chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, COVID-19, Vaccination site pain
Clinical narrative: Contracted Covid in January 2023; little sore at site of vaccines; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted Covid in January 2023) and VACCINATION SITE PAIN (little sore at site of vaccines) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE in 2022, PNEUMOCIN [PNEUMOCOCCAL VACCINE] in 2022 and FLU [INFLUENZA VACCINE] in 2022. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE], MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE; andVARICELLA ZOSTER VACCINE and PNEUMOCIN [PNEUMOCOCCAL VACCINE]. Concurrent medical conditions included Type 2 diabetes mellitus (Controlled) since 2019.    In September 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. In September 2022, the patient experienced VACCINATION SITE PAIN (little sore at site of vaccines). In January 2023, the patient experienced COVID-19 (Contracted Covid in January 2023). At the time of the report, COVID-19 (Contracted Covid in January 2023) outcome was unknown and VACCINATION SITE PAIN (little sore at site of vaccines) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  It was reported that after bivalent booster patient experienced No fever and had Stomach issues (was in the bathroom a lot). Lasted about 1 week. After that week, Patient felt better than before Patient contracted Covid. Patient said that his vaccines and boosters were working to fight off the virus and very happy with Moderna products. Patient stated that patient had these same symptoms in 2019 before patient ever hear of Covid, and thinks it may had been Covid then as well. Patient received 2 primary doses of Moderna Vaccine around March 2021, received his first booster December 2021. In September 2022 patient received the Bivalent booster. Loves Moderna products, because patient hardly gets any side effects, his arm may have been a little sore at site of vaccines and booster, Patient had no other side effects.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Initial date it was stored in the fridge: 21-Sep-2022., administration date: 17-Feb-2023; no adverse event; administration of a dose which was beyond the BUD and the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of a dose which was beyond the BUD and the published expiration date), PRODUCT STORAGE ERROR (Initial date it was stored in the fridge: 21-Sep-2022., administration date: 17-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, 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 17-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of a dose which was beyond the BUD and the published expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initial date it was stored in the fridge: 21-Sep-2022., administration date: 17-Feb-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of a dose which was beyond the BUD and the published expiration date), PRODUCT STORAGE ERROR (Initial date it was stored in the fridge: 21-Sep-2022., administration date: 17-Feb-2023) 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 EXPIRED PRODUCT ADMINISTERED (administration of a dose which was beyond the BUD and the published expiration date) and PRODUCT STORAGE ERROR (Initial date it was stored in the fridge: 21-Sep-2022., administration date: 17-Feb-2023).    No concomitant medications were reported.     The Moderna COVID-19 vaccine of 6 months- 5 years with lot number:  AR9236B and manufacturer expiration date: 11-Feb-2023 was initially stored In fridge on 21-Sep-2022 and was administered on 17-Feb-2023.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; no adverse event; HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.) and NO ADVERSE EVENT (no adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was reported that the site which had Moderna vaccine in a freezer unit had good readings on the digital data logger until August. In Aug-2022, the battery died and they had no logs from 01-Aug-2022 until 01-Jan-2023. Reporter was asking Moderna about the viability of the vaccines. 1 Box of vaccine with Lot 011B22A with more than 12 red vials were expired. Vaccines were still in the freezer. HCP confirmed that there had been some doses given between 01-Aug-2022 to 01-Jan-2023.  HCP checked notes left and indicated 100 doses were received and 30 doses were currently left discarded due to expiration. HCP noted that 49 doses of open multi dose vials in Nov-2022 were expired and discarded. Possibly 2 patients were given that vaccine, one patient on 01-Aug-2022, gender was unknown and birth year was 1940. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712563 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712563:Adult patient
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Prior to vaccination) on 17-Sep-2021.    On 22-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 22-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023).    Other relevant medical information included patient had no allergies. No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not reported nor had side effects after vaccination. Patient received vaccine form individual vial. Vial size was reported as 5.5 mL. Vial was initially stored in the refrigerator on 01-Feb-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse reporting that immunization coordinator informed that a Moderna Monovalent dose was administered today 23Feb2023 to a 4 year old patient after date of expiry on 21Feb2023.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reporting that immunization coordinator informed that a Moderna Monovalent dose was administered today 23Feb2023 to a 4 year old patient after date of expiry on 21Feb2023.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1420B) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 23-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reporting that immunization coordinator informed that a Moderna Monovalent dose was administered today 23Feb2023 to a 4 year old patient after date of expiry on 21Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reporting that immunization coordinator informed that a Moderna Monovalent dose was administered today 23Feb2023 to a 4 year old patient after date of expiry on 21Feb2023.) 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 (Nurse reporting that immunization coordinator informed that a Moderna Monovalent dose was administered today 23Feb2023 to a 4 year old patient after date of expiry on 21Feb2023.).    No concomitant medications was provided. Individual vial was reported. Vial size was 2.5 mL the vial was initially stored in the refrigerator was on 1Feb2023  the vial did not undergo any temperature excursions.  No treatment medications was provided.
