chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dyspnoea, Electrocardiogram abnormal, Gastrointestinal disorder, Inflammatory marker test
Clinical narrative: Patient is a 85 y.o. female patient of MD with history of COPD, VTE, chronic pain syndrome, HTN, previous tobacco abuse,  and neuropathy who presented with shortness of breath and found to have COVID. Problem based management in the hospital is as follows:   Acute hypoxic respiratory failure due to Covid-19 Virus Infection COPD with Exacerbation Date of onset of symptoms: 12/7/2022. Date of covid positive test: 12/7/2022 Nonproductive cough, shortness of breath, generalized weakness, body aches and chills Vaccination status: vaccinated x4 CTPA with GGO in bilateral lower>upper lung fields O2 on adm up to  2L NC, now able to be on room air  Normal inflammatory markers.  Initially declined steroids due to GI disturbances but then agreeable as PPI were started together. .  Continued home Symbicort with scheduled and PRN Albuterol inhaler.  ID following.  Continued remdesivir.  Continued prednisone. PT/OT/UM   AKI, resolved Cr 1.29 on arrival. Down to 0.89 on day of discharge Resumed Hyzaar  Monitor renal function Avoid nephrotoxins   Hx of VTE With DVT 2014 and PE 2017 Continued lifelong Eliquis BID   Chronic Pain Syndrome Chronic OA, back pain and trigeminal neuralgia NARx with Percocet 10/325 mg 4x daily and Gabapentin 400 mg q6 hours  HTN resumed Hyzaar as BP elevated  Elevated Troponin TnT 22 on arrival in setting of AKI without CP MPI (6/2021) without inducible ischemia EKG with sinus tachycardic, PVC, artifact, but no ST changes  Depression Stable, continue home Wellbutrin   After 4 days of hospital stay, patient was doing well so she was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lung opacity, Pain, SARS-CoV-2 test positive, Sinus tachycardia, Troponin increased
Clinical narrative: Patient is a 85 y.o. female patient of MD with history of COPD, VTE, chronic pain syndrome, HTN, previous tobacco abuse,  and neuropathy who presented with shortness of breath and found to have COVID. Problem based management in the hospital is as follows:   Acute hypoxic respiratory failure due to Covid-19 Virus Infection COPD with Exacerbation Date of onset of symptoms: 12/7/2022. Date of covid positive test: 12/7/2022 Nonproductive cough, shortness of breath, generalized weakness, body aches and chills Vaccination status: vaccinated x4 CTPA with GGO in bilateral lower>upper lung fields O2 on adm up to  2L NC, now able to be on room air  Normal inflammatory markers.  Initially declined steroids due to GI disturbances but then agreeable as PPI were started together. .  Continued home Symbicort with scheduled and PRN Albuterol inhaler.  ID following.  Continued remdesivir.  Continued prednisone. PT/OT/UM   AKI, resolved Cr 1.29 on arrival. Down to 0.89 on day of discharge Resumed Hyzaar  Monitor renal function Avoid nephrotoxins   Hx of VTE With DVT 2014 and PE 2017 Continued lifelong Eliquis BID   Chronic Pain Syndrome Chronic OA, back pain and trigeminal neuralgia NARx with Percocet 10/325 mg 4x daily and Gabapentin 400 mg q6 hours  HTN resumed Hyzaar as BP elevated  Elevated Troponin TnT 22 on arrival in setting of AKI without CP MPI (6/2021) without inducible ischemia EKG with sinus tachycardic, PVC, artifact, but no ST changes  Depression Stable, continue home Wellbutrin   After 4 days of hospital stay, patient was doing well so she was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles
Clinical narrative: Patient is a 85 y.o. female patient of MD with history of COPD, VTE, chronic pain syndrome, HTN, previous tobacco abuse,  and neuropathy who presented with shortness of breath and found to have COVID. Problem based management in the hospital is as follows:   Acute hypoxic respiratory failure due to Covid-19 Virus Infection COPD with Exacerbation Date of onset of symptoms: 12/7/2022. Date of covid positive test: 12/7/2022 Nonproductive cough, shortness of breath, generalized weakness, body aches and chills Vaccination status: vaccinated x4 CTPA with GGO in bilateral lower>upper lung fields O2 on adm up to  2L NC, now able to be on room air  Normal inflammatory markers.  