chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pt with PMH of hypertension and obesity has had 1-2 days of fever, dyspnea, and fatigue. He is found to be COVID-19 positive and has Afib with RVR.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received vaccination after the manufacturer expiration date. Stability data from the manufacturer supported the stability and efficacy through 10/19/2022 therefore pt did not need to be notified or revaccinated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Gait inability, Tremor, Visual impairment
Clinical narrative: Pt reported within hours of vaccination onset of severe shaking, weakness and "unable to walk", and "gray vision", "looked into the mirror and could not see anything at all". Day 2 symptoms did improve, however she reported feeling very weak.  On Day 3 symptoms improved.  Day 5 feels much better.  This patient has contacted office requesting that her symptoms be reported to the government.  States she has never had any issue with past vaccines.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Oligomenorrhoea, Pregnancy test negative
Clinical narrative: Break through heavy menstrual bleeding while on the oral contraceptive bleeding was heavy and prolonged-length of duration was 11 days.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: No adverse reaction. However On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30. Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19. For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Genital swelling, Lip swelling, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: Swelling of the lips, face, genitals, and throat and hives on various body part  This has lasted over 30 days.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Developed sore throat and slight congestion. Tested positive for COVID on Aug. 26. Symptoms worsened slightly over weekend. Started feeling better about 4 days later.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Foetal death, Foetal hypokinesia, Uterine dilation and curettage
Clinical narrative: Fetal death. At time of vaccination with first booster patient was five and a half months pregnant. She described that a few days after vaccination saw her obstetrician and apparently the baby was moving less. On 1/3/2022 at 22 weeks gestation ultrasound showed intrauterine fetal death. Admitted to Hospital and suction D&C done 5/5/2022.  Past history miscarriage 2006, 2016, 2017 and missed abortion 8 weeks gestation 5/4/2021. Birth of twins by C-section 2017.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The Moderna Bivalent vaccine was administered after a temperature excursion and the vaccine was not viable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent COVID 19 Booster Vaccine was administered incorrectly, since the FDA removed the authorization to use it as a booster.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after manufacturer expiration date, but manufacturer stability data supports use
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Dizziness, Dyspnoea
Clinical narrative: Full body flushing, increased blood pressure (175/135) Increased heart rate (138), dizziness, body sweating, headache, struggle breathing.     Seen within the clinic and an ambulance called as unable to decrease heart rate and blood pressure.   Sent to ER for treatment.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Flushing, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Full body flushing, increased blood pressure (175/135) Increased heart rate (138), dizziness, body sweating, headache, struggle breathing.     Seen within the clinic and an ambulance called as unable to decrease heart rate and blood pressure.   Sent to ER for treatment.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was supposed to receive Pfizer BiValent dose, but incorrectly received Pfizer (monovalent) dose.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Ear pain, Pulmonary congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 09/05/2022 and I took a home test. My wife tested positive two days prior. I had a mild earache with a dry cough. My doctor indicated no fever or SOB. My doctor diagnosed me with mild symptoms and no significant symptoms outside of my age. I called medical practice where I got a telehealth visit and I was prescribed PAXLOVID but I never took the medication. My symptoms were not that bad. The symptoms are coughing for couple of days and every now and then I get a period of coughing in the morning or late at night. For the most part I mostly have in the mornings and during the night, my cough comes and goes, feels like a chest congestion.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event
Clinical narrative: Provider administered flublok to 17 years old pt. no adverse side effects noted as a result of vaccination
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt. was administered the Fluzone HD in an event at an assisted living facility on 10/25/2022. After administration, about 1/2 hour later, the patient started vomiting and feeling light headed. Patient was being monitored by the nursing staff on site.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood culture positive, Blood test abnormal, Chills, Computerised tomogram abnormal
Clinical narrative: Friday the 18th of June, I started having gas pains and they got worse through the weekend and Monday. I was in in extreme abdominal and lower intestinal pain with chills and fever. I went to ER. Blood cultures and CT scan. Gas had escaped my bowels and noted diverticulitis. I was admitted to the hospital on 21st and released on 24th of June.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis, Flatulence, Gastrointestinal pain, Metabolic function test abnormal, Pyrexia
