chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye discharge, Eye swelling, Feeling abnormal, Foreign travel, Gait inability
Clinical narrative: The evening 02/25/2023, I was having lethargy, my throat hurt and I was coughing. I took a COVID-19 Home Test, and the result was positive immediately.  I went to the clinic, and they tested me again and the result was positive. I quarantined from 02/25/2023 - 03/02/2023, the day we finished the trip. The night of 02/28/2023, my eyes were like tearing, I got Kleenex to wipe my right eye and there was a pale green of gunk on it and on the other eye there were yellow gunk coming out of my eyes. It was thick gunk. All of a sudden my eyes started draining and at the same time the lower part of my face, underneath my nose, my lips was swollen and it swelled up like a balloon right in front of my eyes. I went to the clinic and the doctor prescribed me an antibiotics  and 2 IV's. IV Cetirizine and IV Loratadine. The doctor told me it was a reaction to COVID-19. The next day my eyes were no longer swollen and there wasn't more green and yellow gunk coming out.  I recovered. I see well now. My eyes don't bother me. When I returned back to from the trip, I was so weak and could not walk.  My doctor, on 03/09/2023, diagnosed me with bronchitis and sinusitis and she prescribed antibiotics, and an inhaler, Albuterol. I lost 10 pounds and was wiped out for the whole month of March 2023 and mostly slept, I had a cough. I laid low most of April and returned to work for the first time on 04/24/2023.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersomnia, Impaired work ability, Lacrimation increased, Lethargy, Lip swelling
Clinical narrative: The evening 02/25/2023, I was having lethargy, my throat hurt and I was coughing. I took a COVID-19 Home Test, and the result was positive immediately.  I went to the clinic, and they tested me again and the result was positive. I quarantined from 02/25/2023 - 03/02/2023, the day we finished the trip. The night of 02/28/2023, my eyes were like tearing, I got Kleenex to wipe my right eye and there was a pale green of gunk on it and on the other eye there were yellow gunk coming out of my eyes. It was thick gunk. All of a sudden my eyes started draining and at the same time the lower part of my face, underneath my nose, my lips was swollen and it swelled up like a balloon right in front of my eyes. I went to the clinic and the doctor prescribed me an antibiotics  and 2 IV's. IV Cetirizine and IV Loratadine. The doctor told me it was a reaction to COVID-19. The next day my eyes were no longer swollen and there wasn't more green and yellow gunk coming out.  I recovered. I see well now. My eyes don't bother me. When I returned back to from the trip, I was so weak and could not walk.  My doctor, on 03/09/2023, diagnosed me with bronchitis and sinusitis and she prescribed antibiotics, and an inhaler, Albuterol. I lost 10 pounds and was wiped out for the whole month of March 2023 and mostly slept, I had a cough. I laid low most of April and returned to work for the first time on 04/24/2023.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive, Sinusitis, Swelling face, Weight decreased
Clinical narrative: The evening 02/25/2023, I was having lethargy, my throat hurt and I was coughing. I took a COVID-19 Home Test, and the result was positive immediately.  I went to the clinic, and they tested me again and the result was positive. I quarantined from 02/25/2023 - 03/02/2023, the day we finished the trip. The night of 02/28/2023, my eyes were like tearing, I got Kleenex to wipe my right eye and there was a pale green of gunk on it and on the other eye there were yellow gunk coming out of my eyes. It was thick gunk. All of a sudden my eyes started draining and at the same time the lower part of my face, underneath my nose, my lips was swollen and it swelled up like a balloon right in front of my eyes. I went to the clinic and the doctor prescribed me an antibiotics  and 2 IV's. IV Cetirizine and IV Loratadine. The doctor told me it was a reaction to COVID-19. The next day my eyes were no longer swollen and there wasn't more green and yellow gunk coming out.  I recovered. I see well now. My eyes don't bother me. When I returned back to from the trip, I was so weak and could not walk.  My doctor, on 03/09/2023, diagnosed me with bronchitis and sinusitis and she prescribed antibiotics, and an inhaler, Albuterol. I lost 10 pounds and was wiped out for the whole month of March 2023 and mostly slept, I had a cough. I laid low most of April and returned to work for the first time on 04/24/2023.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe Tinnitus left ear