Initially declined steroids due to GI disturbances but then agreeable as PPI were started together. .  Continued home Symbicort with scheduled and PRN Albuterol inhaler.  ID following.  Continued remdesivir.  Continued prednisone. PT/OT/UM   AKI, resolved Cr 1.29 on arrival. Down to 0.89 on day of discharge Resumed Hyzaar  Monitor renal function Avoid nephrotoxins   Hx of VTE With DVT 2014 and PE 2017 Continued lifelong Eliquis BID   Chronic Pain Syndrome Chronic OA, back pain and trigeminal neuralgia NARx with Percocet 10/325 mg 4x daily and Gabapentin 400 mg q6 hours  HTN resumed Hyzaar as BP elevated  Elevated Troponin TnT 22 on arrival in setting of AKI without CP MPI (6/2021) without inducible ischemia EKG with sinus tachycardic, PVC, artifact, but no ST changes  Depression Stable, continue home Wellbutrin   After 4 days of hospital stay, patient was doing well so she was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Mono-valent was given instead of Bi-valent
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: only sore arm
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysuria, Pain, Prostatitis, Pyrexia, Urine analysis abnormal
Clinical narrative: I developed prostatitis. I went to the doctor, and I am now being treated with antibodies. I had difficulty urinating, pain, and fever.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Blood pressure increased, Chills, Cough, Electrocardiogram normal
Clinical narrative: The first symptom that I had was feeling cold chills and a low grade fever of 99.6. I have not had fever since 1988. I had a really bad cough, constant runny nose, exhaustion, brain fog and feet swelling. However I have constant joint pain due to six herniated discs in my spine so I cannot attribute it to the vaccine. Since I am on hormone therapy I was advised to go to urgent care in the event that I had blood clots. I had a slightly elevated heart rate and blood pressure but all other tests were normal. I have had my doctor review the data from the urgent care and she suggested that it may be a lingering case of COVID. I have a visit with her scheduled for March.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Heart rate increased, Intervertebral disc protrusion
Clinical narrative: The first symptom that I had was feeling cold chills and a low grade fever of 99.6. I have not had fever since 1988. I had a really bad cough, constant runny nose, exhaustion, brain fog and feet swelling. However I have constant joint pain due to six herniated discs in my spine so I cannot attribute it to the vaccine. Since I am on hormone therapy I was advised to go to urgent care in the event that I had blood clots. I had a slightly elevated heart rate and blood pressure but all other tests were normal. I have had my doctor review the data from the urgent care and she suggested that it may be a lingering case of COVID. I have a visit with her scheduled for March.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Laboratory test normal, Peripheral swelling, Pyrexia, Rhinorrhoea, Thrombosis
Clinical narrative: The first symptom that I had was feeling cold chills and a low grade fever of 99.6. I have not had fever since 1988. I had a really bad cough, constant runny nose, exhaustion, brain fog and feet swelling. However I have constant joint pain due to six herniated discs in my spine so I cannot attribute it to the vaccine. Since I am on hormone therapy I was advised to go to urgent care in the event that I had blood clots. I had a slightly elevated heart rate and blood pressure but all other tests were normal. I have had my doctor review the data from the urgent care and she suggested that it may be a lingering case of COVID. I have a visit with her scheduled for March.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Mono-valent instead of Bi-valent
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Mono-valent instead of Bi-valent
