chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Reportedly, 12 doses or vials were initially stored in the refrigerator on 31-Aug-2021. The vials did not undergo any temperature excursions. It was reported that doses were administered after 30-day use by date or after manufacturer date of expiry. Reporter wanted to clarify that this information provided by email was from new patients different than previous patients reported by her colleague on 31-Mar-2022, and that some of these new patients belongs to different clinics but all of them pertained to the same community clinic. Treatment details were not reported by the reporter. This case was linked to MOD-2022-534284 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up document contains additional information regarding patients on same community clinic.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Pain
Clinical narrative: terrible aches/pain; staying in bed; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (terrible aches/pain), BEDRIDDEN (staying in bed) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CICLOSPORIN (RESTASIS) and ESTRADIOL (IMVEXXY) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (terrible aches/pain), BEDRIDDEN (staying in bed) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (terrible aches/pain), BEDRIDDEN (staying in bed) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient received 2 doses of the Moderna COVID19 vaccine and 1 booster dose. Patient was scheduled to receive a 2nd booster the following week.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow Up contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Sensitive skin
Clinical narrative: Left hand swollen; Left hand pain; Arm sensitive; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left hand swollen), PAIN IN EXTREMITY (Left hand pain) and SENSITIVE SKIN (Arm sensitive) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 vaccine (Suspension for injection, Intramuscular, Dose not reported, Batch-unknown, Expiry-unknown.) on 09-Mar-2021, Janssen COVID-19 vaccine (Suspension for injection, Intramuscular, Dose not reported, Batch-unknown, Expiry-unknown) in 2021, Janssen COVID-19 vaccine (Suspension for injection, Intramuscular, Dose not reported, Batch-unknown and Expiry-unknown) in 2021; for Rheumatoid arthritis: HUMIRA (Sub-cutaneous, Batch-not reported and Dose- not reported). Past adverse reactions to the above products included Bruising of arm with Janssen COVID-19 vaccine; Memory loss with Janssen COVID-19 vaccine; and No adverse event with HUMIRA and Janssen COVID-19 vaccine. Concurrent medical conditions included Rheumatoid arthritis.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Left hand swollen), PAIN IN EXTREMITY (Left hand pain) and SENSITIVE SKIN (Arm sensitive). At the time of the report, PERIPHERAL SWELLING (Left hand swollen), PAIN IN EXTREMITY (Left hand pain) and SENSITIVE SKIN (Arm sensitive) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.  The causal relationship between Janssen COVID-19 vaccine and all events were reported as possible. The action taken with Janssen COVID-19 vaccine for all events was Not applicable and HUMIRA(Adalimumab) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination.     Patient didn't have any allergies and any medical history.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up). The patient was treated with EMPAGLIFLOZIN (JARDIANCE) for Adverse event, at an unspecified dose and frequency; FUROSEMIDE for Adverse event, at a dose of UNK,water pill; POTASSIUM for Adverse event, at an unspecified dose and frequency and Physical therapy (compression leg stockings and electric air pump machine that he wears twice a day) for Lymphoedema. At the time of the report, LYMPHOEDEMA (He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up) outcome was unknown.            No concomitant drug information was provided. Reporter reported that the patient was not hospitalized but was advised by his HCP to get hospitalized and stated that  was almost hospitalized and ended up receiving care at  primary care's clinic. Physical therapy and compression leg stockings and electric air pump machine that he wears twice a day. Patient did not have any COVID-19 test.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (barely warm muscle at the injection site for a couple of days), DIZZINESS (Today, she started presenting little pins of headache occasionally and dizziness.), VACCINATION SITE PRURITUS (2 days after the administration, she was a little itchy at the injection site, she barely has it now), HEADACHE (Today, she started presenting little pins of headache occasionally and dizziness) and FATIGUE (Also mentioned fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 058F21A, 010M20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Ulcerative colitis (patient had been symptom free for years). Concomitant products included MESALAZINE (APRISO) for Ulcerative colitis, SIMVASTATIN and CALAMINE for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (2 days after the administration, she was a little