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: patient complains of blurred vision since the day of/after receiving vaccine, recommended seeking medical attention/primary care provider
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Electrocardiogram normal, Laboratory test normal, Vertigo, Vomiting projectile
Clinical narrative: I had Vertigo pretty bad. The ground was moving like I was on a ship in the ocean. I started projectile vomiting and was taken to the Emergency Room. I was in there for four hours before I was seen, and it was almost over. They ran a couple tests, and they were normal, and I was released. They prescribed a couple medications in case I started having Vertigo again, Meclizine and Ondansetron. I have not had to use them though.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired dose. No adverse effects at this time. Vial left on counter from previous day labeled with expiration 4-24. LPN did not check sticker's expiration date and did not ask for verification of vaccination. Error was found in afternoon. LPN was re-educated on correct procedure. LPN will be notifying patient of error.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Autonomic nervous system imbalance, Bedridden, Chronic fatigue syndrome, Echocardiogram
Clinical narrative: long term POTS, CFS, PEM, dysautonomia, MCAS, vagas nerve disfunction, nausea.  All started within a couple weeks of the vaccine and symptoms increased in severity until bedridden most days.  Treatment included vagus nerve therapy, neuro therapy, low histamine diet, H1 and H2 antihistamines, rest, gammacore therapy.  After 6 months of treatment, was reasonably high functioning again, however still has residual affects like occasional POTS and histamine intolerance.  ER trip in late 2021 for stroke like symptoms, diagnosed as
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Histamine intolerance, Laboratory test, Malaise, Mast cell activation syndrome, Migraine
Clinical narrative: long term POTS, CFS, PEM, dysautonomia, MCAS, vagas nerve disfunction, nausea.  All started within a couple weeks of the vaccine and symptoms increased in severity until bedridden most days.  Treatment included vagus nerve therapy, neuro therapy, low histamine diet, H1 and H2 antihistamines, rest, gammacore therapy.  After 6 months of treatment, was reasonably high functioning again, however still has residual affects like occasional POTS and histamine intolerance.  ER trip in late 2021 for stroke like symptoms, diagnosed as
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nerve stimulation test, Neurological symptom, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: long term POTS, CFS, PEM, dysautonomia, MCAS, vagas nerve disfunction, nausea.  All started within a couple weeks of the vaccine and symptoms increased in severity until bedridden most days.  Treatment included vagus nerve therapy, neuro therapy, low histamine diet, H1 and H2 antihistamines, rest, gammacore therapy.  After 6 months of treatment, was reasonably high functioning again, however still has residual affects like occasional POTS and histamine intolerance.  ER trip in late 2021 for stroke like symptoms, diagnosed as
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Tilt table test, Vagus nerve disorder, Vestibular function test
Clinical narrative: long term POTS, CFS, PEM, dysautonomia, MCAS, vagas nerve disfunction, nausea.  All started within a couple weeks of the vaccine and symptoms increased in severity until bedridden most days.  Treatment included vagus nerve therapy, neuro therapy, low histamine diet, H1 and H2 antihistamines, rest, gammacore therapy.  After 6 months of treatment, was reasonably high functioning again, however still has residual affects like occasional POTS and histamine intolerance.  ER trip in late 2021 for stroke like symptoms, diagnosed as
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Limb discomfort, Middle insomnia, Pain in extremity
Clinical narrative: I knew that I was exposed to COVID-19 on Sunday from my relative. I was positive. Tuesday night I woke up in the night and my lower leg hurt and it was uncomfortable. It did not last long and had no other symptoms. I called the doctor and they Paxlovid on Wednesday.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I knew that I was exposed to COVID-19 on Sunday from my relative. I was positive. Tuesday night I woke up in the night and my lower leg hurt and it was uncomfortable. It did not last long and had no other symptoms. I called the doctor and they Paxlovid on Wednesday.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: very loud ringing in both ears
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Pain in extremity
