chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Impaired work ability, Joint range of motion decreased, Pain in extremity
Clinical narrative: He got his vaccine, he had arm pain within 2 hours, then redness in his arm and then he could not lift it.  The redness is still there.  He is able to move it now, but for 2 days he could not move it and missed 2 days of work.  He did took Tylenol for the pain.   He did call the doctor and they do not have any APT's for a week.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Patient came in yesterday for his first dose of monkeypox.  Post monkey pox adm. during observation period  patient stated to feel lightheadedness, diaphoretic, and with nauseous and throwing up.. V/S and BS taken, Water, cookies, and icepacks give,. Patient states he didn't eat that morning and usually gets anxious with certain things. One of our family medicine providers did see him and recommended to go to ER pt refused. Patient got put on Dr schedule to do a more detailed eval. Followed up with the patient this morning and he states he is doing much better and feels great.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: There was a temperature excursion, and the vaccine that was administered may not have been viable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chronic kidney disease, Dizziness, Kidney infection, Laboratory test
Clinical narrative: Starting in 12/2021, I was feeling dizzy, having muscle cramps and I was having a hard time keeping my balance. I went to the ER and they told me I had gone from stage 3 to stage 4 Kidney Disease. They gave me IV fluids and tried to flush them out. They gave me a run of antibiotics due to the kidneys showing infection.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Starting in 12/2021, I was feeling dizzy, having muscle cramps and I was having a hard time keeping my balance. I went to the ER and they told me I had gone from stage 3 to stage 4 Kidney Disease. They gave me IV fluids and tried to flush them out. They gave me a run of antibiotics due to the kidneys showing infection.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient was administered HIB vaccine instead of the ordered HPV vaccine from PCP.  Patient's family reported no side effects, no abnormal s/s following the administration
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity
Clinical narrative: pt states that arm was sore/painful the next day. Says his right arm 2 months later still hurts at injection site, especially if touched.  Has shooting pain / pain in arm from right trapezius down to right hand finger times along with numbness.  States has not seen doctor yet. Took his primary Dr's info.  Contacted Dr office and employee is coordinating office getting him in to be checked out and aware of the adverse event from the booster shot.  Patient denied have any other sort of accident to neck/back/arm that could account for the pain and numbness.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: There was a temperature excursion, and the vaccine that was administered may not have been viable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient admitted to local hospital for diagnosis other than +COVID. + Covid on 8/23/2022. Discharged on 08/28/2022.
Age: 12.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered the incorrect vaccine. Parents reported no adverse reactions and no abnormal s/s
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: There was a temperature excursion, and the vaccine that was administered may not have been viable.
Age: 13.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient was given the incorrect vaccine ordered by the PCP  Patient's parents reported no side effects and no abnormal s/s
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given Moderna vaccine 6 month to 5 years instead of Pfizer 5  11 years.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine mixed with too much diluent.
Age: 25.0
Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: There was a temperature excursion, and the vaccine that was administered may not have been viable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure decreased, Blood test, Dialysis, Dizziness
Clinical narrative: Starting 07/05/2022, I started getting dizzy and I felt like I was about to pass out. I would get extremely light headed if I tried to get up and lift anything. Also, I was feeling nauseous and upset to my stomach. I went to the hospital on 08/10/2022 because my doctor told me my kidney function was severely deteriorating. In the hospital, the doctors said my Kidney Disease had progressed to stage 5 and I was hospitalized and still am to this day. I am currently on Dialysis and likely will be for the rest of my life. There is a small chance I could recover but it is unlikely. Also, my blood pressure has plummeted when I used to have high blood pressure. Its especially worse when I get up to walk around. They are having to give me medicine to raise my blood pressure.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: End stage renal disease, General physical health deterioration, Laboratory test, Nausea, Renal impairment
