chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Pt developed diffuse papular rash 9 days after vaccine. no other smyptoms.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient recieved vaccine was waiting for about 5 minutes while other family members were recieving. She walked out of pharmacy to go sit down and fainted and hit her head on the floor before she got to the chair. She got up right away after faiting and sat in the chair. She was responsive.  911 was called and she was evauluated and released to leave with her family.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Discomfort, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Additional Details: Rotating his arm he is having some issue. Lifting up a certain height there is pain. Uncomfortable to raise arm above shoulder. Patient is really tired.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Additional Details: Rotating his arm he is having some issue. Lifting up a certain height there is pain. Uncomfortable to raise arm above shoulder. Patient is really tired.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chills, Dysphagia
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Medium, Systemic: Fever-Mild, Systemic: rash on leg, stiffness in neck, back pain, abdomnial cramping, sharp pain in stomach-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: Pt states that other vaccines gives similar stomach side effects
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Musculoskeletal stiffness, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Medium, Systemic: Fever-Mild, Systemic: rash on leg, stiffness in neck, back pain, abdomnial cramping, sharp pain in stomach-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: Pt states that other vaccines gives similar stomach side effects
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Medium, Systemic: Fever-Mild, Systemic: rash on leg, stiffness in neck, back pain, abdomnial cramping, sharp pain in stomach-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: Pt states that other vaccines gives similar stomach side effects
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Contusion, Induration
Clinical narrative: In duration, bruise, touches, scratches that site, noted several months before Sept 2021
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC, RV5
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: 24 hours after vaccines, bilateral thighs were swollen all the way around without redness, resolved after 12 hours, (L) thigh was red but (R) was not, 3 days later baby became tired x 12 hours, (L) leg redness resolved but 1.5 cm lump remains
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Received an expired monovalent vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose) 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 (Received an expired monovalent vaccine as a second dose).    No concomitant medications was reported. Vial size was 10 dose vial. Date the vial was initially stored in the refrigerator was 22-Sep-2022. Date of administration of vaccine was 19-Oct-2022. The vial didn't undergo any temperature excursions. No treatment drug details was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event reported; Caller is a medical assistant calling to report that an expired dose of ROTATEQ was administered to the patient on 26SEP2022. Caller reports that the dose of ROTATEQ expired on 17SEP2022 and did not experience a temperautre excursion. No additional i; This spontaneous report was received from a medical assistant and refers to a patient of unknown age.     On 26-SEP-2022, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent(ROTATEQ) l(ot # U011810 with expiration date 17-SEP-2022) for prophylaxis.(expired product administered).and did not experience a temperature excursion. No additional adverse event were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE's and no PQC's were reported; A medical assistant reported that an improperly stored dose of ROTATEQ pursuant to a temperature excursion was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 03-OCT-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (quantity 1, lot #U038863, expiration date: 27-MAY-2023) as directed to prevent rotavirus. The vaccine was exposed to temperature excursion of 9.1 degrees Celsius for 21 minutes. There was no previous temperature excursion. No additional AE's and no PQC's were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient was accidently administered an expired dose of MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 11-OCT-2022, the patient was vaccinated with expired product measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T025927, expiration date: 30-JUL-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).Product had no prior temperature excursions. No further information provided. No additional adverse event reported. No product quality complaint reported.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Gastric disorder, Headache
Clinical narrative: stomach issues; headaches; fatigue; This spontaneous report was received from a female patient of unknown age who refers to herself. Her medical history, concurrent conditions and concomitant therapies were not reported.  On approximately 30-SEP-2022 (reported as 2 weeks ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (dose, strength, lot number, expiration date, and route of administration were not provided).  On an unknown date in 2022, the patient experienced stomach issues, headaches, and fatigue. The outcome of the events was not provided.   The causal relationship between all the reported events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Osteoporosis, Vasculitis
