chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthritis, Blood glucose increased, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: A couple of days after receiving the third dose (april 2022)  the outer side of right foot hurt badly.  After a week, Saw podiatrist who took xrays and said its arthritis.  10 days later, right food pain starts to dissipate but next morning, its on my left foot.  It took about 5 weeks before pain really subsided.  Intermittently reappears for a day or so. .  Had next vaccine on oct 19th and pain in feet are back.  Especially tough getting out of bed in the morning.  Taking motrin to manage the pain.  Unfortunately motrin and pain raise my glucose numbers.  Saw P.A. At endocrinologist  office in may and she said that both of my feet were swollen.  Said its not from the diabetes.  No recommendations.     The podiatrist said its caused by ill fitting gym shoes and get compression stockings. Suggested physical therapy. Said its just an age issue.  When i bring up the potential correlation between the vaccine and my feet pain that hust say they have never heard anything and proceed with their recommendations.   I never xperienced arthritis in my feet before the shots.  I pkay alot of sports (baseball, basketball, hockey, running on occasion, golf) and never had issues with my feet.  Suddenly one day i wake up and have arthritis?!
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: X-ray abnormal
Clinical narrative: A couple of days after receiving the third dose (april 2022)  the outer side of right foot hurt badly.  After a week, Saw podiatrist who took xrays and said its arthritis.  10 days later, right food pain starts to dissipate but next morning, its on my left foot.  It took about 5 weeks before pain really subsided.  Intermittently reappears for a day or so. .  Had next vaccine on oct 19th and pain in feet are back.  Especially tough getting out of bed in the morning.  Taking motrin to manage the pain.  Unfortunately motrin and pain raise my glucose numbers.  Saw P.A. At endocrinologist  office in may and she said that both of my feet were swollen.  Said its not from the diabetes.  No recommendations.     The podiatrist said its caused by ill fitting gym shoes and get compression stockings. Suggested physical therapy. Said its just an age issue.  When i bring up the potential correlation between the vaccine and my feet pain that hust say they have never heard anything and proceed with their recommendations.   I never xperienced arthritis in my feet before the shots.  I pkay alot of sports (baseball, basketball, hockey, running on occasion, golf) and never had issues with my feet.  Suddenly one day i wake up and have arthritis?!
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Reports itchiness, redness, warm to touch, pain and slight swelling. Recommended treatment: Tylenol and Benadryl PRN. Call the office if no better.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Bursitis, Joint range of motion decreased
Clinical narrative: Left shoulder pain and decreased range of motion, exam consistent with subacromial bursitis
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: Pt experienced instant striking pain in right arm, wrist, and excruciating head pain. Soreness in arm and some leg pain. Went away the following day.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysgeusia, Fatigue, Feeling hot
Clinical narrative: I received my first Pfizer booster for COVID-19 on 11/23/21. On the morning of 11/13/2022, I didn't feel well. I felt like I was getting a cold, because I had fatigue. I then later developed a fever, felt hot, and had a slight headache. I took a home antigen test on 11/14/2022 and got a positive result. I contacted my doctor, who prescribed me Paxlovid, which I started taking the morning of 11/15/2022. Along with the abovementioned symptoms, I have had a dry cough, occasional runny nose, and night sweats. Ever since the night of 11/21/2022, I have had night sweats. The sweats were really bad on the nights of 11/21/2022 and 11/22/2022, but they are now less severe. I hope they have finished coming. I have also started coughing more frequently after finishing Paxlovid, though it is still a dry cough. During the time I was taking the Paxlovid, I had a bitter taste in my mouth that was kind of like the aftertaste from eating a grapefruit, but once I finished the medication, the aftertaste went away. Per my doctor's orders, ever since I tested positive on 11/14/2022, I have been taking vitamins D and C and zinc. I took a home antigen test on 11/23/2022 and got a negative result.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nasopharyngitis, Night sweats, Pyrexia
