chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Pediarix dose to a 2 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number YP2Y3, expiry date 08-APR-2023) for prophylaxis.   On 10-APR-2023, the patient received Pediarix (right thigh). On 10-APR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Pediarix dose to a 2 month old patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2023 The registered nurse enquired, how to proceed and what is the efficacy? The reporter reported that they inadvertently administered an expired Pediarix dose to a patient.  The registered nurse confirmed dose was administered in their facility.  The reporter did not consent to follow-up. The patient inadvertently received an expired Pediarix vaccine which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Eructation, Gait disturbance, Pain
Clinical narrative: difficulty walking; pain; belching; indigestion; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (difficulty walking), PAIN (pain), ERUCTATION (belching) and DYSPEPSIA (indigestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), ERUCTATION (belching) (seriousness criterion medically significant) and DYSPEPSIA (indigestion) (seriousness criterion medically significant). At the time of the report, GAIT DISTURBANCE (difficulty walking), PAIN (pain), ERUCTATION (belching) and DYSPEPSIA (indigestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that After the Moderna COVID vaccine the patient became sick from Jul-2021, and stated that the vaccine was totally disabled the patient's condition. No treatment medications were reported.  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) events of Gait disturbance, Pain, Eructation and Dyspepsia that occurred in the context of a dose of mRNA-1273 Vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination and exact onset date of the events was not available. No information on risk factors, medical history, concurrent conditions, detailed clinical course, relevant investigations, treatment received were provided. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19-2
Symptoms: Gastrointestinal disorder, Myalgia, Vomiting
Clinical narrative: severe GI issues; throwing up for approximately 6hrs; minor symptoms (muscle aches); This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (severe GI issues), MYALGIA (minor symptoms (muscle aches)) and VOMITING (throwing up for approximately 6hrs) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023, the patient experienced MYALGIA (minor symptoms (muscle aches)). On 13-Apr-2023, the patient experienced GASTROINTESTINAL DISORDER (severe GI issues) and VOMITING (throwing up for approximately 6hrs). On 13-Apr-2023, VOMITING (throwing up for approximately 6hrs) had resolved. At the time of the report, GASTROINTESTINAL DISORDER (severe GI issues) and MYALGIA (minor symptoms (muscle aches)) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered GASTROINTESTINAL DISORDER (severe GI issues), MYALGIA (minor symptoms (muscle aches)) and VOMITING (throwing up for approximately 6hrs) to be related.    No concomitant medications were reported. No treatment medications were reported.  Patient was throwing up for 6 hours.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for COVID) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 17-May-2022 and Moderna COVID-19 Vaccine on 14-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] and ATENOLOL for an unknown indication.    On 14-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive for COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Height of the patient was reported as 5 feet and 1 and a half inches or 5 feet and 2 inches.  It was reported that the patient got Moderna shot in arm twice.  The patient tested positive for COVID and doctor prescribed Paxlovid. The patient had been sick for few days and the patient was also sick at the time of reporting.
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: Patient mentioned feeling very fatigued the day after receiving the shot(s), Moderna knocked patient on the butt, each dose/Adverse effect; This spontaneous case was reported by a non-health professional and describes the occurrence of FATIGUE (Patient mentioned feeling very fatigued the day after receiving the shot(s), Moderna knocked patient on the butt, each dose/Adverse effect) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to vaccines, medications, food, and other products.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Patient mentioned feeling very fatigued the day after receiving the shot(s), Moderna knocked patient on the butt, each dose/Adverse effect). At the time of the report, FATIGUE (Patient mentioned feeling very fatigued the day after receiving the shot(s), Moderna knocked patient on the butt, each dose/Adverse effect) had resolved.            No concomitant medication information was provided.  It was reported that the patient could not recall the dates of vaccination/booster dose received. The fatigue did subside and the patient noted no other reactions or adverse events (skin, respiratory, etc.) associated with the shots. The event did not cause the patient to seek medical care.  No treatment medication information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered 5 days after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023 at 6:40 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2023 at 6:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD).    No concomitant medications were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No reported symptoms. No additional doses, medications, or treatments was given.
