chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored PROQUAD; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. . The patient's medical history, current conditions, drug reaction or allergies and concomitant medications were not reported.  On 02-AUG-2022, the patient was vaccinated with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin (rHA) (lot number: U029148, which was determined to be valid, with an expiration date on 16-MAR-2023) (dose, route and anatomical location of administration were not reported) (product storage error). Administered dose underwent a temperature excursion of -5.70 degrees Celsius (C) for 1 hour and 10 minutes. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose).    No concomitant medication was reported.  A patient had received first Moderna dose (6 months to less than equals 6 year old) and was supposed to get the second dose but got postponed several times.  The second dose recommendation was 1 month apart and so the patient second dose was more than 30 days since his first dose. Reporter asked if the patient would get another dose 1 month after this second dose even if he might have any certain kinds of immunocompromise and just because of the big gap between the first and the second dose.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Inappropriate schedule of product administration, Musculoskeletal stiffness, Weight, Weight increased
Clinical narrative: WEIGHT GAIN; STIFFNESS; JOINT PAIN IN KNEES; First dose administered on 02-jan-2021, Second dose administered on 01-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (WEIGHT GAIN), MUSCULOSKELETAL STIFFNESS (STIFFNESS), ARTHRALGIA (JOINT PAIN IN KNEES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 02-jan-2021, Second dose administered on 01-Mar-2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 02-jan-2021, Second dose administered on 01-Mar-2021). On an unknown date, the patient experienced WEIGHT INCREASED (WEIGHT GAIN), MUSCULOSKELETAL STIFFNESS (STIFFNESS) and ARTHRALGIA (JOINT PAIN IN KNEES). At the time of the report, WEIGHT INCREASED (WEIGHT GAIN) had not resolved and MUSCULOSKELETAL STIFFNESS (STIFFNESS), ARTHRALGIA (JOINT PAIN IN KNEES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 02-jan-2021, Second dose administered on 01-Mar-2021) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 45 lbs and Gain.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   Patient was administered with booster dose on 02-MAY-2021.  All three doses of moderna vaccine taken one in once.  Patient gained significant amount of weight during their time on therapy 45 lbs.  No treatment information was provided.  The reporter causality for the event of weight gain with RINVOQ (UPADACITINIB) was a reasonable possibility. The reporter causality for the events stiffness and joint pain in knees with RINVOQ (UPADACITINIB) was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Illness
Clinical narrative: really sick; was down for weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick) and DEPRESSED MOOD (was down for weeks) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick) and DEPRESSED MOOD (was down for weeks). At the time of the report, ILLNESS (really sick) and DEPRESSED MOOD (was down for weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick as a dog; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog) in a 35-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick as a dog). At the time of the report, ILLNESS (sick as a dog) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Unexpected therapeutic benefit; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (issues with covid shot with rinvoq (upadacitinib)) and DRUG INEFFECTIVE (possible rinvoq was not working) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In May 2022, the patient experienced DRUG INEFFECTIVE (possible rinvoq was not working). On an unknown date, the patient experienced UNEVALUABLE EVENT (issues with covid shot with rinvoq (upadacitinib)). At the time of the report, UNEVALUABLE EVENT (issues with covid shot with rinvoq (upadacitinib)) and DRUG INEFFECTIVE (possible rinvoq was not working) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication was provided. The patient was starting new medication. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of possible rinvoq was not working and issues with COVID shot was not provided. Treatment medication was not provided by the reporter. Company Comment: This is a Spontaneous case concerning a 50-year-old, male patient, with underlying Rheumatoid Arthritis treated with Upadacitinib, who experienced the non-serious, unexpected adverse event of Unevaluable event in an unknown date, in the context of the administration of a dose of the mRNA-1273 vaccine (unknown dose number and sequence of administration). The underlying medical condition remains as a contributor for the event. It is reported in this case a situation of Lack of drug effect, attributed to a co-suspect UPADACITINIB. But is not mentioned for the COVID-19 vaccine shut. No further clinical information was available for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a 50-year-old, male patient, with underlying Rheumatoid Arthritis treated with Upadacitinib, who experienced the non-serious, unexpected adverse event of Unevaluable event in an unknown date, in the context of the administration of a dose of the mRNA-1273 vaccine (unknown dose number and sequence of administration). The underlying medical condition remains as a contributor for the event. It is reported in this case a situation of Lack of drug effect, attributed to a co-suspect UPADACITINIB. But is not mentioned for the COVID-19 vaccine shut. No further clinical information was available for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and ALOPECIA (Hair loss) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Rheumatoid arthritis and Sjogren's syndrome. Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis and Sjogren's syndrome. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ALOPECIA (Hair loss). At the time of the report, COVID-19 (COVID-19) outcome was unknown and ALOPECIA (Hair loss) had not resolved. Company comment: This is a spontaneous case concerning a 69-year-old female patient with medical history of Rheumatoid arthritis and Sjogren´s syndrome, who experienced the non-serious COVID-19,  within one to two months after the third dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Hear loss was reported as a non-serious event. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment medications was provided by the reporter. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Sender's Comments: Company comment: This is a spontaneous case concerning a 69-year-old female patient with medical history of Rheumatoid arthritis and Sjogren´s syndrome, who experienced the non-serious COVID-19,  within one to two months after the third dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Hear loss was reported as a non-serious event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blister, Immunisation reaction, Inappropriate schedule of product administration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: HAD REACTION TO THE SECOND COVID SHOT; FELT HOT; BLISTER ON FOOT; ARM BLEW UP; Received booster dose in less than 3 month afer receiveing 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (HAD REACTION TO THE SECOND COVID SHOT), VACCINATION SITE WARMTH (FELT HOT), BLISTER (BLISTER ON FOOT), VACCINATION SITE SWELLING (ARM BLEW UP) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose in less than 3 month afer receiveing 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose in less than 3 month afer receiveing 2nd dose). On an unknown date, the patient experienced IMMUNISATION REACTION (HAD REACTION TO THE SECOND COVID SHOT), VACCINATION SITE WARMTH (FELT HOT), BLISTER (BLISTER ON FOOT) and VACCINATION SITE SWELLING (ARM BLEW UP). At the time of the report, IMMUNISATION REACTION (HAD REACTION TO THE SECOND COVID SHOT), VACCINATION SITE WARMTH (FELT HOT), BLISTER (BLISTER ON FOOT) and VACCINATION SITE SWELLING (ARM BLEW UP) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose in less than 3 month afer receiveing 2nd dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Caller asking if she should take another Moderna booster once she is feeling better) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication. No Medical History information was reported. In November 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller asking if she should take another Moderna booster once she is feeling better). At the time of the report, IMMUNISATION REACTION (Caller asking if she should take another Moderna booster once she is feeling better) outcome was unknown.  No concomitant medication was reported. No treatment medication was reported. Patient was administered with Moderna COVID-19 booster dose on NOV-2021.
Age: 77.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 30-Apr-2022, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Treatment information was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient administered Moderna COVID-19 vaccine after the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 003A21A and 004M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date).    Concomitant medication details was not reported by the reporter. Patient did not experience any adverse events. Treatment details was not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-628687 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-628687:Same reporter.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; They gave a 2nd dose of the Moderna Covid-19 Vaccine 1 week too early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a 2nd dose of the Moderna Covid-19 Vaccine 1 week too early) and NO ADVERSE EVENT (No adverse event) in a 29-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a 2nd dose of the Moderna Covid-19 Vaccine 1 week too early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a 2nd dose of the Moderna Covid-19 Vaccine 1 week too early) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a 2nd dose of the Moderna Covid-19 Vaccine 1 week too early).    No concomitant medication was reported. It was reported that patient received the second dose 1 week too early. No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: fluzone quadrivalent np administered to a patient that has been exposed to a temperature excursion with no reported adverse event; fluzone quadrivalent np administered to a patient that has been exposed to a temperature excursion with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a Nurse. (Agency Inquiry Number: 01228367)  This case involves a 21-year-old female patient who has been administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after being exposed to a temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunization; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunization; and Varicella Zoster Vaccine (Varicella Vaccine) for Immunization.  On an unknown date, reportedly fluzone quadrivalent np has been exposed to a temperature excursion with no reported adverse event (product storage error).  On 09-Aug-2022, the patient has been administered fluzone quadrivalent np at dose 0.5ml once via intramuscular route in the left deltoid (lot U7684BA, expiry date: 30-Jun-2023) after being exposed to a temperature excursion with no reported adverse event (poor quality product administered) same day latency. It was not the first-time vaccine was administered.  Action taken: Not applicable. The patient was not using the product at time of report.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for both events.     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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Muscle spasms