Clinical narrative: multiple outbreaks of herpes zoster; osteoporosis; vasculitis; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, osteoporosis and vasculitis. As a result of these symptoms, pt was seen and treated by medical providers and was still under their care at the time of reporting. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not resolved. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of multiple outbreaks of herpes zoster, osteoporosis and vasculitis were considered to be disabling by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE.; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 16-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) 0.5 milliliter, lot number U012004 had been verified to be a valid number; expiration date was reported as 13-JUL-2023 and upon internal validation established as 15-OCT-2022, for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 34.5 degrees Fahrenheit (F), during a time frame of1 hour and y minutes, as recorded by a data logger. There was a previous temperature excursion reported as: 13 hours and 52 minutes. There was no adverse effect reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  009507513-2210USA005917 009507513-2210USA005936 009507513-2210USA005916:
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, COVID-19, Cardiogenic shock, Dyspnoea, Mechanical ventilation
Clinical narrative: Patient stated they were diagnosed with COVID in March 2021.; had their heart shocked 3 times.; on a ventilator; lung damaging; This spontaneous report was received from a male patient of unknown age referring to himself. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On an unknown date (also reported as in the past and unsure if it was before COVID diagnosis or after), the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  In March 2021, the patient was diagnosed with COVID (covid-19). On an unknown date, the patient was hospitalized for covid-19, was on a ventilator (dependence on respirator), had a temperature of 104.1 degrees Fahrenheit and had their heart shocked 3 times (cardiogenic shock). On an unknown date, patient stated he had lung damaging (traumatic lung injury) and still experienced shortness of breath. The outcome of the event of traumatic lung injury and covid-19 was reported as not recovered. The outcome of the events of dependence on respirator and cardiogenic shock was not reported.  The causality assessment between the reported events and the suspect vaccine was not provided.  Upon internal review, the events of cardiogenic shock and dependence on respirator were considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Traumatic lung injury
Clinical narrative: Patient stated they were diagnosed with COVID in March 2021.; had their heart shocked 3 times.; on a ventilator; lung damaging; This spontaneous report was received from a male patient of unknown age referring to himself. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On an unknown date (also reported as in the past and unsure if it was before COVID diagnosis or after), the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  In March 2021, the patient was diagnosed with COVID (covid-19). On an unknown date, the patient was hospitalized for covid-19, was on a ventilator (dependence on respirator), had a temperature of 104.1 degrees Fahrenheit and had their heart shocked 3 times (cardiogenic shock). On an unknown date, patient stated he had lung damaging (traumatic lung injury) and still experienced shortness of breath. The outcome of the event of traumatic lung injury and covid-19 was reported as not recovered. The outcome of the events of dependence on respirator and cardiogenic shock was not reported.  The causality assessment between the reported events and the suspect vaccine was not provided.  Upon internal review, the events of cardiogenic shock and dependence on respirator were considered to be medically significant.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) outcome was unknown.            No concomitant medications were reported. The patient got the second shot of Moderna and passed out. No treatment medications were reported.  Company Comment This spontaneous case concerns a 65-years-old female patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant event  of loss of consciousness in the context of the 2nd.  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.    This case was linked to US-MODERNATX, INC.-MOD-2022-661939, US-MODERNATX, INC.-MOD-2022-662000 (Linked Report).; Sender's Comments: Company Comment This spontaneous case concerns a 65-years-old female patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant event  of loss of consciousness in the context of the 2nd.  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement. US-MODERNATX, INC.-MOD-2022-661939:MOD22-027301 (Same reporter) US-MODERNATX, INC.-MOD-2022-662000:MOD22-027301 (cross linked case) same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Syringe issue
Clinical narrative: Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine; due to faulty Syringe the administered a patient with less that the appropiate dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine), SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose) 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 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 ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine), SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine), SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine) and SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose).    