chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Arthralgia, Barbotage, Bone pain, Bursitis, Calcific deposits removal
Clinical narrative: The events happened within two weeks of my receiving the fourth dose of the Pfizer COVID-19 vaccine. There was significant shoulder pain bilaterally, and it was more pronounced in the right shoulder than in the left. It radiated from the anterior of the shoulder into the clavicle at first. It also radiated from the shoulder to the elbow for about six months. The pain then became significantly worse, and it then radiated to the hand for the last two months. The aforementioned gradual radiation of the pain only affected the right arm. At that point, I went to my PCP, who referred to an orthopedist. My PCP prescribed Norco 5/325, which was not effective in treating the pain. I then saw the orthopedist, who ran X-rays of the right shoulder. The orthopedist diagnosed me with significant right rotator cuff calcification tendinopathy within the resorptive phase with associated severe subacromial subdeltoid calcific bursitis. There are no measurements indicated, but they are abnormally large. The orthopedist also prescribed me 50mg of tramadol, which I was to take every six to eight hours as needed. It reduced the pain significantly more than Norco did.  I have undergone barbotage to have the calcifications broken up, and only 70% could be broken up. The procedure had to be halted after 70% of the calcifications had been removed, because further barbotage would have damaged the tendon. I am currently undergoing physical therapy once a week. After having had the barbotage procedure completed and the physical therapy commenced one week thereafter, the range of motion is now normal. In certain positions in the right shoulder, the range of motion is normal, but with some other positions, there is weakness.
Age: 37.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Joint range of motion decreased, Muscular weakness, Pain, Pain in extremity, Tendon calcification
Clinical narrative: The events happened within two weeks of my receiving the fourth dose of the Pfizer COVID-19 vaccine. There was significant shoulder pain bilaterally, and it was more pronounced in the right shoulder than in the left. It radiated from the anterior of the shoulder into the clavicle at first. It also radiated from the shoulder to the elbow for about six months. The pain then became significantly worse, and it then radiated to the hand for the last two months. The aforementioned gradual radiation of the pain only affected the right arm. At that point, I went to my PCP, who referred to an orthopedist. My PCP prescribed Norco 5/325, which was not effective in treating the pain. I then saw the orthopedist, who ran X-rays of the right shoulder. The orthopedist diagnosed me with significant right rotator cuff calcification tendinopathy within the resorptive phase with associated severe subacromial subdeltoid calcific bursitis. There are no measurements indicated, but they are abnormally large. The orthopedist also prescribed me 50mg of tramadol, which I was to take every six to eight hours as needed. It reduced the pain significantly more than Norco did.  I have undergone barbotage to have the calcifications broken up, and only 70% could be broken up. The procedure had to be halted after 70% of the calcifications had been removed, because further barbotage would have damaged the tendon. I am currently undergoing physical therapy once a week. After having had the barbotage procedure completed and the physical therapy commenced one week thereafter, the range of motion is now normal. In certain positions in the right shoulder, the range of motion is normal, but with some other positions, there is weakness.