Age: 0.5
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023; No adverse event; Dose administered after 30-day Use By Date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2023 and was forwarded to Moderna on 24-Feb-2023.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE 13V on 16-Jan-2023, PEDIARIX on 16-Jan-2023, ROTAVIRUS VACCINE on 16-Jan-2023, INFLUENZA on 16-Jan-2023 and INFLUENZA (second dose) on 13-Feb-2023. Past adverse reactions to the above products included No adverse event with INFLUENZA, INFLUENZA, PEDIARIX, PNEUMOCOCCAL VACCINE 13V and ROTAVIRUS VACCINE.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023).    Concomitant drugs were not reported. The patient did not reported any reactions. It was reported that the monovalent vial of unknown size was first thawed on 05-Jan-2023 and was expired on 04-Feb-2023. It was also reported that the vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712529 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712529:same reporter
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: MMR on 20-Feb-2023, PNEUMOCOCCAL VACCINE (P-13) on 20-Feb-2023 and HIB VACCINE on 23-Feb-2023. Past adverse reactions to the above products included No adverse event with HIB VACCINE, MMR and PNEUMOCOCCAL VACCINE.    On 20-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023).    No concomitant medication were reported.  It was reported that date of first thaw was 5-Jan-2023, so it expired on 4-Feb-2023. The patient did not report any reactions. Vial size was unknown. The vial was initially stored in the refrigerator on 5-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712504:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I received the first of 2 Vaccines in April 2021 and my hands have been numb since and my legs feel like I am walking on air; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (I received the first of 2 Vaccines in April 2021 and my hands have been numb since and my legs feel like I am walking on air) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (I received the first of 2 Vaccines in April 2021 and my hands have been numb since and my legs feel like I am walking on air). At the time of the report, HYPOAESTHESIA (I received the first of 2 Vaccines in April 2021 and my hands have been numb since and my legs feel like I am walking on air) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023 at 7:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2023 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.).    No concomitant medications were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. There was no reported symptoms. the patient had no additional doses, medications or treatments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse avent; Patient was scheduled to receive the Moderna Bivalent Booster dose, but the Monovalent vaccine was accidentaly administered instead.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was scheduled to receive the Moderna Bivalent Booster dose, but the Monovalent vaccine was accidentaly administered instead.) and NO ADVERSE EVENT (No adverse avent) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022H22A) for COVID-19 prophylaxis.     Patient was received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 01-Jun-2021 and PFIZER BIONTECH COVID-19 VACCINE on 22-Jun-2021; for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE on 18-Apr-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 31-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was scheduled to receive the Moderna Bivalent Booster dose, but the Monovalent vaccine was accidentaly administered instead.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse avent). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was scheduled to receive the Moderna Bivalent Booster dose, but the Monovalent vaccine was accidentaly administered instead.) and NO ADVERSE EVENT (No adverse avent) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse avent) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was scheduled to receive the Moderna Bivalent Booster dose, but the Monovalent vaccine was accidentaly administered instead.).    Concomitant medication was not provided.   Treatment information was not provided.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.) and NO ADVERSE EVENT (no adverse event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 22-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.).    No concomitant medications were reported.    The reporter stated that a patient was supposed to receive 0.5 ml as initial booster, but only got 0.25 ml. HCP asked if the recommendation was considered 24 hours or on the same day because the patient got the half dose yesterday 22-Feb2-023. HCP asked if she should give a full dose today 23-Feb-2023.   No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Impaired healing, Magnetic resonance imaging, Skin ulcer