Clinical narrative: Friday the 18th of June, I started having gas pains and they got worse through the weekend and Monday. I was in in extreme abdominal and lower intestinal pain with chills and fever. I went to ER. Blood cultures and CT scan. Gas had escaped my bowels and noted diverticulitis. I was admitted to the hospital on 21st and released on 24th of June.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast abnormal, Urine analysis abnormal
Clinical narrative: Friday the 18th of June, I started having gas pains and they got worse through the weekend and Monday. I was in in extreme abdominal and lower intestinal pain with chills and fever. I went to ER. Blood cultures and CT scan. Gas had escaped my bowels and noted diverticulitis. I was admitted to the hospital on 21st and released on 24th of June.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Feeling cold, Migraine, Myalgia, Photophobia
Clinical narrative: Chills, migraine, photophobia, muscle aches, armpit soreness, extreme thirst. All began about 16 good after my dose and later about 2 days.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Thirst
Clinical narrative: Chills, migraine, photophobia, muscle aches, armpit soreness, extreme thirst. All began about 16 good after my dose and later about 2 days.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Computerised tomogram, Injection site erythema, Injection site paraesthesia, Injection site scar
Clinical narrative: After receiving the Flu Shot at my job health fair, a few hours later I got a tingling sensation around the area and it got swollen and red and a huge blishter formed. The next day my blister popped and I went to the Pharmacy. The Dr. there prescribed me antibiotics for one week. I went back to see her after a week. She then suggested that I go to the ER for IV antibiotics and ultrasound to make sure the infection was not deep. I went to the ER in Hospital. There they gave me pain killers for the pain on my arm, I had two UltraSounds and a CT Scan. It's been almost two weeks and my arm is till sensative and I have a ugly scar.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Injection site vesicles, Scan with contrast, Ultrasound scan
Clinical narrative: After receiving the Flu Shot at my job health fair, a few hours later I got a tingling sensation around the area and it got swollen and red and a huge blishter formed. The next day my blister popped and I went to the Pharmacy. The Dr. there prescribed me antibiotics for one week. I went back to see her after a week. She then suggested that I go to the ER for IV antibiotics and ultrasound to make sure the infection was not deep. I went to the ER in Hospital. There they gave me pain killers for the pain on my arm, I had two UltraSounds and a CT Scan. It's been almost two weeks and my arm is till sensative and I have a ugly scar.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: VACCINE GIVEN IN OFFICE 10/18/22, GRANDMA CALLED TO REPORT PT. HAD A SEIZURE ON 10/19/22
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired quality of life, Insomnia, Mobility decreased, Neuralgia
Clinical narrative: After vaccination, deep sciatic and outer thigh nerve pain along the dermatome caused numbness and tingling down to the outer right foot.  Over time this progressively worsened to impact ability to sleep and move leg decreasing overall quality of life.  Patient treated with anti-inflammatories, stretching, and yoga practices.  No other identified causes.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: After vaccination, deep sciatic and outer thigh nerve pain along the dermatome caused numbness and tingling down to the outer right foot.  Over time this progressively worsened to impact ability to sleep and move leg decreasing overall quality of life.  Patient treated with anti-inflammatories, stretching, and yoga practices.  No other identified causes.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.3mL of the vaccine rather than the recommended 0.2mL.  Patient and family was educated.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: Severe lower back pain
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: The Moderna Bivalent vaccine was administered after a temperature excursion and the vaccine was not viable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose.
Sex: U
Vaccine: DTAP
Symptoms: Abnormal behaviour, Cough, Gait disturbance, Lethargy, Pain in extremity
Clinical narrative: leg pain, limping over next several days fever over night and into next day lethargic odd behavior such as "everyone hates me", "no one likes me" rash on lower back vomiting about 10 days later  coughing since injection Treatments: cold compress, nutritional supplements for detoxing such as cilantro or Chlorophyll, Tylenol for fever. hydration for vomiting and rest.  Epsom salt bath and icing for leg soreness Outcomes: all aside from coughing have resolved.  odd behavior is being monitored
Sex: U
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: leg pain, limping over next several days fever over night and into next day lethargic odd behavior such as "everyone hates me", "no one likes me" rash on lower back vomiting about 10 days later  coughing since injection Treatments: cold compress, nutritional supplements for detoxing such as cilantro or Chlorophyll, Tylenol for fever. hydration for vomiting and rest.  Epsom salt bath and icing for leg soreness Outcomes: all aside from coughing have resolved.  odd behavior is being monitored
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given Moderna Covid Vaccine (Lot # ar9236b 0.5 ml) designed for age 6 M-5 year old by mistake.  Patient was informed about this incident, and was suggested to keep track of signs and symptoms, as well as contact information with the vaccinated clinic in case any adverse events happen. Pt. was contacted on Monday, 10/24/2022, and was not reached.