Clinical narrative: I received my first Pfizer booster for COVID-19 on 11/23/21. On the morning of 11/13/2022, I didn't feel well. I felt like I was getting a cold, because I had fatigue. I then later developed a fever, felt hot, and had a slight headache. I took a home antigen test on 11/14/2022 and got a positive result. I contacted my doctor, who prescribed me Paxlovid, which I started taking the morning of 11/15/2022. Along with the abovementioned symptoms, I have had a dry cough, occasional runny nose, and night sweats. Ever since the night of 11/21/2022, I have had night sweats. The sweats were really bad on the nights of 11/21/2022 and 11/22/2022, but they are now less severe. I hope they have finished coming. I have also started coughing more frequently after finishing Paxlovid, though it is still a dry cough. During the time I was taking the Paxlovid, I had a bitter taste in my mouth that was kind of like the aftertaste from eating a grapefruit, but once I finished the medication, the aftertaste went away. Per my doctor's orders, ever since I tested positive on 11/14/2022, I have been taking vitamins D and C and zinc. I took a home antigen test on 11/23/2022 and got a negative result.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I received my first Pfizer booster for COVID-19 on 11/23/21. On the morning of 11/13/2022, I didn't feel well. I felt like I was getting a cold, because I had fatigue. I then later developed a fever, felt hot, and had a slight headache. I took a home antigen test on 11/14/2022 and got a positive result. I contacted my doctor, who prescribed me Paxlovid, which I started taking the morning of 11/15/2022. Along with the abovementioned symptoms, I have had a dry cough, occasional runny nose, and night sweats. Ever since the night of 11/21/2022, I have had night sweats. The sweats were really bad on the nights of 11/21/2022 and 11/22/2022, but they are now less severe. I hope they have finished coming. I have also started coughing more frequently after finishing Paxlovid, though it is still a dry cough. During the time I was taking the Paxlovid, I had a bitter taste in my mouth that was kind of like the aftertaste from eating a grapefruit, but once I finished the medication, the aftertaste went away. Per my doctor's orders, ever since I tested positive on 11/14/2022, I have been taking vitamins D and C and zinc. I took a home antigen test on 11/23/2022 and got a negative result.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Dyspnoea, Ejection fraction decreased, Viral cardiomyopathy
Clinical narrative: 6 days after my 2nd booster shot  i was having trouble breathing,  the next day after that  i was in the ER diagnosed with viral cardiomyopathy (critical)
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Atrial fibrillation, COVID-19, Condition aggravated, Electrocardiogram
Clinical narrative: After receiving this most recent dose of Pfizer Bivalent, I was diagnosed with A-Fib. My apple watch is what caught it. I went to the ER because I was experiencing a heart rate of 160 bpm, resting. I was given Eliquis to keep clots from forming. I have also contracted COVID-19. I tested positive on 11/21/2022. I was prescribed a prescription for Paxlovid. It was day 4 that I was prescribed that, and I still have not received the medication.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: After receiving this most recent dose of Pfizer Bivalent, I was diagnosed with A-Fib. My apple watch is what caught it. I went to the ER because I was experiencing a heart rate of 160 bpm, resting. I was given Eliquis to keep clots from forming. I have also contracted COVID-19. I tested positive on 11/21/2022. I was prescribed a prescription for Paxlovid. It was day 4 that I was prescribed that, and I still have not received the medication.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crying, Dysstasia, Gait inability
Clinical narrative: I have developed joint pains first. It started with small pains in random joints. One day would be my elbow another day my toes another day my hands they started getting worse over time now the pain is so excruciating that most mornings I cannot walk I cannot stand up without crying.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Mass, X-ray
Clinical narrative: I noticed a week after my Vaccine I took a bath and I noticed it was a little lump in my left clavical, I went to the Dr. and they gave me an x-ray of the infected area.  The Dr. thought it was an infected lymphoid but it was not it was an cyst my nogel. After a few weeks it went away on it's on.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was incorrectly administered monovalent Covid-19 12+ instead of receiving Bivalent booster. Patient had previously completed initial monovalent series 4/21/21, 5/12/2021 and additional booster on 11/18/2021.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ocular hyperaemia, Vision blurred