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Physician/patient reporting having generalize urticaria rash after getting the vaccine; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Physician/patient reporting having generalize urticaria rash after getting the vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not report having allergy or diseases.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Physician/patient reporting having generalize urticaria rash after getting the vaccine). At the time of the report, URTICARIA (Physician/patient reporting having generalize urticaria rash after getting the vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Feeding disorder
Clinical narrative: The patient states that he didn't eat at all; Had very bad stomach pains; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Had very bad stomach pains) and FEEDING DISORDER (The patient states that he didn't eat at all) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ABDOMINAL PAIN UPPER (Had very bad stomach pains). On an unknown date, the patient experienced FEEDING DISORDER (The patient states that he didn't eat at all). The patient was treated with LICORICE [GLYCYRRHIZA GLABRA] at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (BISMUTH SALICYLATE) at an unspecified dose and frequency and SIMETICONE (SIMETHICONE) at a dose of 125 milligram, pills. In January 2023, ABDOMINAL PAIN UPPER (Had very bad stomach pains) had resolved. At the time of the report, FEEDING DISORDER (The patient states that he didn't eat at all) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received Moderna 1st dose on 02-Apr-2021 with batch number 026B21A, 2nd dose on 30-Apr-2021 with batch number 004C21A, third dose on 10-Nov-2021 with batch number 039905 and fourth dose on 22-Jun-2022 with batch number 014B22A. Patient never had any bad reactions to previous shots. It was like he got placebo shot for all of them, except the last one. He had no reaction at all to them. The last one, he did have a bad reaction to it. The only relief was chewing and swallowing natural licorice to help ease the pain. Patient had tried a Pepto Bismol (bismuth salicylate) tablet and Gas-X (simethicone 125mg) pills also. Patient was not experiencing stomach pains anymore. Stomach pains started late fall of 2022 to early January 2023. It was for a few days. Patient didn't have rash, weakness, myocarditis, pericarditis, or nausea.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient missed his second dose of his primary series; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in for a primary dose, she received a vaccine from the grey border box of moderna bivalent; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient came in for a primary dose, she received a vaccine from the grey border box of moderna bivalent) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient came in for a primary dose, she received a vaccine from the grey border box of moderna bivalent) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient came in for a primary dose, she received a vaccine from the grey border box of moderna bivalent) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient came in for a primary dose, she received a vaccine from the grey border box of moderna bivalent).    Concomitant medication details not reported by the reporter. Patient came in for a primary dose, she received a vaccine from the grey border box of moderna bivalent. It was the pharmacist understanding that the vaccine could be used as primary or booster. On the website when filing it says invalid and it is only a booster. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots in lungs, legs, and other areas of the body; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clots in lungs, legs, and other areas of the body) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots in lungs, legs, and other areas of the body) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (Blood clots in lungs, legs, and other areas of the body) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient got hospitalized that lasted for more than 1 week. Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by other health care professional, concerning an elderly male patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Thrombosis, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. As reported, patient had blood clots in lungs, legs and other areas of the body. He was hospitalized for more than 1 week. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling, Vaccination site pain