Clinical narrative: 12 open sores that won't heal
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Cellulitis with redness and inflammation.  Patient received an Rx for prednisone and cephalexin
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Cerebrovascular accident, Computerised tomogram head, Death, Hemiplegia
Clinical narrative: My father received both the Pfizer booster (#5 shot which was the annual booster that was promoted as good for a year).  He was given this booster in the arm.  At the same time, he received the annual flu vaccine.  Two weeks later, my Dad had multiple strokes on 9/23/2022.  After strokes lead to him being bed-bound and paralysis on his left side.  He eventually died on 2/14/2023.  Immediately after the strokes, he was hospitalized for two (3) months straight, with a brief period on rehab, then ICU, then into hospice.   After being in for two months (while being hospitalized at hospital, he was transported.  He was hospitalized at Hospital.  He died in Hospice Care at Hospital
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Laboratory test, Magnetic resonance imaging
Clinical narrative: My father received both the Pfizer booster (#5 shot which was the annual booster that was promoted as good for a year).  He was given this booster in the arm.  At the same time, he received the annual flu vaccine.  Two weeks later, my Dad had multiple strokes on 9/23/2022.  After strokes lead to him being bed-bound and paralysis on his left side.  He eventually died on 2/14/2023.  Immediately after the strokes, he was hospitalized for two (3) months straight, with a brief period on rehab, then ICU, then into hospice.   After being in for two months (while being hospitalized at hospital, he was transported.  He was hospitalized at Hospital.  He died in Hospice Care at Hospital
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms or reaction per Patient.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Chest discomfort, Chills, Dyspnoea
Clinical narrative: I had a runny nose, sneezing, coughing, coughing up phlegm, fever, fatigue, difficult breathing, tightness of the chest. I experienced asthma like symptoms as well as hot and cold chills. I called my doctor, and they sent me a prescription to help alleviate symptoms. I took the medication for seven days twice a day. I didn't get any better after seven days, so I went to see a doctor for my lungs, and they prescribed ADVAIR.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling of body temperature change, Productive cough, Pulmonary function test abnormal, Pyrexia
Clinical narrative: I had a runny nose, sneezing, coughing, coughing up phlegm, fever, fatigue, difficult breathing, tightness of the chest. I experienced asthma like symptoms as well as hot and cold chills. I called my doctor, and they sent me a prescription to help alleviate symptoms. I took the medication for seven days twice a day. I didn't get any better after seven days, so I went to see a doctor for my lungs, and they prescribed ADVAIR.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had a runny nose, sneezing, coughing, coughing up phlegm, fever, fatigue, difficult breathing, tightness of the chest. I experienced asthma like symptoms as well as hot and cold chills. I called my doctor, and they sent me a prescription to help alleviate symptoms. I took the medication for seven days twice a day. I didn't get any better after seven days, so I went to see a doctor for my lungs, and they prescribed ADVAIR.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Chest discomfort, Dyspnoea, Headache, Musculoskeletal stiffness
Clinical narrative: TIA stroke on 25th of February 2023 at Apx 10:30pm, next morning headache & neck stiffness on 26th of February 2023. Shortness of breath & chest compression on February 27th 2023.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TIA stroke on 25th of February 2023 at Apx 10:30pm, next morning headache & neck stiffness on 26th of February 2023. Shortness of breath & chest compression on February 27th 2023.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test negative, Conjunctival oedema, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: Swollen eye lids, red eyes. Worse on right side. Diagnosis was chemosis . Treated with antibiotics, steroids, antihistamine, compresses and it still continues.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Laboratory test, Polymenorrhoea, Ultrasound scan