Clinical narrative: Patient reported that the day after he received his vaccine, his left eye was very bloodshot.  He did not experience pain however his vision in that eye was a little hazy.  I attempted to contact the patient to ask how long this lasted or if it had cleared up but was unable to do so.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast cancer, Breast cancer female, Breast mass, Intraductal proliferative breast lesion
Clinical narrative: I was diagnosed with breast cancer in the left. I noticed a lump in my left breast. They gave mammogram and they didn't see anything suspicious. I had an Ultrasound on April 29, 2022, and they found a hypoechoic mass in the left breast. In October they recommended that I come in for a biopsy on October 24. They diagnosed me with Ductal carcinoma in situ. I have a tumor in my left breast. I am still in the mist of treatment. I am scheduled for a mastectomy on December 06, 2022. I have to meet with a doctor post treatment to see if I need chemo. I had another ultrasound on April 29, 2022 and found that the mass had grown. I also had an MRI on November 3rd. They confirmed Malignancy of the tumor in my left breast. I started health therapist also and. I have also seen a genetic counselor. I will see an oncologist next week.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging breast abnormal, Mammogram normal, Ultrasound breast abnormal
Clinical narrative: I was diagnosed with breast cancer in the left. I noticed a lump in my left breast. They gave mammogram and they didn't see anything suspicious. I had an Ultrasound on April 29, 2022, and they found a hypoechoic mass in the left breast. In October they recommended that I come in for a biopsy on October 24. They diagnosed me with Ductal carcinoma in situ. I have a tumor in my left breast. I am still in the mist of treatment. I am scheduled for a mastectomy on December 06, 2022. I have to meet with a doctor post treatment to see if I need chemo. I had another ultrasound on April 29, 2022 and found that the mass had grown. I also had an MRI on November 3rd. They confirmed Malignancy of the tumor in my left breast. I started health therapist also and. I have also seen a genetic counselor. I will see an oncologist next week.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test, Sinus disorder
Clinical narrative: I had coughing and a severe head cold with congestion. The coughing was dry like it affected my sinuses.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Mass, X-ray
Clinical narrative: I noticed a week after my Vaccine I took a bath and I noticed it was a little lump in my left clavical, I went to the Dr. and they gave me an x-ray of the infected area.  The Dr. thought it was an infected lymphoid but it was not it was an cyst my nogel. After a few weeks it went away on it's on.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, COVID-19, Fatigue, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The symptoms lasted about 4 days. At first I was more tired more than usual, then blowing my nose a lot, then scratchy throat and loosing my voice. I got a antihistamine nasal and within the same day I started healing. Friday I was ok and Monday I went back to work. So total was a week.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: The symptoms lasted about 4 days. At first I was more tired more than usual, then blowing my nose a lot, then scratchy throat and loosing my voice. I got a antihistamine nasal and within the same day I started healing. Friday I was ok and Monday I went back to work. So total was a week.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Since the monovalent and the bivalent vial look alike. The monovalent was taken from the fridge and administered to the patient
Age: 42.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Laboratory test abnormal, Loss of personal independence in daily activities, Myocardial infarction
Clinical narrative: I am working and I was feeling well, and they took me to the hospital. When they ran test, and my transonic levels were up, and I was having a heart attack. I have to take several medications. I have notice some limitations to what I am use to doing.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was incorrectly administered Covid-19 monovalent vaccine. Patient should have received Covid-19 bivalent booster. Patient received initial series on: 4/8/21, 4/29/21 and initial booster on 12/28/2021.