itchy at the injection site, she barely has it now). On 07-Apr-2022, the patient experienced DIZZINESS (Today, she started presenting little pins of headache occasionally and dizziness), HEADACHE (Today, she started presenting little pins of headache occasionally and dizziness) and FATIGUE (Also mentioned fatigue). On an unknown date, the patient experienced VACCINATION SITE WARMTH (barely warm muscle at the injection site for a couple of days). At the time of the report, VACCINATION SITE WARMTH (barely warm muscle at the injection site for a couple of days) had resolved, DIZZINESS (Today, she started presenting little pins of headache occasionally and dizziness.) had not resolved, VACCINATION SITE PRURITUS (2 days after the administration, she was a little itchy at the injection site, she barely has it now) was resolving and HEADACHE (Today, she started presenting little pins of headache occasionally and dizziness) and FATIGUE (Also mentioned fatigue) outcome was unknown. The patient had no allergies. It was reported that patient had never been diagnosed/tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient received second booster dose on 04-Apr-2022. The adverse events did not cause patient to seek medical care. It was reported that some of symptoms improved. No treatment was given. This case was linked to MOD-2021-019539, MOD-2022-535387, MOD-2022-535389 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (milder reaction to the 1st booster dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 058F21A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Ulcerative colitis. Concomitant products included MESALAZINE (APRISO) for Ulcerative colitis, SIMVASTATIN and CALAMINE for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (milder reaction to the 1st booster dose). At the time of the report, VACCINATION COMPLICATION (milder reaction to the 1st booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient height was reported as 5'2". Treatment details was not reported by the reporter. This case was linked to MOD-2021-019539, MOD-2022-535387 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: reaction to the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     Patient did not have any allergies. Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Ulcerative colitis (was symptom free for years). Concomitant products included MESALAZINE (APRISO) for Ulcerative colitis, SIMVASTATIN and CALAMINE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the second dose). At the time of the report, VACCINATION COMPLICATION (reaction to the second dose) outcome was unknown.            Patient did not seek medical care. No treatment medication were provided.   This case was linked to MOD-2021-019539, MOD-2022-535378, MOD-2022-535389 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little sore arm after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm after the 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (Glaucoma suspect), Food allergy, Seasonal allergy and Allergy to animals (Cat allergy). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, LATANOPROST (XALATAN) for Glaucoma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Little sore arm after the 1st dose). At the time of the report, VACCINATION SITE PAIN (Little sore arm after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient felt fine with just a little sore arm. She did not have any Covid-19 diagnosis prior to or after getting the vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-535464 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: Felt she had a bad flu after the 2nd dose; Was sick within 24 hours after getting the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt she had a bad flu after the 2nd dose) and ILLNESS (Was sick within 24 hours after getting the 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not have any COVID-19 diagnosis prior to or after getting the vaccine.  Previously administered products included for Product used for unknown indication: Flu vaccine (6 weeks prior to getting the 1st booster dose of the Moderna Covid-19 vaccine.) in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Glaucoma (Glaucoma suspect), Food allergy, Seasonal allergy and Allergy to animal (whenever she plays with cats.). Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, LATANOPROST (XALATAN) for Glaucoma.   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. On an unknown date, the patient experienced INFLUENZA (Felt she had a bad flu after the 2nd dose) and ILLNESS (Was sick within 24 hours after getting the 2nd dose). At the time of the report, INFLUENZA (Felt she had a bad flu after the 2nd dose) outcome was unknown and ILLNESS (Was sick within 24 hours after getting the 2nd dose) had resolved.            It was reported that after 2nd dose patient had a bad flu and was sick within 24 hours and at 5:00pm on the same day she felt sick and when she woke up at 3:00am the next day, she felt fine. No treatment details were reported.  After the 1st booster dose, she felt nothing.   