Clinical narrative: 2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023; The patients left injection site arm was sore the night after the vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023) and VACCINATION SITE PAIN (The patients left injection site arm was sore the night after the vaccination) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 1), PFIZER BIONTECH COVID-19 VACCINE (first booster) and PFIZER BIONTECH COVID-19 VACCINE (dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 11-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (The patients left injection site arm was sore the night after the vaccination). On 13-Apr-2023, the patient experienced SWELLING (2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023). At the time of the report, SWELLING (2 days later the patient experienced puffiness and swelling in the space between her left shoulder and neck which the patient described as the spot where her bra strap would be located/swelling started on April 13, 2023) and VACCINATION SITE PAIN (The patients left injection site arm was sore the night after the vaccination) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patients left injection site arm was sore the night after the vaccination and then 2 days later the patient experienced puffiness and swelling in the space between the left shoulder and neck which the patient described as the spot where her bra strap would be located. No treatment information was provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Disorientation, Feeling abnormal, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: In late March 2023, I was feeling "off" for a few days and called the doctor. I was feeling disoriented and thought I was having blood sugar issues. I began to feel really out of it and I went to the emergency department at 2:30AM. I tested positive for COVID-19. I got a prescription for PAXLOVID. I began taking it on Saturday and it began to help. I felt better in about 3 days. I had a severe sore throat that lasted for about 2 days. Several days later, March 29, 2023, I tested negative but then had a rebound case. I tested positive again on April 2, 2023.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: site redness, swelling, painful to touch, chills, fever, and not feeling well in general.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: site redness, swelling, painful to touch, chills, fever, and not feeling well in general.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out 5 min after administering vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE COVID 19 EXPIRED  11/22/2022
Age: 76.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has red area (it expanded), swelling and warm to touch on the injection site.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: none COVID 19 VACCINE EXPIRED 11/2022 GIVEN 12/10/2022
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE COVID 19 VACCINE EXPIRED 11/22/2022
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: Patient received Janssen COVID vaccine on 4/7/21, Pfizer COVID vaccine on 10/25/21 and 4/11/22, and Pfizer Bivalent COVID booster vaccine on 10/21/22. On 4/6/23, patient admitted to our inpatient facility (med/surg unit) with COVID-19 pneumonia with resulting acute hypoxic respiratory failure and thrombocytopenia. Patient discharged home on 4/10/23.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Dyspnoea, Malaise, Myalgia
Clinical narrative: Each time I received a COVID-19 I have experienced the same side effects that last for about a week afterwards, shortness of breath, loss of energy, cough - especially when prone position. In addition, there can be some muscle soreness. I am in a program through the HCF for individuals that experience long-COVID-19 symptoms but have never had COVID-19. I was given naltrexone to help treat the symptoms of long-COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: I had a severe headache on the top of my head and sinus like symptoms. I had a fever that went up to 102 degrees. The next morning I went to the urgent care. They did a flu and COVID swab and they treated me for a sinus infection and gave me antibiotics. I didn't find out until later in the day that my COVID test was positive. I continued the antibiotics they gave me. The following Monday I called my doctor and had a Telehealth visit with her. She gave me prednisone which worked wonders. I was extremely tired and slept a lot. It never went into my chest. By the end of the following week I felt better.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive, Sinus disorder, Sinusitis
Clinical narrative: I had a severe headache on the top of my head and sinus like symptoms. I had a fever that went up to 102 degrees. The next morning I went to the urgent care. They did a flu and COVID swab and they treated me for a sinus infection and gave me antibiotics. I didn't find out until later in the day that my COVID test was positive. I continued the antibiotics they gave me. The following Monday I called my doctor and had a Telehealth visit with her. She gave me prednisone which worked wonders. I was extremely tired and slept a lot. It never went into my chest. By the end of the following week I felt better.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Patient didn't mention about this ADR till today and said he thought it was Flu shot that caused Numbness on his face possible Bell's Palsy, however, he said he has seen md in hospital, Urgent Care, and Neurologist, none of them said bc of vaccines that caused this kind of reaction.  Neurologist couldn't find any evidence of the correlation between his issue to any vaccines.  Patient was not sure if it 's was the Flu shot he got 9 days prior or Moderna vaccine he got 5 months prior. Patient has gotten Flu shot every year for years without issue in the past.  He had no issue with tdap or shingrix either.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Headache, sweats, dizziness, and fainting twice. My husband found me on bathroom floor blacked out, then helped me to feet once he was able to wake me, walked me to bed where I again fainted.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Resident expired