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: After receiving Booster, I was infected with Covid-19 with symptoms which included fever, trouble breathing, congestion,  dizziness, head ache, and  muscle pain. Started PAXLOVID on 11/12/2022. Experienced rebound Covid-19 symptoms on 11/23/2022 with an additional positive  rapid antigen test.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: After receiving Booster, I was infected with Covid-19 with symptoms which included fever, trouble breathing, congestion,  dizziness, head ache, and  muscle pain. Started PAXLOVID on 11/12/2022. Experienced rebound Covid-19 symptoms on 11/23/2022 with an additional positive  rapid antigen test.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Chills, Fatigue, Feeling abnormal, Malaise
Clinical narrative: My COVID-19 symptoms started on 12/06/2022 I went to a work party at around 08:00PM, where I couldn't feel the drink that I was drinking. It felt weird. On 12/07/2022 I had a fatigue and a sore throat. By the evening my symptom's got worse along with the symptoms I got chills. I did a home COVID-19 test on 12/09/2022 which was positive. On 12/10/2022 I called my doctor's office on Saturday since it was a weekend the office was closed my phone line was transferred to a hotline. They told me to fill out a form which I did it online and said someone will get back to me within 24 hours. The PAXLOVID will be shipped within 1-2 business days since my symptoms already started and it was the 3rd day of my symptoms. The time frame for the PAXLOVID to work was within 5 days of my symptoms. I decided not to wait to the medication. I took TYLENOL for first couple of nights.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive, Sensory loss
Clinical narrative: My COVID-19 symptoms started on 12/06/2022 I went to a work party at around 08:00PM, where I couldn't feel the drink that I was drinking. It felt weird. On 12/07/2022 I had a fatigue and a sore throat. By the evening my symptom's got worse along with the symptoms I got chills. I did a home COVID-19 test on 12/09/2022 which was positive. On 12/10/2022 I called my doctor's office on Saturday since it was a weekend the office was closed my phone line was transferred to a hotline. They told me to fill out a form which I did it online and said someone will get back to me within 24 hours. The PAXLOVID will be shipped within 1-2 business days since my symptoms already started and it was the 3rd day of my symptoms. The time frame for the PAXLOVID to work was within 5 days of my symptoms. I decided not to wait to the medication. I took TYLENOL for first couple of nights.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Malaise, Nausea
Clinical narrative: A PHN administered Pfizer Bivalent booster COVID 19 vaccine Lot # GK1337 in the left arm at 11:40 am. At 11: 45 am the PHN went to check on client. Client stated he "wasn't ok" and complained of a "stomach ache" and nausea, sudden onset. Client denied feeling dizzy, denied itchiness, skin color dry and appropriate. The PHN assisted client to sit down. Client reported history of "permanent nerve damage," uticaria, smoker, substance use,  and anxiety. Client stated no known history of allergies. Client stated he was not currently taking any medication. Vitals taken at 11:47 am: 96% Spo2, 94 bpm, RR16, BP 120/92 while sitting. At 11:50 am client stated he felt better and "it was all gone." At 11:55 am the PHN gave client applesauce to eat. At 12:00 pm vitals taken while sitting: 87 bpm, 96% SPo2. At 12:01 pm the PHN assisted client to stand. Client stated he felt "good" and denied dizziness, denied headache, denied nausea. Vitals taken: BP 135/92, RR 18, 96% SpO2, 96 bpm. The PHN educate to follow up with primary care physician in 24 hours.  PHN educated when to seek emergent care. PHN educated, supported, and referred to continue with behavioral health services to reschedule his appointment.  Client completed observation period and walked away with a steady gait at 12:10 pm.
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: COVID-19, Cough, Hyperhidrosis, Influenza, Respiratory tract congestion
Clinical narrative: I thought I had allergies. I was sneezing and coughing. Later that night I had head congestion. Then I started to have day and night sweats. I did an at home COVID-19 test and it was positive. I talked to my doctor, and she prescribed me LAGEVRIO, benzoate, and nasal spray. I also had the flu 2 weeks prior from me getting COVID-19. Sometimes when I wake up in the morning I am congested but it goes away.