Clinical narrative: Within one hour of receiving my second Covid-19 Vaccination , I began to have severe left hip, back and leg pain.  Walking was very difficult.  This pain has continued, some times it is less and other times more severe.  I have not talked with a health care provider about these symptoms.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt presents to clinic 6 days after vaccine c/o warmth left upper arm. 15 x 15 cm area of redness/warmth left upper arm. Dr. evaluated. Prescribed antiobiotic but pt declined. Wants to speak to his primary doctor who returns to office 4/26/23.Declined phone visit appt with PCP in 1 week. Message sent to PCP.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Nasopharyngitis
Clinical narrative: I had a cold in February with coughing. The cold went away, but the coughing remained. It's a nagging cough. I still have it, but it is infrequent. I didn't have any type of lingering cough after the other vaccines so this is new for me. My husband is experiencing the same symptoms after receiving his third dose as well. There is no distinguishing time when the cough come and goes, but it lasted about 8 weeks back when it started in February. I've been taking allergy medicine, and it helps. It's a non-productive dry cough. It's similar to my experience after taking Metoprolol. I mentioned the cough to my doctor in my annual well visit.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third shingrix vaccine given after series was completed.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: Vaccine was given in error on 4/13/23, not appropriate for her age. Symptoms unknown, still waiting for a response from the health department in how to proceed.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Headache, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: FEVER, BACK HURTS, NAUSEA, SORE THROAT, BODY ACHE, HEADACHE,STUFFY NOSE, RESOLVED IN TWO WEEKS. FEVER IN  THE FIRST 2 DAYS MAXIMUM 102 F THAN LOW GRADE FEVER ON AND OFF REST OF THE TWO WEEKS AND RESOLVED.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER, BACK HURTS, NAUSEA, SORE THROAT, BODY ACHE, HEADACHE,STUFFY NOSE, RESOLVED IN TWO WEEKS. FEVER IN  THE FIRST 2 DAYS MAXIMUM 102 F THAN LOW GRADE FEVER ON AND OFF REST OF THE TWO WEEKS AND RESOLVED.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Asthenia, COVID-19, Chills, Cough, Headache
Clinical narrative: I got sick on the 12, I took the test, and it was negative; on the 13th very sick, I took another test, and it was positive. I called my doctor; I spoke to him on the 14th. I had really bad headache, nausea, chills, very weak, a fever was very low, 99, plus I had a cough and congestion. I gave the doctor my symptoms and he gave me anti-virus and started taking it on the 14th.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Malaise, Nausea, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I got sick on the 12, I took the test, and it was negative; on the 13th very sick, I took another test, and it was positive. I called my doctor; I spoke to him on the 14th. I had really bad headache, nausea, chills, very weak, a fever was very low, 99, plus I had a cough and congestion. I gave the doctor my symptoms and he gave me anti-virus and started taking it on the 14th.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse effects noted. Patient notified they were given vaccine after BUD.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Developed hearing loss and tinnitus.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Impaired work ability, Nasal congestion, Nasopharyngitis
Clinical narrative: On April 3, 2023, I noticed I didn't sleep very well on Sunday night.  I was exhausted Monday.  Tuesday I had cold symptoms and fatigue.  I called in sick Wednesday morning and was fatigued.  Then I had more cold-like symptoms and a sore throat and progressed to feeling like I was swallowing broken glass.  Thursday my throat was still painful and fatigue.  I tested positive on Friday, April 7, 2023.  I began taking Paxlovid and started to feel better the following Sunday.  As of today, I still have nasal congestion and fatigue.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Odynophagia, Oropharyngeal pain, Poor quality sleep, SARS-CoV-2 test positive
Clinical narrative: On April 3, 2023, I noticed I didn't sleep very well on Sunday night.  I was exhausted Monday.  Tuesday I had cold symptoms and fatigue.  I called in sick Wednesday morning and was fatigued.  Then I had more cold-like symptoms and a sore throat and progressed to feeling like I was swallowing broken glass.  Thursday my throat was still painful and fatigue.  I tested positive on Friday, April 7, 2023.  I began taking Paxlovid and started to feel better the following Sunday.  As of today, I still have nasal congestion and fatigue.
