown"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "pain/jabbing/pain all over her body. Like a knife all over her body"; TREMOR (non-serious) with onset 2022, outcome "unknown", described as "tremors".  Additional information:-As per transferring agent caller would like to know if the reactions she reported are unusual. She had previously experienced some reactions with the previous doses, but now it was more severe. Caller confirms the previous information. Patient got the booster dose on Thursday. She couldn't get up, not even to the bathroom Patient was very active person, she can't go to the bathroom because she didn't moved around. It's not the first time it happened to the patient many times, but this time it was more severe. her friends, her husband, her family had suffered it but they didn't react like that. Caller would like to know if her symptoms were usual. AE - E-transfer to agent that it may possibly duplicated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.