Age: 37.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Tendon disorder, X-ray limb abnormal
Clinical narrative: The events happened within two weeks of my receiving the fourth dose of the Pfizer COVID-19 vaccine. There was significant shoulder pain bilaterally, and it was more pronounced in the right shoulder than in the left. It radiated from the anterior of the shoulder into the clavicle at first. It also radiated from the shoulder to the elbow for about six months. The pain then became significantly worse, and it then radiated to the hand for the last two months. The aforementioned gradual radiation of the pain only affected the right arm. At that point, I went to my PCP, who referred to an orthopedist. My PCP prescribed Norco 5/325, which was not effective in treating the pain. I then saw the orthopedist, who ran X-rays of the right shoulder. The orthopedist diagnosed me with significant right rotator cuff calcification tendinopathy within the resorptive phase with associated severe subacromial subdeltoid calcific bursitis. There are no measurements indicated, but they are abnormally large. The orthopedist also prescribed me 50mg of tramadol, which I was to take every six to eight hours as needed. It reduced the pain significantly more than Norco did.  I have undergone barbotage to have the calcifications broken up, and only 70% could be broken up. The procedure had to be halted after 70% of the calcifications had been removed, because further barbotage would have damaged the tendon. I am currently undergoing physical therapy once a week. After having had the barbotage procedure completed and the physical therapy commenced one week thereafter, the range of motion is now normal. In certain positions in the right shoulder, the range of motion is normal, but with some other positions, there is weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Delirium, Intensive care, Malaise, Memory impairment
Clinical narrative: Patient started to not feel well the day after her vaccine, worsening to a delirious state of not remembering getting to the hospital.  Blood Glucose was reported at 1100 per patient upon arrival to the hospital, and eventually taken to intensive care.  She had a stent put in place the day prior to discharge.  She spent a total of 7 days in the hospital.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Stent placement
Clinical narrative: Patient started to not feel well the day after her vaccine, worsening to a delirious state of not remembering getting to the hospital.  Blood Glucose was reported at 1100 per patient upon arrival to the hospital, and eventually taken to intensive care.  She had a stent put in place the day prior to discharge.  She spent a total of 7 days in the hospital.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Caesarean section, Coagulation test, Exposure during pregnancy, Foetal death
Clinical narrative: with history of 3 normal, healthy term pregnancies and births with no complications as well as 1 SAB at 10 weeks with pregnancy #2.  Only risk factor is BMI of 61. EDD 03/25/2023.  Patient received the Moderna Bivalent on Friday and felt "unwell" with typical vaccine symptoms that afternoon. She felt better on Saturday and reported a busy day. Saturday evening she felt that baby was moving less than usual but thought she just wasn't noticing the movement due to position change. By Monday morning, she contacted me as her care provider and when I assessed, I could not find so we went immediately to the hospital and was confirmed by ultrasound. Baby was born by cesarean at 38.2 weeks and a thrombus was noted at the base of the cord as well as several small clots on the placenta. Based on baby's appearance, it was estimated baby had died about 48 hours before birth, sometimes on Saturday.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Foetal heart rate abnormal, Foetal hypokinesia, Foetal vascular malperfusion, Malaise, Pathology test
Clinical narrative: with history of 3 normal, healthy term pregnancies and births with no complications as well as 1 SAB at 10 weeks with pregnancy #2.  Only risk factor is BMI of 61. EDD 03/25/2023.  Patient received the Moderna Bivalent on Friday and felt "unwell" with typical vaccine symptoms that afternoon. She felt better on Saturday and reported a busy day. Saturday evening she felt that baby was moving less than usual but thought she just wasn't noticing the movement due to position change. By Monday morning, she contacted me as her care provider and when I assessed, I could not find so we went immediately to the hospital and was confirmed by ultrasound. Baby was born by cesarean at 38.2 weeks and a thrombus was noted at the base of the cord as well as several small clots on the placenta. Based on baby's appearance, it was estimated baby had died about 48 hours before birth, sometimes on Saturday.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound antenatal screen abnormal, Umbilical cord thrombosis
Clinical narrative: with history of 3 normal, healthy term pregnancies and births with no complications as well as 1 SAB at 10 weeks with pregnancy #2.  Only risk factor is BMI of 61. EDD 03/25/2023.  Patient received the Moderna Bivalent on Friday and felt "unwell" with typical vaccine symptoms that afternoon. She felt better on Saturday and reported a busy day. Saturday evening she felt that baby was moving less than usual but thought she just wasn't noticing the movement due to position change. By Monday morning, she contacted me as her care provider and when I assessed, I could not find so we went immediately to the hospital and was confirmed by ultrasound. Baby was born by cesarean at 38.2 weeks and a thrombus was noted at the base of the cord as well as several small clots on the placenta. Based on baby's appearance, it was estimated baby had died about 48 hours before birth, sometimes on Saturday.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chromaturia, Fatigue, Immunology test abnormal, Linear IgA disease, Oxygen saturation decreased
Clinical narrative: I broke out in a blistering rash on both buttocks, both hands, and both arms.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash vesicular
Clinical narrative: I broke out in a blistering rash on both buttocks, both hands, and both arms.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: I had a sore throat, cough, body aches, chills, and fatigue. I went to an urgent care to get tested for COVID-19 and it came back positive. I was not prescribed anything, and I was told to get some rest and take over the counter medication. I still have a cough.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, SARS-CoV-2 test positive
Clinical narrative: I had a sore throat, cough, body aches, chills, and fatigue. I went to an urgent care to get tested for COVID-19 and it came back positive. I was not prescribed anything, and I was told to get some rest and take over the counter medication. I still have a cough.