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: I returned to clinic after 2 weeks of PTO. I read an email that there was a change by the FDA to the Covid vaccination recommendations. Patient presented to clinic for Covid vaccine dose 2. She had previously received Moderna monovalent formula.  Before administration, I wanted to verify changes.   I referred to website. According to the new guideline overview for individuals 6 months - 5 years: "Individuals who have received one dose of Moderna COVID-19 Vaccine: A single dose of Moderna COVID-19 Vaccine, Bivalent is administered 1 month after the dose of Moderna COVID-19 Vaccine."   I proceeded to prepare the Moderna Covid-19 Bivalent original and omicron BA.4/BA.5 vaccine [80777-283-02].  I gave mom the new Fact Sheet for Recipients and Caregivers. I administered 0.2mL of Bivalent Covid vaccine in patient's right vastus lateralis.   Later in the day I was able to continue reading the Fact Sheet for Healthcare Professionals. It was then I noticed it only referred to using the Blue Cap & Grey Border for individuals 6 months and older. I continued to read until I finally found reference to "Multiple-Dose Vials with Dark Pink Caps and Labels with a Yellow Box. The cartons and vial labels state ?BOOSTER DOSES ONLY.? This presentation is authorized to provide certain doses for individuals 6 months through 5 years of age. [See Dose and Schedule (2.3)]" I now understand that this is to be used as a booster dose (3rd dose) to children age 6 months - 5 years who completed their primary series with the monovalent formula.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient had no reaction to the vaccine after administration. Tested positive for COVID 3/24/2023.  Patient expired 4/22/2023
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse effects noted. Patient notified they were given the vaccine past the BUD.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal X-ray, Blood urine present, Computerised tomogram kidney abnormal, Nephrolithiasis, Pain
Clinical narrative: I had blood in my urine in December 2022. I made an appointment with my doctor; he ordered bloodwork and CT scan with contrast. I was referred to a Urologist, that I was to see in January 2023. I started having pain a week before the appointment I had terrible pain that caused me to go into the emergency room. I had been vomiting, they looked over my chart saw that I had the kidney stones, and I was presenting for pain of the kidney stones. I was given pain medication, antinausea medication sent home. Once I got into the doctor's appointment, we discussed that the kidney stone had moved, and it should pass. After a while it I started having pain again, I made another appointment, I had x-rays where we discovered the stone was stuck in the ureter, the decision was made to remove the stone.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Renal stone removal, Scan with contrast abnormal, Ureteric obstruction, Urine analysis normal, Vomiting
Clinical narrative: I had blood in my urine in December 2022. I made an appointment with my doctor; he ordered bloodwork and CT scan with contrast. I was referred to a Urologist, that I was to see in January 2023. I started having pain a week before the appointment I had terrible pain that caused me to go into the emergency room. I had been vomiting, they looked over my chart saw that I had the kidney stones, and I was presenting for pain of the kidney stones. I was given pain medication, antinausea medication sent home. Once I got into the doctor's appointment, we discussed that the kidney stone had moved, and it should pass. After a while it I started having pain again, I made another appointment, I had x-rays where we discovered the stone was stuck in the ureter, the decision was made to remove the stone.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Tinnitus started about 2 weeks after vaccine and is ongoing. Mild dizziness as well.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects noted. Patient notified that they received the vaccine after BUD.