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: I thought I had allergies. I was sneezing and coughing. Later that night I had head congestion. Then I started to have day and night sweats. I did an at home COVID-19 test and it was positive. I talked to my doctor, and she prescribed me LAGEVRIO, benzoate, and nasal spray. I also had the flu 2 weeks prior from me getting COVID-19. Sometimes when I wake up in the morning I am congested but it goes away.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: mother stated SE started that evening post vaccination on 12/14/22.  Redness, swelling, heat at injection site with itchiness.  mom used a cream for the itchiness (couldn't remember name) but it helped. patient presented today for flu shot and showed me the reaction on the LA arm.  outline of redness with injection site noticeable in the center.  no swelling but patient stated it still itched off and on. mother did not use ice for swelling/redness/heat but just the cream for the itchiness per mother statement. advised mother to get second shot with MD and to wait for one hour post vaccination if MD decides to continue with the inoculation or not. will need note for school if not given.  advised mom on ibuprofen for children (gave kg chart) in future for localized redness/heat/swelling and/or fever.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The vaccine was ordered by porotocol to be given as a 0.5ml dose. The vaccine given was 1.0 ml
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pruritus, Pyrexia
Clinical narrative: 101 temperature, chills, nausea and itchiness.  Temp back to normal in 24 hours.  Itchiness and slight nausea still there 48 hours later.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Injury associated with device, Urine analysis
Clinical narrative: Immunizing Technician had a needlestick following giving the injection. Went to Urgent Care to begin a preventative treatment.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Fatigue
Clinical narrative: I had a hoarse voice, cough, fatigue. The provider prescribed PAXLOVID for treatment. I was in isolation for 11 days.
Age: 26.0
Sex: F
Vaccine: COVID19-2, FLU4, TDAP
Symptoms: Syncope
Clinical narrative: Adverse Event: patient fainted after receiving third vaccination. She received adacel and fluzone quad in left arm and then pfizer bivalent in right arm.  Treatment: Caught patient when she was falling out of chair and gently laid her on the floor. She came back to consciousness within about 5-10 seconds. We provided her with water and orange juice and also gave her an ice pack. We had her remain at the pharmacy until she was feeling better.  Outcome: patient recovered and said she was feeling ok within about 15 minutes.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest X-ray normal, Discomfort, Dyspnoea, Dyspnoea exertional
Clinical narrative: On December 5, 2022, I noticed I was becoming short of breath when I would do my walking. I felt pressure and I was struggling to get enough air. It became so unpleasant I did not want to go for a walk. I noticed I had swollen glands and then a sore throat. I would wake up in the night and having trouble to get enough air, but I was able to get back to sleep. The swollen glands and sore throat went away. I continue to have difficulty breathing especially upon activity such as climbing stairs. I notified the neurologist that I was visiting at the time, and I was encouraged to go the emergency department. I went to the urgent care instead and they ran several tests, but none were conclusive. My blood pressure was high, though. I cannot remember the names of the tests they performed but they checked for heart attack.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Hypertension, Laboratory test normal, Lymphadenopathy, Middle insomnia
Clinical narrative: On December 5, 2022, I noticed I was becoming short of breath when I would do my walking. I felt pressure and I was struggling to get enough air. It became so unpleasant I did not want to go for a walk. I noticed I had swollen glands and then a sore throat. I would wake up in the night and having trouble to get enough air, but I was able to get back to sleep. The swollen glands and sore throat went away. I continue to have difficulty breathing especially upon activity such as climbing stairs. I notified the neurologist that I was visiting at the time, and I was encouraged to go the emergency department. I went to the urgent care instead and they ran several tests, but none were conclusive. My blood pressure was high, though. I cannot remember the names of the tests they performed but they checked for heart attack.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain
Clinical narrative: On December 5, 2022, I noticed I was becoming short of breath when I would do my walking. I felt pressure and I was struggling to get enough air. It became so unpleasant I did not want to go for a walk. I noticed I had swollen glands and then a sore throat. I would wake up in the night and having trouble to get enough air, but I was able to get back to sleep. The swollen glands and sore throat went away. I continue to have difficulty breathing especially upon activity such as climbing stairs. I notified the neurologist that I was visiting at the time, and I was encouraged to go the emergency department. I went to the urgent care instead and they ran several tests, but none were conclusive. My blood pressure was high, though. I cannot remember the names of the tests they performed but they checked for heart attack.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node of left armpit
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the 6 months to 5 years Bivalent Booster for his first vaccine instead of the 6 months to 5 years old Monovalent primary series.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Per Dr.: Left thigh area of erythema was outlined with a pen. There is a mild increase in heat and tenderness but no localized blanching or reaction. 12 x 14 cm area. It became red and painful. He is still walking normally.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Eye pain, Fatigue, Headache, Rash
Clinical narrative: Within 24-30 hours had asthma; skin infection; fatigue; extreme headache; eyes hurt went to eye doctor developed whole in left eye; pcp treated asthma and skin rash. Eye surgeon operated on left eye to verify it healed on it's own.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: Within 24-30 hours had asthma; skin infection; fatigue; extreme headache; eyes hurt went to eye doctor developed whole in left eye; pcp treated asthma and skin rash. Eye surgeon operated on left eye to verify it healed on it's own.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Jaw disorder, Magnetic resonance imaging head abnormal, Osteoarthritis
Clinical narrative: Fullness in left ear with constant need to clear; pain in left ear; tinnitus and pulsatile tinnitus. All symptoms worsened with subsequent vaccination. Pulsating and tinnitus persist; under pain management with daily use of prescribed pharmaceutical.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus, X-ray abnormal
Clinical narrative: Fullness in left ear with constant need to clear; pain in left ear; tinnitus and pulsatile tinnitus. All symptoms worsened with subsequent vaccination. Pulsating and tinnitus persist; under pain management with daily use of prescribed pharmaceutical.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 21 November 2022 after testing negative on 18 November with approved test kits at home.  I had a fever that never got over 100.5 F for one or two days, heavy cough, congestion, etc.  I continued to test positive until 10 December 2022 at 5 PM testing ever two or three days.  I treated with Mucinex Day and Night Fast-Max as needed (never close the max allowed).
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Chest pain, Cough, Electrocardiogram normal, Oropharyngeal pain
Clinical narrative: I started having chest pains. I went the ER and they did at EKG and it was normal. They also did a chest X-ray and it showed pneumonia. They prescribed me antibodies for 7 days. I went to get another chest X-ray and it was clear for pneumonia. 3 days later I started to get a raw sore throat, and coughing from the chest. The doctor prescribed me more medication but I am going in for another chest x-ray.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia
Clinical narrative: I started having chest pains. I went the ER and they did at EKG and it was normal. They also did a chest X-ray and it showed pneumonia. They prescribed me antibodies for 7 days. I went to get another chest X-ray and it was clear for pneumonia. 3 days later I started to get a raw sore throat, and coughing from the chest. The doctor prescribed me more medication but I am going in for another chest x-ray.