Age: 47.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Adverse event, Burning sensation, Cardiac stress test, Chest pain, Cough
Clinical narrative: My adverse event started on 12/2022 in the evening. I had chest pains. It was on my  left side between my heart and shoulder. The pain quickly spread to upper chest to bottom of throat. The pain lasted for 10-25minutes. It shows up all of a sudden. It can happen in the morning , afternoon and more in the evening after 9:00pm. I couldn't relate this to stress or anything else. I went to my Pulmonologist 02/24/2023  on who did all kinds of tests including  asthma . Pulmonary function test was done on 03/17/2023 which  negative and also a Methacholine  test which was negative.  She also referred me to a cardiologist.  I went to the Cardiologist on  02/17/2023 it was a consultation she didn't believe it was a cardio issue. She said it might from acid reflux or musculoskeletal. She ordered a Stress EKG which I did  today 03/17/2023. They said the result will come in by next week. On late January  25/2023. in the evening and I started getting   terrible  itching/ rash on my hands and feet. It started in my feet then to my hands. It's like a burn. It usually more at night. It  itches and I feel like a burning sensation and getting bit by a bug. It stared getting worse now it became hives. It's on my hands, feet and my chest.  This is an ongoing issue. I went to a Dermatologist for the Hives on 01/21/2023 they prescribe me Ivermectin ( 1 week ) , Hydroxyzine HCL, Betamethasone Propionate,  and Zyrtec. The Dermatologist  diagnosed me with 2 things what are Urticaria and Dermatographias.  She said it could be triggered by a virus, reaction to Amoxicillin, allergy or chronic hives.   I had a follow up with my Dermatologist on 03/08/2023 . I  went to my regular doctor  03/09/2023 who I also  shared this information with him. He said it could be a reaction to Amoxicillin, possibly to Mono, allergies or chronic hives. He agreed on the medication the Dermatologist prescribed and advised me to continue. On 02/09/2023 in the morning I had a sore throat, low grade fever, and cough.  I went to the walk-in clinic they determined that it was a upper respiratory infection. They told me to take Dayquil and Nyquil for few days to see if I get better or not. Since, It  got worse I went to another walk-in clinic I told them that cough was getting worse and nothing was helping . They diagnosed me as Acute Upper Respiratory and   Sinusitis. They prescribe me with 2 medication for my symptoms which are Amoxicillin,  ( 10 days) and Methyl prednisone ( 6 days) . When I finished taking the Methyl Prednisone I had hives all over my torso. My doctor thinks I have reaction to Amoxicillin.  As of today the hives has been improved but hasn't recovered fully yet. The chest pains I still have but not as much as before. The upper respiratory issues has resolved.