Clinical narrative: Starting 07/05/2022, I started getting dizzy and I felt like I was about to pass out. I would get extremely light headed if I tried to get up and lift anything. Also, I was feeling nauseous and upset to my stomach. I went to the hospital on 08/10/2022 because my doctor told me my kidney function was severely deteriorating. In the hospital, the doctors said my Kidney Disease had progressed to stage 5 and I was hospitalized and still am to this day. I am currently on Dialysis and likely will be for the rest of my life. There is a small chance I could recover but it is unlikely. Also, my blood pressure has plummeted when I used to have high blood pressure. Its especially worse when I get up to walk around. They are having to give me medicine to raise my blood pressure.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: date of death 07-05-2022,  tested + 6-18-22
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash macular
Clinical narrative: Generalized macular rash 9 days following vaccination.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient came for second dose of Pfizer vaccine. Moderna 6 mo-5 yr 0.25 ml was administered instead of Pfizer 5 yr- 11 yr 0.2 ml. First Pfizer orange cap 5yr- 11yr dose  was administered 8/3/22.  Patient's mom is aware and is waiting on response from CDC and from response of pediatrician of possible symptoms.  We are contacting CDC and will have pediatrician call mom back.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron decreased, Blood test abnormal, Haematemesis, Haemoglobin decreased, Nausea
Clinical narrative: Felt nauseous around 8 pm; woke up at 9:15 pm vomiting food; a few minutes later began projectile vomiting large amounts of blood and blood clots. Arrived at ER at 10:30 pm. Continued vomiting water he drank until he was given zofran at 5:00 am. Was prescribed pepcid and zofran. 8/22/22 blood labs showed low hemoglobin; 8/25/22 labs showed extremely low iron levels. Received blood transfusion on 8/26/22.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Transfusion, Vomiting projectile
Clinical narrative: Felt nauseous around 8 pm; woke up at 9:15 pm vomiting food; a few minutes later began projectile vomiting large amounts of blood and blood clots. Arrived at ER at 10:30 pm. Continued vomiting water he drank until he was given zofran at 5:00 am. Was prescribed pepcid and zofran. 8/22/22 blood labs showed low hemoglobin; 8/25/22 labs showed extremely low iron levels. Received blood transfusion on 8/26/22.
Age: 69.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, some darker red in the middle, mild itching,  induration. PCP describes as possible necrosis
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus, Vertigo
Clinical narrative: Persistant severe vertigo, tinnitus, brain fog.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Amnesia, Dizziness, Erythema, Eye movement disorder, Loss of consciousness
Clinical narrative: patient received 1st dose of Menquadfi  ( received menactra on 12/28/16).  After vaccination, patient stated: he felt dizzy and started to turn pale. Subsequently, turned bright red, limbs became stiff started to slide off seat, leaning over, shaking and eyes rolled back.   patient resumed consciousness after 25 seconds. No memory of incident. Patent remembered getting vaccine and stating dizziness and stated he closed his eyes and heard the alarm to wake up to find nursing staff and provider surrounding him .   patient was transported to local ED with parent after provider  assessment.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Pallor, Tremor
Clinical narrative: patient received 1st dose of Menquadfi  ( received menactra on 12/28/16).  After vaccination, patient stated: he felt dizzy and started to turn pale. Subsequently, turned bright red, limbs became stiff started to slide off seat, leaning over, shaking and eyes rolled back.   patient resumed consciousness after 25 seconds. No memory of incident. Patent remembered getting vaccine and stating dizziness and stated he closed his eyes and heard the alarm to wake up to find nursing staff and provider surrounding him .   patient was transported to local ED with parent after provider  assessment.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Tinnitus
Clinical narrative: Onset of tinnitus, sought diagnoses from primary care physician, referred to an ENT office, administered several tests and checks, no other hearing related issues besides the perception of ringing in the years, no actual loss in hearing
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Amyloidosis senile, Asthenia, Blood potassium decreased, Blood uric acid increased
Clinical narrative: PFIZER COVID VACCINE #3 GIVE 1/6/22, LOT #330258D; 12/23/21 pt admitted to hospital with increasing generalized weakness, mild cough, and falls at home throughout the week; 12/25/22 pt c/o epigastric pain; TTR amyloidosis, was to receive treatment once discharged; Echocardiogram revealed left ventricular ejection fraction of 40% with grade II diastolic dysfunction; pt experienced increase in confusion and hallucinations; potassium levels had dropped; uric acid levels were high; medications given; 1/20/22 pt requiring more O2 supplementation; found to be positive for COVID; Infectious Disease consulted; pt had a cardiac arrest the next day and passed away in the hospital