This case was linked to MOD-2022-535460 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Tinnitus; First dose on 17 Jan 2021 and second dose on 09 Feb 2021; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Tinnitus) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17 Jan 2021 and second dose on 09 Feb 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Hypertension.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17 Jan 2021 and second dose on 09 Feb 2021). In May 2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17 Jan 2021 and second dose on 09 Feb 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After receiving the second dose of the Moderna Covid 19 vaccine and before receiving the first booster dose patient developed tinnitus.  The patient did not took any treatment medication for this symptom.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine is given 30 days from storage and is expired; administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 10:54 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 01-Mar-2022 Vial did not undergone to any temperature excursion. No treatment medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not tested positive for COVID-19 Patient did not have acute illness at the time of vaccination up to one month before Patient did not have chronic or long standing health conditions.     On 30-Mar-2022 at 11:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 6:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  No adverse events were reported by the patient. The vial was initially stored in the refrigerator on 01-Mar-2022 The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-532165 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not tested positive for COVID-19  Patient did not have acute illness at the time of vaccination and up to month before. It was reported that there were no known drug allergies and no known chronic or long-standing health conditions.     On 30-Mar-2022 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported It was unknown whether the patient took any prescriptions, over-the-counter medications, dietary supplements or herbal medicines at the time of vaccination or at the time of adverse event. No adverse events were reported by the patient. The vial was initially stored in the refrigerator on 01-Mar-2022. The vial did not undergo any temperature excursions. No treatment medications were reported. This case was linked to MOD-2022-532165 (Patient Link).
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of DAPTACEL was given to a patient ; practice discovered that the Daptacel that was administered had expired ( with no reported adverse event); Initial information received on 01-Apr-2022 along with live follow-up regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 10 years old male patient for whom expired dose of daptacel was given to a patient ; practice discovered that the daptacel that was administered had expired ( with no reported adverse event) while receiving vaccine Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), and family history were not provided. Patient received no concomitant vaccines. At the time of the event, the patient had ongoing Diabetes.   On an unknown date, the patient received 5 doses of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route. On 31-Mar-2022 he also received a Booster dose of the same vaccine  (lot C5706EA; expiry date: 11 Mar 2022) via intramuscular route in the right deltoid.  On 31-MAR-2022 the patient developed a non-serious event  expired dose of daptacel was given to a patient ; practice discovered that the daptacel that was administered had expired ( with no reported adverse event) (expired product administered) (unkown latency).  It was reported that is there any safety data on giving an extra dose of Daptacel (or other vaccines), how does Daptacel compare with Adacel in terms of the amount of the active ingredients/antigen in each of the vaccines and the age ranges they are approved for, is there information on use of Daptacel in patients 7 years of age and old as a booster.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Tachycardia
Clinical narrative: Contracted covid the very next week after vaccination, as well as experiencing tachycardia.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary mass, Balance disorder, Dizziness, Fatigue
Clinical narrative: swollen lymph nodes, purple spot like the size of a quarter under left arm. Then swelling goes down 3 1/2 inches and about 2 1/2 inches wide. EXTREME fatigue...sleeping 12 hours plus 1 or 2 naps., no energy. Swelling is also under right arm but smaller. headaches, blurry vision, dizzy, out of balance. There are many lumps under my arm pits. All I want to do is sleep. After first shot, I got the second on March 12, 2021 and third 10/25/2021. I don't know if I should get the fourth.  . Each vaccination has been worse, fever from 99.3 to 100.8 comes and goes. Severe body aches also come and go.  Somedays I mostly stay in bed. THE MAIN THING I WANT TO KNOW IS SHOULD I GET THE 4TH VACCINATION...I'M I GOING TO GET MORE ILL?
