chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Laboratory test, Optic ischaemic neuropathy, Retinal artery occlusion
Clinical narrative: 1. non-arteritic anterior ischemic uptic neruropathy (NAION) in right eye - an eye stroke- permanent loss of most of vision in right eye. 2.  had same issue  with left eye (Moderna Vaccine booster in November of 2021 and NAION in left eye in Februrary of 2022 - permanent loss of about half of vision in left eye
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angiogram normal
Clinical narrative: I had a non stem I heart attack.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Vaccine administration error. MMR vaccine was administered too early, it was given two weeks after varicella vaccine was administered.
Age: 70.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: 2 days after immunizations, he started to get itchy blisters on the forearm of the side he got Shingrix, so he thought it may be because of the vaccine.  4 days later it is still itchy and blisters.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Psoriasis
Clinical narrative: I received two doses of the Pfizer BioNTech COVID-19 vaccine via my employer.  The first dose was administered on 20 May 2021 and the second dose on 10 June 2021.  I then presented with significant swelling and redness on both feet in approximately August 2021.  After the symptoms persisted for several weeks I visited my primary care practitioner in October 2021.  Her initial conclusion was that my symptoms were consistent with psoriasis, and recommended I consult a dermatologist.  In November 2021 a dermatologist confirmed the psoriasis diagnosis, noting that the instances of psoriasis had spread beyond my feet to my arms and legs.  The dermatologist began a course of topical steroids.  While the steroids provided temporary relief, use did not provide long term resolution of my psoriasis, which has become increasing worse over time.  I m a healthy adult male with no history of serious illness, no family history of psoriasis, and I had no significant health incidents in 2021 other than receiving the vaccination.  There are several scientific papers published indicating a relationship between COVID-19 vaccination and the development of adult onset plaque psoriasis.  I consider this event to be permanent damage due to the inability to cure psoriasis.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram abnormal, Juvenile myoclonic epilepsy, Myoclonus
Clinical narrative: Developed myoclonic jerks several times a week approximately 2 weeks after vaccine.  These symptoms continued and eventually patient was diagnosed with Juvenile Myoclonic Epilepsy after an EEG in February, 2023.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Insulin therapy, Laboratory test, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: A few months following the Covid vaccine. My son started losing weight. Didnt think much of it.. He went back to his gynastics.  Started being more active after being in lock down from covid pandemic.. He continued to lose more weight.. Went to the doctor. Doctor was concerned and ask to come back to take some blood tests.  Type 1 diabetes was the diagnosis.. Was admitted to the hospital.  Since then he has been on insulin therapy.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular, Oligomenorrhoea
Clinical narrative: Abnormal menstrual cycle, prolonged menstrual cycle, erratic menstrual cycle, closer together menstrual cycle
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus.  It is now 2023, and the tinnitus has persisted.  I have had my hearing tested extensivey, and nothing is wrong with my hearing.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Rash erythematous, Rash papular
Clinical narrative: talked to pt on phone. described arm red from shoulder to mid bicep. has 2 red raised bumps close to each other on bicep. also says she can't move her arm. I recommended being evaluated as soon as possible and to start benadryl. unsure if pt followed through with evaluation
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blood potassium decreased, Computerised tomogram normal, Electrocardiogram normal, Hypoaesthesia
Clinical narrative: Left eye with fast twitch, left sided muscles around mouth drawing, from medial to lateral, left side of face went numb.  Reported to PCP 11/15/21 after about 1 week of symptoms.  Went to ED 11/21/21 when numbness spread over left side of face.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Magnetic resonance imaging normal, Muscle disorder
Clinical narrative: Left eye with fast twitch, left sided muscles around mouth drawing, from medial to lateral, left side of face went numb.  Reported to PCP 11/15/21 after about 1 week of symptoms.  Went to ED 11/21/21 when numbness spread over left side of face.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Significant localized redness 4cm x 5cm and swelling starting just a few hours after the vaccination. As of 9 days post vaccine when he came to have the site evaluated, the localized reaction is still present with mildly swollen firm leathery textured skin 4cm X 5cm to the injection site of the left deltoid, but no evidence of pain or distress. No other systemic symptoms noted. Left arm function remains fully intact.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: PT STOPPED BY PHARMACY AND SAID SHE STILL HAVE A PAIN ON HER LEFT DELTOID SINCE LAST MODERNA BIVALENT BOOSTER SHOT ON 12/13/2022
