chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC15
Symptoms: Crying, Developmental regression, Fatigue, Personality change
Clinical narrative: My son experienced a a low grade fever of 99.9 degrees Fahrenheit. He experienced regressions in milestones and sleep. He also experienced changes in his personality. These changes all occurred within hours following his 6 month vaccinations. His milestone regression was that he was able to roll from his stomach to his back and his back to his stomach easily for several weeks. Immediately following his vaccinations, he could not roll for seven days. In regards to his personality, he became scared of everything, including his mother?s (my) noises who he spent time with almost 24 hours a day/seven days a week. He would inconsolably cry for several minutes anytime I would cough, sneeze, laugh, and use my silly voices. These things prior to the vaccinations did not bother him. It took 33 days for this to resolve. My son could not enter into deep sleep until complete exhaustion would hit around 2:00 A.M. or 3:00 A.M. Prior to vaccinations, he was able to be laid down in his bed with a pacifier. After vaccinations, he had to be constantly nursed to sleep. Even then, he would wake up every 15-90 minutes and would wail like I had never heard before the vaccinations. He would be up for at least 2 hours every night for three and half weeks. He would cry inconsolably during this time. Gas relief medications and teething pain medication would typically help if he was crying inconsolably. Nothing helped soothe him after the vaccinations for three and a half weeks.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Vomiting
Clinical narrative: 02 episodes of vomit
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient received a suboptimal dose (0.3ml) and did not want to come back to get the remaining full dose within the same day, so it is 0.3ml for one dose as stated before as being suboptimal.
Age: 24.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This patient came in for dose two of this vaccine on (7/28/2023). After these vaccines were administered the RPh filling out the patient's vaccine card noticed the vaccines were administered too early (First dose was administered on 7/8/2023). The patient is aware and is going to return ~8/7/2023 when he should have been due for the 2nd dose of these vaccines.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amenorrhoea, Anxiety, Arthralgia, Axillary pain
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Brain fog, Cardiovascular disorder, Chest pain, Cough
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dizziness, Dysstasia, Erythema, Exercise tolerance decreased
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Herpes zoster, Hypertension, Hypoaesthesia, Hypotension
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Laboratory test, Lymphadenopathy, Nervous system disorder, Neuralgia
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pallor, Palpitations, Panic attack, Paraesthesia
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Quality of life decreased, Rash, Raynaud's phenomenon, Skin discolouration
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Systemic lupus erythematosus, Tachycardia, Tooth extraction, Tooth infection
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: roller coaster since January 2022 - complex history, new ongoing symptoms now diagnosed with Raynaud's and Lupus. Circulation, nerve, skin, vision, hair issues. Weightless and fatigue everyday. No period for 7 month. Developed shingles, and abnormal lymph nodes, biopsies. Chest pain and palpitations and high and low blood pressure, tachycardia and fatigue, now panic attacks with steady throbbing pain redness in hands. Shooting pain in armpits and head. Hard to walk and stand and shakes and tremors.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram, Angiogram pulmonary normal, Autonomic nervous system imbalance, Blood catecholamines, Blood test
Clinical narrative: Patient had palpitations for several weeks (starting one week after the vaccine).  On the 6th week of the vaccine the patient had a syncope episode and was taken to the Emergency department.  She was noted to have tachycardia.  The next week her symptoms progressed to muscular weakness, brain fog, shortness of breath.  Was re-evaluated at the emergency department on 1/5/2023 for concerns for a pulmonary embolus with a CT angiogram which was negative.  She was sent home.  She then saw pulmonary medicine and neurology the following week and was diagnosed with dysautonomia, POTS.  She was then hopsitalized due to progression of symptoms on 1/15 - 1/16, was diagnosed with a second neurologist with dysautonomia.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood thyroid stimulating hormone, Brain fog, Cardiac monitoring, Chest X-ray, Dyspnoea
Clinical narrative: Patient had palpitations for several weeks (starting one week after the vaccine).  On the 6th week of the vaccine the patient had a syncope episode and was taken to the Emergency department.  She was noted to have tachycardia.  The next week her symptoms progressed to muscular weakness, brain fog, shortness of breath.  Was re-evaluated at the emergency department on 1/5/2023 for concerns for a pulmonary embolus with a CT angiogram which was negative.  She was sent home.  She then saw pulmonary medicine and neurology the following week and was diagnosed with dysautonomia, POTS.  She was then hopsitalized due to progression of symptoms on 1/15 - 1/16, was diagnosed with a second neurologist with dysautonomia.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram, Electrocardiogram, Full blood count, Metabolic function test, Muscular weakness