Age: 20.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Nausea, Syncope
Clinical narrative: Patient stated he felt nauseous. A minute later fainted briefly. Approximately 10 seconds and revived.  Patient was seated at the time.  Emergency Medical services were called.  His vitals were checked and determined the patient could leave.  Patient did not want to go to hospital.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The pt had to get the new bivalent booster for pfizer. Since the pfizer monovalent and bivalent vaccine vials look the same, the monovalent vial was grabbed from the fridge instead of the bivalent vial.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient incorrectly received Covid-19 monovalent vaccine. Patient should have received Covid-19 bivalent booster. Patient had previously completed initial Covid-19 series on: 3/24/21, 4/14/21 and initial booster on 10/27/21.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The pfizer monovalent and bivalent vials look alike. The Monovalent vial was pulled from the fridge instead of the bivalent vial. The pt was here to get the bivalent vaccine
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired COVID-19 vaccine given to patient. COVID vaccine lot FL2757 expired 09/30/2022 (also thawed on 09/30/2022) and was given  on 10/4/2022.  no adverse events reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy hives covering most of body. This is second vaccine, no reaction with first.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cancer surgery, Cellulitis, Chills, Decreased appetite, Fatigue
Clinical narrative: Reporting adverse events after the 2nd dose noted above.  Developed cellulitis; deep cancer lesion (left leg), "extreme fatigue, no appetite, severe shaking, chills, nausea for 6 weeks +"; spike/advancing symptoms of osteoarthritis;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neoplasm malignant, Osteoarthritis, Tremor
Clinical narrative: Reporting adverse events after the 2nd dose noted above.  Developed cellulitis; deep cancer lesion (left leg), "extreme fatigue, no appetite, severe shaking, chills, nausea for 6 weeks +"; spike/advancing symptoms of osteoarthritis;
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: The monovalent and pfizer bialent vacines  look alike vials. The monovalent was administered instead of the bivalent. Patient doesn't report any adverse events. They were told to come in after 2 months to get the bivalent vaccine
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Approximately 48 hours after receiving Moderna bivalent booster from her workplace employee health provider, patient developed red itchy rash to bilateral upper legs, lower abdomen, lower back, posterior upper neck.   No shortness of breath, chest tightness, facial swelling, or signs of anaphylaxis.  Presents to Clinic 11/25/22  (8 days post vaccination) with persistent rash and itching.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye irritation, Eye pain, Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: Starting 2 days after receiving the vaccine, the patient noticed that her left eye felt "funny".  The next morning she had sharp pain in her left eye, swelling of the eye area and left cheek, and her left eye was very bloodshot.  As of today, she said her eye is almost back to normal and the pain has subsided.  She can just barely tell anymore that it was bloodshot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic, Fatigue, Gastrointestinal disorder, Headache, Pyrexia
Clinical narrative: On 11/23/2022 in the morning I had fever, fatigue, headache, gall bladder pain. I went to the GI doctor on 10/27/2022. She didn't prescribed me with any medication since I have glaucoma. I took TYLENOL for 5 days but it's not helping. All my symptoms resolved within 72 hours except for my GI problem.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: On 11/23/2022 in the morning I had fever, fatigue, headache, gall bladder pain. I went to the GI doctor on 10/27/2022. She didn't prescribed me with any medication since I have glaucoma. I took TYLENOL for 5 days but it's not helping. All my symptoms resolved within 72 hours except for my GI problem.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Started coughing and sneezing a lot. Took a home COVID-19 test and was positive. Called Dr. and a prescribed PAXLOVID. Took full prescription, wasn't clearing up. Was prescribed azithromycin 5 dose pack. Tested negative for COVID-19 a week later.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: Patient asked to lay down because she usually gets dizzy after receiving vaccines. Patient closed eyes and briefly became unresponsive to conversation, but awoke again with a sternal rub. Patient was monitored for 30 minutes and left at baseline.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered incorrect dose.  Pfizer COVID Bivalent for 12+ was administered, NOT the one for 5-11 year old children