Clinical narrative: Severe muscle spasms in arm where vaccine was given and the corresponding shoulder blade. Fluttering in chest.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 27 y/o previously healthy male received 3rd dose of Moderna "booster" on 9 June 2022. Full body urticaria without angioedema developed on/around 13 June 2022 and has continued since then. Not improved with prednisone or oral antihistamines.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Hemiparesis, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Bottom lip swelling and tingling and left side of tongue tingling, lt side of body weakness and tingling a few minutes after receiving anthrax vaccine. Initially started in rt arm then migrated to lt within minutes of receiving immunization.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone normal, Complement factor C4, Electrophoresis protein normal, Helicobacter test negative
Clinical narrative: Patient notes 6 days after receiving 3rd dose of Moderna "booster", patient developed full body urticaria without angioedema. Improved with oral antihistamines.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test normal, Urticaria, White blood cell count increased
Clinical narrative: Patient notes 6 days after receiving 3rd dose of Moderna "booster", patient developed full body urticaria without angioedema. Improved with oral antihistamines.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Deep vein thrombosis, Myocardial injury
Clinical narrative: Patient started experiencing right lower leg pain on July 24, 2022. He decided to come to the ER on August 9, 2022 due to worsening symptoms. At that time an ultrasound was performed which showed an acute non occluding DVT popliteal vein and thrombus in the peroneal vein. Patient was prescribed Eliquis 10mg twice a day. Patient started having chest pain on August 11, 2022. He returned to the ER August 14, 2022 due to increased chest pain. A CT scan was performed which revealed bilateral pulmonary emobli with right heart strain.  The right involving the main, lobar, segmental, and subsegmental branches. The left involving lobar and segmental branches. Patient is now admitted for management of pulmonary emboli.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Patient started experiencing right lower leg pain on July 24, 2022. He decided to come to the ER on August 9, 2022 due to worsening symptoms. At that time an ultrasound was performed which showed an acute non occluding DVT popliteal vein and thrombus in the peroneal vein. Patient was prescribed Eliquis 10mg twice a day. Patient started having chest pain on August 11, 2022. He returned to the ER August 14, 2022 due to increased chest pain. A CT scan was performed which revealed bilateral pulmonary emobli with right heart strain.  The right involving the main, lobar, segmental, and subsegmental branches. The left involving lobar and segmental branches. Patient is now admitted for management of pulmonary emboli.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of SHINGRIX in November 2020, second dose yesterday, August 7, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2020).   On 7th August 2022, the patient received the 2nd dose of Shingrix. On 7th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comment: The patient self-reported this case. The patient received her second dose yesterday (day before reporting). The patient did not consent to follow-up.  The reporter did not wish to provide further contact information as the reporter was moving.  The reporter needed to end the call before this agent was able to obtain further information. Additional supportive information: The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered dose 08Aug2022, expiration date of 07Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAB (Twinrix adult) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-AUG-2022 Reporter's comment: The pharmacist reported that a nurse had administered a dose of Twinrix and after administration, the nurse had noticed that the vaccine had an expiration date of 7th August 2022.This was the patient's first dose in the series. At the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Twinrix, which led to expired vaccine used.
Age: 55.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Cold sweat, Confusional state, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient complained of feeling faint.  He stated, "I feel dizzy."  Suddenly lost consciousness in the moment following statement.  Client's breathing stopped.  No respirations noted.  Skin pale and clammy.  Epinephrine administered via left lateral thigh.  After administration, client immediately regained consciousness.  Appeared dazed and confused, stating, "What happened, how long was I out?"  He complained of extreme thirst.  911 called.  Emergency response arrived, assessed client.  They advised client to go to hospital.  Client declined.