Clinical narrative: Patient had palpitations for several weeks (starting one week after the vaccine).  On the 6th week of the vaccine the patient had a syncope episode and was taken to the Emergency department.  She was noted to have tachycardia.  The next week her symptoms progressed to muscular weakness, brain fog, shortness of breath.  Was re-evaluated at the emergency department on 1/5/2023 for concerns for a pulmonary embolus with a CT angiogram which was negative.  She was sent home.  She then saw pulmonary medicine and neurology the following week and was diagnosed with dysautonomia, POTS.  She was then hopsitalized due to progression of symptoms on 1/15 - 1/16, was diagnosed with a second neurologist with dysautonomia.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome, Syncope, Tachycardia, Thyroxine
Clinical narrative: Patient had palpitations for several weeks (starting one week after the vaccine).  On the 6th week of the vaccine the patient had a syncope episode and was taken to the Emergency department.  She was noted to have tachycardia.  The next week her symptoms progressed to muscular weakness, brain fog, shortness of breath.  Was re-evaluated at the emergency department on 1/5/2023 for concerns for a pulmonary embolus with a CT angiogram which was negative.  She was sent home.  She then saw pulmonary medicine and neurology the following week and was diagnosed with dysautonomia, POTS.  She was then hopsitalized due to progression of symptoms on 1/15 - 1/16, was diagnosed with a second neurologist with dysautonomia.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tri-iodothyronine, Troponin
Clinical narrative: Patient had palpitations for several weeks (starting one week after the vaccine).  On the 6th week of the vaccine the patient had a syncope episode and was taken to the Emergency department.  She was noted to have tachycardia.  The next week her symptoms progressed to muscular weakness, brain fog, shortness of breath.  Was re-evaluated at the emergency department on 1/5/2023 for concerns for a pulmonary embolus with a CT angiogram which was negative.  She was sent home.  She then saw pulmonary medicine and neurology the following week and was diagnosed with dysautonomia, POTS.  She was then hopsitalized due to progression of symptoms on 1/15 - 1/16, was diagnosed with a second neurologist with dysautonomia.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Varicella given, but patient has already recieved 2 MMRV vaccines previously. No symptoms reported. Provider who saw patient for his exam was notified of the extra varicella vaccine and given the documentation supporting the patient already reieved 2 doses of MMRV. Provider was to call parent(s)/guardian(s) to inform them of this error and advise further instructions on their behalf for the patient.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Left arm Hives, welts
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 1/15/21 lot# EK9231;  Pfizer 2/5/21 lot# EL3248
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/24/21 Lot# 002B21A;  Moderna 4/26/21 lot# 043B21A
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Paraesthesia, Pharyngeal swelling
Clinical narrative: panic attack; her throat closing up; face numb; feels like there's a lump in her throat; she may be allergic to SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of panic attack in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2023, the patient received the 1st dose of Shingrix (left arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced panic attack (Verbatim: panic attack), throat constriction (Verbatim: her throat closing up), numbness facial (Verbatim: face numb), throat discomfort (Verbatim: feels like there's a lump in her throat) and allergy to vaccine (Verbatim: she may be allergic to SHINGRIX). The patient was treated with benadryl (nos) (Benadryl). The outcome of the panic attack and allergy to vaccine were not reported and the outcome of the throat constriction and throat discomfort were not resolved and the outcome of the numbness facial was resolved.   It was unknown if the reporter considered the panic attack, throat constriction, numbness facial, throat discomfort and allergy to vaccine to be related to Shingrix.     It was unknown if the company considered the panic attack, throat constriction, numbness facial, throat discomfort and allergy to vaccine to be related to Shingrix.   Additional Information: GSK receipt date: 25- JUL-2023 The patient reported hours later, she experienced her throat closing up, she stated she took Benadryl. The next day it got better, but the following day (12-JUL-2023) her throat was closing up again and she went to urgent care clinic, where she was diagnosed with a panic attack. She stated she still feels like there's a lump in her throat and that she may be allergic to shingrix. She stated she would not get dose 2. Medical information phone number provided Referred to HCP. Did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Hypoaesthesia, Oropharyngeal discomfort, Panic attack, Sensation of foreign body
