chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Weight increased
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Giant cell arteritis
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Asthenia, Biopsy artery abnormal
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain scan abnormal, Capillary fragility, Cyanosis, Dyspnoea, Fatigue
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Giant cell arteritis, Headache, Hypoaesthesia, Impaired work ability
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, Loss of personal independence in daily activities, Memory impairment, Muscle spasms, Myalgia
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oesophageal obstruction, Pain in extremity, Painful respiration, Peripheral swelling
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Weight increased
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Giant cell arteritis
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation, Blood pressure (marginal) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]), MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the vaccine starting in 27-Jan-2021 and his second dose on 05-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-653342 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site, Rash erythematous
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Memory impairment, Mental disorder, Pain, Pain in extremity
Clinical narrative: He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster; He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: The phone answered by consumer who said he didn't take the pill, he never took it at all this was the response of product Paxlovid. He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suicidal ideation, Thrombosis, White blood cell count, White blood cell count decreased
Clinical narrative: He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster; He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: The phone answered by consumer who said he didn't take the pill, he never took it at all this was the response of product Paxlovid. He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster; He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: The phone answered by consumer who said he didn't take the pill, he never took it at all this was the response of product Paxlovid. He had a lot of conditions for the COVID. He got 3 Pfizer doses, he got COVID after the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 28.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 23.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 23.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Chills, Extra dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Fear, Headache, Vomiting
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Accidental overdose, Arthralgia, Chills, Feeling abnormal, Headache
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 51.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Received flu vaccine at approx. noon. on way home at 3 pm noted facial numbness & tingling to left side of face from chin up to corner of left eye. Did take Benadryl 50 mg at 1510. Notified supervisor. Numbness & tingling did improve by around 1700 and at that time remained to left check. as of 09/20/22 @ 0847 symptoms remain unchanged.
Age: 51.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Received flu vaccine at approx. noon. on way home at 3 pm noted facial numbness & tingling to left side of face from chin up to corner of left eye. Did take Benadryl 50 mg at 1510. Notified supervisor. Numbness & tingling did improve by around 1700 and at that time remained to left check. as of 09/20/22 @ 0847 symptoms remain unchanged.
Age: 33.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Syncope
Clinical narrative: Resident felt lightheaded and got up to let front desk know , as patient was going back to sit down he missed the chair and slipped to the floor in a sitting position. Patient did not hit his head, no injuries noted, sweating, clammy,  disoriented. VS taken and reading was very low, cool wet cloth placed on head and shoulders, Patient stated he felt really weak, monitor patient until EMS arrive to transport patient to ER at Hospital.
Age: 33.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Asthenia, Cold sweat, Disorientation, Dizziness, Fall
Clinical narrative: Resident felt lightheaded and got up to let front desk know , as patient was going back to sit down he missed the chair and slipped to the floor in a sitting position. Patient did not hit his head, no injuries noted, sweating, clammy,  disoriented. VS taken and reading was very low, cool wet cloth placed on head and shoulders, Patient stated he felt really weak, monitor patient until EMS arrive to transport patient to ER at Hospital.
Age: 33.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Hyperhidrosis
Clinical narrative: Resident felt lightheaded and got up to let front desk know , as patient was going back to sit down he missed the chair and slipped to the floor in a sitting position. Patient did not hit his head, no injuries noted, sweating, clammy,  disoriented. VS taken and reading was very low, cool wet cloth placed on head and shoulders, Patient stated he felt really weak, monitor patient until EMS arrive to transport patient to ER at Hospital.
Age: 10.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 10.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Body ache; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache) and PYREXIA (Slight fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesterolemia. Concomitant products included METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Body ache) and PYREXIA (Slight fever). At the time of the report, PAIN (Body ache) and PYREXIA (Slight fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medications included high cholesterol medications. No treatment information was provided.   This case was linked to MOD-2022-653217, MOD-2022-653189 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body ache; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache) and PYREXIA (Slight fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesterolemia. Concomitant products included METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Body ache) and PYREXIA (Slight fever). At the time of the report, PAIN (Body ache) and PYREXIA (Slight fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medications included high cholesterol medications. No treatment information was provided.   This case was linked to MOD-2022-653217, MOD-2022-653189 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cytokine storm, HIV-associated neurocognitive disorder, Hypnagogic hallucination, Hypnopompic hallucination
Clinical narrative: Reporting cytokine storm increasing with continued booster injections aggravating hiv associated cytokine inflammation in the brain resulting in high pitched hiss, hypnogogic/hypnopompic hallucinations and increased severity of narcolepsy.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Narcolepsy, Noninfective encephalitis, Tinnitus
Clinical narrative: Reporting cytokine storm increasing with continued booster injections aggravating hiv associated cytokine inflammation in the brain resulting in high pitched hiss, hypnogogic/hypnopompic hallucinations and increased severity of narcolepsy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: Chills, nausea, arm pain