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Injection site hypoaesthesia, Injection site pain, Muscular weakness, Pain, X-ray limb
Clinical narrative: C/o L deltoid and shoulder pain with weakness and numbness radiating to the arm since IZs placed 9/2022
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Injection site pain, Injection site reaction, Pain, Sleep disorder
Clinical narrative: C/o L deltoid and shoulder pain with weakness and numbness radiating to the arm since IZs placed 9/2022
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, COVID19, COVID19, COVID19-2
Symptoms: X-ray
Clinical narrative: C/o L deltoid and shoulder pain with weakness and numbness radiating to the arm since IZs placed 9/2022
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hepatic mass, Hepatic pain, Ultrasound liver abnormal
Clinical narrative: Liver and joint pain. My liver pain persists even after a year after the vaccination.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: When I entered the Bivalent 5-11yr vaccine in database, it showed "not valid" therefore the Pfizer 5-11yr monovalent dose was given. Database accepted it as a 2nd booster.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: When I entered the Bivalent 5-11yr vaccine in database, it showed "Not Valid" therefore the Pfizer 5-11yr Monovalent dose was given. Database accepted it as a 2nd Booster.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Erythema, Pain of skin, Rash
Clinical narrative: Quarter size area began on 2/5/23 to the outer area of L thigh (SQ) area. Had few "dot" like areas. Tender to touch, red. No fever noted. Still present today.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Myocarditis, Pericarditis
Clinical narrative: diagnosed with myocarditis and Pericarditis; diagnosed with myocarditis and Pericarditis; I eventually improved still have weird side effects to this day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), PERICARDITIS (hospitalization, medically significant), outcome "unknown" and all described as "diagnosed with myocarditis and Pericarditis";  IMMUNISATION REACTION (non-serious), outcome "unknown", described as "I eventually improved still have weird side effects to this day".  Clinical course: Description of Event Outcome reported as follows, the patient stated that it concerning delayed covid vaccination side effects would like to tell you my brief history after my second pfizer shot about 2 weeks following I became short of breath and having chest pains ,I went to the hospital and was diagnosed with myocarditis and pericarditis, I could hardly do anything for about six months but I eventually improved still have weird side effects.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Nasopharyngitis
Clinical narrative: ADMINSITRATION ERROR: She was given a COVID booster instead of her first does. Had cold symptoms for a month after the vaccine. Currently she does not have a no symptoms.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or PQC.; PNEUMOVAX 23 was inadvertently administered after it's expiration date; This spontaneous report as received from a licensed practical nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 24-JAN-2023, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (lot # U010533 with expiration date: 29-OCT-2022; 0.5 milliliter, strength and route were unknown) for prophylaxis (expired product administered). No symptomatic side effects reported during time of report. No additional adverse event (AE) details or product quality complaints (PQC).
Age: 34.0
Sex: F
Vaccine: HEP, HPV9, TDAP, VARCEL, HEP, HPV9, TDAP, VARCEL
Symptoms: Pregnancy test urine positive, Uterine haemorrhage, Vaginal haemorrhage
Clinical narrative: No additional AEs; a pregnant patient received VARIVAX on 01/18/2023; This spontaneous report has been received from a registered nurse concerning a 34-year-old pregnant female patient. Her current concurrent conditions included Stage I Hypertension, the patient's medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on the left arm intramuscularly, as prophylaxis, lot number W011453 with expiration date 29-NOV-2024 (dosage regimen was not provided). The patient was also vaccinated with the second dose of hepatitis b vaccine administered on the right arm intramuscularly, lot number 25K3M with expiration date 02-JUN-2024 (dosage regimen was not provided), and the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on the left arm intramuscularly, as prophylaxis, lot number 397B5 with expiration date 30-NOV-2024 (dosage regimen was not provided).  The patient was seen at the clinic for initial refugee screening, and conferenced prior vaccine administration. The patient denied pregnancy and reported she was currently on her period. The urine collection for urine pregnancy test was delayed since the patient could not produce sample. On 18-JAN-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis, lot number W008712 with expiration date 14-MAR-2024 (also reported as 23-MAY-2024, conflicting information) (dosage regimen was not provided), or lot number W008715 which is an invalid lot number for  varicella virus vaccine live (Oka/Merck) (VARIVAX) with expiration date 23-MAY-2024,administered on the patient's right arm subcutaneously (dosage regimen was not provided). On the same date after vaccination, the patient had a positive pregnancy test (Maternal exposure during pregnancy). Outcome of the event maternal exposure during pregnancy was unknown (also reported as resolved, conflicting information). No additional adverse events were reported (No adverse events).