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: PROVIDER WENT BACK IN WITH FAMILY TO INFORM INCIDENT, FAMILY WAS FINE NO SYMTOMS OR SIGNS, PATIENT WAITED 15 MINUTES AFTER.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Hospitalized for a stroke 23 days after this vaccine, (#2).  Also - I had a previous stroke 23 days after vaccine given on 5/9/2022,  (#1).  This stroke occurred on 6/1/2022  No brain or vascular problem before this.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient incorrectly received Covid-19 monovalent vaccine. Patient should have received Covid-19 bivalent vaccine. Patient completed initial series on: 3/32/21, 4/13/21, and initial booster on 12/9/21.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peripheral swelling, Scan lymph nodes, X-ray
Clinical narrative: Progressive swelling in left leg for 18 months.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received 2nd dose of Moderna at 21 days  No adverse side effects
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to plants, Dry skin, Eczema, Erythema, Photosensitivity reaction
Clinical narrative: 3/30/21 after 2nd vax, got rash torso/back, itchy.  several wks of itching went to Urgent Care.  prescribed oral prednisone 5 days.Cleared up. 6/2021 started getting bumps/itchy areas, dermatologist diagnosed as SUN ALLERGIES. Prescribed HYDROXYZINE 25mg. sort of helped. 10/2021 started getting dry areas.  Dermatologist diagnosed eczema-spot treat with prednisone ointment&Aveeno. sort of subsided.  then early 2022 got purpura arms/lower legs. Awful, constant red areas, sensitive skin.  more details when asked. Purpura has been the worse.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Purpura, Rash, Sensitive skin, Skin test positive
Clinical narrative: 3/30/21 after 2nd vax, got rash torso/back, itchy.  several wks of itching went to Urgent Care.  prescribed oral prednisone 5 days.Cleared up. 6/2021 started getting bumps/itchy areas, dermatologist diagnosed as SUN ALLERGIES. Prescribed HYDROXYZINE 25mg. sort of helped. 10/2021 started getting dry areas.  Dermatologist diagnosed eczema-spot treat with prednisone ointment&Aveeno. sort of subsided.  then early 2022 got purpura arms/lower legs. Awful, constant red areas, sensitive skin.  more details when asked. Purpura has been the worse.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Chest discomfort, Cough
Clinical narrative: One month after latest booster protecting from Omicron I had Covid (a different variant, possible BQ 1 or BQ1.11. After 5 days on an antiviral medication I no longer had symptoms: hacki.ng dry cough, sneezing, runny nose, tightness in chest.  Three days later the symptoms returned . treated in ER and was told I now have rebound Covid.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Symptom recurrence
Clinical narrative: One month after latest booster protecting from Omicron I had Covid (a different variant, possible BQ 1 or BQ1.11. After 5 days on an antiviral medication I no longer had symptoms: hacki.ng dry cough, sneezing, runny nose, tightness in chest.  Three days later the symptoms returned . treated in ER and was told I now have rebound Covid.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt recieved second pfizer bivalent dosage on 11/25/22. No adverse reactions noted, Pt has no questions or concerns.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose of Modena at 21 days instead of 4 weeks
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer Bivalent Booster was given to patient in error when patient was supposed to get the first dose in the primary series.  No adverse effects were reported.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: no adverse effects; pt was given pfizer monovalent instead of pfizer bivalent as the booster dose
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: had the 2 shot-series several years ago; shingles; vaccination failure; This spontaneous report was received from a patient of unknown age and gender reporting on theirself via manufacturer.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) administered as prophylaxis (formulation, dose, strength, lot #, expiry date, and route of administration were not provided). The patient received the dose, then was told it was not good enough, so the patient had the 2 shot-series several years ago (Extra dose administered).  On an unknown date in 2022 (reported as "over the weekend"), the patient developed shingles and "it was miserable" (vaccination failure). The outcome of the events of shingles and vaccination failure were not reported.  The event of vaccination failure was determined to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was not reported.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Epilepsy, Respiratory syncytial virus infection, Seizure