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Condition aggravated, Confusional state, Cough
Clinical narrative: PFIZER COVID VACCINE #3 GIVE 1/6/22, LOT #330258D; 12/23/21 pt admitted to hospital with increasing generalized weakness, mild cough, and falls at home throughout the week; 12/25/22 pt c/o epigastric pain; TTR amyloidosis, was to receive treatment once discharged; Echocardiogram revealed left ventricular ejection fraction of 40% with grade II diastolic dysfunction; pt experienced increase in confusion and hallucinations; potassium levels had dropped; uric acid levels were high; medications given; 1/20/22 pt requiring more O2 supplementation; found to be positive for COVID; Infectious Disease consulted; pt had a cardiac arrest the next day and passed away in the hospital
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diastolic dysfunction, Echocardiogram abnormal, Ejection fraction, Fall
Clinical narrative: PFIZER COVID VACCINE #3 GIVE 1/6/22, LOT #330258D; 12/23/21 pt admitted to hospital with increasing generalized weakness, mild cough, and falls at home throughout the week; 12/25/22 pt c/o epigastric pain; TTR amyloidosis, was to receive treatment once discharged; Echocardiogram revealed left ventricular ejection fraction of 40% with grade II diastolic dysfunction; pt experienced increase in confusion and hallucinations; potassium levels had dropped; uric acid levels were high; medications given; 1/20/22 pt requiring more O2 supplementation; found to be positive for COVID; Infectious Disease consulted; pt had a cardiac arrest the next day and passed away in the hospital
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, SARS-CoV-2 test positive
Clinical narrative: PFIZER COVID VACCINE #3 GIVE 1/6/22, LOT #330258D; 12/23/21 pt admitted to hospital with increasing generalized weakness, mild cough, and falls at home throughout the week; 12/25/22 pt c/o epigastric pain; TTR amyloidosis, was to receive treatment once discharged; Echocardiogram revealed left ventricular ejection fraction of 40% with grade II diastolic dysfunction; pt experienced increase in confusion and hallucinations; potassium levels had dropped; uric acid levels were high; medications given; 1/20/22 pt requiring more O2 supplementation; found to be positive for COVID; Infectious Disease consulted; pt had a cardiac arrest the next day and passed away in the hospital
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: An incorrect dose of Pfizer COVID-19 vaccine was administered to this patient. A pediatric 5-11yr vial was used in error. MA was intending to draw up infant vaccine doses. Ped (5-11yr) vial was reconstituted with 2.2mL of diluent. (The amount used to reconstitute infant vials). This resulted in 10 syringes being drawn up of an incorrect dose of 6.9mcg/0.2mL dose. The syringes were then labeled with light blue infant labels and placed back into the refrigerator in the location of the (PEDS) (5-11yr) vials, where the vial was pulled from. The lot information for the vial used (Ped 5-11yr) was recorded on those stickers. An incorrect dose was then administered to this patient. No known issues. Dr. spoke with patients mother. Patient is doing well.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix vaccine given had expiration date of 8/26/2022.
Age: 59.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Muscle spasms
Clinical narrative: He got his vaccine, He could feel a muscle jumping in the back left side of his neck.  This has continued since the vaccine.  It has not gotten any better or any worse, but it is constant and just stays the same.  He has never had this type of reaction in the past.  He did not speak with his doctor.  He started to read his paperwork and decided to call and report it, but will call his doctor.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Laboratory test, Optic nerve infarction, Ultrasound Doppler, Vision blurred
Clinical narrative: I had an optic nerve stroke in my left eye on 9/1/2021. My vision is "blurry" in my left eye and it is unrepairable.  I went initially to an Opthomologist (9/2/21) and he immediately sent me to a Neuro-Opthomologist (9/3/21) the following morning where she diagnosed me with the Optic Nerve Stroke.  I advised her that I had received my initial dose of the Covid vaccine 3 days earlier.  She told me to have multiple tests done to make sure that my heart was healthy and to rule that out as a cause.  I had a sonogram of my carotid artery, full blood panel completed and other tests performed over the next 7-10 days.  The results of the tests were outstanding.  I had no issues with my heart, blood pressure, blockage of arteries etc.  Needless to say, I never received my 2nd dose of the vaccine and really wish I had never took the first dose.  My life has forever been changed (and not for the good!)
