chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Impaired work ability, Mobility decreased, Pain, Speech disorder
Clinical narrative: Barely able to speak; So much Pain; Chills; Headache; Stomach ache; Bedridden; was not able to eat; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Shingrix. On 8th October 2022, 2 days after receiving Shingrix, the patient experienced chills, headache and stomach pain. On 12th October 2022, the patient experienced pain. In October 2022, the patient experienced bedridden and unable to eat. On an unknown date, the patient experienced aphasia. On 10th October 2022, the outcome of the unable to eat was recovered/resolved. On an unknown date, the outcome of the chills, pain and aphasia were not recovered/not resolved and the outcome of the headache and stomach pain were recovering/resolving and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the chills, headache, stomach pain, bedridden, unable to eat, pain and aphasia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a wife of the patient. The reporter reported that the patient received Shingrix vaccine. On 8th October 2022 after 2 days of received Shingrix vaccine the patient experienced chills, headache and a stomach ache. The reporter stated that the patient was bedridden until the Monday (10th October 2022), when the symptoms seemed to resolved. The reporter stated that the patient was not able to eat anything after received vaccine until Monday, 10th October 2022. The reporter reported that the patient felt well enough to complete some yardwork on Tuesday (11th October 2022). On 11th October 2022 the patient went out on the road as they are truck driver and on 12th October 2022 the patient was again experienced chills and pain the reporter stated that the patient had so much pain they were required to pull off of the road to lie down. The reporter reported that the patient was barely able to speak. The reporter did not provide the patient's demographics as they were attending to the emergency. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Nov2021, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 1st November 2021, the patient received 1st dose of Shingrix in unknown arm via intramuscular route).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment:  The patient was not told by the doctor's office that, she needed to come back for the second Shingrix vaccine in 2 to 6 months (Inappropriate Schedule of Vaccine). The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN ON ARM WITH THE FIRST SHOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hpa (secondary-hypothalamic- pituitary-adrenal insufficiency) (since she was a kid). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 063A21A expiry: UNKNOWN) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced pain on arm with the first shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain on arm with the first shot was not reported. This report was non-serious. This case, involving the same patient is linked to 20221022922.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.) and NO ADVERSE EVENT (no adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.).    No concomitant medications were reported.  The Moderna suspect vaccine indications were also reported as Hypersensitivity symptom, Hypersensitivity reactions NOS, Reaction hypersensitivity (NOS), Allergy NOS, Hypersensitivity NOS, Hypersensitivity reaction, Allergy.  It was reported that the patient was made aware that he received a 0.25 mL of Moderna Bivalent Booster dose. Patient denies to had distress at this time. Patient denied to had to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in eight weeks from  15-Sep-2022. Patient stated would like to be re vaccinated. Patient made aware that they will reach out to patient regarding to receive full vaccination.   It was reported that reporter reviewed side effects and serve allergic reactions with parent and encouraged patient to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine) 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 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 WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  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 (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine).    No concomitant medications were reported. The reporter was not aware of any adverse events after the vaccine was given.  No treatment medication was reported. This case contains information about 21st patient out of the 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  This case belonged to adult patient 1 of 2 patients described by the reporter.  Company comment: This literature non study case concerns an adult patient of unknown age and gender, with no reported medical history, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. No information on risk factors, detailed clinical course, investigations including cardiac biomarkers, electrocardiography, cardiac imaging, treatment of the event, outcome and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-657773 (Linked Report).; Sender's Comments: This literature non study case concerns an adult patient of unknown age and gender, with no reported medical history, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. No information on risk factors, detailed clinical course, investigations including cardiac biomarkers, electrocardiography, cardiac imaging, treatment of the event, outcome and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-657773:Same Article Patient 2
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: contracted COVID; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID) and FEELING ABNORMAL (brain fog) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 033F21A, 009C21A and 006B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Environmental allergy and Blood cholesterol abnormal. Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-May-2022, the patient experienced COVID-19 (contracted COVID). On an unknown date, the patient experienced FEELING ABNORMAL (brain fog). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID) and FEELING ABNORMAL (brain fog) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: excess of 103.         