Age: 74.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Blood test normal, COVID-19, Chest X-ray normal, Chills, Dysphonia
Clinical narrative: On about 11/18/2022, I developed fatigue that lasted maybe two or three days. I was so fatigued that I went to bed at about 5:00 PM. I had the chills, so I covered up with every blanket in the house. At around 8:00 PM, I awakened, and I was extremely hot. I attempted to take a step to go to the bathroom, but I was unable to walk. I then called 911, and I was transported to the ER. At the ER, I underwent a COVID-19 test. They also did bloodwork and a urinalysis. A few white cells were detected in the urine, but not enough to cause alarm. The COVID-19 test yielded a positive result. I underwent a chest X-ray, which was normal. I was given fluids, which helped. The results of my bloodwork were also normal. I stayed at the ER for about five hours before I was discharged. I notified my rheumatologist, who prescribed me PAXLOVID. The main symptoms I experienced with COVID-19 were fatigue and hoarseness. I took a home antigen test about 18 days after being treated at the ER, and the result was positive. My rheumatologist then advised me to self-isolate for another week and then test myself again. Seven days after he told me that, I took another home antigen test, and the result was negative. The worst part of my illness was the isolation. I recuperated upstairs, while my family stayed downstairs. I really missed and needed the human contact.
Age: 74.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Fatigue, Feeling hot, Gait inability, SARS-CoV-2 test positive, Urine analysis abnormal
Clinical narrative: On about 11/18/2022, I developed fatigue that lasted maybe two or three days. I was so fatigued that I went to bed at about 5:00 PM. I had the chills, so I covered up with every blanket in the house. At around 8:00 PM, I awakened, and I was extremely hot. I attempted to take a step to go to the bathroom, but I was unable to walk. I then called 911, and I was transported to the ER. At the ER, I underwent a COVID-19 test. They also did bloodwork and a urinalysis. A few white cells were detected in the urine, but not enough to cause alarm. The COVID-19 test yielded a positive result. I underwent a chest X-ray, which was normal. I was given fluids, which helped. The results of my bloodwork were also normal. I stayed at the ER for about five hours before I was discharged. I notified my rheumatologist, who prescribed me PAXLOVID. The main symptoms I experienced with COVID-19 were fatigue and hoarseness. I took a home antigen test about 18 days after being treated at the ER, and the result was positive. My rheumatologist then advised me to self-isolate for another week and then test myself again. Seven days after he told me that, I took another home antigen test, and the result was negative. The worst part of my illness was the isolation. I recuperated upstairs, while my family stayed downstairs. I really missed and needed the human contact.
Age: 74.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: White blood cells urine positive
Clinical narrative: On about 11/18/2022, I developed fatigue that lasted maybe two or three days. I was so fatigued that I went to bed at about 5:00 PM. I had the chills, so I covered up with every blanket in the house. At around 8:00 PM, I awakened, and I was extremely hot. I attempted to take a step to go to the bathroom, but I was unable to walk. I then called 911, and I was transported to the ER. At the ER, I underwent a COVID-19 test. They also did bloodwork and a urinalysis. A few white cells were detected in the urine, but not enough to cause alarm. The COVID-19 test yielded a positive result. I underwent a chest X-ray, which was normal. I was given fluids, which helped. The results of my bloodwork were also normal. I stayed at the ER for about five hours before I was discharged. I notified my rheumatologist, who prescribed me PAXLOVID. The main symptoms I experienced with COVID-19 were fatigue and hoarseness. I took a home antigen test about 18 days after being treated at the ER, and the result was positive. My rheumatologist then advised me to self-isolate for another week and then test myself again. Seven days after he told me that, I took another home antigen test, and the result was negative. The worst part of my illness was the isolation. I recuperated upstairs, while my family stayed downstairs. I really missed and needed the human contact.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypotension, Hypoxia, Metastases to bone
Clinical narrative: I95.9 HYPOTENSION 4/26/2022 CANCER METASTATIC TO BONE J96.10 CHRONIC RESPIRATORY FAILURE 4/15/2022 CANCER METASTATIC TO BONE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2022 CANCER METASTATIC TO BONE R09.02 HYPOXIA 3/17/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 4/26/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 4/15/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 3/17/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Respiratory failure