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Dizziness, Fall, Vomiting
Clinical narrative: PT states that she went home after receiving the vaccines to take a nap.  At "some point" several hours later she woke up dizzy and fell down then vomited.  She did not seek medical attention stating that she felt better the next day.  Will speak with dr before administering second dose of shingrix.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pediatric dose was given to adult patient anticipating adult Bivalent dose
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension, Renal function test normal, Urine analysis normal
Clinical narrative: Hypertension Blood Pressure 185/110 taken 5 days after vaccination  Prior BP s have been 120s/70s
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Pediatric Monovalent (6 months to 5 years) was incorrectly administered for patient anticipating adult Bivalent dose
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site streaking, Pallor, Petechiae, Rash
Clinical narrative: Per Dr.: Left deltoid with a 2  cm area of induration below the injection site. No skin erythema. Further down on the forearm is a 5 cm area of streaky red, blanching rash that patient says is extremely itchy and has been tempted to scratch it. There are a few petechiae from scratching. No axillary lymphadenopathy noted. No tenderness on palpation and exam of indurated area of red area.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash pruritic
Clinical narrative: Per Dr.: Left deltoid with a 2  cm area of induration below the injection site. No skin erythema. Further down on the forearm is a 5 cm area of streaky red, blanching rash that patient says is extremely itchy and has been tempted to scratch it. There are a few petechiae from scratching. No axillary lymphadenopathy noted. No tenderness on palpation and exam of indurated area of red area.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: on the 12th night after vaccination, I woke with extreme itching on my buttocks and discovered that my pelvic area and buttocks were covered in hives.   other areas including my arms, legs, and torso have been having periodic breakouts for 2 days now. treatment with Allegra and Benadryl is helpful but does does not complete mitigate the symptoms
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Pediatric monovalent dose was incorrectly administered for adult patient anticipating adult Bivalent
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache
Clinical narrative: Headache chills
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Pediatric monovalent vaccine was incorrectly administered for adult patient anticipating adult bivalent dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO known adverse event. However, this individual was administered a Moderna Monovalent Primary 0.5 mL dose by a clinical support team member, when the individual should have received a Moderna Bivalent dose. This individual has already completed the Moderna Monovalent primary series (2 doses) and a 1/2 dose primary series booster (in April 2022).
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient arrived for the Pfizer COVID Bivalent Booster. Instead he received the Pfizer pediatric monovalent  dose.  The event was reported to patient's pediatrician.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had redness, itching, and swelling at the injection site.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine given after vaccine was stored in a refrigerator that underwent a temperature excursion
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, C-reactive protein increased, Fatigue, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: New onset polyarthritis, morning joint stiffness and fatigue persistent since the injection and still currently present.  Tenderness and stiffness MCPs both hands and shoulders.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Polyarthritis, Rheumatoid factor positive, Tenderness
Clinical narrative: New onset polyarthritis, morning joint stiffness and fatigue persistent since the injection and still currently present.  Tenderness and stiffness MCPs both hands and shoulders.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Muscle tightness, Pain in extremity, Rash
Clinical narrative: Numbness and strong pain in right arm (arm in which patient was vaccinated) starting 4 days after vaccination.  Also some pain in upper right back area starting at this time.  Also rash on right arm and palm of right hand and tightened muscles in right arm.  (Patient had received four (4) prior doses of the original Pfizer COVID-19 vaccine - two primary vaccinations followed by two boosters - and was mildly ill after these doses, but then recovered completely.  The booster that seemingly caused the most recent effects was the recent Omicron-targeting Pfizer  booster.)  Patient received chiropractic treatment on 12/20, 12/21 and 12/22 for this issue; partial success in relieving pain.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was given after vaccine had been in a refrigerator that underwent a temperature excursion
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: light ringing in my left ear started within a week of this vaccine.   Went to my Dr. as well as Ear Dr. to test if my hearing was different but hearing is still fine in both ears.   No treatment seems to be available and I am open to trying whatever as it has been 24 hours a day 7 days a week for 21 months.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 65.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 53.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Injection site pruritus, Nausea
Clinical narrative: Fever, chills, fatigue, body pain, headache, nausea, rash on arm, itching at injection site. Alternated Tylenol and Ibuprofen for symptoms. Symptoms lasted about 48 hours except for the rash and itching which are still ongoing.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Fever, chills, fatigue, body pain, headache, nausea, rash on arm, itching at injection site. Alternated Tylenol and Ibuprofen for symptoms. Symptoms lasted about 48 hours except for the rash and itching which are still ongoing.