Even with the Paxlovid patient had symptoms of fatigue and brain fog for 10 days. The symptoms fever in excess of 103, body aches, chills, congestion was subsumed under diagnosis of contracted COVID. Patient had virtual appointment with doctor. The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-658071 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccinated 7 patients after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients 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 (vaccinated 7 patients after the expiration date) 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 EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients after the expiration date).    Concomitant medications details were not reported by the reporter.   At the time of an unannounced visit by a health department bureau representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the office which were looked well after but they were uncompliant since that lot of Moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, instead they had to scan the QR code to determine the actual expiration code, which they failed, by not reading carefully the packing slip.  The patient had received the expired vaccine on 15-Jul-2022.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Significant live follow-up added. Patient identifiers added.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022; no adverse events; patient received an expired Monovalent First Primary (Presumed repeat) dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose), PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022) and NO ADVERSE EVENT (no adverse events) in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 1, Unknown Brand and On unknown date in another country). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine.    On 12-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022) and NO ADVERSE EVENT (no adverse events). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose), PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022) and NO ADVERSE EVENT (no adverse events) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse events) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose) and PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022).    Concomitant medications were not reported.  They were not sure of spacing between first and second primary shot. The vial size was 5.5 ml. The vial did not undergo any temperature excursions Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Patient had arthritis in her hands after the Moderna shot; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRITIS (Patient had arthritis in her hands after the Moderna shot) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ARTHRITIS (Patient had arthritis in her hands after the Moderna shot). At the time of the report, ARTHRITIS (Patient had arthritis in her hands after the Moderna shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was provided that the patient is about 50-year-old.  No concomitant medication information was provided.  No treatment medication was provided.  Company comment: This spontaneous case report concerns an adult female patient (about 50-year-old), with no medical history provided, who experienced non-serious unexpected event of special interest - Arthritis. The event occurred after the patient had received the mRNA-1273 vaccine (as booster dose). Temporal relationship between vaccine administration and occurrence of the event cannot be determined since dates were not provided. According to the provided information, the patient had arthritis in hands. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the events were provided. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns an adult female patient (about 50-year-old), with no medical history provided, who experienced non-serious unexpected event of special interest - Arthritis. The event occurred after the patient had received the mRNA-1273 vaccine (as booster dose). Temporal relationship between vaccine administration and occurrence of the event cannot be determined since dates were not provided. According to the provided information, the patient had arthritis in hands. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the events were provided. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Minor body aches after first vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Minor body aches after first vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sudafed allergy (tachycardia)). Concomitant products included NADOLOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Minor body aches after first vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Minor body aches after first vaccine) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had shivering and body aches with 2nd shingles vaccine.   This case was linked to MOD-2022-658188 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 002B21A, 033F21A and 005M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: flu shot on 07-Sep-2022, shingles (2nd shingles vaccine) and shingles (2nd shingles vaccine). Past adverse reactions to the above products included Myalgia with shingles; No adverse event with flu shot; and Shivering with shingles. Concurrent medical conditions included Drug allergy (Sudafed (tachycardia)). Concomitant products included NADOLOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced MYALGIA (With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: First night fever was 103.5.   On 07-Sep-2022, the patient received fifth dose of Moderna bivalent (unknown route) .5 milliliter with Lot number as AS7144B.  The event does not cause the patient to seek medical care.  Patient states that with the 2nd through 5th doses of the Moderna COVID-19 vaccine but no other symptoms.  Patient had yet to test positive for COVID despite patient exposure to husband.  It was reported just seems like a strange coincidence that patient husband contracted COVID exactly 1 month and 2 days post these last two vaccines. Would love to know why the virus is successful in bypassing the vaccine in patient husband body and so far not in patient.   This case was linked to MOD-2022-658148 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, SARS-CoV-2 test