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Lymphadenopathy, Oedema peripheral, Pain
Clinical narrative: swollen lymph nodes, purple spot like the size of a quarter under left arm. Then swelling goes down 3 1/2 inches and about 2 1/2 inches wide. EXTREME fatigue...sleeping 12 hours plus 1 or 2 naps., no energy. Swelling is also under right arm but smaller. headaches, blurry vision, dizzy, out of balance. There are many lumps under my arm pits. All I want to do is sleep. After first shot, I got the second on March 12, 2021 and third 10/25/2021. I don't know if I should get the fourth.  . Each vaccination has been worse, fever from 99.3 to 100.8 comes and goes. Severe body aches also come and go.  Somedays I mostly stay in bed. THE MAIN THING I WANT TO KNOW IS SHOULD I GET THE 4TH VACCINATION...I'M I GOING TO GET MORE ILL?
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Somnolence, Swelling, Vision blurred
Clinical narrative: swollen lymph nodes, purple spot like the size of a quarter under left arm. Then swelling goes down 3 1/2 inches and about 2 1/2 inches wide. EXTREME fatigue...sleeping 12 hours plus 1 or 2 naps., no energy. Swelling is also under right arm but smaller. headaches, blurry vision, dizzy, out of balance. There are many lumps under my arm pits. All I want to do is sleep. After first shot, I got the second on March 12, 2021 and third 10/25/2021. I don't know if I should get the fourth.  . Each vaccination has been worse, fever from 99.3 to 100.8 comes and goes. Severe body aches also come and go.  Somedays I mostly stay in bed. THE MAIN THING I WANT TO KNOW IS SHOULD I GET THE 4TH VACCINATION...I'M I GOING TO GET MORE ILL?
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Insomnia, Pain in extremity
Clinical narrative: sever pain on left arm, numbness on fingers, sharp pain to chest. Cannot sleet at night. Using pain medications,/
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Malaise
Clinical narrative: PT REPORTS DURING HOSPITAL STAY THAT AS SOON AS SHE RECEIVED HER COVID VACCINE SHE FELT SICK, WAS DIAGNOSED WITH BREAST CANCER ONE MONTH LATER. PT STATED SHE HAD NO OTHER MEDICAL HISTORY OTHER THAN GETTING FLU OR COLD ONCE IN A WHILE
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Injury, Maternal exposure before pregnancy, Ultrasound scan abnormal
Clinical narrative: LMP 1/11/2022 FIRST TRIMESTER MISCARRIAGE CONFIRMED WITH ULTRASOUND ON 3/21/22 AND 4/11/22.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dyspnoea, Injection site pain, Pain in extremity
Clinical narrative: pain at injection site; heavy breathing; weakness; PAIN IN WHOLE ARM; PAIN IN UPPER SHOULDER; This case was reported by a consumer and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 18th December 2021). Concurrent medical conditions included arthritis and swelling.   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 1st April 2022, the dose was an unknown dose. On 1st April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, labored respiration, weakness, pain in arm and shoulder pain. On an unknown date, the outcome of the injection site pain, weakness, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the labored respiration was recovering/resolving.   It was unknown if the reporter considered the injection site pain, labored respiration, weakness, pain in arm and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's comment: The case was reported by the patient's wife. The patient did not have any side effects from first dose of Shingrix. The patient received second dose of Shingrix in left arm and experienced heavy breathing, weakness, pain at injection site, pain in whole arm and upper shoulder of right arm. At the time of reporting heavy breathing was subsiding and all other events were still ongoing. The patient was suffering from arthritis (from before he had the Shingrix vaccine). The reporter consented to follow up. Additional Supportive Information: This case is linked with case US2022058853 and US2022AMR062396 by same reporter for different patient. Note:-As it seems swelling is due to arthritis as it is one of it's symptoms, it is captured as current condition and not event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058853:Wife's case US-GLAXOSMITHKLINE-US2022AMR062396:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 10 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 10 days ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced COVID-19 (COVID-19 10 days ago). At the time of the report, COVID-19 (COVID-19 10 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred on an unspecified date in Mar2022 after administration of the third dose (first booster dose) of the Moderna mRNA-1273 vaccine on an unspecified date. There was no information regarding the initial two doses. Treatment information was also not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred on an unspecified date in Mar2022 after administration of the third dose (first booster dose) of the Moderna mRNA-1273 vaccine on an unspecified date. There was no information regarding the initial two doses. Treatment information was also not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial which has been kept longer than its standard time frame was administered to patient.; Vial which has been kept longer than its standard time frame was administered to patient. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial which has been kept longer than its standard time frame was administered to patient.) and PRODUCT STORAGE ERROR (Vial which has been kept longer than its standard time frame was administered to patient.