Clinical narrative: epilepsy; RSV; received PROQUAD on 11/18/2021 at 1 year old and then received a 2nd dose of PROQUAD on 3/9/2022.; This spontaneous report has been received from a consumer referring to a 1-year-old female patient. Information of concurrent condition, pertinent medical history and concomitant medication was not reported. No known drug allergies (NKDA).   On 18-NOV-2021, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection for prophylaxis. And then, on 09-MAR-2022, the patient received a 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection for prophylaxis (both strength, dose, frequency, lot#, expiration date, route of administration and anatomical location were unknown).  In April 2022 (conflicting information: also reported as 09-MAR-2022), the patient started having seizures and had been diagnosed with epilepsy. In 2022, the patient experienced Respiratory syncytial virus infection (RSV). The patient was hospitalized in October 2022 for seizures and RSV. The patient had sought medical attention. Electroencephalography (EEG) and magnetic resonance imaging (MRI) were ordered. The outcome of the events was reported as not recovered.   The causality assessment between the suspect product and events was not provided.  Upon internal review, the event epilepsy was determined to be medically significant.
Sex: U
Vaccine: SMALLMNK
Symptoms: CD4 lymphocytes increased, HIV test positive, Monkeypox, Orthopoxvirus test positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004662, is a spontaneous case report initially received from a physician via company (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient's medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes at 766 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On unspecified date, an unspecified amount of time after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox. As reported, dates of vaccinations and event onset were unclear.  At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via company on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) unknown amount of time after the first and the second dose of Jynneos were administered. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) unknown amount of time after the first and the second dose of Jynneos were administered. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.
Sex: U
Vaccine: SMALLMNK
Symptoms: HIV test negative, Monkeypox, Orthopoxvirus test positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004663, is a spontaneous case report initially received from a physician via company (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history was not provided.  The patient's concomitant medication was not provided.  On an unspecified date, the patient was negative to human immunodeficiency virus (HIV).  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and unknown anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On an unspecified date, reported as one month after the second Jynneos dose, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via company on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after second dose of Jynneos vaccine was administered. Monkeypox is unlisted per the CCDS v1 and the PI. Concomitant medications and medical history were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after second dose of Jynneos vaccine was administered. Monkeypox is unlisted per the CCDS v1 and the PI. Concomitant medications and medical history were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.
Sex: U
Vaccine: SMALLMNK
Symptoms: HIV test positive, Monkeypox, Orthopoxvirus test positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004665, is a spontaneous case report initially received from a physician via Agency (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history included human immunodeficiency virus (HIV).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On unspecified date, as reported one month after second Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via Agency on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after the second dose of Jynneos vaccine was administered to decrease the incidence of monkeypox. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after the second dose of Jynneos vaccine was administered to decrease the incidence of monkeypox. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.