Clinical narrative: panic attack; her throat closing up; face numb; feels like there's a lump in her throat; she may be allergic to SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of panic attack in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2023, the patient received the 1st dose of Shingrix (left arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced panic attack (Verbatim: panic attack), throat constriction (Verbatim: her throat closing up), numbness facial (Verbatim: face numb), throat discomfort (Verbatim: feels like there's a lump in her throat) and allergy to vaccine (Verbatim: she may be allergic to SHINGRIX). The patient was treated with benadryl (nos) (Benadryl). The outcome of the panic attack and allergy to vaccine were not reported and the outcome of the throat constriction and throat discomfort were not resolved and the outcome of the numbness facial was resolved.   It was unknown if the reporter considered the panic attack, throat constriction, numbness facial, throat discomfort and allergy to vaccine to be related to Shingrix.     It was unknown if the company considered the panic attack, throat constriction, numbness facial, throat discomfort and allergy to vaccine to be related to Shingrix.   Additional Information: GSK receipt date: 25- JUL-2023 The patient reported hours later, she experienced her throat closing up, she stated she took Benadryl. The next day it got better, but the following day (12-JUL-2023) her throat was closing up again and she went to urgent care clinic, where she was diagnosed with a panic attack. She stated she still feels like there's a lump in her throat and that she may be allergic to shingrix. She stated she would not get dose 2. Medical information phone number provided Referred to HCP. Did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: panic attack; her throat closing up; face numb; feels like there's a lump in her throat; she may be allergic to SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of panic attack in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2023, the patient received the 1st dose of Shingrix (left arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced panic attack (Verbatim: panic attack), throat constriction (Verbatim: her throat closing up), numbness facial (Verbatim: face numb), throat discomfort (Verbatim: feels like there's a lump in her throat) and allergy to vaccine (Verbatim: she may be allergic to SHINGRIX). The patient was treated with benadryl (nos) (Benadryl). The outcome of the panic attack and allergy to vaccine were not reported and the outcome of the throat constriction and throat discomfort were not resolved and the outcome of the numbness facial was resolved.   It was unknown if the reporter considered the panic attack, throat constriction, numbness facial, throat discomfort and allergy to vaccine to be related to Shingrix.     It was unknown if the company considered the panic attack, throat constriction, numbness facial, throat discomfort and allergy to vaccine to be related to Shingrix.   Additional Information: GSK receipt date: 25- JUL-2023 The patient reported hours later, she experienced her throat closing up, she stated she took Benadryl. The next day it got better, but the following day (12-JUL-2023) her throat was closing up again and she went to urgent care clinic, where she was diagnosed with a panic attack. She stated she still feels like there's a lump in her throat and that she may be allergic to shingrix. She stated she would not get dose 2. Medical information phone number provided Referred to HCP. Did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Bursitis, Rotator cuff syndrome, Vaccination site joint movement impairment, Vaccination site pain
Clinical narrative: The injection was administered high on my arm near my shoulder. At first, I felt what I considered to be typical discomfort after an injection. Within a couple of days, though, the pain increased & moved up my neck to my left ear & I thought I might have an ear infection. My arm became stiff & mobility was limited & painful. As the pain persisted, and because the pain was in my left arm, I thought I was having a heart attack so I went to the ER but a heart attack was ruled out. The pain continued so I went to Urgent Care & was prescribed prednisone, which gave mild relief but once the script was used up the pain returned. I went back to the UC & was referred to orthopedics, who administered a cortisone shot in my left shoulder and referred me to PT. I am currently in PT 3x/week for 8 weeks and there has been little to no reduction in pain. I have been unable to sleep at night since May due to the pain. Activities of daily living, such as dressing, showering, fastening my seat belt, etc. are all painful & difficult.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Ear pain, Incorrect route of product administration, Injection site discomfort, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: The injection was administered high on my arm near my shoulder. At first, I felt what I considered to be typical discomfort after an injection. Within a couple of days, though, the pain increased & moved up my neck to my left ear & I thought I might have an ear infection. My arm became stiff & mobility was limited & painful. As the pain persisted, and because the pain was in my left arm, I thought I was having a heart attack so I went to the ER but a heart attack was ruled out. The pain continued so I went to Urgent Care & was prescribed prednisone, which gave mild relief but once the script was used up the pain returned. I went back to the UC & was referred to orthopedics, who administered a cortisone shot in my left shoulder and referred me to PT. I am currently in PT 3x/week for 8 weeks and there has been little to no reduction in pain. I have been unable to sleep at night since May due to the pain. Activities of daily living, such as dressing, showering, fastening my seat belt, etc. are all painful & difficult.