Clinical narrative: I95.9 HYPOTENSION 4/26/2022 CANCER METASTATIC TO BONE J96.10 CHRONIC RESPIRATORY FAILURE 4/15/2022 CANCER METASTATIC TO BONE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2022 CANCER METASTATIC TO BONE R09.02 HYPOXIA 3/17/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 4/26/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 4/15/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 3/17/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I participated in CDC surveys after receiving Covid vaccines. I never mentioned tinnitus in those surveys but I now recognize that the condition appeared after receiving the vaccines. My first shot was in January 2021 and by July 2021 I was researching tinnitus and discussing it with family. At the time, I didn?t realize it could be related. The condition persists today.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: I was having a cough, sore throat, headache, shortness of breath, a low-grade fever. I took a home COVID-19 home test and it was positive. I went into a pharmacy and got a test, and it was positive as well. I reached out to my health care provider, and they put me on PAXLOVID and that did help. I was so fatigued and was napping everyday.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza virus test, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I was having a cough, sore throat, headache, shortness of breath, a low-grade fever. I took a home COVID-19 home test and it was positive. I went into a pharmacy and got a test, and it was positive as well. I reached out to my health care provider, and they put me on PAXLOVID and that did help. I was so fatigued and was napping everyday.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: I broke out in Hives on Lower Arms (Including palms & fingers), Lower Legs (including top and bottom of feet), mid-section of my body as well as the crotch area.  It was incredible itching.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hearing aid user, Tinnitus
Clinical narrative: Tinnitus treated with hearing aids.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest X-ray normal, Dyspnoea, Dyspnoea exertional, Echocardiogram normal
Clinical narrative: About a month ago, I was coming up the stairs and I got short winded I had to stop and keep stopping and it started after that. If I go the restroom from my bed, I get short winded. Talking makes me short winded. I am not as bad as I was at first, but I am still having shortness of breath. I went to the Emergency Room on April 14, 2023, because I thought it was my heart. The tests they took on my heart came out negative. I do not know what caused it. They did blood work, chest X-ray, Echocardiogram. They checked for any blood clots in my legs the results were negative.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test normal
Clinical narrative: About a month ago, I was coming up the stairs and I got short winded I had to stop and keep stopping and it started after that. If I go the restroom from my bed, I get short winded. Talking makes me short winded. I am not as bad as I was at first, but I am still having shortness of breath. I went to the Emergency Room on April 14, 2023, because I thought it was my heart. The tests they took on my heart came out negative. I do not know what caused it. They did blood work, chest X-ray, Echocardiogram. They checked for any blood clots in my legs the results were negative.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Fibromyalgia, Migraine, Seizure like phenomena
Clinical narrative: I started having Migraines, which then started seizure like activity is what they are calling it as they are still trying to figure out what is going on. Medications for the migraines are; Amitriptlyline, Naratriptan, Propanolol, and Riboflavin, also getting botox injections. Medications for the 'seizure like activity' is 2 that i was already on is Lamictal (bipolar and mood swings) and Neurontin (nerve damage in back). I am also in the process to confirm if i have P.O.T.S. I am also being treated for Fibromyalgia. Medications are Neurontin and Flexiril. so on top of the other health issues I already have, I am having to deal with all of this now too.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Cardiac arrest, Cervix carcinoma recurrent, Cervix carcinoma stage III, Chemotherapy
Clinical narrative: Pt. had received the Gardisil shots in 2008. In 2019 she started to have pain during sex. She thought she had fibroids . She actually had stage 3 cervical cancer . Never thought she could get this due to the shots she got in 2008. Has treatment - proton radiation and chemo , she was clear for a year . After that year the cancer returned. All?s treatments the doctors had given her included more chemo, even newer chemo that was shown to help with cervical cancer . Tivdak. With this she had to have cold packs on her eyes during treatment and see an eye specialist before each treatment . Feb 8, 2023 pt. was in a lot of pain. She went to the hospital and the doctors tried to treat the pain . Pt. ended up on a ventilator and after a little bit her blood pressure wouldn?t stay up and eventually her heart stopped  Time if death 11:28 pm. .