Age: 49.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Disturbance in attention, Fatigue, Headache, Influenza like illness
Clinical narrative: Moderate to severe flu like symptoms (fever, ache, headache, chills, extremely tired, sleepy, couldn't concentrate. This lasted for 2.5 days, Did not have a sore throat or cough.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Moderate to severe flu like symptoms (fever, ache, headache, chills, extremely tired, sleepy, couldn't concentrate. This lasted for 2.5 days, Did not have a sore throat or cough.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient has had no adverse events. Patient received the primary series of Moderna Covid 19 instead of the updated bivalent moderna booster for little ones.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Transient ischaemic attack
Clinical narrative: Per pt call on 12.29.22. pt started having half body paralyzed on and off about 7-8 days after injection. After discussing with regular MD was rushed to ER. Pt ok know, but per pt a neurologist said that he had many mini strokes. per pt around 21 mini strokes.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Death, Dysphagia
Clinical narrative: Caused inability to swallow. Death followed the following week
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Death of relative, Exposure during pregnancy, Foetal cardiac disorder, Foetal heart rate decreased, Hydrops foetalis
Clinical narrative: I was less than 12 weeks pregnant at the time that I received the vaccine. A few hours after the vaccine I had contractions on my lower belly for the rest of the day.  In December (about 20 weeks pregnant) during a routine ultrasound they notice my baby had a very slow heart beat and I was send to a local Hospital. At the hospital they determined that indeed my baby?s heart rate was dropping to 40 beats per minute. I was then transferred to another Hospital for higher level of care. After a referral to a third hospital in another county  with a fetal specialist it was determined that my baby in fact was suffering from a congenital complete heart block with hydrops with really poor outcomes. By baby was born at 29 weeks and was alive for less than 15 minutes.  Prior to this pregnancy, I had 2 healthy pregnancy with healthy babies, my first child was born four years ago  and my second child was born two years ago . Both of them are healthy and with no issues.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Premature delivery, Ultrasound antenatal screen abnormal, Uterine contractions abnormal
Clinical narrative: I was less than 12 weeks pregnant at the time that I received the vaccine. A few hours after the vaccine I had contractions on my lower belly for the rest of the day.  In December (about 20 weeks pregnant) during a routine ultrasound they notice my baby had a very slow heart beat and I was send to a local Hospital. At the hospital they determined that indeed my baby?s heart rate was dropping to 40 beats per minute. I was then transferred to another Hospital for higher level of care. After a referral to a third hospital in another county  with a fetal specialist it was determined that my baby in fact was suffering from a congenital complete heart block with hydrops with really poor outcomes. By baby was born at 29 weeks and was alive for less than 15 minutes.  Prior to this pregnancy, I had 2 healthy pregnancy with healthy babies, my first child was born four years ago  and my second child was born two years ago . Both of them are healthy and with no issues.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was in for 2nd dose of Monovalent Covid vaccine but instead received the Bivalent vaccine.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was in for 2nd dose of Monovalent Covid vaccine but instead received the Bivalent vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was supposed to get his second Monovalent and instead got the Bivalent.  No side effects were noted.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: FN6205) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history included: "temporal lobe epilepsy" (unspecified if ongoing), notes: 16 year old male with history of temporal lobe epilepsy. The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 03Mar2021, outcome "unknown". Therapeutic measures were taken as a result of seizure.  Clinical course: Patient experienced a seizure immediately within 10 minutes after initial dose of COVID 19 vaccine on 03Mar2021. Patient did not have a seizure in about 10 years. Taking Trileptal 600mg 2x a day. Sender's Comments: Based on the information provided in the narrative, a causal association between the event Seizure and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Imaging procedure, Immunoglobulin therapy, Laboratory test, Pain