Age: 59.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Nasal congestion, Pain, SARS-CoV-2 test positive
Clinical narrative: On 09/16/2022 I had vaccination. On 10/17/2022 I started to feel aches and stuffiness. I took at home COVID-19 test and it was negative. On 10/18/2022 I took 2 COVID-19 tests and they were both positive. I contacted my doctor office on 10/18/2022 and they prescribed PAXLOVID.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Fatigue
Clinical narrative: Within 2 minutes of second vaccine (Fluarix) patient asked if she could sit on the floor stating "This sometimes happens to me with needles, I feel dizzy and need to sit"    Immediately provided a space to sit on floor and assisted her to sit.  She then laid down flat and was monitored for 5 minutes.  No s/s of distress noted.  After 5 minutes she was allowed to sit for 5 minutes at which time she stated "I feel much better",  allowed to stand to determine if dizziness would return and monitored for an additional 15 mins while seated in a chair.  Encourage to drink fluids and call provider if any further symptoms of concern.  Was able to walk from clinic with no return of symptoms.   Called patient on 10/26/22 to assess needs. States she was "a little tired last evening" but feels "fine" today.  Denies any return of dizziness.   Encourage to drink fluids and call provider if any further symptoms of concern.
Age: 11.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Malaise, Pallor
Clinical narrative: After patient received both vaccines from LVN, pt started to complain of dizziness and "not feeling well". pt appeared pale. Pt was given water and juice, remained completely alert and oriented with age-appropriate mentation. Pt denied pain, difficulty breathing, rash, or itching.  Pt was able to ambulate from a chair to a gurney where he was observed for another 10 min with parent standing by. Pt reported then that he felt better and parent expressed that she felt comfortable with taking patient home. patient ambulated out of vaccine clinic with a steady gait, accompanied by parent
Age: 36.0
Sex: M
Vaccine: FLU4, SMALLMNK
Symptoms: Product storage error
Clinical narrative: Patient was administered with both vaccines that were at 35.2F for 1:05 duration time.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer monovalent instead of Pfizer bivalent as a Covid-19 booster dose
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive  COVID 10/3/2022
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Redness, warmth, swelling size of quarter, red raised bumps no fluid filled to sight of injection. " few red raised bumps to chest not fluid filled".   Reported 10/20/2022 at 4:29 No difficulty breathing, chest tightness, or throat tightness. Benadryl given.   10/21/2022 09:25- updated call that pt now has hives all over his body, has been giving benadryl 25 mg every 4 hours over night. no difficulty breathing, or throat difficulties. md instructed to give benadryl 50 mg every 6-8 hours, start zyrtec 10 mg daily.  No further calls from family after this call. Issues resolved.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Rash papular, Urticaria
Clinical narrative: Redness, warmth, swelling size of quarter, red raised bumps no fluid filled to sight of injection. " few red raised bumps to chest not fluid filled".   Reported 10/20/2022 at 4:29 No difficulty breathing, chest tightness, or throat tightness. Benadryl given.   10/21/2022 09:25- updated call that pt now has hives all over his body, has been giving benadryl 25 mg every 4 hours over night. no difficulty breathing, or throat difficulties. md instructed to give benadryl 50 mg every 6-8 hours, start zyrtec 10 mg daily.  No further calls from family after this call. Issues resolved.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood pressure increased, Headache, Heart rate increased, Nausea
Clinical narrative: Patient had a syncope episode along with nausea, backpain, and a headache after receiving the flu vaccine.  Patient was given juice and observed.  The patient's symptoms worsened.  The patient was laid down and vital signs were taken.  The patient's blood pressure, heart rate, and respiratory rate were elevated.  EMS called and patient transported to the hospital.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory rate increased, Syncope
Clinical narrative: Patient had a syncope episode along with nausea, backpain, and a headache after receiving the flu vaccine.  Patient was given juice and observed.  The patient's symptoms worsened.  The patient was laid down and vital signs were taken.  The patient's blood pressure, heart rate, and respiratory rate were elevated.  EMS called and patient transported to the hospital.