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: The injection was administered high on my arm near my shoulder. At first, I felt what I considered to be typical discomfort after an injection. Within a couple of days, though, the pain increased & moved up my neck to my left ear & I thought I might have an ear infection. My arm became stiff & mobility was limited & painful. As the pain persisted, and because the pain was in my left arm, I thought I was having a heart attack so I went to the ER but a heart attack was ruled out. The pain continued so I went to Urgent Care & was prescribed prednisone, which gave mild relief but once the script was used up the pain returned. I went back to the UC & was referred to orthopedics, who administered a cortisone shot in my left shoulder and referred me to PT. I am currently in PT 3x/week for 8 weeks and there has been little to no reduction in pain. I have been unable to sleep at night since May due to the pain. Activities of daily living, such as dressing, showering, fastening my seat belt, etc. are all painful & difficult.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: X-ray
Clinical narrative: The injection was administered high on my arm near my shoulder. At first, I felt what I considered to be typical discomfort after an injection. Within a couple of days, though, the pain increased & moved up my neck to my left ear & I thought I might have an ear infection. My arm became stiff & mobility was limited & painful. As the pain persisted, and because the pain was in my left arm, I thought I was having a heart attack so I went to the ER but a heart attack was ruled out. The pain continued so I went to Urgent Care & was prescribed prednisone, which gave mild relief but once the script was used up the pain returned. I went back to the UC & was referred to orthopedics, who administered a cortisone shot in my left shoulder and referred me to PT. I am currently in PT 3x/week for 8 weeks and there has been little to no reduction in pain. I have been unable to sleep at night since May due to the pain. Activities of daily living, such as dressing, showering, fastening my seat belt, etc. are all painful & difficult.
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX Temperature Excursion. Improperly stored VARIVAX was administered; Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; This spontaneous report was received from a pharmacist concerning a 27-year-old female.  The patient's concurrent conditions and concomitant therapies were not reported. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known. Historical vaccines administered on 02-JUN-2023 included Measles, Mumps, and Rubella Virus Vaccine, Live (MMR), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), and hepatitis b vaccine rhbsag (yeast) (HEPLISAV B).  On 26-JUN-2023, the patient received the second dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the right arm for prophylaxis. The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011965: US-009507513-2307USA011964: US-009507513-2307USA011966:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event, Product storage error
Clinical narrative: Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; VARIVAX Temperature Excursion. Improperly stored VARIVAX was administered; Varivax # of previous doses: 2; This spontaneous report was received from a pharmacist concerning a 11-year-old female.  The patient's concurrent conditions and concomitant therapies were not reported. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known.  On 22-JUN-2023, the patient received the third dose (number of previous doses: 2) of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the left arm for prophylaxis (Extra dose administered). The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011966: US-009507513-2307USA000909: US-009507513-2307USA011965:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The MMR II TE and administration occurred today, 07/27/2023, and no adverse issues or side effects are reported.; A HBP called to report a TE for MMR II that had also been administered post excursion.  The MMR II TE and administration occurred today, 07/27/2023, and no adverse issues or side effects are reported.; This spontaneous report was received from other health care professional referring to a 4-years-old patient. The patient's medical history, concomitant therapies, and drug reactions or allergies were not reported.  On 27-JUL-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection (lot number: W023508 was verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (M-M-R II), expiration date was provided and upon internal validation was confirmed to be: 25-JUL-2024) 0.5 mL, via injection in the left thigh as prophylaxis (strength and frequency were not reported) administered post excursion (Product storage error) and no adverse issues or side effects were reported (No adverse event). The reporter could not provide the diluent lot number or expiration date and the vaccine was not available for retrieval as it had already been discarded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Premature menopause