Clinical narrative: Patient had side effect after receiving every single dose of the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had side effect after receiving every single dose of the Moderna vaccine) in a 79-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. Patient had no history of acute and chronic illness at the time of vaccination.  The patient's past medical history included COVID-19 (Night before patient passed out and called the ambulance. Hospitalization 30 days, treatment received for Covid19:oxygen, some pill ,insulin shot for glucose.) in November 2019.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had side effect after receiving every single dose of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Patient had side effect after receiving every single dose of the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, SARS-CoV-2 test: (Positive) Positive.         It was reported that patient was taking other medication. Treatment medications were not reported.   This case was linked to MOD-2022-658658, MOD-2022-658660 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, SARS-CoV-2 test
Clinical narrative: Patient calling to report he had side effect after receiving every single dose of the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient calling to report he had side effect after receiving every single dose of the Moderna vaccine) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. Patient had no acute and chronic illness at the time of vaccination.  The patient's past medical history included COVID-19 (Night before patient passed out and called the ambulance. Hospitalization 30 days, treatment received for Covid19:oxygen, some pill ,insulin shot for glucose.) in November 2019. 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 IMMUNISATION REACTION (Patient calling to report he had side effect after receiving every single dose of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Patient calling to report he had side effect after receiving every single dose of the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, SARS-CoV-2 test: (Positive) Positive.         It was reported that patient was taking other medication.  Treatment medications were not reported.   This case was linked to MOD-2022-658656, MOD-2022-658660 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Balance disorder, Chills, Confusional state, Fatigue
Clinical narrative: Problem with good balance; Confuse; Weak; Fatigue; Chills; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Problem with good balance), CONFUSIONAL STATE (Confuse), ASTHENIA (Weak), FATIGUE (Fatigue) and CHILLS (Chills) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (Flu vaccine) for an unknown indication.    Patient medical history and allergies were not reported.  The patient's past medical history included COVID-19 (Hospitalization 30 days, treatment received for Covid19:oxygen, some pill ,insulin shot for glucose.) in November 2019.   On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (Flu vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced PYREXIA (Slight fever). On an unknown date, the patient experienced BALANCE DISORDER (Problem with good balance), CONFUSIONAL STATE (Confuse), ASTHENIA (Weak), FATIGUE (Fatigue) and CHILLS (Chills). On 13-Oct-2022, PYREXIA (Slight fever) had resolved. At the time of the report, BALANCE DISORDER (Problem with good balance), CONFUSIONAL STATE (Confuse), ASTHENIA (Weak), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, SARS-CoV-2 test: (Positive) Positive.         The patient had Covid-19 in Nov-2019. Date symptoms began: The night before, patient passed out and had to call the ambulance.  No concomitant medication details was reported. It was reported that patient was taking other medication.  No acute and chronic illnesses at the time of vaccination. Patient had side effect after receiving every single dose of the Moderna vaccine. Patient stated, always had reaction when got the Moderna vaccine. Patienr received the booster yesterday on 12Oct2022. Patient said he had most of the side effect except vomiting and irritability. Patient was having problem with good balance. Patient had fatigue and chills. He had a slight fever yesterday which went away today. Patient was confused and weak. Caller stated he could not find the vaccination card.   HCP was aware of the side effects. Treatment drugs were not reported.   This case was linked to MOD-2022-658656, MOD-2022-658658 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Problem with good balance; Confuse; Weak; Fatigue; Chills; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Problem with good balance), CONFUSIONAL STATE (Confuse), ASTHENIA (Weak), FATIGUE (Fatigue) and CHILLS (Chills) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (Flu vaccine) for an unknown indication.    Patient medical history and allergies were not reported.  The patient's past medical history included COVID-19 (Hospitalization 30 days, treatment received for Covid19:oxygen, some pill ,insulin shot for glucose.) in November 2019.   On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (Flu vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced PYREXIA (Slight fever). On an unknown date, the patient experienced BALANCE DISORDER (Problem with good balance), CONFUSIONAL STATE (Confuse), ASTHENIA (Weak), FATIGUE (Fatigue) and CHILLS (Chills). On 13-Oct-2022, PYREXIA (Slight fever) had resolved. At the time of the report, BALANCE DISORDER (Problem with good balance), CONFUSIONAL STATE (Confuse), ASTHENIA (Weak), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, SARS-CoV-2 test: (Positive) Positive.         The patient had Covid-19 in Nov-2019. Date symptoms began: The night before, patient passed out and had to call the ambulance.  No concomitant medication details was reported. It was reported that patient was taking other medication.  No acute and chronic illnesses at the time of vaccination. Patient had side effect after receiving every single dose of the Moderna vaccine. Patient stated, always had reaction when got the Moderna vaccine. Patienr received the booster yesterday on 12Oct2022. Patient said he had most of the side effect except vomiting and irritability. Patient was having problem with good balance. Patient had fatigue and chills. He had a slight fever yesterday which went away today. Patient was confused and weak. Caller stated he could not find the vaccination card.   HCP was aware of the side effects. Treatment drugs were not reported.   This case was linked to MOD-2022-658656, MOD-2022-658658 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Sinus congestion, Sinusitis