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, SARS-CoV-2 test positive
Clinical narrative: 09/02/22 presents to ED for "sharp chest pain". PMHx of "HTN, former smoker"
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient registered for Moderna COVID-19 Bivalent Vaccine (18+ yrs Booster). She was given Moderna Covid Vaccine (Lot # ar9236b 0.5 ml) designed for age 6 M-5 year old by mistake.  Patient was informed about this incident, and was suggested to monitored signs and symptoms, as well as contact information with the vaccinated clinic in case any adverse events happen. Pt. was followed up on Monday, 10/24/2022. No adverse event was noted in the past few days.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received a higher-than-authorized dose administered (e.g., incorrect dose volume, incorrect product resulting in higher-than-authorized dose).  Pt received Pfizer 12+ monovalent when patient should have received 5-11yr Pfizer monovalent.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Hemiplegia, Magnetic resonance imaging, X-ray
Clinical narrative: RIGHT SIDE PARALYSIS, EMERGENCY, REHABILITATION CARE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Tachycardia
Clinical narrative: Atrial Fibrilation with heart rate of 130-140, no shortness of breath, no chest pain, no other physical symptoms beyond tachycardia....required ing dose of metoprolol tartrate  25 mg by mouth to resolve
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache, body aching
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Received bivalent moderna as first dose
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event occurred. After we administered the Covid bivalent booster, and went to enter in the state IIS, it was then we noticed she had received the same booster on 9/20/2022. Before we administered we had asked and she claimed she had not received any vaccines recently. We also gave her Fluzone HD. We failed to check the state database in advance.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Pt was given a bivalent 5 thru 11 yrs  booster that had not been diluted...
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Malaise, SARS-CoV-2 test positive
Clinical narrative: 09/02/22 presents to ED for "shortness of breath and COVID symptoms". PMHx of "cell disease with history of acute chest syndrome"
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The Moderna Bivalent vaccine was administered after a temperature excursion and the vaccine was not viable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: On 10/15/2022, I had a sore throat that night. The sore throat continued to the next morning. I tested myself for COVID-19 and it was negative. Throughout the day, I developed body aches as well. I tested positive later that night. The night of 10/16/2022, I developed a pretty bad headache. On 10/17/2022, I had a telehealth visit with a doctor other than my primary. We discussed taking Paxlovid but ultimately, I did not since I was unable to get the baseline kidney test that he suggested at that time.10/17/2022-10/19/2022, I experienced head cold like symptoms, a lot of mucus, coughing, and mild body aches. From 10/19/2022-10/20/2022, everything has pretty much cleared up. Since then, I have had some sinus congestion that seems to be taking a while to drain out, so I still have to occasionally blow my nose or cough. I never experienced a fever.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test positive, Secretion discharge, Sinus congestion
Clinical narrative: On 10/15/2022, I had a sore throat that night. The sore throat continued to the next morning. I tested myself for COVID-19 and it was negative. Throughout the day, I developed body aches as well. I tested positive later that night. The night of 10/16/2022, I developed a pretty bad headache. On 10/17/2022, I had a telehealth visit with a doctor other than my primary. We discussed taking Paxlovid but ultimately, I did not since I was unable to get the baseline kidney test that he suggested at that time.10/17/2022-10/19/2022, I experienced head cold like symptoms, a lot of mucus, coughing, and mild body aches. From 10/19/2022-10/20/2022, everything has pretty much cleared up. Since then, I have had some sinus congestion that seems to be taking a while to drain out, so I still have to occasionally blow my nose or cough. I never experienced a fever.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: MANUFACTURER EXPIRATION WAS FOR 9/30/2022. DOSE WAS ADMINISTERED 10/01/2022. "On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19."