Age: 34.0
Sex: F
Vaccine: HEP, HPV9, TDAP, VARCEL, HEP, HPV9, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: No additional AEs; a pregnant patient received VARIVAX on 01/18/2023; This spontaneous report has been received from a registered nurse concerning a 34-year-old pregnant female patient. Her current concurrent conditions included Stage I Hypertension, the patient's medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on the left arm intramuscularly, as prophylaxis, lot number W011453 with expiration date 29-NOV-2024 (dosage regimen was not provided). The patient was also vaccinated with the second dose of hepatitis b vaccine administered on the right arm intramuscularly, lot number 25K3M with expiration date 02-JUN-2024 (dosage regimen was not provided), and the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on the left arm intramuscularly, as prophylaxis, lot number 397B5 with expiration date 30-NOV-2024 (dosage regimen was not provided).  The patient was seen at the clinic for initial refugee screening, and conferenced prior vaccine administration. The patient denied pregnancy and reported she was currently on her period. The urine collection for urine pregnancy test was delayed since the patient could not produce sample. On 18-JAN-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis, lot number W008712 with expiration date 14-MAR-2024 (also reported as 23-MAY-2024, conflicting information) (dosage regimen was not provided), or lot number W008715 which is an invalid lot number for  varicella virus vaccine live (Oka/Merck) (VARIVAX) with expiration date 23-MAY-2024,administered on the patient's right arm subcutaneously (dosage regimen was not provided). On the same date after vaccination, the patient had a positive pregnancy test (Maternal exposure during pregnancy). Outcome of the event maternal exposure during pregnancy was unknown (also reported as resolved, conflicting information). No additional adverse events were reported (No adverse events).
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered
Clinical narrative: No additional adverse event reported; Medical assistant reports patient was accidently administered an expired dose of VAQTA on 30-JAN-2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.      On 30-JAN-2023, the patient was accidently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # U031911, expiration date 11-NOV-2022, for prophylaxis (dose and route were not reported) (expired product administered). Product had no prior temperature excursions. No additional adverse event and not product quality complaint were reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Medical assistant reports patient was accidently administered an expired dose of VAQTA on 30-JAN-2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.      On 30-JAN-2023, the patient was accidently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # U031911, expiration date 11-NOV-2022, for prophylaxis (dose and route were not reported) (expired product administered). Product had no prior temperature excursions. No additional adverse event and not product quality complaint were reported.
Age: 7.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered after a temperature excursion.; This spontaneous report was received from Other and refers to a 7-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength, and dose were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 47.9 degrees Fahrenheit for 47 minutes. There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Basedow's disease, Diarrhoea, Hyperthyroidism, Laboratory test abnormal
Clinical narrative: diagnosed with Grave's disease; This spontaneous case was reported by a patient and describes the occurrence of BASEDOW'S DISEASE (diagnosed with Grave's disease) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1 and Lot: 037B21A) on 02-May-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Thyroid disorder, Anxiety and Palpitation. Concomitant products included METHIMAZOLE for Thyroid disorder.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BASEDOW'S DISEASE (diagnosed with Grave's disease) (seriousness criterion medically significant). The patient was treated with FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, at a dose of 20 milligram; ATENOLOL for Palpitations, at a dose of 25 milligram; CLOBETASOL at a dose of 0.05 UNK; FLUOCINOLONE ACETONIDE (FLUOCINOLONE) for Scalp disorder, at a dose of 1%; KETOCONAZOLE for Scalp disorder, at a dose of 2% and METRONIDAZOLE for Skin disorder, at a dose of 500 milligram. At the time of the report, BASEDOW'S DISEASE (diagnosed with Grave's disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After a month of receiving second dose of vaccination, between that summer, patient had flaky scalp, hot flashes, overheated body temperature, weight loss, anxiety, heart palpitation, skin was breaking out, skin rash all over her body and rash in scalp, hand tremors and puffy eyes (both eyes). On Nov-2021, she was diagnosed with Grave's disease. Blood work was off the scale. Lab work included TSH (unknown results). Patient took Nyst-tac-znpste 0.1-20% for skin.  Company Comment: This is a Spontaenous case reported by a patient, concerning a 50-year-old female patient, with relevant medical condition of thyroid disorder, who experienced the unexpected and serious (due to medically significant) event of Basedows disease, which occurred approximately 5 months after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, a month after vaccination, patient experienced flaky scalp, hot flashes, overheated body temperature, weight loss, anxiety, heart palpitations, skin breaking out, skin rash all over her body and rash in scalp, hand tremors and puffy eyes. 5 months after vaccine, Grave´s disease was diagnosed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event outcome was unknown. Underlying thyroid disorder could be a confounding factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling, Pruritus, Skin exfoliation, Vision blurred