Clinical narrative: Early menopause, irregular periods lead to menopause
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Fever, welt-like rash, swelling
Sex: F
Vaccine: HEP
Symptoms: CDKL5 deficiency disorder, Dyskinesia, Electroencephalogram, Seizure
Clinical narrative: Movements in arm and body that were later diagnosed as seizures
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Arthralgia, Blood test normal, Bone pain, Decreased appetite
Clinical narrative: Several hours after 1st injection, I began to experience severe (scale of 9) bone pain in both of my legs top to bottom.  Followed with general body ache.  Ability to completely fall asleep was gone.  It was like I was one of those dimmer switches and instead of being able to turn off the light I only get to the dimmer settings.  I?m needing to take ambient to fall asleep.  And now I continue to suffer bone pains on both my knees, shoulders and fingers.  Have lost quite a bit of weight unplanned.  Lacking appetite.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Pain, Pain in extremity
Clinical narrative: Several hours after 1st injection, I began to experience severe (scale of 9) bone pain in both of my legs top to bottom.  Followed with general body ache.  Ability to completely fall asleep was gone.  It was like I was one of those dimmer switches and instead of being able to turn off the light I only get to the dimmer settings.  I?m needing to take ambient to fall asleep.  And now I continue to suffer bone pains on both my knees, shoulders and fingers.  Have lost quite a bit of weight unplanned.  Lacking appetite.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Antiphospholipid syndrome, Foetal heart rate abnormal, Habitual abortion, Immunoglobulins increased
Clinical narrative: Found out I was pregnant in early may, miscarried on june 6 2021. Pregnant again  Sept 5, 2021, had ultrasound that showed heartbeat. No heartbeat 10/8/21, d and c on 10/12/21. Referred to doc. Fertility work up done and APS was suggested as possible reason for miscarriages but would need follow up test to confirm, testing done and indicative of APLS  in conjunction with multiple miscarriages
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal, Pregnancy, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: Found out I was pregnant in early may, miscarried on june 6 2021. Pregnant again  Sept 5, 2021, had ultrasound that showed heartbeat. No heartbeat 10/8/21, d and c on 10/12/21. Referred to doc. Fertility work up done and APS was suggested as possible reason for miscarriages but would need follow up test to confirm, testing done and indicative of APLS  in conjunction with multiple miscarriages
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Limb mass, Muscle mass, Muscle spasms, Myalgia
Clinical narrative: Left deltoid still aches with muscle spasms, stretches helps the ache; Left deltoid still aches with muscle spasms, stretches helps the ache; eczema on my forearms have noticed an increase in outbreaks; nodules under the skin/still have a noticeable lump in my left deltoid; have sporadic patches of skin on left arm that sting / stinging skin; sporadic patches of skin on left arm that sting and hurt to the touch; This non-serious case was reported by a consumer and described the occurrence of muscle spasm in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF) for prophylaxis.   Concurrent medical conditions included blood pressure high, type ii diabetes mellitus and arthritis. Concomitant products included loratadine (Claritine), paracetamol (Tylenol), semaglutide (Ozempic), valsartan and fluticasone propionate (Flovent Diskus).   On 07-DEC-2022, the patient received Shingrix .5 ml. On 19-JUL-2023, 224 days after receiving Shingrix, the patient experienced skin nodule (Verbatim: nodules under the skin/still have a noticeable lump in my left deltoid), stinging skin (Verbatim: have sporadic patches of skin on left arm that sting / stinging skin) and patchy rash (Verbatim: sporadic patches of skin on left arm that sting and hurt to the touch). On an unknown date, the patient experienced muscle spasm (Verbatim: Left deltoid still aches with muscle spasms, stretches helps the ache), muscle pain (Verbatim: Left deltoid still aches with muscle spasms, stretches helps the ache) and eczema (Verbatim: eczema on my forearms have noticed an increase in outbreaks). The outcome of the muscle spasm, eczema, skin nodule, stinging skin and patchy rash were not resolved and the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the muscle spasm, muscle pain, eczema, skin nodule, stinging skin and patchy rash to be related to Shingrix.     It was unknown if the company considered the muscle spasm, muscle pain, eczema, skin nodule, stinging skin and patchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2023 The reporter was a patient. The patient still had a noticeable lump in her left deltoid, had sporadic patches of skin on left arm that sting and hurt to the touch. The reporter reported that the left deltoid still aches with muscle spasms, stretches helps the ache, but nothing helps the stinging skin. The patient also had eczema on her forearms and have noticed an increase in outbreaks and nodules under the skin. The reporter gave a permission to contact.