No concomitant medication details was reported. Due to faulty Syringe the patient was administered with less that the appropiate dose. No treatment medication details was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Fever, Fatigue, and pain in the left arm but it was worst with the 2nd shot and the booster.; Worst Fever after 2nd shot/Worst Fever after first Monovalent Booster Shot; Worst Fatigue after2nd shot/Worst Fatigue after first Monovalent Booster Shot; Worst Pain in the left arm after 2nd shot/Worst Pain in the left arm after first Monovalent Booster Shot; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (Fever, Fatigue, and pain in the left arm but it was worst with the 2nd shot and the booster.), PYREXIA (Worst Fever after 2nd shot/Worst Fever after first Monovalent Booster Shot), FATIGUE (Worst Fatigue after2nd shot/Worst Fatigue after first Monovalent Booster Shot) and VACCINATION SITE PAIN (Worst Pain in the left arm after 2nd shot/Worst Pain in the left arm after first Monovalent Booster Shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Fever, Fatigue, and pain in the left arm but it was worst with the 2nd shot and the booster.), PYREXIA (Worst Fever after 2nd shot/Worst Fever after first Monovalent Booster Shot), FATIGUE (Worst Fatigue after2nd shot/Worst Fatigue after first Monovalent Booster Shot) and VACCINATION SITE PAIN (Worst Pain in the left arm after 2nd shot/Worst Pain in the left arm after first Monovalent Booster Shot). In 2020, VACCINATION SITE PAIN (Worst Pain in the left arm after 2nd shot/Worst Pain in the left arm after first Monovalent Booster Shot) outcome was unknown. At the time of the report, CONDITION AGGRAVATED (Fever, Fatigue, and pain in the left arm but it was worst with the 2nd shot and the booster.), PYREXIA (Worst Fever after 2nd shot/Worst Fever after first Monovalent Booster Shot) and FATIGUE (Worst Fatigue after2nd shot/Worst Fatigue after first Monovalent Booster Shot) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-661795.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 026L21B, 050E214 and 088D21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. No additional medications or treatments.   This case was linked to MOD-2022-661803 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient lips got numb in 5 minutes; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes). At the time of the report, HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes) outcome was unknown.            No medical history information was reported.  No treatment medication was provided.   This case was linked to MOD-2022-661777 (E2B Linked Report). This case was linked to MOD-2022-662000 (Patient Link).; Sender's Comments:  MOD-2022-661777:MOD22-027301 (Same reporter)
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: Patient lips got numb in 5 minutes; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes). At the time of the report, HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes) outcome was unknown.            No medical history information was reported.  No treatment medication was provided.   This case was linked to MOD-2022-661777 (E2B Linked Report). This case was linked to MOD-2022-662000 (Patient Link).; Sender's Comments:  MOD-2022-661777:MOD22-027301 (Same reporter)
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: left side of face was bright red/no hives, transient and mild/a little bit of pink; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (left side of face was bright red/no hives, transient and mild/a little bit of pink) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left side of face was bright red/no hives, transient and mild/a little bit of pink). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness of face, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (left side of face was bright red/no hives, transient and mild/a little bit of pink) had resolved.            No medical history information was reported. Pharmacist gave patient a Benadryl and had to sit for 30 minutes and it went away.   This case was linked to MOD-2022-661777 (E2B Linked Report). This case was linked to MOD-2022-661939 (Patient Link).; Sender's Comments:  MOD-2022-661777:MOD22-027301 (cross linked case) same reporter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: left side of face was bright red/no hives, transient and mild/a little bit of pink; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (left side of face was bright red/no hives, transient and mild/a little bit of pink) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left side of face was bright red/no hives, transient and mild/a little bit of pink). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness of face, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (left side of face was bright red/no hives, transient and mild/a little bit of pink) had resolved.            No medical history information was reported. Pharmacist gave patient a Benadryl and had to sit for 30 minutes and it went away.   This case was linked to MOD-2022-661777 (E2B Linked Report). This case was linked to MOD-2022-661939 (Patient Link).; Sender's Comments:  MOD-2022-661777:MOD22-027301 (cross linked case) same reporter
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: extra dose of ACTHIB was administered to a patient on the same date with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who  was administered  extra dose of acthib on the same date with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2022, the patient received a once booster dose of suspect HIB (PRP/T) VACCINE (lot UJ637AAA  and expiration date: 30-Nov-2022) at a dose of 0.5ml (twice)via intramuscular route in the left thigh for prophylactic vaccination.  On 13-Oct-2022 (latency: same day), the patient was administered extra dose of acthib on the same date with no reported adverse event (extra dose administered)   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcomes: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.t