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PT RECEIEVED SECOND DOSE OF VACCINE 3 DAYS TOO EARLY. 1ST DOSE GIVEN WAS ON 8/9/22. PT DID NOT HAVE ANY ADVERSE REACTIONS BUT DID RECEIVE THE VACCINE TOO EARLY.
Age: 8.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose given to child.  No immediate adverse effect.  Arm without swelling or tenderness. No noted systemic effect after 30 minutes.  Parent given specific instructions on reporting and treatment of any local and systemic effects including contact numbers of health department
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, No adverse event
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 07/17/2022 from a home test. I have asthma and I am prone to bronchitis. I had extreme fatigue, chills, achy all over and a bad cough. I contacted my doctor and was prescribed Paxlovid but had to stop after four days due to diarrhea.  After I stopped taking Paxlovid I had a rebound case of COVID-19. Same symptoms as listed above.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 07/17/2022 from a home test. I have asthma and I am prone to bronchitis. I had extreme fatigue, chills, achy all over and a bad cough. I contacted my doctor and was prescribed Paxlovid but had to stop after four days due to diarrhea.  After I stopped taking Paxlovid I had a rebound case of COVID-19. Same symptoms as listed above.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Needle issue, Syringe issue
Clinical narrative: Patient was to receive Jynneos MPX vaccine intradermally. Vaccinator used proper technique, however the needle was too superficial, so when she injected the vaccine content, the content leaked out of the injection site.  Following evaluation, pt was revaccinated via subcutaneous administration.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Death
Clinical narrative: date of death 5-14-22   Presented to ER with CP 3/22
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chronic fatigue syndrome, Condition aggravated, Dyspepsia, Headache
Clinical narrative: On 8/25/21 I experienced soreness on arm of the injection site as well as chills and digestive problems.  This lasted for about 3 weeks along with headaches, body aches, muscle spasms, Renaults flare-ups.  I experienced extreme digestive issues where I was constantly using the bathroom until Jan 2022.  I contacted my PcP but they told me there was nothing they could do but to wait out the symptoms.  My chronic fatigue started in Jan 2022 as well.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle spasms, Raynaud's phenomenon
Clinical narrative: On 8/25/21 I experienced soreness on arm of the injection site as well as chills and digestive problems.  This lasted for about 3 weeks along with headaches, body aches, muscle spasms, Renaults flare-ups.  I experienced extreme digestive issues where I was constantly using the bathroom until Jan 2022.  I contacted my PcP but they told me there was nothing they could do but to wait out the symptoms.  My chronic fatigue started in Jan 2022 as well.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: An incorrect dose of Pfizer COVID-19 vaccine was administered to this patient, and three others. (A total of 4 patients were affected by this vial/reconstitution error.)  A pediatric 5-11yr vial was used in error.  MA was intending to draw up infant vaccine doses. Ped (5-11yr) vial was reconstituted with 2.2mL of diluent. (The amount used to reconstitute infant vials)  This resulted in 10 syringes being drawn up of an incorrect dose of 6.9mcg/0.2mL dose.  The syringes were then labeled with light blue infant labels and placed back into the refrigerator in the location of the peds (5-11yr) vials, where the vial was pulled from.  The lot information for the vial used (Ped 5-11yr) was recorded on those stickers. A in incorrect dose was then administered to this patient.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 8/29/2022.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given out of recommended age range. No known adverse outcome with patient.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy tonsil, COVID-19, Death, Dysphagia, Failure to thrive
Clinical narrative: 9/9/21 pt brought to ED and admitted with severe FTT over the past 9 months; noncompliant with doctor's follow ups; refused to see a dr in the past; admitted; found to be positive for COVID; severe dysphagia; 50 pound weight loss in 2 months; pt not requiring O2 supplement; found to have right peritonsillar mass; bx done; squamous cell carcinoma posterior pharyngeal wall and hypopharynx; not a candidate for surgery; PEG tube placed; dc'd from hospital to facility; records show pt passed away at home on 11/21/21
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrostomy, Keratinising squamous cell carcinoma of nasopharynx, Mass, Oropharyngeal squamous cell carcinoma, SARS-CoV-2 test positive