Clinical narrative: diagnosed with Grave's disease; This spontaneous case was reported by a patient and describes the occurrence of BASEDOW'S DISEASE (diagnosed with Grave's disease) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1 and Lot: 037B21A) on 02-May-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Thyroid disorder, Anxiety and Palpitation. Concomitant products included METHIMAZOLE for Thyroid disorder.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BASEDOW'S DISEASE (diagnosed with Grave's disease) (seriousness criterion medically significant). The patient was treated with FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, at a dose of 20 milligram; ATENOLOL for Palpitations, at a dose of 25 milligram; CLOBETASOL at a dose of 0.05 UNK; FLUOCINOLONE ACETONIDE (FLUOCINOLONE) for Scalp disorder, at a dose of 1%; KETOCONAZOLE for Scalp disorder, at a dose of 2% and METRONIDAZOLE for Skin disorder, at a dose of 500 milligram. At the time of the report, BASEDOW'S DISEASE (diagnosed with Grave's disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After a month of receiving second dose of vaccination, between that summer, patient had flaky scalp, hot flashes, overheated body temperature, weight loss, anxiety, heart palpitation, skin was breaking out, skin rash all over her body and rash in scalp, hand tremors and puffy eyes (both eyes). On Nov-2021, she was diagnosed with Grave's disease. Blood work was off the scale. Lab work included TSH (unknown results). Patient took Nyst-tac-znpste 0.1-20% for skin.  Company Comment: This is a Spontaenous case reported by a patient, concerning a 50-year-old female patient, with relevant medical condition of thyroid disorder, who experienced the unexpected and serious (due to medically significant) event of Basedows disease, which occurred approximately 5 months after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, a month after vaccination, patient experienced flaky scalp, hot flashes, overheated body temperature, weight loss, anxiety, heart palpitations, skin breaking out, skin rash all over her body and rash in scalp, hand tremors and puffy eyes. 5 months after vaccine, Grave´s disease was diagnosed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event outcome was unknown. Underlying thyroid disorder could be a confounding factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basedow's disease
Clinical narrative: diagnosed with Grave's disease; This spontaneous case was reported by a patient and describes the occurrence of BASEDOW'S DISEASE (diagnosed with Grave's disease) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1 and Lot: 037B21A) on 02-May-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Thyroid disorder, Anxiety and Palpitation. Concomitant products included METHIMAZOLE for Thyroid disorder.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BASEDOW'S DISEASE (diagnosed with Grave's disease) (seriousness criterion medically significant). The patient was treated with FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, at a dose of 20 milligram; ATENOLOL for Palpitations, at a dose of 25 milligram; CLOBETASOL at a dose of 0.05 UNK; FLUOCINOLONE ACETONIDE (FLUOCINOLONE) for Scalp disorder, at a dose of 1%; KETOCONAZOLE for Scalp disorder, at a dose of 2% and METRONIDAZOLE for Skin disorder, at a dose of 500 milligram. At the time of the report, BASEDOW'S DISEASE (diagnosed with Grave's disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After a month of receiving second dose of vaccination, between that summer, patient had flaky scalp, hot flashes, overheated body temperature, weight loss, anxiety, heart palpitation, skin was breaking out, skin rash all over her body and rash in scalp, hand tremors and puffy eyes (both eyes). On Nov-2021, she was diagnosed with Grave's disease. Blood work was off the scale. Lab work included TSH (unknown results). Patient took Nyst-tac-znpste 0.1-20% for skin.  Company Comment: This is a Spontaenous case reported by a patient, concerning a 50-year-old female patient, with relevant medical condition of thyroid disorder, who experienced the unexpected and serious (due to medically significant) event of Basedows disease, which occurred approximately 5 months after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, a month after vaccination, patient experienced flaky scalp, hot flashes, overheated body temperature, weight loss, anxiety, heart palpitations, skin breaking out, skin rash all over her body and rash in scalp, hand tremors and puffy eyes. 5 months after vaccine, Grave´s disease was diagnosed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event outcome was unknown. Underlying thyroid disorder could be a confounding factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date).    Concomitant Medication use information was not provided by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19.   called because they reported that they had accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date. It was patient's first primary dose.  Treatment Medication use information was not provided by reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports there have been no additional adverse experiences reported.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a physician referring to patient of unknown age and gender, whose medical history, concurrent conditions, and previous adverse drug reaction/allergies were not provided.  On 12-JAN-2023, the patient vaccinated with 1 dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (lot number: W021743, which was verified to be valid, with an expiration date: 10-JUL-2024; strength, dose, frequency, route of administration and anatomical injection site were not provided) (product storage error).  The vaccine underwent temperature excursion of 10 degrees Celcius for 1 hour 28 minutes. There was no previous temperature excursion.  No adverse event was reported (no adverse event).