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Gave .2ml without being diluted.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchitis, COVID-19, Cough, Headache, Night sweats
Clinical narrative: On April 10, 2023, I had a slight cough but the next day it progressed, and I had a low-grade fever. I had a headache, and no pain reliever would help. Thursday, I had very mild body aches. I continued to cough. I had night sweats. I went to the clinic on the 13th and tested positive for COVID-19. When the doctor checked my lungs, she noted I had a bit of bronchitis. I was prescribed a Z-PAK.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On April 10, 2023, I had a slight cough but the next day it progressed, and I had a low-grade fever. I had a headache, and no pain reliever would help. Thursday, I had very mild body aches. I continued to cough. I had night sweats. I went to the clinic on the 13th and tested positive for COVID-19. When the doctor checked my lungs, she noted I had a bit of bronchitis. I was prescribed a Z-PAK.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I felt like I was getting a cold.  I was tired, no fever, nasal drainage. I didn't have serious symptoms.  I did not suffer greatly.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac function test, Cardiac stress test, Chest discomfort, Electrocardiogram
Clinical narrative: Chest pressure with palpitations and rapid heart beats. Skips beats when laying down or standing up suddenly.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Extrasystoles, Heart rate increased, Palpitations, Scan myocardial perfusion
Clinical narrative: Chest pressure with palpitations and rapid heart beats. Skips beats when laying down or standing up suddenly.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time abnormal, Aortic aneurysm, Arrhythmia, Coagulopathy, Deep vein thrombosis
Clinical narrative: Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer increased, Gastrooesophageal reflux disease, Haematemesis, Haemoptysis
Clinical narrative: Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperfibrinogenaemia, Hypotension, International normalised ratio, Laboratory test, Leukocytosis
Clinical narrative: Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Oesophageal disorder, Oesophageal haemorrhage, Pericarditis, Pleurisy
Clinical narrative: Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumothorax, Pulmonary embolism, Renal failure, Tachycardia, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Bi-lateral Pulmonary Embolism-14 days after vaccination. Aortic Aneurysm. Acute DVT. Kidney Failure. Leukocytosis Hyperfibrinogenemia Partially collapsed lungs. Ground glass opacities in upper lobes of both lungs. Hemoptysis Hematemesis Pleurisy Esophageal Bleeding/Lesion. Has developed  into GERD over past year despite protonix. Heart Arrythmia. Pericarditis. Vertigo. Tachycardia/hypotension. Possible Myocarditis. Blood coagulation disorder-Abnormal APTT, INR, Elevated D-Dimer 1+ year after vaccination. All is consistent with findings  and timeline of VITT, " Vaccine Induced immune Thrombotic Thrombocytopenia"
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: This was an erronous second bivalent booster given outside of guidelines. Patient had no reactions
Age: 60.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Discomfort, Injection site erythema, Mobility decreased, Pain, Vaccination site swelling
Clinical narrative: Beginning overnight after being vaccinated patient reports a bothersome redness and swelling at the site of vaccination that made moving her arm to certain positions uncomfortable and difficult. Patient took acetaminophen for the pain with marginal benefit. Patent reported to the pharmacy the night of 4/18/23 to report the reaction and says that today the swelling and soreness appears to be improving.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Palpitations
Clinical narrative: Heart palpitations, and period was suddenly very heavy, and long, lasted over 1 month( 3 weeks of spotting )
Age: 0.83
Sex: M
Vaccine: FLUC4, HEP
Symptoms: Crying, Cyanosis, Immediate post-injection reaction, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Immediately after the vaccines the patient was crying, turned blue, stopped crying and slumped over on to mom's chest. This was brief and only a few seconds.  This happened again while mom was driving the patient home and took longer to get the patient to respond.  She pulled over and felt like the patient was OK, so she did not take him to the emergency room as advised.  So far after this he has been OK and without any odd episodes.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: None Covid 19 vaccine expired 11/22/2022 Covid 19 vaccine given 12/09/2022
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none covid 19 vaccine expired 11/22/2022 Given 12/09/2022
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: None covid 19 vaccine expired 11/22/2022 Given 12/09/2022