Age: 47.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Electrocardiogram, Mechanical urticaria, Oropharyngeal pain, Pruritus, Pulmonary function challenge test normal
Clinical narrative: My adverse event started on 12/2022 in the evening. I had chest pains. It was on my  left side between my heart and shoulder. The pain quickly spread to upper chest to bottom of throat. The pain lasted for 10-25minutes. It shows up all of a sudden. It can happen in the morning , afternoon and more in the evening after 9:00pm. I couldn't relate this to stress or anything else. I went to my Pulmonologist 02/24/2023  on who did all kinds of tests including  asthma . Pulmonary function test was done on 03/17/2023 which  negative and also a Methacholine  test which was negative.  She also referred me to a cardiologist.  I went to the Cardiologist on  02/17/2023 it was a consultation she didn't believe it was a cardio issue. She said it might from acid reflux or musculoskeletal. She ordered a Stress EKG which I did  today 03/17/2023. They said the result will come in by next week. On late January  25/2023. in the evening and I started getting   terrible  itching/ rash on my hands and feet. It started in my feet then to my hands. It's like a burn. It usually more at night. It  itches and I feel like a burning sensation and getting bit by a bug. It stared getting worse now it became hives. It's on my hands, feet and my chest.  This is an ongoing issue. I went to a Dermatologist for the Hives on 01/21/2023 they prescribe me Ivermectin ( 1 week ) , Hydroxyzine HCL, Betamethasone Propionate,  and Zyrtec. The Dermatologist  diagnosed me with 2 things what are Urticaria and Dermatographias.  She said it could be triggered by a virus, reaction to Amoxicillin, allergy or chronic hives.   I had a follow up with my Dermatologist on 03/08/2023 . I  went to my regular doctor  03/09/2023 who I also  shared this information with him. He said it could be a reaction to Amoxicillin, possibly to Mono, allergies or chronic hives. He agreed on the medication the Dermatologist prescribed and advised me to continue. On 02/09/2023 in the morning I had a sore throat, low grade fever, and cough.  I went to the walk-in clinic they determined that it was a upper respiratory infection. They told me to take Dayquil and Nyquil for few days to see if I get better or not. Since, It  got worse I went to another walk-in clinic I told them that cough was getting worse and nothing was helping . They diagnosed me as Acute Upper Respiratory and   Sinusitis. They prescribe me with 2 medication for my symptoms which are Amoxicillin,  ( 10 days) and Methyl prednisone ( 6 days) . When I finished taking the Methyl Prednisone I had hives all over my torso. My doctor thinks I have reaction to Amoxicillin.  As of today the hives has been improved but hasn't recovered fully yet. The chest pains I still have but not as much as before. The upper respiratory issues has resolved.
Age: 47.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pulmonary function test normal, Pyrexia, Rash, Sinusitis, Upper respiratory tract infection
Clinical narrative: My adverse event started on 12/2022 in the evening. I had chest pains. It was on my  left side between my heart and shoulder. The pain quickly spread to upper chest to bottom of throat. The pain lasted for 10-25minutes. It shows up all of a sudden. It can happen in the morning , afternoon and more in the evening after 9:00pm. I couldn't relate this to stress or anything else. I went to my Pulmonologist 02/24/2023  on who did all kinds of tests including  asthma . Pulmonary function test was done on 03/17/2023 which  negative and also a Methacholine  test which was negative.  She also referred me to a cardiologist.  I went to the Cardiologist on  02/17/2023 it was a consultation she didn't believe it was a cardio issue. She said it might from acid reflux or musculoskeletal. She ordered a Stress EKG which I did  today 03/17/2023. They said the result will come in by next week. On late January  25/2023. in the evening and I started getting   terrible  itching/ rash on my hands and feet. It started in my feet then to my hands. It's like a burn. It usually more at night. It  itches and I feel like a burning sensation and getting bit by a bug. It stared getting worse now it became hives. It's on my hands, feet and my chest.  This is an ongoing issue. I went to a Dermatologist for the Hives on 01/21/2023 they prescribe me Ivermectin ( 1 week ) , Hydroxyzine HCL, Betamethasone Propionate,  and Zyrtec. The Dermatologist  diagnosed me with 2 things what are Urticaria and Dermatographias.  She said it could be triggered by a virus, reaction to Amoxicillin, allergy or chronic hives.   I had a follow up with my Dermatologist on 03/08/2023 . I  went to my regular doctor  03/09/2023 who I also  shared this information with him. He said it could be a reaction to Amoxicillin, possibly to Mono, allergies or chronic hives. He agreed on the medication the Dermatologist prescribed and advised me to continue. On 02/09/2023 in the morning I had a sore throat, low grade fever, and cough.  I went to the walk-in clinic they determined that it was a upper respiratory infection. They told me to take Dayquil and Nyquil for few days to see if I get better or not. Since, It  got worse I went to another walk-in clinic I told them that cough was getting worse and nothing was helping . They diagnosed me as Acute Upper Respiratory and   Sinusitis. They prescribe me with 2 medication for my symptoms which are Amoxicillin,  ( 10 days) and Methyl prednisone ( 6 days) . When I finished taking the Methyl Prednisone I had hives all over my torso. My doctor thinks I have reaction to Amoxicillin.  As of today the hives has been improved but hasn't recovered fully yet. The chest pains I still have but not as much as before. The upper respiratory issues has resolved.