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was received on 14-Oct-2022 from Med Communications (reference number: SEQW22-04542), reported by other non-healthcare professional (consumer) and concerned a 74-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  The patient stated he had not been sick for some time; he was taking precautions and was sensible in relation to health. The patient exercised and was not a smoker. His triglycerides value was usually around 50 to 60 g/ml. In addition, the patient stated that he usually did not get headaches,.   On 13-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as 0.5 ml, anatomical location: left arm, route of administration: not reported) for active immunization against influenza caused by influenza virus subtypes A and types B contained in the vaccine. The batch number was not reported. The expiry date was reported as unspecified date in 2023.  On the same date, three or four hours after receiving Fluad Quadrivalent, the patient experienced a headache that then went away. The patient had to take half an Aspirin (acetylsalicylic acid) as treatment. The patient denied having injection site pain and fatigue.   The patient's triglycerides value is usually around 50 to 60 mg/dL.  On 13-Oct-2022, the patient recovered from the event of headache.  Next morning the patient also felt fine when he woke up.   The reporter considered the event as related to Fluad Quadrivalent. The patient stated that he had several vaccines over the time because of his career but this one probably hit a little harder than most.  The case was assessed as non-serious.  Company comment: The event of headache is assessed as related to Fluad Quadrivalent due to plausible temporal relationship.; Reporter's Comments: The patient stated that he had several vaccines over the time because of his career but this one probably hit a little harder than most.; Sender's Comments: The event of headache is assessed as related to Fluad Quadrivalent.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Didn't feel good; This spontaneous case was received on 15-Oct-2022 from non-healthcare professional (consumer) via Communications (reference number: SEQW22-04546) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported  On unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On unspecified date, after receiving the influenza vaccine, the patient didn't feel good.  On an unspecified date, after a couple of days, the patient recovered from the event.  The outcome of the event was not reported.  The reporter assessed the event of 'feeling unwell' as related to influenza vaccine. The patient usually does not feel good for a couple of days after she has the flu shot.  The case was assessed as non-serious.  This case is linked to case 202205638  (the same patient).  Company comment: Due to lack of information and unclear temporal relationship, causality for feeling unwell is assessed as unassessable.; Reporter's Comments: The patient usually does not feel good for a couple of days after she has the flu shot.; Sender's Comments: Due to lack of information and unclear temporal relationship, causality for feeling unwell is assessed as unassessable.
Age: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Injection site rash
Clinical narrative: PATIENT DESCRIBED LATER IN EVENING HAVING A RASH AT INJECTION SITE SIZE OF COIN AND LATER HAVING DIARRHEA. NO SHORTNESS OF BREATH AND NO OTHER SYMPTOMS.  PATIENT TOOK BENADRYL.  NEXT DAY RASH AND DIARRHEA RESOLVED. NO FURTHER ISSUES
Age: 46.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event - just an expired dose administer  Pneumovax 23 expires 10/15/2022
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 3/20/21, 4/17/21, 1/25/22. Positive on 10/17/22
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: PT was supposed to receive moderna bivalent but instead received a 0.5mL dose of the regular covid vaccine. His Moderna covid vaccine dates are 2/17/21, 3/16/21, 11/5/21, 4/28/22.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Neck pain
Clinical narrative: Intense shoulder pain and weakness. Intense neck pain
Age: 12.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: PATIENT RECEIVED 5-11 BIVALENT BOOSTER INSTEAD OF 12+ BIVALENT BOOSTER
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid Positive
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Starting  12 hours after injection and lasting until 36 hours post injection: low grade fever (99.9 F degrees), full body muscle aches, fatigue, injection site soreness.
Age: 16.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: Patient was 16 years old at the time of the vaccination and given ID Jynneos vaccine. Patient had no adverse effects/side effects. Parent informed SQ should have been given and will be given 4 weeks later at dose #2.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: TESTED + FOR COVID ON    1-18-22 AT  HOSPITAL    ; AGAIN ON   2-10-22     AT       HOSPITAL                            . DECEASED 2-24-22.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID positive
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID positive
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccination of COVID, developed COVID.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Vaccination of COVID, developed COVID.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Confusional state, Lethargy, Neck pain
Clinical narrative: Severe joint pain.  Continued  Pain radiating to side of neck (vaccine side) left.  Lower back pain.  Confusion, lethargic.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Severe joint pain.  Continued  Pain radiating to side of neck (vaccine side) left.  Lower back pain.  Confusion, lethargic.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: breakthrough case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Vaccinated patient developed COVID
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID positive
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient presented for a nurse care visit for her meningococcal vaccine. Nurse went and grabbed medication from fridge, checked to make sure medication is correct and expiration is up to date, reconstituted medication. Medication was logged, under patient's immunizations tab, searched through NDC. Medication given to patient, patient tolerated well and left clinic. Nurse then entered in site of injection then system prompted LOT #. Nurse tried typing in LOT # but was not able to find. Nurse looked at both bottles and realized powder bottle was expired (07/2022) but liquid bottle will be expiring in January 2023.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: While vaccinating at an offsite clinic at Middle School, Staff administered a Hep B vaccine to the patient instead of the scheduled TDAP.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in ears started at 8 AM on the day after the booster shot. It comes and goes. It depends on the position of my head.