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash, Skin mass, Tenderness
Clinical narrative: Left deltoid still aches with muscle spasms, stretches helps the ache; Left deltoid still aches with muscle spasms, stretches helps the ache; eczema on my forearms have noticed an increase in outbreaks; nodules under the skin/still have a noticeable lump in my left deltoid; have sporadic patches of skin on left arm that sting / stinging skin; sporadic patches of skin on left arm that sting and hurt to the touch; This non-serious case was reported by a consumer and described the occurrence of muscle spasm in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF) for prophylaxis.   Concurrent medical conditions included blood pressure high, type ii diabetes mellitus and arthritis. Concomitant products included loratadine (Claritine), paracetamol (Tylenol), semaglutide (Ozempic), valsartan and fluticasone propionate (Flovent Diskus).   On 07-DEC-2022, the patient received Shingrix .5 ml. On 19-JUL-2023, 224 days after receiving Shingrix, the patient experienced skin nodule (Verbatim: nodules under the skin/still have a noticeable lump in my left deltoid), stinging skin (Verbatim: have sporadic patches of skin on left arm that sting / stinging skin) and patchy rash (Verbatim: sporadic patches of skin on left arm that sting and hurt to the touch). On an unknown date, the patient experienced muscle spasm (Verbatim: Left deltoid still aches with muscle spasms, stretches helps the ache), muscle pain (Verbatim: Left deltoid still aches with muscle spasms, stretches helps the ache) and eczema (Verbatim: eczema on my forearms have noticed an increase in outbreaks). The outcome of the muscle spasm, eczema, skin nodule, stinging skin and patchy rash were not resolved and the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the muscle spasm, muscle pain, eczema, skin nodule, stinging skin and patchy rash to be related to Shingrix.     It was unknown if the company considered the muscle spasm, muscle pain, eczema, skin nodule, stinging skin and patchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2023 The reporter was a patient. The patient still had a noticeable lump in her left deltoid, had sporadic patches of skin on left arm that sting and hurt to the touch. The reporter reported that the left deltoid still aches with muscle spasms, stretches helps the ache, but nothing helps the stinging skin. The patient also had eczema on her forearms and have noticed an increase in outbreaks and nodules under the skin. The reporter gave a permission to contact.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol withdrawal syndrome, COVID-19
Clinical narrative: Presented to ER with the complaints of alcohol withdrawal; incidental finding of COVID-19.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Haematemesis, SARS-CoV-2 test positive
Clinical narrative: Presenting to the Emergency Department, via EMS from home, complaining of blood in vomit onset today; incidental COVID-10 finding on pre-procedural testing; asymptomatic.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood test abnormal, COVID-19
Clinical narrative: Pt came to ED with elevated creatinine on regular blood work; recently diagnosed with COVID-19 but asymptomatic
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Presented to ED w/COVID-like symptoms; tx w/ abx, discharged home from ED
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, COVID-19, Chest pain, Troponin increased
Clinical narrative: Presented with left-sided chest pain consistent with elevated troponin caused by NSTEMI; incidental COVID-19 finding but asymptomatic
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented to ED via EMS c/o fever and chills; COVID-19+ finding but asymptomatic
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: Presented w/ acute hypoxic respiratory failure and COVID-19 pneumonia; tx w/ remdesivir, steroids, O2; weaned to RA for dc home.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Ageusia, Anosmia, Back pain, COVID-19
Clinical narrative: Presents to the emergency department complaining decreased appetite, diarrhea, shortness of breath, cough, congestion, loss of taste and smell, and back pain, onset 5 days ago; admitted for sepsis w/acute renal failure, COVID-19 virus infection; tx w/remdesivir, abx; O2 not required; dc'd home.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Dyspnoea, Respiratory tract congestion
Clinical narrative: Presents to the emergency department complaining decreased appetite, diarrhea, shortness of breath, cough, congestion, loss of taste and smell, and back pain, onset 5 days ago; admitted for sepsis w/acute renal failure, COVID-19 virus infection; tx w/remdesivir, abx; O2 not required; dc'd home.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Presents to the emergency department complaining decreased appetite, diarrhea, shortness of breath, cough, congestion, loss of taste and smell, and back pain, onset 5 days ago; admitted for sepsis w/acute renal failure, COVID-19 virus infection; tx w/remdesivir, abx; O2 not required; dc'd home.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Diarrhoea, Haematochezia