Clinical narrative: 9/9/21 pt brought to ED and admitted with severe FTT over the past 9 months; noncompliant with doctor's follow ups; refused to see a dr in the past; admitted; found to be positive for COVID; severe dysphagia; 50 pound weight loss in 2 months; pt not requiring O2 supplement; found to have right peritonsillar mass; bx done; squamous cell carcinoma posterior pharyngeal wall and hypopharynx; not a candidate for surgery; PEG tube placed; dc'd from hospital to facility; records show pt passed away at home on 11/21/21
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: 9/9/21 pt brought to ED and admitted with severe FTT over the past 9 months; noncompliant with doctor's follow ups; refused to see a dr in the past; admitted; found to be positive for COVID; severe dysphagia; 50 pound weight loss in 2 months; pt not requiring O2 supplement; found to have right peritonsillar mass; bx done; squamous cell carcinoma posterior pharyngeal wall and hypopharynx; not a candidate for surgery; PEG tube placed; dc'd from hospital to facility; records show pt passed away at home on 11/21/21
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: No energy after the vaccine, tired and stayed in bed for several days; headaches. Extreme fatigue, no appetite, I got COVID-19 test on June 27th and it was a negative but on the 29th I took another test and it was positive. Both were home tests. I felt bad for 3 days and on July 1st I felt better. On the 30th of June I went to the ER to get the medicine and I felt better.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive
Clinical narrative: No energy after the vaccine, tired and stayed in bed for several days; headaches. Extreme fatigue, no appetite, I got COVID-19 test on June 27th and it was a negative but on the 29th I took another test and it was positive. Both were home tests. I felt bad for 3 days and on July 1st I felt better. On the 30th of June I went to the ER to get the medicine and I felt better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Lymphadenopathy, Rash erythematous
Clinical narrative: red rash at injection site and swelling of the lymph node, no arm soreness - her PCP prescribed medrol dose pack for the symptoms and recommended she use claritin 12 hour tablets
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, COVID-19, Chest pain, Headache
Clinical narrative: Breakthrough. Started getting a sore throat,  headache and nasal congestion. I took a  Home  COVID-19 test and it was positive.  Went to Urgent Care because I was having chest pains.  They gave me a Rapid COVID-19 test and it was Negative at Urgent care. Send out a PCR test and it came back positive the next day. She noticed me wheezing and prescribed Albuterol Inhaler. Come back if I felt like I was getting worse. A few days after that I started having severe burning knee pain. I went to Orthopedics Dr and they thought it may have been due to COVID vaccine. Injected Depo-medrol into knee and it helped.  Feeling better now.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive, Vaccine breakthrough infection, Wheezing
Clinical narrative: Breakthrough. Started getting a sore throat,  headache and nasal congestion. I took a  Home  COVID-19 test and it was positive.  Went to Urgent Care because I was having chest pains.  They gave me a Rapid COVID-19 test and it was Negative at Urgent care. Send out a PCR test and it came back positive the next day. She noticed me wheezing and prescribed Albuterol Inhaler. Come back if I felt like I was getting worse. A few days after that I started having severe burning knee pain. I went to Orthopedics Dr and they thought it may have been due to COVID vaccine. Injected Depo-medrol into knee and it helped.  Feeling better now.
Age: 10.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: An incorrect dose of Pfizer COVID-19 vaccine was administered to this patient, and three others. (A total of 4 patients were affected by this vial/reconstitution error.)  A pediatric 5-11yr vial was used in error.  MA was intending to draw up infant vaccine doses. Ped (5-11yr) vial was reconstituted with 2.2mL of diluent. (The amount used to reconstitute infant vials)  This resulted in 10 syringes being drawn up of an incorrect dose of 6.9mcg/0.2mL dose.  The syringes were then labeled with light blue infant labels and placed back into the refrigerator in the location of the peds (5-11yr) vials, where the vial was pulled from.  The lot information for the vial used (Ped 5-11yr) was recorded on those stickers. A in incorrect dose was then administered to this patient.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: There was no adverse event and patient is well. Baby was listed for Pfizer infant/toddler injection on schedule. When mom & dad entered the room with baby, I asked mom if this was for baby Pfizer shot, in which she replied "yes".   Upon chart review, after baby had received Pfizer, it was noticed that the first vaccine give to baby was Moderna.