Sex: U
Vaccine: SMALLMNK
Symptoms: CD4 lymphocytes increased, HIV test positive, Monkeypox, Orthopoxvirus test positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004669, is a spontaneous case report initially received from a healthcare professional via Agency (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes, at 915 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, reported as two weeks after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via Agency on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668 (same reporter).; Reporter's Comments: A patient of unknown demographics received two doses of Jynneos, applied on unknown dates for monkeypox prevention. Two weeks after vaccination, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the CCDS V1 and PI for Jynneos. Medical history included HIV, with CD4 lymphocytes level currently at 915. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, and that the event occurred two weeks after vaccination, the event is assessed as not related to Jynneos. As with any other vaccine, vaccination with Jynneos may not result in protection in all cases.; Sender's Comments: A patient of unknown demographics received two doses of Jynneos, applied on unknown dates for monkeypox prevention. Two weeks after vaccination, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the CCDS V1 and PI for Jynneos. Medical history included HIV, with CD4 lymphocytes level currently at 915. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, and that the event occurred two weeks after vaccination, the event is assessed as not related to Jynneos. As with any other vaccine, vaccination with Jynneos may not result in protection in all cases.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated. Is recovering from shingles/suspected vaccination failure; awful shingles on face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comment: This case was reported by a consumer on behalf of his/her mother via interactive digital media. The patient received a dose of Shingles vaccine and she was now recovering from shingles on her face. The reporter reported that it was awful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Polymyalgia rheumatica
Clinical narrative: Got 1st Shingrex then developed auto immune syndrome (PMR); This case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   The reporter considered the polymyalgia rheumatica to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comments: The case was reported via interactive digital media. The patient got his or her first Shingrix shot then developed an auto immune syndrome called PMR. The patient was on steroids for almost four years. Getting shingles would had been better and ended in months not years. The patient will probably have PMR flares for years to come, especially after receiving other vaccines. The patient said investigate your family health history before getting this vaccine. The patient said a text was received from a friend as she had shingles.  She then described how painful and uncomfortable her experience was.  The patient had read articles about shingles, learned about prevention and talked with his/her doctor.  After listening to his/her friend describe what she was going through, the patient took action. Learn more about the risk of shingles and take steps to prevent the painful, blistering skin rash. The reporter did not consent to follow. Additional supportive information: The onset date of event was given as 18th November 2022 however as per narrative it seems that the patient was taking steroids since 4 years for PMR. Hence onset date and end date was not captured for the event.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose almost one year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose almost one year ago with batch number K7T79).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The patient asked that he/she have to start the series over, since it was been more than six months or might he/she just count this next dose as the second. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain on shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   The reporter considered the muscle pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles shot. The patient experienced muscle pain on the 2nd day from the vaccination. The patient was asking can he/she rub alcohol on shoulder due to muscle pain. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2020, didnt get the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 12 December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment:  The consumer reported that the patient received the first dose. The patient did not receive the second dose. The patient was asking should he/she still get the second dose or start over. The patient was asking that could there be possible adverse reaction and what could that be because primary care physician could not tell any more than GlaxoSmithKline have. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Peripheral swelling
Clinical narrative: Swelling of right foot/Lymphedema
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose at 21 days rather the required 4 weeks
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: The patient was supposed to receive the Pfizer bivalent booster vaccination, but was accidently given the Pfizer bivalent age 5y to <12 y booster , 0.3mL undiluted. We have not yet been able to reach the patient. It is unknown whether the patient is having any adverse reactions to the shot. I did speak with a Pfizer representative and they said they did receive an appropriate dosage since it was undiluted, but that we should still report it due to it being the wrong vaccine form/strength.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dental discomfort, Discomfort, Gingival discomfort, Gingival pain, Pain in jaw
Clinical narrative: Pain And discomfort of gums, teeth and upper jaw. Intermittent. Started 1.5 days after injection. Pain continuing 16 hours after it started. No history of gum disease or TMJ
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Toothache
Clinical narrative: Pain And discomfort of gums, teeth and upper jaw. Intermittent. Started 1.5 days after injection. Pain continuing 16 hours after it started. No history of gum disease or TMJ
Age: 52.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Feeling abnormal, Feeling of body temperature change, Headache, Injection site erythema, Injection site pain
Clinical narrative: pain swelling of site and hot to touch.  Woke up with bad headache and my whole body hurt.  Felt like I was run over by a truck.  bouts of freezing then burning up all that lasted for 24 hours still sore and swollen and red and hot today but don't feel like I was hit by a truck.
Age: 52.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: pain swelling of site and hot to touch.  Woke up with bad headache and my whole body hurt.  Felt like I was run over by a truck.  bouts of freezing then burning up all that lasted for 24 hours still sore and swollen and red and hot today but don't feel like I was hit by a truck.