Age: 1.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant reported that 15 month old patient received ROTATEQ.; No additional AEs were reported; This spontaneous report has been received from a medical assistant, concerning a 15-months-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On an unknown date, the patient was administered with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid first dose as prophylaxis (strength, dose, route of administration, lot number, and expiration date were not provided) (product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE or PQC reported; HCP reported MMR II was inadvertently administered with PROQUAD. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 06-FEB-2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U017524, expiration date: 03-JUN-2023 (strength, and route of administration were not provided) and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #W017572, expiration date: 29-NOV-2023 (strengths, doses, vaccination schedules, sites and route of administration were not provided) for prophylaxis (Accidental overdose). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AEs; PROQUAD was administered to 4 year old patient on 2/9/23 who had just received VARIVAX on 1/6/2023; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 09-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, once, lot #W024972, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). No additional adverse events details or product quality complaints were reported (no adverse event).
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; MMR II was administered via IM route instead of SC; This spontaneous report has been received from a registered nurse concerning a 62-year-old male patient. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 09-FEB-2023, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) 0.5 ml once, administered as prophylaxis, lot number U014655 with expiration date 07-MAY-2023. The patient was vaccinated intramuscularly instead of subcutaneous route (Incorrect route of product administration). No additional adverse events were reported (No adverse event).
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; VARIVAX was inadvertently administered via intramuscular route rather than intended subcutaneous; This spontaneous report has been received from a nurse prescriber concerning male patient of unknown age. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 09-FEB-2023, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, administered as prophylaxis, lot number W022293 with expiration date 13-JUL-2024. The patient was vaccinated intramuscularly instead of the intended subcutaneous route (Incorrect route of product administration). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX that experienced temperature excursion was administered to one patient; This spontaneous report was received from an other and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, one patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W021743, expiration date: 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) concomitantly with sterile diluent (dose, strength, route of administration, lot#, expiration date were not provided) after a temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) for 10 minutes which occurred on 09-FEB-2023 (product storage error). There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (47.3 Fahrenheit) for 11 hours 50 minutes. No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided. No additional AE reported. No PQC.; HCP reporting one dose of VARIVAX and one dose of MMR II were administered after a temperature excursion.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 27-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection at a dose 0.5 milliliter (ml) as prophylaxis (lot number W011625 has been verified to be valid; expiration date reported and established as 06-APR-2024) (strength, route of administration, and anatomical location were not provided), and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) subcutaneous injection at a dose of 0.5 ml as prophylaxis (lot number U031359 has been verified to be valid; expiration date reported and established as 07-OCT-2023) (strength, route of administration and anatomical location were not provided). The administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of 30.4 degrees Fahrenheit (F), during a time frame of 1 hour and 15 minutes, and the administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) was stored at a temperature of 53.1 degrees F, during a time frame of 1 hour and 15 minutes. There was not a previous temperature excursion reported. There was no adverse effect reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE reported; the patient was administered PROQUAD and VARIVAX on the same day; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On 08-FEB-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) subcutaneous injection (0.5 ml, lot#: W024970, expiration date: 05-FEB-2024) subcutaneously for prophylaxis and varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (0.5ml, lot#: W011625, expiration date: 06-APR-2024) subcutaneously for prophylaxis (overdose). No additional adverse events (AE) were reported (no adverse event).