Age: 55.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Pallor, Respiratory arrest, Thirst
Clinical narrative: Patient complained of feeling faint.  He stated, "I feel dizzy."  Suddenly lost consciousness in the moment following statement.  Client's breathing stopped.  No respirations noted.  Skin pale and clammy.  Epinephrine administered via left lateral thigh.  After administration, client immediately regained consciousness.  Appeared dazed and confused, stating, "What happened, how long was I out?"  He complained of extreme thirst.  911 called.  Emergency response arrived, assessed client.  They advised client to go to hospital.  Client declined.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Last Friday (5 Aug 2022) I took Patient to a Pharmacy local to me for his first dose of the Pfizer COVID-19 vaccine for kids 4 and under. He complained of a tummy ache and threw up in the car about 20 minutes after his shot, so I took him to Urgent Care. The urgent care intake staff triaged him and recommended hydration and monitoring for any other symptoms. He initially had a temp of 99.6F, was able to sip water & a little bit of pedialite and fell asleep for about three hours (continued).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 3/8/21  012A21A dose 2 Moderna 4/8/21  017B21A
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Pt. had her Boostrix TDAP vaccine with me on 07/09/22.she called the pharmacy 33days(08/11/22) complaining about a severe pain that she has been experiencing on her left side.she states that she can barely move her left arm & that the pain is due to the vaccine she received.She also told me that she has a dr's appt today and followup MRI.I did apologized to her over the phone & told her to stop by the pharmacy for in-person apology.She did stopby at around 630pm.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 2/26/21 024M20A dose 2 Moderna 3/26/21 030A21A dose 3 Moderna 10/22/21 046C21A
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Body temperature increased, COVID-19, Catheterisation cardiac abnormal
Clinical narrative: 4/21/2022-Presents to ED chest pain. Covid - test. Admit OBS Chest pain r/o AC. Intial trop 0.20 and EKG NSR. 4/23/2022-Cardiac Cath completed. Severe restenosis of the LAD stents.  4/26/2022- Coughing, chills, sore throat and congestion. T-101.5  Covid + test. Creatnine 1.4 AKI. Given bebtelovimab.  4/28/2022-Afebrile. Maintaining spo2 on RA.  4/29/2022- D/C and transfer to hospital possible cardiac transplant.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Electrocardiogram normal, Oropharyngeal pain
Clinical narrative: 4/21/2022-Presents to ED chest pain. Covid - test. Admit OBS Chest pain r/o AC. Intial trop 0.20 and EKG NSR. 4/23/2022-Cardiac Cath completed. Severe restenosis of the LAD stents.  4/26/2022- Coughing, chills, sore throat and congestion. T-101.5  Covid + test. Creatnine 1.4 AKI. Given bebtelovimab.  4/28/2022-Afebrile. Maintaining spo2 on RA.  4/29/2022- D/C and transfer to hospital possible cardiac transplant.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Troponin, Vascular stent stenosis
Clinical narrative: 4/21/2022-Presents to ED chest pain. Covid - test. Admit OBS Chest pain r/o AC. Intial trop 0.20 and EKG NSR. 4/23/2022-Cardiac Cath completed. Severe restenosis of the LAD stents.  4/26/2022- Coughing, chills, sore throat and congestion. T-101.5  Covid + test. Creatnine 1.4 AKI. Given bebtelovimab.  4/28/2022-Afebrile. Maintaining spo2 on RA.  4/29/2022- D/C and transfer to hospital possible cardiac transplant.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Computerised tomogram head normal, Full blood count normal
Clinical narrative: 4/22/2022- AMS with weakness, from SNF, T-99, BP-141/77. Covid + test. CT Head- no eveidenc of intracranial hemorrhage. CXR-scattered calcified granulomas within lungs again notes. Admit AMS s/t Covid-19. Started bebtelovimab and doxy. Currently on 2L NC. 4/24/2022- Spo2 94% on RA. Afebrile. CMP and CBC unremarkable. 4/26/2022 D/C to Assisted living. Afebrile and BP-122/82.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mental status changes, Metabolic function test, Metabolic function test normal, Pulmonary calcification, Pulmonary granuloma
Clinical narrative: 4/22/2022- AMS with weakness, from SNF, T-99, BP-141/77. Covid + test. CT Head- no eveidenc of intracranial hemorrhage. CXR-scattered calcified granulomas within lungs again notes. Admit AMS s/t Covid-19. Started bebtelovimab and doxy. Currently on 2L NC. 4/24/2022- Spo2 94% on RA. Afebrile. CMP and CBC unremarkable. 4/26/2022 D/C to Assisted living. Afebrile and BP-122/82.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 4/22/2022- AMS with weakness, from SNF, T-99, BP-141/77. Covid + test. CT Head- no eveidenc of intracranial hemorrhage. CXR-scattered calcified granulomas within lungs again notes. Admit AMS s/t Covid-19. Started bebtelovimab and doxy. Currently on 2L NC. 4/24/2022- Spo2 94% on RA. Afebrile. CMP and CBC unremarkable. 4/26/2022 D/C to Assisted living. Afebrile and BP-122/82.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Given 12 year old dose to an 11 year 10 month old. No other reactions or adverse events noted.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest injury, Lymphadenopathy, Myalgia