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Recalled product administered
Clinical narrative: Pfizer pediatric shots were received on 07/29, 10 weeks would be 10/7.   Recall notice was received on 10/13 for LOT FL2757 that this lot was expired per manufacturer's expiration of 09/30. Information has been received that the manufacturer indicating that the stability data supports the use of this product through 10/19
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Cough, Fatigue, Headache, Inflammation
Clinical narrative: I had fever, headache, fatigue, nausea, swollen glands, my throat was so inflamed I could hardly talk, I was coughing so bad I couldn't sleep, and had terrible chest congestion. I did a steam inhalation to break the congestion up. I was so sick I could hardly get out of bed. My relatives insisted that I go to Urgent Care. I tested negative for COVID-19 on 10/22/2022. When they listened to my lungs, they knew that something was wrong. They did a chest X-ray on 10/21/22 and it showed that I had Pneumonia. I have to go back in 2 weeks for another chest X-ray. I will be taking antibiotics until 11/1/22.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Malaise, Mobility decreased, Nausea, Pneumonia
Clinical narrative: I had fever, headache, fatigue, nausea, swollen glands, my throat was so inflamed I could hardly talk, I was coughing so bad I couldn't sleep, and had terrible chest congestion. I did a steam inhalation to break the congestion up. I was so sick I could hardly get out of bed. My relatives insisted that I go to Urgent Care. I tested negative for COVID-19 on 10/22/2022. When they listened to my lungs, they knew that something was wrong. They did a chest X-ray on 10/21/22 and it showed that I had Pneumonia. I have to go back in 2 weeks for another chest X-ray. I will be taking antibiotics until 11/1/22.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative, Sleep disorder, Speech disorder
Clinical narrative: I had fever, headache, fatigue, nausea, swollen glands, my throat was so inflamed I could hardly talk, I was coughing so bad I couldn't sleep, and had terrible chest congestion. I did a steam inhalation to break the congestion up. I was so sick I could hardly get out of bed. My relatives insisted that I go to Urgent Care. I tested negative for COVID-19 on 10/22/2022. When they listened to my lungs, they knew that something was wrong. They did a chest X-ray on 10/21/22 and it showed that I had Pneumonia. I have to go back in 2 weeks for another chest X-ray. I will be taking antibiotics until 11/1/22.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: I had fever, headache, fatigue, nausea, swollen glands, my throat was so inflamed I could hardly talk, I was coughing so bad I couldn't sleep, and had terrible chest congestion. I did a steam inhalation to break the congestion up. I was so sick I could hardly get out of bed. My relatives insisted that I go to Urgent Care. I tested negative for COVID-19 on 10/22/2022. When they listened to my lungs, they knew that something was wrong. They did a chest X-ray on 10/21/22 and it showed that I had Pneumonia. I have to go back in 2 weeks for another chest X-ray. I will be taking antibiotics until 11/1/22.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I started getting symptoms but did not test positive to COVID-19. Both my daughter and husband tested positive. I took PAXLOVID for 5 days and was feeling better then on the 19th I spiked a fever then tested and I was positive. I still have sniffles and congestion today.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I started getting symptoms but did not test positive to COVID-19. Both my daughter and husband tested positive. I took PAXLOVID for 5 days and was feeling better then on the 19th I spiked a fever then tested and I was positive. I still have sniffles and congestion today.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: there was no adverse event... a pharmacist gave an injection on 10/12/2022 that expired on 10/13/2022..   instruction came down from our home office that we should pull and hold that vaccine because manufacturer said it may be expired but the communication came after 3 pm in which vaccine was delivered...  our market director required us to fill out a VAERS report
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects, given after expiration date of 9/30/2022
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Mobility decreased, Neck pain, Sleep disorder
Clinical narrative: Pain at shoulder and neck, moving to shoulder and back.  Has lost some mobility in arm and has difficulty lifting items.  Cannot sleep on that side and wakes frequently during the night due to pain.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product expiration date issue, Product storage error
Clinical narrative: Vaccine was given exp date of 9/30/22.....was not thrown out on that night, dose was given in am on 10/01.....vaccine was later extended exp date until 10/19 so no harm etc just reporting as a potential event
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood glucose abnormal, Irritability, Thirst, Type 1 diabetes mellitus