Clinical narrative: Presented to hospital with chief complaints of diarrhea, blood in stool as well as abdominal pain; has current COVID infection but asymptomatic.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Fatigue, Injection site pain, SARS-CoV-2 test positive
Clinical narrative: Presented to ED with complaint of tiredness and bilateral knee pain and left elbow pain pain that have been going on for the last couple days; tested COVID-19+ 2 days prior; asymptomatic.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: Presented to the ED with c/o multiple falls ongoing for few days, with most recent today. COVID-19+ but asymptomatic
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, COVID-19, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: Presents to ED complaining of 2 days of progressively worsening shortness of breath. He denies having any fevers or cough but he does report a week ago he was exposed to somebody was positive for COVID-19.  Admitted for NSTEMI; developed COVID-19 during stay but asymptomatic.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chills, Cough, Dyspnoea
Clinical narrative: Admitted on account of fever chills shortness of breath cough and congestion for about a week. He had been diagnosed with COVID 4 days earlier and came to the hospital account of worsening of his symptoms.  Evaluation emergency room confirmed COVID pneumonia with hypoxemia. Tx w/ abx, steroids, O2, Vit C, zinc; dc'd home w/HHC & O2.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pyrexia, Respiratory tract congestion
Clinical narrative: Admitted on account of fever chills shortness of breath cough and congestion for about a week. He had been diagnosed with COVID 4 days earlier and came to the hospital account of worsening of his symptoms.  Evaluation emergency room confirmed COVID pneumonia with hypoxemia. Tx w/ abx, steroids, O2, Vit C, zinc; dc'd home w/HHC & O2.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: Admitted to the hospital for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Tx w/steorids, abx, fluvoxamine, invermectin, O2. Pt refused O2 or home discharge.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chemotherapy, SARS-CoV-2 test positive
Clinical narrative: Pt transferred from facility for chemotherapy at facility. Pt was admitted at facility on 12/31 and tested positive for COVID on 1/6 and received remdesivir course at facility. Incidentally COVID-19, asymptomatic.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Fatigue, Nausea, Physical deconditioning
Clinical narrative: Came in with the chief complaint of generalized fatigue nausea vomiting.  Admitted for weakness and physical deconditioning. He was diagnosed with COVID-19.  Tx w/ abx, Vit C, zinc; did not require O2.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Came in with the chief complaint of generalized fatigue nausea vomiting.  Admitted for weakness and physical deconditioning. He was diagnosed with COVID-19.  Tx w/ abx, Vit C, zinc; did not require O2.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea
Clinical narrative: Admitted for shortness of breath secondary to COVID-19 pneumonia. Tx w/ steroids, zinc, bronchodilators; did not require O2.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Fatigue
Clinical narrative: Presents to the ED c/o generalized weakness fatigue for 1 week. Diagnosed w/COVID-19 pna; tx w/abx, steroids, zinc, O2.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive, Condition aggravated, Hepatic failure, Mental status changes
Clinical narrative: Admited to the hospital for CHF exacerbation; COVID-19 pna+; tx w/abx, Vit C, zinc, steroids, singulair, O2. developed hepatic failure, renal failure, and worsening mental status; dc'd to hospice.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, SARS-CoV-2 test positive
Clinical narrative: Admited to the hospital for CHF exacerbation; COVID-19 pna+; tx w/abx, Vit C, zinc, steroids, singulair, O2. developed hepatic failure, renal failure, and worsening mental status; dc'd to hospice.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea, Illness, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ short of breath, ill & weakP; COVID+; tx w/steroids, singulair, O2; weaned off of O2; dc'd home
Age: 0.08
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, Fatigue, body aches, joint pain, chills and headache Narrative:
Age: 0.08
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache, Myalgia, Arthralgia, Fatigue, body aches, joint pain, chills and headache Narrative:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Fever Extreme arm swelling and redness, chills Narrative:
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Feeling abnormal, Immunisation, Pain in extremity
Clinical narrative: Patient was given a dose of Td that was expired on 7/28/2023 @ around 12pm. When error was discovered Dr was informed. Pt was called by Dr and voicemail was left for pt to call back. Dr looked into it and said pt need to have 2nd dose of Td as soon as patient can get back to office. I called patient on 7/29/23 and advised her of the error Patient came back to the off on 7/29/23 and we readministered the Td. Vaccine was double check by nurse practitioner that was working that day. I called and followed up with patient on Sunday 7/30/23 and Monday 7/31/23 to see how she was feeling. Patient said that she felt bad just a little sore arm.