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Death, Dyspareunia, Laboratory test, Mechanical ventilation, Pain
Clinical narrative: Pt. had received the Gardisil shots in 2008. In 2019 she started to have pain during sex. She thought she had fibroids . She actually had stage 3 cervical cancer . Never thought she could get this due to the shots she got in 2008. Has treatment - proton radiation and chemo , she was clear for a year . After that year the cancer returned. All?s treatments the doctors had given her included more chemo, even newer chemo that was shown to help with cervical cancer . Tivdak. With this she had to have cold packs on her eyes during treatment and see an eye specialist before each treatment . Feb 8, 2023 pt. was in a lot of pain. She went to the hospital and the doctors tried to treat the pain . Pt. ended up on a ventilator and after a little bit her blood pressure wouldn?t stay up and eventually her heart stopped  Time if death 11:28 pm. .
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Proton radiation therapy, Scan
Clinical narrative: Pt. had received the Gardisil shots in 2008. In 2019 she started to have pain during sex. She thought she had fibroids . She actually had stage 3 cervical cancer . Never thought she could get this due to the shots she got in 2008. Has treatment - proton radiation and chemo , she was clear for a year . After that year the cancer returned. All?s treatments the doctors had given her included more chemo, even newer chemo that was shown to help with cervical cancer . Tivdak. With this she had to have cold packs on her eyes during treatment and see an eye specialist before each treatment . Feb 8, 2023 pt. was in a lot of pain. She went to the hospital and the doctors tried to treat the pain . Pt. ended up on a ventilator and after a little bit her blood pressure wouldn?t stay up and eventually her heart stopped  Time if death 11:28 pm. .
Age: 48.0
Sex: M
Vaccine: FLU4, HEPAB, MMR, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: PATIENT GOT DIZZY AND PUT HEAD DOWN. HE THEN QUICKLY RECOVERED AND WAS FINE. WE MONITERED PATIENT FOR 30 MINUTES AFTER AND HE WAS OK. HIS FRIEND DROVE HIM HOME.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; A HCP called and reported that a dose of VARIVAX was reconstituted with Sodium Chloride instead of the Merck supplied diluent and was administered to a patient.; This spontaneous report has been received from Other Health Professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.    On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, for prophylaxis, (lot number: W025273, which was determined to be valid, expiration date reported and validated as 10-AUG-2024) (strength, dose, route of administration and anatomical location were not reported) in combination with Sodium chloride (strength, dose, route of administration, lot number and expiration date were unknown)(Product preparation error).  No additional adverse events were reported in the patient.  This case was determined to be non-valid due to the lack of patient's identifiers.  Follow up information has been received from the physician assistance on 21-APR-2023. This case was regarding a 24-years-old female patient.  On 18-MAR-2023, the patient was vaccinated by a trained health care profeccionalwith the reported dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, in the right deltoid (lot number: W025273, which was determined to be valid, expiration date on 10-AUG-2024) in combination with hepatitis b vaccine rhbsag (YEAST) (ENGERIX-B), in the left deltoid (lot number: NT9X3), both as prophylaxis (strengths, doses, schemes and routes of administration were not reported). It was previously reported, the administered varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with 0.9% sodium chloride instead of diluent. It was reported the patient was notified and there was no adverse event. On 21-APR-2023, the patient was administered an additional dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration and indication, lot number and expiration date were not reported). The outcome of product preparation error was reported as recovered.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient was inadvertently administered an expired dose of MMR II; This spontaneous report was received from a nurse and a vaccine provider referring to a 31-year-old male patient. Concomitant vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and varicella virus vaccine live (oka/merck) (VARIVAX). The patient's current conditions included gout, vitamin d deficiency, hepatitis c and vitamin b12 deficiency. The patient's illness at time of vaccination was reported as none.   On 30-MAR-2023, the patient came in to his appointment for immunizations and was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (0.5 ml (full dose), lot # T013727, expiration date 21-APR-2022; strength was not reported) intramuscularly in the left deltoid for prophylaxis (expired product administered). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was later discovered to have been expired. The operator of vaccine was a trained health professional. The remained expired vials were disposed. No prescription drug treatment for the experience required. The patient agreed to return in 4 weeks to have another measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine since dose was invalid due to expiration. The patient had no complaints. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered to patient with temperature excursion; This spontaneous report was received from a nurse prescriber and refers to 11 year old female patient. No illness at time of vaccine. No significant past medical history. The patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO).   