Clinical narrative: Patient had her first Pfizer shot on 11/16/21. She had her second shot of Pfizer as recommended on 12/7/21. In early 2022, she began to lose weight, was thirsty, and seemed weak and irritable. Finally, over the two-day period of 4/16/21-4/17/21, her parents noticed unbelievable thirst and inability to control urination at night. Took her to her pediatrician at local Health Associates the morning of 4/18/21, where her blood sugar was checked and she was sent to hospital with suspected Type 1 diabetes. The diagnosis was confirmed that day. She stayed in the hospital for 2 days. She now needs daily insulin therapy to control her type 1 diabetes. We believe the two-part COVID-19 vaccination led to her Type 1 diabetes. She was otherwise healthy.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary incontinence, Weight decreased
Clinical narrative: Patient had her first Pfizer shot on 11/16/21. She had her second shot of Pfizer as recommended on 12/7/21. In early 2022, she began to lose weight, was thirsty, and seemed weak and irritable. Finally, over the two-day period of 4/16/21-4/17/21, her parents noticed unbelievable thirst and inability to control urination at night. Took her to her pediatrician at local Health Associates the morning of 4/18/21, where her blood sugar was checked and she was sent to hospital with suspected Type 1 diabetes. The diagnosis was confirmed that day. She stayed in the hospital for 2 days. She now needs daily insulin therapy to control her type 1 diabetes. We believe the two-part COVID-19 vaccination led to her Type 1 diabetes. She was otherwise healthy.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Recalled product administered
Clinical narrative: Pfizer pediatric shots were received on 07/29, 10 weeks would be 10/7.   Recall notice was received on 10/13 for LOT FL2757 that this lot was expired per manufacturer's expiration of 09/30. Information has been received that the manufacturer indicating that the stability data supports the use of this product through 10/19
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Pulmonary embolism, Thrombosis
Clinical narrative: I developed a blood clot and pulmonary embolism in May 2022.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: I developed a blood clot and pulmonary embolism in May 2022.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: left arm and should er pain and decreased ROM
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: given after manufacturer expiration 9/30/2022
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered pediatric dose of bivalent booster with no history of primary series
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Injection site pain, Myalgia
Clinical narrative: Instead of regular Fluzone Quadrivalent, patient was administered Fluzone high dose quadrivalent dose 0.7mL. Patient is currently pregnant. Did feel light-headed after administration but patient reported she usually feels that way with vaccines. Manager was called to report medication error and educated patient that because received higher dose, would have more potential symptoms from receiving the high dose vaccine such as muscle aches, fatigue, soreness at site. Also educated patient would call Sanofi to determine if there was any other safety concerns.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray normal, Dyspnoea, Dyspnoea exertional
Clinical narrative: I regularly swim a couple of hours 4 days a week. I have a water aerobic class in shallow end and deep-water class in deep end. I also have a running class in the water. I always recover within 30 seconds. On Tuesday October 11 following the flu vaccine I didn't feel in the pool. I was fatigued and my body ached. I didn't take the second class that day. Thursday, October 13, 2022, I went for the running class in the water. (13th) I missed the warm up for the class. I started swimming and did the first lap. At the end of the second lap, I was out of breath which was abnormal for me. I started swimming again but was having trouble catching my breath. I was near the deep end of the pool. My friend had to pull me to the end of the pool and could not catch my breath. From temple to temple, I had a headache which is normal sometimes when I swim. I was unable to swim any more laps. I just didn't feel right and my husband took me to the ER. I was triaged and did an EKG, chest x-ray and other tests. All tests were ok except my blood pressure. It was 220/73. My blood pressure is usually 118/59. I was discharged from ER. Over the next two days my blood pressure started to lower. I went out of town but continued to monitor my blood pressure and it has continued to stay within normal range. The ER told me to stay out of the water. I have other tests scheduled for November.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Exercise tolerance decreased, Fatigue, Feeling abnormal, Headache