Age: 47.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Urticaria
Clinical narrative: My adverse event started on 12/2022 in the evening. I had chest pains. It was on my  left side between my heart and shoulder. The pain quickly spread to upper chest to bottom of throat. The pain lasted for 10-25minutes. It shows up all of a sudden. It can happen in the morning , afternoon and more in the evening after 9:00pm. I couldn't relate this to stress or anything else. I went to my Pulmonologist 02/24/2023  on who did all kinds of tests including  asthma . Pulmonary function test was done on 03/17/2023 which  negative and also a Methacholine  test which was negative.  She also referred me to a cardiologist.  I went to the Cardiologist on  02/17/2023 it was a consultation she didn't believe it was a cardio issue. She said it might from acid reflux or musculoskeletal. She ordered a Stress EKG which I did  today 03/17/2023. They said the result will come in by next week. On late January  25/2023. in the evening and I started getting   terrible  itching/ rash on my hands and feet. It started in my feet then to my hands. It's like a burn. It usually more at night. It  itches and I feel like a burning sensation and getting bit by a bug. It stared getting worse now it became hives. It's on my hands, feet and my chest.  This is an ongoing issue. I went to a Dermatologist for the Hives on 01/21/2023 they prescribe me Ivermectin ( 1 week ) , Hydroxyzine HCL, Betamethasone Propionate,  and Zyrtec. The Dermatologist  diagnosed me with 2 things what are Urticaria and Dermatographias.  She said it could be triggered by a virus, reaction to Amoxicillin, allergy or chronic hives.   I had a follow up with my Dermatologist on 03/08/2023 . I  went to my regular doctor  03/09/2023 who I also  shared this information with him. He said it could be a reaction to Amoxicillin, possibly to Mono, allergies or chronic hives. He agreed on the medication the Dermatologist prescribed and advised me to continue. On 02/09/2023 in the morning I had a sore throat, low grade fever, and cough.  I went to the walk-in clinic they determined that it was a upper respiratory infection. They told me to take Dayquil and Nyquil for few days to see if I get better or not. Since, It  got worse I went to another walk-in clinic I told them that cough was getting worse and nothing was helping . They diagnosed me as Acute Upper Respiratory and   Sinusitis. They prescribe me with 2 medication for my symptoms which are Amoxicillin,  ( 10 days) and Methyl prednisone ( 6 days) . When I finished taking the Methyl Prednisone I had hives all over my torso. My doctor thinks I have reaction to Amoxicillin.  As of today the hives has been improved but hasn't recovered fully yet. The chest pains I still have but not as much as before. The upper respiratory issues has resolved.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: IT WAS THE PATIENT'S SECOND meningococcal DOSE.   I injected Trumenba. The pharmacy was busy. I did not Realize that the patient had received Bexcero for the first shot.  The patient's mother called. She informed me that I had made a mistake. She was very upset . She requested to speak to my manager. I called the Manager at home. informed him of the situation and gave him the phone number of the Mother. to call.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Migraine, Nausea
Clinical narrative: nauseous, cold sweats, migraine
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: no adverse events, just received Monovalent instead of bivalent
Age: 29.0
Sex: F
Vaccine: PNC20
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: ADMINISTRATION ERROR -- Patient came to the pharmacy to receive a "pneumonia shot." Patient never specified which pneumonia shot she wanted. Patient is 29 years old and immunocompromised; per guidelines, she received Prevnar 20. Patient had a prescription from Dr. for Pneumovax 23, but pharmacist did not see the prescription until the following day when patient called the pharmacy upset. Patient was supposed to receive Pneumovax 23 per Dr. Patient needed Pneumovax 23 in order to qualify for a clinical trial. Per patient, she is now unable to participate in clinical trial because she received Prevnar 20.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Joint range of motion decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Headache and severe muscle pain in right shoulder blade effecting range of motion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect product formulation administered, Pain
Clinical narrative: fatigue, achy- but generally okay. Just received monovalent instead of bivalent
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: no issues, just received monovalent instead of bivalent vaccine
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: The patient who is 5 years old got the adult amount (1, 440U) of Hep-A vaccine which is double amount of the kids should get.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: after 5 weeks, arm is still (at times extremely) sore, from back of shoulder to top of hand, frequent headaches--not normal
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Peripheral coldness, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Contracted Covid.  Extreme cold hands and feet.  Congestion
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site dryness, Injection site haemorrhage, Injection site rash, Injection site urticaria