On 10-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot # W008712, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 14-MAR-2024), administered for prophylaxis (anatomical location, and route of administration were not reported) (Product storage error). Temperature excursion as following: 15.7 Fahrenheit (F) for 0 hours 20 minutes. No adverse events related to vaccination.   This is one of six reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AEs; administered PEDVAX HIB after being expired; This spontaneous report was received from a nurse referring to a 6 month old female patient. Information of concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 10-APR-2023, the patient was administered haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection 1 time dose ((lot# T026962, expiration date 06-APR-2023; strength, dose, route were not reported) for prophylaxis after being expired (expired product administered). No additional adverse events (AEs) (no adverse event) was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  Varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, this valid case was split from original case 2303USA002114. This spontaneous report was regarding a 4 years old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 10-DEC-2022. the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023) underwent temperature excursion for 1 hour. The digital data logger was involved in recording excursion details. On 21-DEC-2022, the patient was vaccinated with the improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, a valid case was split from original case 2303USA002114. This spontaneous report was regarding a 4-year-old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 20-JAN-2023. the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019627, expiration date 19-DEC-2023) underwent temperature excursion for 1 hour. The digital data logger was involved in recording excursion details. On 25-JAN-2023, the patient was vaccinated with the improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019627, expiration date 19-DEC-2023, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837: US-009507513-2304USA007931:
Sex: F
Vaccine: HEP, PNC15
Symptoms: Haematochezia, Product administered to patient of inappropriate age
Clinical narrative: 2 bloody stools; a 9 month old patient received third dose of VAXENUVANCE; This spontaneous report has been received from a nurse regarding to 9 month old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 06-APR-2023, the patient received the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) strength 0.5 ml administered with 3rd dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) strength 2.5/0.5 (unit unknown) for prophylaxis (dose, route, lot#, expiration date and indication were not reported) (inappropriate age at vaccine administration).  On 17-APR-2023, the patient experienced had 2 bloody stools. The outcome of the 2 bloody stools was unknown.  The causality assessment was not provided.  Upon internal review, 2 bloody stools was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was administered Expired ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient medical history, current condition, and concomitant medication.      On 20-APR-2023 the patient was vaccinated with dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # W000381 and expiration date 13-APR-2023 for prophylaxis (exact dose and route of administration were not provided) (expired product administered and no adverse event).
Sex: F
Vaccine: HEPA
Symptoms: Injury associated with device, Skin laceration, Syringe issue, Wound
Clinical narrative: A nurse (name unknown) had a cut on her finger from the broken syringe; A nurse (name unknown) had a cut on her finger from the broken syringe; had a cut on her finger from the broken syringe; This spontaneous report was received from a consumer referring to a female nurse of unknown age. Information about her pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 21-APR-2023, it was noticed during opening the box to take the syringe out that the 2 syringes of hepatitis A vaccine, inactivated (VAQTA) (formulation prefilled syringe, lot # X004813, expiration date 28-JUL-2024) from VAQTA INJ 25U/0.5ML PED PF SYR CARTON OF 1000006409502 were broken (syringe broken). On that day, the nurse cut her finger from the broken syringe (laceration of finger, injury associated with device). It was reported that the syringe was broken into 2 or more pieces from the bottom of the syringe (ring). There was not liquid or dried residue in the tray. The outcome of the events was unknown. Action taken with suspect vaccine was not applicable.   The causal relationship between events and suspect vaccine was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No other AE/PQC reported.; MA calling to report expired dose of GARDASIL 9 was accidentally administered to a patient. Permission to contact HCP was unspecified. Vaccine was supported through expiry date however caller disconnected before information was provided. No other AE/; This spontaneous report was received from medical assistantand refers to a patient of unknown age and gender (initials were reported).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #U007477, expiration date: 14-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 21-APR-2023, Medical Assistant calling to report expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was accidentally administered to a patient. Permission to contact HCP was unspecified. Vaccine was supported through expiry date however caller disconnected before information was provided. No other AE/PQC reported.