Clinical narrative: Chest trauma adenopathy, left axillary adenopathy, continued left arm myalgias continued onset since 2 days after vaccination
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Nasopharyngitis, Pain in extremity, Respiratory tract congestion
Clinical narrative: My arm was sore for about a day and that was it.  I had a very mild case of COVID-19. I felt like I like I had a bad cold or a minor case of flu. I called my doctors  office and they prescribed Paxlovid. I really don't think it helped that much. As of today I still have the congestion and runny nose. I do go out with a mask.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: My arm was sore for about a day and that was it.  I had a very mild case of COVID-19. I felt like I like I had a bad cold or a minor case of flu. I called my doctors  office and they prescribed Paxlovid. I really don't think it helped that much. As of today I still have the congestion and runny nose. I do go out with a mask.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac arrest, Chest X-ray abnormal, Chest tube insertion
Clinical narrative: 6/16/22 pt had a positive COVID test at Care Center; 6/19/22 pt brought to ED with dyspnea; O2 saturations in the 80s on RA; placed on O2 supplement; admitted; CXR showed moderate bilateral multifocal opacities and pleural effusions; A Fibrillation; dexamethasone; pneumothorax, chest tube placed; suffered cardiac arrest; CPR; transferred to CCU; treated with medications; ABX started for suspected sepsis; family decided to withdraw care; comfort care; pt expired in the hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Dyspnoea, Intensive care, Lung opacity
Clinical narrative: 6/16/22 pt had a positive COVID test at Care Center; 6/19/22 pt brought to ED with dyspnea; O2 saturations in the 80s on RA; placed on O2 supplement; admitted; CXR showed moderate bilateral multifocal opacities and pleural effusions; A Fibrillation; dexamethasone; pneumothorax, chest tube placed; suffered cardiac arrest; CPR; transferred to CCU; treated with medications; ABX started for suspected sepsis; family decided to withdraw care; comfort care; pt expired in the hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Pneumothorax, Resuscitation, SARS-CoV-2 test positive, Sepsis
Clinical narrative: 6/16/22 pt had a positive COVID test at Care Center; 6/19/22 pt brought to ED with dyspnea; O2 saturations in the 80s on RA; placed on O2 supplement; admitted; CXR showed moderate bilateral multifocal opacities and pleural effusions; A Fibrillation; dexamethasone; pneumothorax, chest tube placed; suffered cardiac arrest; CPR; transferred to CCU; treated with medications; ABX started for suspected sepsis; family decided to withdraw care; comfort care; pt expired in the hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram normal, Computerised tomogram normal, Magnetic resonance imaging head normal, Neurological symptom
Clinical narrative: Acute neurologic event within 48 hours of vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, COVID-19, Chest X-ray abnormal, Condition aggravated, Death
Clinical narrative: Patient with a PMH of Copd with oxygen at home.  ESRD on HD, and tobacco use.  He presented to Medical Center on 02/21/2022 with complaints of progressive dyspnea on exertion eventually leading  to dyspnea at rest.  Patient stated sleeping in tripod position.  Patient admitted to hospital for respiratory failure, Covid-19 and ESRD.  Chest X-ray revealed bilateral pleural effusions with marked interval increase in large left pleural effusion, left lung atelectasis with bilateral airspace disease.  Patient had ST changes on EKG, and elevated troponin.  Patient expired on 03/09/2022.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea at rest, Dyspnoea exertional, Electrocardiogram ST segment abnormal, End stage renal disease, Lung disorder
Clinical narrative: Patient with a PMH of Copd with oxygen at home.  ESRD on HD, and tobacco use.  He presented to Medical Center on 02/21/2022 with complaints of progressive dyspnea on exertion eventually leading  to dyspnea at rest.  Patient stated sleeping in tripod position.  Patient admitted to hospital for respiratory failure, Covid-19 and ESRD.  Chest X-ray revealed bilateral pleural effusions with marked interval increase in large left pleural effusion, left lung atelectasis with bilateral airspace disease.  Patient had ST changes on EKG, and elevated troponin.  Patient expired on 03/09/2022.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Respiratory failure, Sleep disorder, Troponin increased