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster, Laboratory test abnormal, Rash, SARS-CoV-2 test positive
Clinical narrative: on 25 July 2022 I developed a rash on my left pectoral, left back and left underarm which I went to the hospital for on 26 July 2022.  They diagnosed it as shingles and covid.  So I got shingles  WHEN I got covid and I don't think is normal, I believe it is an aftereffect of the vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: on 25 July 2022 I developed a rash on my left pectoral, left back and left underarm which I went to the hospital for on 26 July 2022.  They diagnosed it as shingles and covid.  So I got shingles  WHEN I got covid and I don't think is normal, I believe it is an aftereffect of the vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Bursitis, Injection site bruising, Injection site reaction, Joint swelling
Clinical narrative: Bursitis in right knee - moderate pain for first 12 hours. Joint was swollen and warm to touch. Pain and swelling has gradually subsided but it is still present 5 days later.  Injection site reaction - large bruising compared to previous COVID injections or any flu shots in the past.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Skin warm
Clinical narrative: Bursitis in right knee - moderate pain for first 12 hours. Joint was swollen and warm to touch. Pain and swelling has gradually subsided but it is still present 5 days later.  Injection site reaction - large bruising compared to previous COVID injections or any flu shots in the past.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patiently given full primary dose (0.5 mL) of Moderna for patient's 12 and older instead of dose for 6 months-5 years.  No negative side effects noted. Issue identified when reconciling vaccinations at end of day.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patiently given full primary dose (0.5 mL) of Moderna for patient's 12 and older instead of dose for 6 months-5 years.  No negative side effects noted. Issue identified when reconciling vaccinations at end of day.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Large red area at the injection site , fever of 103, nausea, vomiting several times.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Asthenia, Autoimmune disorder, Chest discomfort
Clinical narrative: Major inflammatory response starting with fever, malaise, myalgias followed by  severe joint pain in all proximal joints. ANA 1,280. Protein in urine.  Of note, patient was healthy with normal labs just weeks prior to vaccine, Received second moderna on 7/28/2021. Approx 3-4 days later burning muscles, weakness, muscle twitching, numbness, unable to lift infant out of crib. On 9/5/2021 chest felt heavy and weak and it became difficult to breathe. Admitted to hospital on 9/5/2021 for 6 days and received IVIG therapy for possible GBS. Now taking plaquenil for new onset post vaccination chronic joint pain and vaccine triggered autoimmune disease.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Immunoglobulin therapy, Malaise, Muscle twitching
Clinical narrative: Major inflammatory response starting with fever, malaise, myalgias followed by  severe joint pain in all proximal joints. ANA 1,280. Protein in urine.  Of note, patient was healthy with normal labs just weeks prior to vaccine, Received second moderna on 7/28/2021. Approx 3-4 days later burning muscles, weakness, muscle twitching, numbness, unable to lift infant out of crib. On 9/5/2021 chest felt heavy and weak and it became difficult to breathe. Admitted to hospital on 9/5/2021 for 6 days and received IVIG therapy for possible GBS. Now taking plaquenil for new onset post vaccination chronic joint pain and vaccine triggered autoimmune disease.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Protein urine present, Pyrexia, Systemic inflammatory response syndrome, Urine analysis abnormal
Clinical narrative: Major inflammatory response starting with fever, malaise, myalgias followed by  severe joint pain in all proximal joints. ANA 1,280. Protein in urine.  Of note, patient was healthy with normal labs just weeks prior to vaccine, Received second moderna on 7/28/2021. Approx 3-4 days later burning muscles, weakness, muscle twitching, numbness, unable to lift infant out of crib. On 9/5/2021 chest felt heavy and weak and it became difficult to breathe. Admitted to hospital on 9/5/2021 for 6 days and received IVIG therapy for possible GBS. Now taking plaquenil for new onset post vaccination chronic joint pain and vaccine triggered autoimmune disease.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported/No adverse side effects have been reported; Medical Assistant reported that an improperly stored dose of MMR-II was administered to a patient on 8/22/2022. Caller stated no adverse side effects have been reported from the patient. No additional AEs reported. No PQCs reported.         ?    Na; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-AUG-2022, the patient was vaccinated witha a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U022985, expiration date 22-JUL-2023, albumin status has been verified as recombinant human albumin (rHA), 0.5 mL, subcutaneously (anatomical location was not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of -12.3 degrees Celsius (C) for 1 hour (LLT:  Product storage error temperature too low). There were no previous temperature excursions reported. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs reported.; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2022, 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status recombinant human albumin (rHA)  0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022, administered subcutaneously (anatomical location was not provided) was administered for the patient for prophylaxis. The vaccine experienced a temperature excursion of -12.3 degree Celsius for 1 hour (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE details available.; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F) on 05-SEP-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002779: US-009507513-2209USA002746: US-009507513-2209USA002481: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002722: US-009507513-2209USA002574: US-009507513-2209USA002469: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606: US-009507513-2209USA002532:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional Adverse Event reported; PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from a health business professional, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (product storage error), for prophylaxis (lot number W017570 has been verified to be valid; expiration date reported and established as 29-NOV-2023) (dosage, vaccination scheme, route of administration, and anatomical site of injection were not provided). The administered dose of the vaccine was stored at a temperature of 5.7 degrees Fahrenheit (F), during a time frame of 30 minutes. There was a previous temperature excursion reported as 6 up to 14 degrees F during a time frame of 1 hour and 6 minutes. There was no adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.