Clinical narrative: After first vaccine my arm began hurting and continued hurting. The pain continued in my arm and began spreading everywhere. For the last 20 months I have suffered from extreme pain. I have seen over 50 physicians and had numerous hospitalizations. They have run too many tests for me to keep track. I finally began seeing a Dr. in June or July and he did IVIG therapy and it has offered some relief.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After first vaccine my arm began hurting and continued hurting. The pain continued in my arm and began spreading everywhere. For the last 20 months I have suffered from extreme pain. I have seen over 50 physicians and had numerous hospitalizations. They have run too many tests for me to keep track. I finally began seeing a Dr. in June or July and he did IVIG therapy and it has offered some relief.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electrocardiogram, Hypoaesthesia, Immediate post-injection reaction, Magnetic resonance imaging
Clinical narrative: receiving the shot burning in arm and  numbness occurred right  away.  shortly after that fingers went numb. After three months started seeing doctor and refered to therapy.Started Therapy  in November. nothing seemed to help
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aortic disorder, Condition aggravated, Pericarditis, Pruritus
Clinical narrative: After the first booster, he was itching just on his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262; Anatomical location: left arm), administration date: 02Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EM9810; Anatomical location: left arm), administration date: 21Feb2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the first booster, he was itching just on his back". Therapeutic measures were taken as a result of pruritus.  Additional information: After the first booster, he was itching just on his back and was given gaba and the itching phased off towards end of year. Lot:  is what is written on the card. Hard to read the writing. All of his vaccines were Pfizer vaccines, and they were all given in his left arm at the (withheld). Did not receive any other vaccines that same day. The patient saw  the allergist the first time it happened with the first booster. Allergist said no, its not an allergic reaction and prescribed the gaba at first. Allergist thought it was a neurological issue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416811 same patient, same event different dose (dose 2);US-PFIZER INC-202201387218 same patient, same event different dose (second booster);US-PFIZER INC-202201387232 same patient, same event different dose (LOE);US-PFIZER INC-202201387233 same reporter, different patient, different event;
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: After the first booster, he was itching just on his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262; Anatomical location: left arm), administration date: 02Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EM9810; Anatomical location: left arm), administration date: 21Feb2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the first booster, he was itching just on his back". Therapeutic measures were taken as a result of pruritus.  Additional information: After the first booster, he was itching just on his back and was given gaba and the itching phased off towards end of year. Lot:  is what is written on the card. Hard to read the writing. All of his vaccines were Pfizer vaccines, and they were all given in his left arm at the (withheld). Did not receive any other vaccines that same day. The patient saw  the allergist the first time it happened with the first booster. Allergist said no, its not an allergic reaction and prescribed the gaba at first. Allergist thought it was a neurological issue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416811 same patient, same event different dose (dose 2);US-PFIZER INC-202201387218 same patient, same event different dose (second booster);US-PFIZER INC-202201387232 same patient, same event different dose (LOE);US-PFIZER INC-202201387233 same reporter, different patient, different event;
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pericarditis, Pruritus
Clinical narrative: After the first booster, he was itching just on his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262; Anatomical location: left arm), administration date: 02Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EM9810; Anatomical location: left arm), administration date: 21Feb2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the first booster, he was itching just on his back". Therapeutic measures were taken as a result of pruritus.  Additional information: After the first booster, he was itching just on his back and was given gaba and the itching phased off towards end of year. Lot:  is what is written on the card. Hard to read the writing. All of his vaccines were Pfizer vaccines, and they were all given in his left arm at the (withheld). Did not receive any other vaccines that same day. The patient saw  the allergist the first time it happened with the first booster. Allergist said no, its not an allergic reaction and prescribed the gaba at first. Allergist thought it was a neurological issue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416811 same patient, same event different dose (dose 2);US-PFIZER INC-202201387218 same patient, same event different dose (second booster);US-PFIZER INC-202201387232 same patient, same event different dose (LOE);US-PFIZER INC-202201387233 same reporter, different patient, different event;