Age: 10.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Incorrect product formulation administered
Clinical narrative: An incorrect dose of Pfizer COVID-19 vaccine was administered to this patient, and three others. (A total of 4 patients were affected by this vial/reconstitution error.)  A pediatric 5-11yr vial was used in error.  MA was intending to draw up infant vaccine doses. Ped (5-11yr) vial was reconstituted with 2.2mL of diluent. (The amount used to reconstitute infant vials)  This resulted in 10 syringes being drawn up of an incorrect dose of 6.9mcg/0.2mL dose.  The syringes were then labeled with light blue infant labels and placed back into the refrigerator in the location of the peds (5-11yr) vials, where the vial was pulled from.  The lot information for the vial used (Ped 5-11yr) was recorded on those stickers. A in incorrect dose was then administered to this patient.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: deceased on 5-6-22,  tested + covid 2-22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Dyspnoea, Hypophagia, Refusal of treatment by patient
Clinical narrative: 1/17/22 pt admitted to Hospital; found to be positive for COVID; pt having SOB; refused dialysis; does want to be treated for dyspnea; on continuous O2 supplementation; poor oral intake; requested hospice care; 1/18/22 admitted to Hospice with ESRD; pt passed away at the facility.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 1/17/22 pt admitted to Hospital; found to be positive for COVID; pt having SOB; refused dialysis; does want to be treated for dyspnea; on continuous O2 supplementation; poor oral intake; requested hospice care; 1/18/22 admitted to Hospice with ESRD; pt passed away at the facility.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Aura, Vision blurred
Clinical narrative: On 05/04/2022 I had my second vaccination. On 08/01/2022 I started to experience a visual aura. It was in both eyes. It was like a clear watery single wavy horizontal line and there seemed to be a brightness between the blur. It started being subtle to very strong where it was very blurry. This lasted for about an hour and then went away.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus got much worse
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical assistant reported PROQUAD was administered after a temperature excursion to multiple patients. This case is for patient one of four. No further information provided. Cross reference cases: 02219832, 02219848 and 02219874. No additional AE re; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On unknown date, vaccines measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin [rHA]) underwent temperature excursion at 5.56 degrees Fahrenheit for 9 hours and 30 minutes. There was no previous temperature excursion.  On 03-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, once, lot #W010061, expiration date: 20-SEP-2023 (strength, dose, and route of administration were not provided), administered for prophylaxis (product storage error). There was no additional adverse event reported.  This is one of four reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got so sick from it; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that patient got his/her second shingles vaccination on Sunday.  The patient was so sick from it. But it was better than having the shingles they were the worst. The follow-up could not be possible as no contact details were available.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 17 yo received an adult dose of the Havrix; 17 yo received an adult dose of the Havrix; expired on 6/14/2022; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HAV (Havrix adult) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th August 2022, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 19th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the overdose, adult product administered to child and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Aug-2022 Reporter's comments: The healthcare professional reported that the patient received an adult dose of the Havrix and it was also expired on 14th June 2022.  This was the 2nd dose in the series.  There were no reactions reported.  The vaccine administration facility was the same as primary reporter.  The reporter consent to follow-up via email. Additional Supportive Information: The 17 years old patient received expired adult dose of Havrix, which led to overdose, adult product administered to child and expired vaccine used.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: LITTLE TEMPERATURE; ARM SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 195 pounds, and height was 67 inches.  