Clinical narrative: Patient with a PMH of Copd with oxygen at home.  ESRD on HD, and tobacco use.  He presented to Medical Center on 02/21/2022 with complaints of progressive dyspnea on exertion eventually leading  to dyspnea at rest.  Patient stated sleeping in tripod position.  Patient admitted to hospital for respiratory failure, Covid-19 and ESRD.  Chest X-ray revealed bilateral pleural effusions with marked interval increase in large left pleural effusion, left lung atelectasis with bilateral airspace disease.  Patient had ST changes on EKG, and elevated troponin.  Patient expired on 03/09/2022.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Pain
Clinical narrative: -Dizziness began on 08/12/2022 and subsided on 08/14/2022 -Headache began on 08/12/2022 and subsided on 08/14/2022 -Soreness at the injection site began on 08/12/2022 and subsided on 08/14/2022 -Mild body aches began on 08/12/2022 and subsided on 08/14/2022
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: 05/13/2022 I had my vaccination. 05/20/2022 I went to see the dermatologist. I believe I had the rash beforehand but I cannot remember the dates. The rash seemed a weak area on my cheek. When it flares up, it is also on the back of my neck and head. I thought it was because I was trying to sleep on my back. The rash, I got little bumps. It spread to the rest of my head and eyelids. My right eye is still swollen. The dermatologist they were not sure what to recommend. They told me to try Acyclovir for 7 days and apply twice a day. Then they also gave me a Cortisone prescription. That seemed to improve the symptoms. I now only use when it flares up and it seems to get a little better.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Male patient of 25 years receives first dose of Moderna of 0.25ml by administration error.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Body temperature increased, COVID-19, Chills, Cough
Clinical narrative: On 06/26/2022, I was very hot and tired, but I assumed it was due to the weather. The next day I was fine, but overnight I developed a scratchy throat, chills, and a cough. That next day, Tuesday, I took an at home COVID-19 test and it was positive. After testing positive, I spoke with my doctor who prescribed antibiotics because he thought there may be an underlying bacterial infection. I had a slightly elevated temperature and was very tired and still had a scratchy throat. Wednesday, I was still tired, had a cough and scratchy throat. The rest of the week, I was very tired. I tested negative for COVID-19 on 07/10/2022 but was still experiencing fatigue. By 07/19/2022, I was feeling less tired and more normal. By the beginning of August, until around last week, I am still feeling an underlying fatigue mentally and physically. Around last Thursday, 08/11/2022, I began feeling normal again.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On 06/26/2022, I was very hot and tired, but I assumed it was due to the weather. The next day I was fine, but overnight I developed a scratchy throat, chills, and a cough. That next day, Tuesday, I took an at home COVID-19 test and it was positive. After testing positive, I spoke with my doctor who prescribed antibiotics because he thought there may be an underlying bacterial infection. I had a slightly elevated temperature and was very tired and still had a scratchy throat. Wednesday, I was still tired, had a cough and scratchy throat. The rest of the week, I was very tired. I tested negative for COVID-19 on 07/10/2022 but was still experiencing fatigue. By 07/19/2022, I was feeling less tired and more normal. By the beginning of August, until around last week, I am still feeling an underlying fatigue mentally and physically. Around last Thursday, 08/11/2022, I began feeling normal again.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Cough, Death
Clinical narrative: Patient presented to local hospital on 09/04/2021 with c/o SOB and weakness; with a PMH significant for Leukemia, CAD, Type 2 DM, HTN, HLD. Patient was diagnosed with COVID one week prior to hospitalization. Also c/o fevers, diarrhea, nausea, and decreased oral intake, SOB with nonproductive cough. In the ED patient was placed on oxygen and given IV fluids. CXR showed patchy bilateral infiltrate's. EKG showed sinus rhythm without acute ischemic changes.  Patient also received Decadron in ED. Patient was admitted to hospital. Patient was intubated on 09/12/2021 and expired on 09/18/2021.