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered. No additional AEs. no PQCs reported.; This spontaneous report was received from a nurse concerning to a 51-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-FEB-2023, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml/once m (lot # U034712 has been verified to be a valid lot, expiration date 30-JUL-2023)  (strength  and anatomical location was not provided) for prophylaxis (Product storage error). There were multiple temperature excursions dating back to 03-FEB-2023. No additional adverse event was reported.  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004511: US-009507513-2302USA004369: US-009507513-2302USA004361:
Sex: U
Vaccine: RV5, UNK
Symptoms: Product storage error
Clinical narrative: No additional AEs/no PQCs; VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion.; This spontaneous report has been received from an office administrator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1892788 with expiration date: 02-DEC-2023) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection (lot # U7255AA with expiration date: 03-DEC-2024; route unknown), both for prophylaxis after a temperature excursion. The dose and strength were nor reported for suspect vaccines. No additional adverse events (AEs)/no product quality complaints (PQCs).   Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) experienced the temperature excursion above 9 degree Celsius (C) (10.92C) for 1 hour 0 minutes 0 seconds. No previous temperature excursions reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient./ Temperature above 9 Celsius degrees (13,25 Celsius degrees); This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender.  The patient medical history, current conditions and concomitant medications were not reported.  On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1879875 and expiration date 19-NOV-2023 (dose, strength and route of administration were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # W015926, expiration date 14-FEB-2025, (dose, strength, anatomical location and route of administration were not provided) for prophylaxis (Product storage error). The suspect vaccines experienced temperature excursion (temperature above 9 degrees Celsius (13.25 degrees Celsius) for 2 hour 32 minutes) on unknown date over the weekend. There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age.     On 06-FEB-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, lot #W012163, expiration date 12-APR-2024, strength was not provided) for prophylaxis (Product storage error). Temperature excursion was reported as 7 Fahrenheit, time frame 1 hour. There was no previous temperature excursion.. No additional adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: No additional AEs; RMA calling to report that patient pulled away during injection of GARDASIL 9 vaccine and full dose was not administered on 2/14/2023. Caller states this was 2nd dose in series to 14 year old patient. No additional AEs, no PQCs reported.; This spontaneous report has been received from a health care professional concerning a 14-years-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On an unknown date, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided). Later, on 14-FEB-2023, the patient received a second dose of the vaccine at a dose of 0.5 milliliters (ml) once intramuscularly as prophylaxis (lot number U028825, has been verified to be valid; expiration date reported as 02-JAN-2023 but upon internal validation established as 02-NOV-2023), however during the injection the patient pulled away and a full dose was not administered (incorrect dose administered). No other adverse events were reported.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies, and reactions were not provided. The concomitant medications included sterile diluent.  On 13-FEB-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) (lot #W029899 had been verified to be a valid number; expiration date 16-MAY-2024, and upon internal validation established as the same date); varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W024335 had been verified to be a valid number; expiration date 01-AUG-2024, and upon internal validation established as the same date); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #W012118 had been verified to be a valid number; expiration date 24-DEC-2023, and upon internal validation established as the same date) all the vaccines were administered for prophylaxis (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported).   The administered dose of the vaccine hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored at a temperature of 9 degrees Celsius (C), for a time frame of 2 hours and 32 minutes, as recorded by a digital data logger. The administered dose of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of 8 degrees Celsius (C), for a time frame of 1 hours and 40 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: GARDASIL 9 alternate dosing schedule. Caller reports that adult patient (21+ years old); No addtional AD; This spontaneous report has been received from Pharmacist, regarding to an adult patient of unknown gender. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On an unknown date, (also reported as over 1 year ago) the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0,5 milliliter (ml), for prophylaxis (strength, routes of administration, anatomical sites of injection, lot number, and expiration date were not provided). At the time of the reporting the patient was request second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration).  No additional adverse events were reported in the patient.