Clinical narrative: About 3 months after injection I started to have 2 periods every month. By December 2022, I bled from December 30th 2022 until February 12th 2023 (45 days) and have now started my period again on February 27th 2023. I now have to undergo surgery due to this.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given dose on 2/14/23 from a vial that was 4 days past the BUD.  Vial as removed from the freezer on 1/11/23 and should have been salvaged on 2/10/23.  Patient states that she has not experienced any adverse effects from the immunization as of 2/27/23.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Anxiety, Blood test normal, Chills, Computerised tomogram abdomen normal, Condition aggravated
Clinical narrative: FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Defaecation urgency, Depression, Diarrhoea, Faeces soft, Feeling abnormal
Clinical narrative: FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Feeling cold, Gastrointestinal disorder, Gastrointestinal pain, Headache, Hyperhidrosis
Clinical narrative: FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Impaired work ability, Laboratory test, Pyrexia, Tremor, Urine analysis normal
Clinical narrative: FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Coeliac disease, Fatigue, Feeling abnormal, Gastrointestinal disorder, Investigation
Clinical narrative: FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Pain
Clinical narrative: FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Condition aggravated, Deafness, Deafness unilateral, Tinnitus
Clinical narrative: The symptoms started 2 days after my second Covid 19 booster shot. I used to have non bothering very mild tinnitus on my left ear. But after second booster it became very bad and difficult.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fasting, Hepatic pain, Hypoaesthesia, Nausea
Clinical narrative: Awakened at 5:00 am, second day after Pfizer injection, with severe vertigo, nausea and vomiting.  In the following days, rapidly developed cascade of difficulties: bilateral, sharp breast pain. Sharp liver pain. Tinnitus, right side to begin, now bilateral.  No feeling in feet; felt like I was walking on blocks of wood.   Saw numerous alternative practitioners with lessening of vertigo.  March 1, 2022, traveled to health center for physician-monitored fasting with clearance of breast and liver pain and recovery of some feeling in both feet.  Tinnitus continues unabated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vomiting
Clinical narrative: Awakened at 5:00 am, second day after Pfizer injection, with severe vertigo, nausea and vomiting.  In the following days, rapidly developed cascade of difficulties: bilateral, sharp breast pain. Sharp liver pain. Tinnitus, right side to begin, now bilateral.  No feeling in feet; felt like I was walking on blocks of wood.   Saw numerous alternative practitioners with lessening of vertigo.  March 1, 2022, traveled to health center for physician-monitored fasting with clearance of breast and liver pain and recovery of some feeling in both feet.  Tinnitus continues unabated.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: She reports every time she bends over she gets dizzy and nauseous. Reports this happens when she bends over and states she feels she has been "drinking". Denies any fever or ill like sx.
Age: 47.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Blood test, Fatigue, Gait disturbance, Joint range of motion decreased, Joint swelling
Clinical narrative: The day after getting the vaccinations, I woke up with swelling hands and extremely fatigued.  I kept falling asleep all day and don't remember much.  I was rushed to the ER that night with a 104 degree fever and was diagnosed with pneumonia.  The joints in my hands, wrists, elbows, knees, ankles and feet were all swollen so I could barely walk.  I was put on antibiotics and two days later I was admitted into the hospital.  It took weeks for the swelling to go down and I need physical therapy to regain full motion.
Age: 47.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Magnetic resonance imaging, Memory impairment, Peripheral swelling, Pneumonia, Pyrexia
Clinical narrative: The day after getting the vaccinations, I woke up with swelling hands and extremely fatigued.  I kept falling asleep all day and don't remember much.  I was rushed to the ER that night with a 104 degree fever and was diagnosed with pneumonia.  The joints in my hands, wrists, elbows, knees, ankles and feet were all swollen so I could barely walk.  I was put on antibiotics and two days later I was admitted into the hospital.  It took weeks for the swelling to go down and I need physical therapy to regain full motion.