Clinical narrative: I regularly swim a couple of hours 4 days a week. I have a water aerobic class in shallow end and deep-water class in deep end. I also have a running class in the water. I always recover within 30 seconds. On Tuesday October 11 following the flu vaccine I didn't feel in the pool. I was fatigued and my body ached. I didn't take the second class that day. Thursday, October 13, 2022, I went for the running class in the water. (13th) I missed the warm up for the class. I started swimming and did the first lap. At the end of the second lap, I was out of breath which was abnormal for me. I started swimming again but was having trouble catching my breath. I was near the deep end of the pool. My friend had to pull me to the end of the pool and could not catch my breath. From temple to temple, I had a headache which is normal sometimes when I swim. I was unable to swim any more laps. I just didn't feel right and my husband took me to the ER. I was triaged and did an EKG, chest x-ray and other tests. All tests were ok except my blood pressure. It was 220/73. My blood pressure is usually 118/59. I was discharged from ER. Over the next two days my blood pressure started to lower. I went out of town but continued to monitor my blood pressure and it has continued to stay within normal range. The ER told me to stay out of the water. I have other tests scheduled for November.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Pain
Clinical narrative: I regularly swim a couple of hours 4 days a week. I have a water aerobic class in shallow end and deep-water class in deep end. I also have a running class in the water. I always recover within 30 seconds. On Tuesday October 11 following the flu vaccine I didn't feel in the pool. I was fatigued and my body ached. I didn't take the second class that day. Thursday, October 13, 2022, I went for the running class in the water. (13th) I missed the warm up for the class. I started swimming and did the first lap. At the end of the second lap, I was out of breath which was abnormal for me. I started swimming again but was having trouble catching my breath. I was near the deep end of the pool. My friend had to pull me to the end of the pool and could not catch my breath. From temple to temple, I had a headache which is normal sometimes when I swim. I was unable to swim any more laps. I just didn't feel right and my husband took me to the ER. I was triaged and did an EKG, chest x-ray and other tests. All tests were ok except my blood pressure. It was 220/73. My blood pressure is usually 118/59. I was discharged from ER. Over the next two days my blood pressure started to lower. I went out of town but continued to monitor my blood pressure and it has continued to stay within normal range. The ER told me to stay out of the water. I have other tests scheduled for November.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Hyperhidrosis
Clinical narrative: I started off with a dry cough, sweats, fever, chills, body aches, and headaches. I took some Mucinex and Tylenol. I'm using an inhaler. I started on some melatonin to help me sleep.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I started off with a dry cough, sweats, fever, chills, body aches, and headaches. I took some Mucinex and Tylenol. I'm using an inhaler. I started on some melatonin to help me sleep.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given Pfizer Bivalent vaccine on 9/20 and again on 10/3
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: since after injection pt has been having pain to left arm; up to now 4 weeks post vaccine; continues with pain to arm with limited ROM due to this.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: PATIENT HAS SEVERE PAIN IN DELTOID MUSCLE.  STATES SHE HAS LOST MOST MOBILITY AND CANNOT LIFT HER ARM.  PER PATIENT
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I had a bad cold, sore throat and I got tested for COVID-19 on 10/06/2022 and it was positive. I consulted with my doctor and I was prescribed PAXLOVID (low renal dose), cough medicine (benzonatate) for my symptoms. I also did not have much energy after testing positive for COVID-19. My symptoms started on 10/04/2022, I was coughing, sore throat and sniffles. We had not been around people and we caught COVID-19 and I had not had a cold or flu for years, this was very odd. I have my first doctor's appointment with my doctor coming up due to changing doctors on 11/04/2022. I have recovered from my symptoms and have been fine for over one week.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a bad cold, sore throat and I got tested for COVID-19 on 10/06/2022 and it was positive. I consulted with my doctor and I was prescribed PAXLOVID (low renal dose), cough medicine (benzonatate) for my symptoms. I also did not have much energy after testing positive for COVID-19. My symptoms started on 10/04/2022, I was coughing, sore throat and sniffles. We had not been around people and we caught COVID-19 and I had not had a cold or flu for years, this was very odd. I have my first doctor's appointment with my doctor coming up due to changing doctors on 11/04/2022. I have recovered from my symptoms and have been fine for over one week.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Loss of consciousness, Migraine, Pain in extremity
Clinical narrative: sever headache took Rizatriptan at 1130 pm; woke at night to use restroom and felt dizzy - waited a bit and tried to get back to bed but passed out; woke up what I believe to be a few minutes later (4:30 am I think) laying on bathroom floor; got back in bed; woke at 6:30 am and took another Riza and tried to sleep more; 11:30 am still terrible headache took 400mg ibuprofen; 3:00pm 400mg ibuprofen and 4pm 200 more; no relief; took 1000 Tylenol at 5:00pm; 400mg ibuprofen 9:00pm; headache still severe; 11:30 pm 1000mg Tylenol; slept 5 hours and woke up Oct 23 at 5:45 with severe headache and took 1000mg Tylenol; fell back to sleep and woke at 8:30 am with headache presenting more like a migraine in upper right eyebrow area so took Rizatriptan; felt much better for rest of the day (not 100 % but much much better(; woke with slight headache Oct 24 and took 400mg ibuprofen 10:30 am; Oct 25 slight headache in morning with strange arm tingle/pain on right arm (shot was left arm) may be unrelated