Clinical narrative: Patient complains of a rash (very itchy but not painful) inferior to vaccine site after TDap given 7 days ago. Patient's vital signs are WNL at time of office visit. Provider's general examination of skin: small, approximately nickel sized ecchymosis area of injection superior aspect of deltoid. Just inferior to this there is a rash - confluent wheals, lightly erythematous, dry, no vesicles. Provider prescribed and recommended hydroxyzine prn for itching and rash, as well as topical hydrocortisone and ice for discomfort.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Patient complains of a rash (very itchy but not painful) inferior to vaccine site after TDap given 7 days ago. Patient's vital signs are WNL at time of office visit. Provider's general examination of skin: small, approximately nickel sized ecchymosis area of injection superior aspect of deltoid. Just inferior to this there is a rash - confluent wheals, lightly erythematous, dry, no vesicles. Provider prescribed and recommended hydroxyzine prn for itching and rash, as well as topical hydrocortisone and ice for discomfort.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Lip oedema, Oropharyngeal pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: c/o itching, hives, left arm swelling, warmth (L) hand swelling lip edema, sore throat.  Methylpred 125 IM / Benadryl 50IM Ibuprofen 600mg PO.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: c/o itching, hives, left arm swelling, warmth (L) hand swelling lip edema, sore throat.  Methylpred 125 IM / Benadryl 50IM Ibuprofen 600mg PO.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypersensitivity, Vitiligo
Clinical narrative: All allergy reaction is vitiligo related to Covid shot, which spread today both legs. Lips, face, cheek,  both hands + fingers. Hes mentally and physically, seen by dermatologist.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypersensitivity, Vitiligo
Clinical narrative: All allergy reaction a vitiligo related to covid shot. Which spread body both legs, both arms, lips face, cheeks, both hands and fingers. He is mentally physically affected. Seen by medical doctor.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Memory loss since the first dose - continuous to worsen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), on 21Jan2021 at 10:00 as dose 1, single (Lot number: EL3302) at the age of 77 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (medically significant) with onset 2021, outcome "unknown", described as "Memory loss since the first dose - continuous to worsen". Therapeutic measures were not taken as a result of amnesia.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colitis ulcerative, Colonoscopy abnormal, Haematochezia, Mucous stools
Clinical narrative: 3 weeks after receiving the booster, I started having stomach pain. This lead to mucus in my stool within 4 weeks after booster. Within 6 weeks after receiving the booster I had blood in my stool. I met with my primary care physician who referred me to my gastroenterologist. I was then scheduled for an colonoscopy in February if 2022.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; administered expired PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-MAR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) subcutaneous injection (lot#: U024507, expiration date: 02-FEB-2023; strength, dose, route of administration, and anatomical location were not reported) which was reconstituted via corresponding sterile diluent (lot#: U006619, expiration date: 09-JUL-2023) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired MMRII on 03/01/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-MAR-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) subcutaneous injection (lot#: U006485, expiration date: 26-FEB-2023; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: a lump and pain on her left deltoid where she received the injection; a lump and pain on her left deltoid where she received the injection; This spontaneous report was received from a registered nurse via a company representative and refers to a 29-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-FEB-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023 (reported as few weeks after her injection), the patient experienced a lump and pain on her left deltoid where she received the vaccination. The lump was described as having no discoloration or heat. The patient described the pain as a "zing" that was worse when she leaned on her left arm. The patient felt better with acetaminophen (TYLENOL) and reached out the healthcare professional who advised the patient to take non-steroid anti-inflammatory drugs and ice the area. The patient was treated for a lump and pain on her left deltoid where she received the vaccination.  At the time of reporting, the patient had not recovered from the event of a lump and pain on her left deltoid where she received the vaccination.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 54.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product use issue, Smear cervix abnormal