Age: 47.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Somnolence, X-ray
Clinical narrative: The day after getting the vaccinations, I woke up with swelling hands and extremely fatigued.  I kept falling asleep all day and don't remember much.  I was rushed to the ER that night with a 104 degree fever and was diagnosed with pneumonia.  The joints in my hands, wrists, elbows, knees, ankles and feet were all swollen so I could barely walk.  I was put on antibiotics and two days later I was admitted into the hospital.  It took weeks for the swelling to go down and I need physical therapy to regain full motion.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bradykinesia, Dizziness, Exploratory operation, Gait disturbance
Clinical narrative: Felt sick all  over, body aches, continued weight loss, dizziness, general malaise. She has impaired gait and memory issues since this injection. She now has trouble walking and balance since the injection.  She  moves very slow and can  no longerdrive. She wasavery active  person before this shot. She was a volunteer registered nurse at the free clinic in Glendale and no longer can ambulatedue to balance and edema issues in legs. She has just been diagnosed with Parkinson's Sydrome.  and Lymphedema. These symptoms started right after the booster. Symptoms have  now advanced into memory problems, speech problems, and ovarian cancer. Surgery for ovary removal just occured a few weeks  ago.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Impaired driving ability, Lymphoedema, Malaise, Memory impairment
Clinical narrative: Felt sick all  over, body aches, continued weight loss, dizziness, general malaise. She has impaired gait and memory issues since this injection. She now has trouble walking and balance since the injection.  She  moves very slow and can  no longerdrive. She wasavery active  person before this shot. She was a volunteer registered nurse at the free clinic in Glendale and no longer can ambulatedue to balance and edema issues in legs. She has just been diagnosed with Parkinson's Sydrome.  and Lymphedema. These symptoms started right after the booster. Symptoms have  now advanced into memory problems, speech problems, and ovarian cancer. Surgery for ovary removal just occured a few weeks  ago.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Oophorectomy, Ovarian cancer, Pain, Parkinsonism
Clinical narrative: Felt sick all  over, body aches, continued weight loss, dizziness, general malaise. She has impaired gait and memory issues since this injection. She now has trouble walking and balance since the injection.  She  moves very slow and can  no longerdrive. She wasavery active  person before this shot. She was a volunteer registered nurse at the free clinic in Glendale and no longer can ambulatedue to balance and edema issues in legs. She has just been diagnosed with Parkinson's Sydrome.  and Lymphedema. These symptoms started right after the booster. Symptoms have  now advanced into memory problems, speech problems, and ovarian cancer. Surgery for ovary removal just occured a few weeks  ago.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Weight decreased
Clinical narrative: Felt sick all  over, body aches, continued weight loss, dizziness, general malaise. She has impaired gait and memory issues since this injection. She now has trouble walking and balance since the injection.  She  moves very slow and can  no longerdrive. She wasavery active  person before this shot. She was a volunteer registered nurse at the free clinic in Glendale and no longer can ambulatedue to balance and edema issues in legs. She has just been diagnosed with Parkinson's Sydrome.  and Lymphedema. These symptoms started right after the booster. Symptoms have  now advanced into memory problems, speech problems, and ovarian cancer. Surgery for ovary removal just occured a few weeks  ago.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypophagia, Nausea, Throat tightness
Clinical narrative: pt came in pharmacy 2/27/23 and reported that she got severe nausea (couldn't eat or drink) for 3 days after 1st dose of Pfizer and after the 2nd dose of Pfizer, her throat closed up ( pt had to take benadryl and pepcid ac, and antinausea med, (did not go to hospital either times )
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: She noted itching immediately on injection and when she looked at her arm 15 minutes later noted localized redness and hardness of the skin
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/25/21 Lot# EN6204;  5/1/21 Pfizer Lot#EW017
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 2/23/21 Lot# 023M20A;  Moderna 3/23/21 Lot# 047A21A
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fall, Intensive care
Clinical narrative: Hospitalized 7/10/22-7/12/22 fall, lightheadedness, weakness, UTI, tachypnea, elevated troponin, SOB, transferred to Medical Center ICU,
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tachypnoea, Troponin increased, Urinary tract infection
Clinical narrative: Hospitalized 7/10/22-7/12/22 fall, lightheadedness, weakness, UTI, tachypnea, elevated troponin, SOB, transferred to Medical Center ICU,