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: sever headache took Rizatriptan at 1130 pm; woke at night to use restroom and felt dizzy - waited a bit and tried to get back to bed but passed out; woke up what I believe to be a few minutes later (4:30 am I think) laying on bathroom floor; got back in bed; woke at 6:30 am and took another Riza and tried to sleep more; 11:30 am still terrible headache took 400mg ibuprofen; 3:00pm 400mg ibuprofen and 4pm 200 more; no relief; took 1000 Tylenol at 5:00pm; 400mg ibuprofen 9:00pm; headache still severe; 11:30 pm 1000mg Tylenol; slept 5 hours and woke up Oct 23 at 5:45 with severe headache and took 1000mg Tylenol; fell back to sleep and woke at 8:30 am with headache presenting more like a migraine in upper right eyebrow area so took Rizatriptan; felt much better for rest of the day (not 100 % but much much better(; woke with slight headache Oct 24 and took 400mg ibuprofen 10:30 am; Oct 25 slight headache in morning with strange arm tingle/pain on right arm (shot was left arm) may be unrelated
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Pain, Pain in extremity
Clinical narrative: Extreme joint pain and body aches Joints feel swollen and stiff. Burning and sharp pains in all joints- including fingers and toes
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PFizer covid vaccine when diluting it put 0.2ml solution instead of 2.2 ml
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a vaccine outside of expiration date. Product expired 9/30/22 and was administered on 10/7/22.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: developed shingles 9 days after receiving Pfizer Bivalent
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given past expiration
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Diarrhoea, Electrocardiogram normal, Heart rate increased, Pyrexia
Clinical narrative: I was vomiting with diarrhea and a temperature or fever of 103 degrees, my heart rate has been running @ 119BPM and occasionally has spiked to 132BPM.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I was vomiting with diarrhea and a temperature or fever of 103 degrees, my heart rate has been running @ 119BPM and occasionally has spiked to 132BPM.
Age: 10.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: This patient was given the Adult Pfizer COVID-19, Bivalent instead of the Pediatric Pfizer COVID-19, Bivalent. The patient did not report any adverse events.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Fall, Pneumonia aspiration, SARS-CoV-2 test positive
Clinical narrative: PFIZER (COMIRNATY) COVID VACCINE #3 GIVEN 6/23/22, LOT # FM7553); 6/23/22 pt placed in a SNF after recent hospitalization due to falling at home and aspiration pneumonia; 6/27/22 pt  had a positive COVID test while in the facility; pt passed away in the facility
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Wrong product administered
Clinical narrative: Patient handed vaccine administration form. Verbally confirmed she would be getting flu shot. Asked what arm and how old patient is. Patient replied ?68 years old, I have a birthday coming up.? Vaccinator said she would get the high dose flu for those over 65 years old. Before injecting left deltoid, vaccinator said aloud ?this is your flu shot?. Administered without issue. Patient told she did not have to wait and replied that she thought this was the covid booster shot. Directed back to front desk to get covid booster paperwork, said she did the flu paperwork online. Pharmacist informed, this vaccinator directed to fill out form
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient handed vaccine administration form. Verbally confirmed she would be getting flu shot. Asked what arm and how old patient is. Patient replied ?68 years old, I have a birthday coming up.? Vaccinator said she would get the high dose flu for those over 65 years old. Before injecting left deltoid, vaccinator said aloud ?this is your flu shot?. Administered without issue. Patient told she did not have to wait and replied that she thought this was the covid booster shot. Directed back to front desk to get covid booster paperwork, said she did the flu paperwork online. Pharmacist informed, this vaccinator directed to fill out form
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Pfizer 5-11 vaccine inadvertently rather than the Pfizer 6 month to 4 year vaccine. Disclosed to mother that incorrect dose was given and advised to contact clinic for any adverse reactions. No adverse reaction noted at the time of vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: A week after receiving the booster I tested positive for Covid. I found out on the day I tested positive that I was exposed 4 days earlier.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypoxia, Increased bronchial secretion, SARS-CoV-2 test positive
Clinical narrative: 09/03/22 presents to ED for "hypoxia and increased respiratory secretions". PMHx of "PE, recent hospitalization for multidrug-resistant pseudomonal pneumonia, history of stroke, trach dependent"