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Vial which has been kept longer than its standard time frame was administered to patient.) and PRODUCT STORAGE ERROR (Vial which has been kept longer than its standard time frame was administered to patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial which has been kept longer than its standard time frame was administered to patient.) and PRODUCT STORAGE ERROR (Vial which has been kept longer than its standard time frame was administered to patient.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care profession stated that, the vial was not expired.  No treatment information was reported.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient had never tested positive for COVID-19. Patient had no history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (felt very tired). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and FATIGUE (felt very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medication were Medicines for endoscopy.  No treatment information was provided   This case was linked to MOD-2022-535531, MOD-2022-535530, MOD-2022-535529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received added reporter details and updated batch number.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Urinary tract infection
Clinical narrative: sore arm; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient had never tested positive for COVID-19. Patient had no history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (felt very tired). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and FATIGUE (felt very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medication were Medicines for endoscopy.  No treatment information was provided   This case was linked to MOD-2022-535531, MOD-2022-535530, MOD-2022-535529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received added reporter details and updated batch number.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     The patient had never tested positive for COVID-19. Patient had no history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) outcome was unknown.            Other concomitant medication taken by the patient included medicines for endoscopy. No treatment information were reported.   This case was linked to MOD-2022-535531, MOD-2022-535530, MOD-2022-535527 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up was received and reporter information, batch number were updated.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Urinary tract infection
Clinical narrative: Sore arm; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     The patient had never tested positive for COVID-19. Patient had no history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) outcome was unknown.            Other concomitant medication taken by the patient included medicines for endoscopy. No treatment information were reported.   This case was linked to MOD-2022-535531, MOD-2022-535530, MOD-2022-535527 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up was received and reporter information, batch number were updated.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Urinary track infection; Sore arm; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary track infection), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 009C21A and 009C21A) for COVID-19 vaccination.     Patient had no COVID test or diagnosis. Patient did not have any acute and chronic illnesses at the time of vaccination. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary track infection), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Urinary track infection), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) outcome was unknown.            The patient took unspecified medicines for blood pressure and endoscopy.   Patient stated that about 2 weeks or 1 month ago she had a urinary track infection.   This case was linked to MOD-2022-535531, MOD-2022-535527, MOD-2022-535529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Added reporter details, vaccine dosage information. Amended narrative accordingly.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Urinary tract infection
Clinical narrative: Urinary track infection; Sore arm; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary track infection), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 009C21A and 009C21A) for COVID-19 vaccination.     Patient had no COVID test or diagnosis. Patient did not have any acute and chronic illnesses at the time of vaccination. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary track infection), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Urinary track infection), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt very tired) outcome was unknown.            The patient took unspecified medicines for blood pressure and endoscopy.   Patient stated that about 2 weeks or 1 month ago she had a urinary track infection.   This case was linked to MOD-2022-535531, MOD-2022-535527, MOD-2022-535529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Added reporter details, vaccine dosage information. Amended narrative accordingly.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date; Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient had no known drug allergies.     On 30-Mar-2022 at 11:12 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 11:12 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed or tested positive for COVID-19. No concomitant medications were reported. The date the vial was initially stored in the refrigerator was on 01-Mar-2022. The nurse (healthcare provider) at a local county health department that they inadvertently administered the expired Moderna COVID-19 vaccines to 17 patients on 30-Mar-2022 with expiration date was 19-Mar-2022. No patients had reported any adverse events for now. The adverse event had not caused the patient to seek the medical care. The vial had not undergone any temperature excursions. No treatment medications were reported.