Age: 16.0
Sex: M
Vaccine: COVID19-2, HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt given COVID bivalent booster as first dose in series. No adverse reaction, RN confirmed CDC recommendations and spoke with pts father regarding event. Father has no further questions.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Cardiac failure acute, Cardiac failure congestive, Condition aggravated
Clinical narrative: Discharge Provider: MD Primary Care Provider:  MD Admission Date: 10/16/2022 Discharge Date: 10/20/2022 Presenting Problem: Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure (HCC)  HOSPITAL COURSE: Patient is a 43 y.o. male with past and current medical history of severe biventricular heart failure NICM EF 15%, severe VHD; severe MR and mod/severe TR, persistent afib and hx LAA thrombus on Eliquis, chronic pericardial effusion, and social history of medication noncompliance, homelessness, marijuana use, tobacco use and hx ETOH abuse who presented to the ED on 10/16 with complaints of dyspnea, orthopnea, leg swelling, weight gain and viral syndrome. He was found to be in decompensated  heart failure massively fluid overloaded due to non compliance with his medications. He was admitted for diuresis.    He was diuresed to a weight of 79.2 kg from an admit weight of 96.2 kg. Diuresed a total of net negative 19 liters during admission and symptoms significantly improved. Patient was transitioned to Torsemide 40 mg PO daily.   Upon admission, he also was diagnosed with COVID. He was treated with remdesivir 10/17-10/20 and did very well from a covid perspective. Patient on RA and lungs clear, therefore felt ok to discontinue COVID treatment at this time.   Patient w/ hx of noncompliance and not taking medications for various reasons. In an attempt to streamline and reduce burden of medications to hopefully improve compliance, ARB was discontinued and Eliquis was changed to Xarelto for once daily dosing.    The patient is homeless with issues making it to his appointments. Social work was consulted for assistance. Patient discharged with plans to stay at shelter at least 1 day with cab voucher given. Unfortunately, patient not wanting to live in shelter and has no family/friends available. Resources given by care management. Patient discharged in stable condition on 10/20/22.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypervolaemia, Left ventricular failure, Orthopnoea, Peripheral swelling
Clinical narrative: Discharge Provider: MD Primary Care Provider:  MD Admission Date: 10/16/2022 Discharge Date: 10/20/2022 Presenting Problem: Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure (HCC)  HOSPITAL COURSE: Patient is a 43 y.o. male with past and current medical history of severe biventricular heart failure NICM EF 15%, severe VHD; severe MR and mod/severe TR, persistent afib and hx LAA thrombus on Eliquis, chronic pericardial effusion, and social history of medication noncompliance, homelessness, marijuana use, tobacco use and hx ETOH abuse who presented to the ED on 10/16 with complaints of dyspnea, orthopnea, leg swelling, weight gain and viral syndrome. He was found to be in decompensated  heart failure massively fluid overloaded due to non compliance with his medications. He was admitted for diuresis.    He was diuresed to a weight of 79.2 kg from an admit weight of 96.2 kg. Diuresed a total of net negative 19 liters during admission and symptoms significantly improved. Patient was transitioned to Torsemide 40 mg PO daily.   Upon admission, he also was diagnosed with COVID. He was treated with remdesivir 10/17-10/20 and did very well from a covid perspective. Patient on RA and lungs clear, therefore felt ok to discontinue COVID treatment at this time.   Patient w/ hx of noncompliance and not taking medications for various reasons. In an attempt to streamline and reduce burden of medications to hopefully improve compliance, ARB was discontinued and Eliquis was changed to Xarelto for once daily dosing.    The patient is homeless with issues making it to his appointments. Social work was consulted for assistance. Patient discharged with plans to stay at shelter at least 1 day with cab voucher given. Unfortunately, patient not wanting to live in shelter and has no family/friends available. Resources given by care management. Patient discharged in stable condition on 10/20/22.