Clinical narrative: sinus congestion; heavy head; sinus infection; This spontaneous case was reported by a patient and describes the occurrence of SINUS CONGESTION (sinus congestion), HEAD DISCOMFORT (heavy head) and SINUSITIS (sinus infection) 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 fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS CONGESTION (sinus congestion), HEAD DISCOMFORT (heavy head) and SINUSITIS (sinus infection). At the time of the report, SINUS CONGESTION (sinus congestion), HEAD DISCOMFORT (heavy head) and SINUSITIS (sinus infection) outcome was unknown. No concomitant medication information was provided. Patient had sinus infection, heavy head and sinus congestion after the fourth dose /booster shot. Patient had no cold.  No treatment medication were provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (primary series, Dose 1), Pfizer Covid-19 vaccine (booster dose), Pfizer Covid-19 vaccine (primary series and Dose 2). Past adverse reactions to the above products included No adverse reaction with Pfizer Covid-19 vaccine, Pfizer Covid-19 vaccine and Pfizer Covid-19 vaccine.   On 13-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient is not certain is she received the Moderna bivalent vaccine today/Patient thinks she may have received the Moderna monovalent vaccine today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       No concomitant medication was reported. The patient did not believe that what she experienced was an adverse event. The patient said that since nothing bad happened this was not an adverse event. The patient wass not certain was she received the Moderna bivalent vaccine . Patient reported that she might had received the Moderna monovalent vaccine. No treatment medication was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated 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 (patient was vaccinated after the expiration date) 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 EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date).    At the time of an unannounced visit by a Moderna representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the health department which were looked well after but they were uncompliant since that lot of Moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, instead they had to scan the QR code to determine the actual expiration code, which they failed, by not reading carefully the packing slip.  The patient had received the expired vaccine on 26-Aug-2022.  Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received vaccine from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received vaccine from pediatric vials instead of bivalent vaccine) 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 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received vaccine from pediatric vials 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 (Patient received vaccine from pediatric vials 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 (Patient received vaccine from pediatric vials instead of bivalent vaccine).    No concomitant medications were reported.  The 26 adult patients received vaccine on 8-Oct-2022, 9-Oct-2022 and 10-Oct-2022, from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. The reporter was not aware of any adverse events after the vaccines were given.   No treatment medications were reported.  This case contains information for the 25 of 26 patients described by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) 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 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials 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 (Administration error: 26 doses administered to adult patients from pediatric vials 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 (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication information was provided. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given.  No treatment medication reported.  This case refers to patient-18 out of 26 patients.
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Rash macular, Skin disorder
Clinical narrative: Lot of spots on body; splotches into small bumps was drying them all over body; Splotches into small bumps was drying them all over body; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Lot of spots on body), DRY SKIN (splotches into small bumps was drying them all over body) and RASH MACULAR (Splotches into small bumps was drying them all over body) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.  4782589) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SKIN DISORDER (Lot of spots on body), DRY SKIN (splotches into small bumps was drying them all over body) and RASH MACULAR (Splotches into small bumps was drying them all over body). At the time of the report, SKIN DISORDER (Lot of spots on body), DRY SKIN (splotches into small bumps was drying them all over body) and RASH MACULAR (Splotches into small bumps was drying them all over body) outcome was unknown.            No concomitant product was reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: rash on chest; Stiffness in arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in arm) and RASH (rash on chest) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 vaccination.     The patient had never been tested positive for Covid-19.  Concurrent medical conditions included Drug allergy (Neoprene allergy) and Allergy to antibiotic (bacitracin allergy). Concomitant products included APIXABAN (ELIQUIS), FLECAINIDE ACETATE, METOPROLOL SUCCINATE, SIMVASTATIN, CENTRUM SILVER ADULTS 50+, FAMOTIDINE and FISH OIL for an unknown indication.    On 10-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in arm). On 11-Oct-2022, the patient experienced RASH (rash on chest). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) on 11-Oct-2022 for Rash, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in arm) outcome was unknown and RASH (rash on chest) had not resolved.            On 26-Jan-2021, the patient received first dose of Moderna vaccine (lot no.: 010M20A).  On 25-Feb-2021, the patient received second dose of Moderna vaccine (lot no.: 013A21A).  On 26-Oct-2021, the patient received third/first booster dose of Moderna vaccine (lot no.: 012F21A).  On 10-Oct-2022, the patient received the second booster dose of Moderna vaccine, and she felt stiffness in her arm.  On 11-Oct-2022, the patient developed a rash on her chest and took Benadryl for it, but it would nor disappear. She called the pharmacy where she received the vaccine and they told her to take Zyrtec and if it does not get any better, then the patient was advised to consult healthcare provider.   This case was linked to US-MODERNATX, INC.-MOD-2022-658626 (Linked Report). This case was linked to MOD-2022-658814 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Live follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658626:Husband case