The patient's past medical history included: cold, covid-19 (Got covid toes. Patient was seen by the doctor, and she tested negative, and titer was negative but back then the titers weren't very good. Her purple toes, and did lots of cardiovascular studies and there was nothing wrong.), joint replacements, and flu (after getting the flu shot still got flu), and concurrent conditions included: paroxysmal atrial tachycardia (rapid heart rate), neuropathy, arthritic pain (joint pain), and drug allergy (get rapid heart rate from Robaxin a muscle relaxant, significant GI irritation from cipro, rapid heart rate and palpitations from allopurinol), and other pre-existing medical conditions included: The patient was nurse by profession. The patient was not pregnant at the time of reporting. Patient was healthy. Patient's sister had residual polio in one of her legs. The patient was not diagnosed with any autoimmune disorders or immunosuppressive disorders. The patient was previously treated with tetanus vaccine for prophylactic vaccination, and influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 66 years old. Concomitant medications included meloxicam for anti-inflammatory, gabapentin for neuropathy, metoprolol succinate for rapid heart rate, and famotidine.  On 11-MAY-2021, the patient experienced arm soreness. On 12-MAY-2021, the patient experienced little temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness and little temperature was not reported. This report was non-serious. This case, involving the same patient is linked to 20220832455.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medications were reported. No treatment details were reported. Number of doses from vials were 2 second booster doses. The vial was initially stored in the refrigerator and moved from freezer to room temperature to thawed on 23-Aug-2022. The vial did not undergo any temperature excursions.   This case was linked to US-MODERNATX, INC.-MOD-2022-635821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635821:1 of 2 Patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Psoriasis patches everywhere on chest belly; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis patches everywhere on chest belly) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis patches everywhere on chest belly). At the time of the report, PSORIASIS (Psoriasis patches everywhere on chest belly) had not resolved.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  The reporter's causality for the event Psoriasis patches everywhere on chest belly / not improving skin on Skyrizi unknown onset with SKYRIZI (RISANKIZUMAB) was no reasonable possibility.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 4 years old and received a vaccine for ages 5-11 year old. Patient waited in room with nurse for 10 minutes and no adverse reactions noted at this time.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Aura, Vision blurred
Clinical narrative: I had the vaccination 07/18/2022. On 08/02/2022 I started to experience a visual aura again. It was similar to blurry horizontal line that increased in blurriness and waviness for about an hour. After that hour, it disappeared. I did a telephone consult and Dr. stated to monitor.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient has received an extra dose of COVID-19 Vaccine. Patient has completed vaccine series previous to this dose.  First dose: Moderna 02/03/21, Second dose: Moderna 03/03/21, Booster dose: Moderna 12/03/21. Extra dose administered Pfizer 03/22/22.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Lymphadenopathy, Pruritus
Clinical narrative: Itch pain and swollen lymph node under armpit
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Chest pain, Computerised tomogram, Echocardiogram normal, Endoscopy upper gastrointestinal tract normal
Clinical narrative: Inflammation in the entire upper body.  We have been to ER twice.  Ruled out pulmonary embolism, had echo gram (no heart problem), had upper GI endoscopy (negative), went to Rheumatologist? and sent to physical therapy and at inflammatories.  Nothing is helping. Getting worse.  PT says he can?t do much because inflammation is so bad and entire body is so painful to touch.  Referred to pain management, but no openings until December.  Getting worse everyday.  Ices down all day.  Can?t sing in choir anymore, can?t swim in swim team, having trouble attending school.  Always exhausted.  We need help!!!!
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Inflammatory marker test, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Inflammation in the entire upper body.  We have been to ER twice.  Ruled out pulmonary embolism, had echo gram (no heart problem), had upper GI endoscopy (negative), went to Rheumatologist? and sent to physical therapy and at inflammatories.  Nothing is helping. Getting worse.  PT says he can?t do much because inflammation is so bad and entire body is so painful to touch.  Referred to pain management, but no openings until December.  Getting worse everyday.  Ices down all day.  Can?t sing in choir anymore, can?t swim in swim team, having trouble attending school.  Always exhausted.  We need help!!!!