Clinical narrative: No additional AE reported; the patient was vaccinated with GARDASIL 9 at age 54; This spontaneous report was received from a medical assistant referring to a 54-year-old female patient. The patient once had an abnormal pap smear. The patient's other medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On 01-MAR-2023 (also reported as "after having an abnormal pap smear"), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 ml, lot#: W021345, expiration date was reported as 01-MAY-2023 but upon internal validation indicated as 01-DEC-2024; strength, route of administration, and anatomical location were not reported) for prevention of human papillomavirus (HPV) (product use issue). No additional adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: misadministration of the MMR II vaccine/ the patient received her first dose of MMR II vaccine on 2/20/2023 and her second dose on 3/9/2023; No additional AE's; This spontaneous report was received from a consumer and refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 20-FEB-2023, the patient received her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and her second dose on 09-MAR-2023 (exact dose, injection site, route of administration, lot # and expiration date were not reported for both) for prophylaxis (inappropriate schedule of vaccine administered).  No additional adverse events were reported.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; 4 year old patient received GARDASIL 9 today 3/13/2023; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 13-MAR-2023, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: w004648, expiration date: 06-OCT-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Nurse is requesting employee immunization record related to PNEUMOVAX 23. Caller states the employee is currently in the hospital for an unspecified reason; This spontaneous report was received from a Registered Nurse (R.N.) concerning to a currently 70-year-old patient (also reported as "employee") of unspecified gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.  On an unknown date, the patient was hospitalized for an unspecified reason (adverse event). It was unknown by the reporter if patient received treatment for the event.  At the reporting time, the outcome of the event was not provided. However, patient remained hospitalized (reported as "currently in the hospital"). Reporter was requiring patient's immunization record related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The causal relationship between adverse event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Injection
Clinical narrative: Jynneos vaccine was administered intradermally, past beyond use date ; Jynneos vaccine was administered intradermally, past beyond use date ; Case reference number US-BN-2023-000316 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0295) and concerns a male patient.  The patient's medical history and concomitant medications details were not provided.  On 31-Jan-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023 (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000321, US-BN-2023-000322, US-BN-2023-000323 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 31-Jan-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 31-Jan-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos vaccine was administered intradermally, past beyond use date; Jynneos vaccine was administered intradermally, past beyond use date; Case reference number US-BN-2023-000322 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0302) and concerns a male patient.  The patient's medical history and concomitant medications details were not provided.  On 13-Feb-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023 (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000316, US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000321, US-BN-2023-000323 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 13-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 13-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos vaccine was administered intradermally, past beyond use date; Jynneos vaccine was administered intradermally, past beyond use date; Case reference number US-BN-2023-000323 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0303) and concerns an adult male patient.  The patient's medical history and concomitant medications details were not provided.  On 16-Feb-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023 (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000316, US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000321, US-BN-2023-000322 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 16-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 16-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: vaccination following 1st shingles episode / got Shingles twice one episode followed the other / Suspected vaccination failure; vaccination following 1st shingles episode / got Shingles twice one episode followed the other; Covid; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 1 episode prior to shingles vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccination following 1st shingles episode / got Shingles twice one episode followed the other / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: vaccination following 1st shingles episode / got Shingles twice one episode followed the other) and covid-19 (Verbatim: Covid).  The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 02-Mar-2023 This case was reported by patient's friend via interactive digital media. The reporter informed that the patient got Shingles twice, one episode followed the other and then she got covid and reporter asked also twice. The reporter stated poor thing the patient had vaccination following 1st shingles episode and she had vaccination prior to 1st case of covid. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Put me in the ER / Hospitalization; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hospitalization (Verbatim: Put me in the ER / Hospitalization) (serious criteria hospitalization).  The outcome of the hospitalization was not recovered/not resolved.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the Shingles shot put him/her in the emergency room.  The patient was sent to the emergency room and it was unknown if the patient was hospitalized after that. Follow-up would not possible as no contact details were available.