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Scan with contrast
Clinical narrative: Inflammation in the entire upper body.  We have been to ER twice.  Ruled out pulmonary embolism, had echo gram (no heart problem), had upper GI endoscopy (negative), went to Rheumatologist? and sent to physical therapy and at inflammatories.  Nothing is helping. Getting worse.  PT says he can?t do much because inflammation is so bad and entire body is so painful to touch.  Referred to pain management, but no openings until December.  Getting worse everyday.  Ices down all day.  Can?t sing in choir anymore, can?t swim in swim team, having trouble attending school.  Always exhausted.  We need help!!!!
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Palpitations
Clinical narrative: Patient called the day after the vaccine and said she had palpitations.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain/weakness in left arm from below elbow to wrist when using arm, no shoulder issues
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rash, Swelling face
Clinical narrative: Severe swelling and skin rash on the face with watery eyes. Treated with cool compress. Hives: Zyrtec and Benadryl. After 4 days signs began to go away. Completely gone after 7 days.
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: No wheal obtained with first injection
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient recieved Moderna primary series #1 on 03/29/2021, Moderna primary series #2 on 04/26/2021. This dose was not present in the system at the time the 3rd dose of J&J was administered. It was entered historical 05/31/2022. The J&J vaccination was unapproved, yet administered 06/30/2021 (2 months after Moderna primary series #2). Patient then received 4th vaccination of Pfizer on 05/31/2022.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall
Clinical narrative: she had covid 8/2021.    Had fall 1/2022
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypotension, Pain
Clinical narrative: Patient states since December 2021 after receiving Pfizer Covid vaccine he has intermittent episodes every other month that last for several days of the following symptoms: pain in the middle of his forehead, hypotension, fatigue, burning skin, chills, body aches and fever.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation
Clinical narrative: Patient states since December 2021 after receiving Pfizer Covid vaccine he has intermittent episodes every other month that last for several days of the following symptoms: pain in the middle of his forehead, hypotension, fatigue, burning skin, chills, body aches and fever.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product administration error, Underdose, Wrong product administered
Clinical narrative: Reporting an error, not an adverse event.  Pediatric patient's guardian requested Moderna COVID vaccine for 5 year old child, but patient was erroneously given Pfizer COVID Vaccine indicated for 6 month to 4 year olds. The Pfizer vaccine information (which was actually administered to the patient) was recorded on the patient's COVID Vaccine card and the guardian noticed the discrepancy during the post-immunization observation period and brought it to the attention of the vaccine clinic staff. Contributing factors identified is multiple various vaccine preparations with various age ranges and doses, as well as busy clinic with distractions.  Of note, in addition to the brand discrepancy, the Pfizer vaccine given is of a lower dosage than is indicated for a 5 year old child. The Pfizer 6 month-4 year vaccine that was administered contains 3 mcg/0.2 mL, whereas the Pfizer vaccine indicated for children 5 to 11 years contains 10 mcg/0.2 mL. Being reviewed by local expert to determine if a make-up vaccine dose is indicated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I tested positive for COVID-19. I had a sore throat; sneezing; and slight fever of 100.5. I called my doctor he prescribed me PAXLOVID. My symptoms lasted for 5 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received an extra dose of Shingrix inadvertently.  Patient had no adverse event
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, COVID-19, Condition aggravated, Death, Facial bones fracture
Clinical narrative: deceased on 02/20/2022:  had covid 12/2021  and was admitted after a fall 2/13/22 with closed fx of nasal bone, sepsis, jaundice, anemia in setting  of myeloproliferative disorder.  placed on  comfort measures and  discharged 2-16-22  to hospice
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Jaundice, Myeloproliferative neoplasm, Sepsis
Clinical narrative: deceased on 02/20/2022:  had covid 12/2021  and was admitted after a fall 2/13/22 with closed fx of nasal bone, sepsis, jaundice, anemia in setting  of myeloproliferative disorder.  placed on  comfort measures and  discharged 2-16-22  to hospice
Age: 30.0
Sex: U
Vaccine: SMALLMNK
Symptoms: Blood pressure decreased, Heart rate decreased, Syncope
Clinical narrative: Right after vaccination Patient fainted for 2 seconds by sitting on the chair.  Cold packs and water  provided, legs elevated. Vital signs obtained. Patient states that she is athletic and her Vital sings are lot at base line.  In the begining  her pulse and blood pressure were low but improved in 10 minutes.