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: NONE COVID 19
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: none covid 19 vaccine expired 11/22/2022 given 12-09-2022
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none covid 19 vaccine expired 11/22/2022 given 12/09/2022
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none COVID 19 EXPIRED 11/22/2022 GIVEN 12/08/2022
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aspiration bone marrow, Blood test abnormal, Haematocrit increased, Platelet count increased, Ultrasound spleen
Clinical narrative: I had my first dose of Moderna, went for wellness checkup between vaccinations - 4-20-21. My platelet and hemocrit levels were extremely high. I was referred to see a hematologist 5/11, and he performed a bone marrow test 5/19 and ultrasound of the spleen 6/11. Visited another hematologist 6/17 and had blood work done, which reinforced the original blood results. It may not be related to my vaccination, but the possibility of blood clots made me wonder. So I am sending this form.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain
Clinical narrative: Patient was given a Pfizer vaccine. Approximately 10 mins after receiving same her mother reported that patient was having chest. Brought into observation Rm and closely monitored & within normal limits. 14:44 BP 106/69 HR 83 R 14 O2 Sat 96% Pain 7/10 14:54 B/P 113/71 HR 71 R 14 Pain 1/10
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Asthenia, Back pain, Balance disorder
Clinical narrative: 6-5-21 8.20pm Pain in  heart, shortness of breath, needing to breathe through mouth, not nose. Held on to counter&walls for balance. Earlier  had joint pain and pain in back. 8:45pm arrive at Urgent Care. Turned away. told to go to ER. 9:15 in ER, Temp 102 pain in heart continues. Given inflammatory at 11pmPain stops shortly after. EKG and Blood work taken. "Small abnormality" s on EKG.Pain ilntermitt through Wed.Motrin given as needed. Energy level low, &tired. Pain constant Wed afternoon. 6/1021 Followup w/family practitioner. Advised to start motrin every 6 hours. 6/11/21 Hospital for EKG,ultrasound , Cardiologist consult. Irregular intermittent p curve. Continue motrin, limit exercise.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature increased, Dyspnoea, Echocardiogram abnormal, Electrocardiogram P wave abnormal
Clinical narrative: 6-5-21 8.20pm Pain in  heart, shortness of breath, needing to breathe through mouth, not nose. Held on to counter&walls for balance. Earlier  had joint pain and pain in back. 8:45pm arrive at Urgent Care. Turned away. told to go to ER. 9:15 in ER, Temp 102 pain in heart continues. Given inflammatory at 11pmPain stops shortly after. EKG and Blood work taken. "Small abnormality" s on EKG.Pain ilntermitt through Wed.Motrin given as needed. Energy level low, &tired. Pain constant Wed afternoon. 6/1021 Followup w/family practitioner. Advised to start motrin every 6 hours. 6/11/21 Hospital for EKG,ultrasound , Cardiologist consult. Irregular intermittent p curve. Continue motrin, limit exercise.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fatigue, Nasal congestion, Pain
Clinical narrative: 6-5-21 8.20pm Pain in  heart, shortness of breath, needing to breathe through mouth, not nose. Held on to counter&walls for balance. Earlier  had joint pain and pain in back. 8:45pm arrive at Urgent Care. Turned away. told to go to ER. 9:15 in ER, Temp 102 pain in heart continues. Given inflammatory at 11pmPain stops shortly after. EKG and Blood work taken. "Small abnormality" s on EKG.Pain ilntermitt through Wed.Motrin given as needed. Energy level low, &tired. Pain constant Wed afternoon. 6/1021 Followup w/family practitioner. Advised to start motrin every 6 hours. 6/11/21 Hospital for EKG,ultrasound , Cardiologist consult. Irregular intermittent p curve. Continue motrin, limit exercise.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Death, Hyperviscosity syndrome, Multiple organ dysfunction syndrome
Clinical narrative: Patient brought to the ED by EMS on 1/1/23 for evaluation of a stroke. Per EMS, the patient received a COVID vaccine on 12/27/22 and has been endorsing left arm soreness and lethargy. His wife reported he went to the bathroom and back to bed around 1pm, his last known time at normal baseline. His wife checked on him around 6pm and the patient was not responding, so EMS was called. On MRI, he was noted to have several embolic strokes. Additionally, a COVID PCR test returned positive. Patient was admitted 1/1/23. Within 24 hours after admission, he developed progressive unresponsiveness, possible seizure, profound and progressive circulatory collapse, hemoconcentration and worsening metabolic acidosis. Additionally he had a cardiac arrest. The patient was resuscitated initially however given his progressive organ failure and extreme critical illness, family elected to move toward comfort care. The patient passed away on 1/2/23. Discharge diagnoses include:  1. COVID infection; 2. h/o recent COVID vaccine; 3. probable idiopathic capillary leak syndrome due to #1 or #2; 4. profound circulatory shock due to #3; and 5. multisystem organ failure including metabolic acidosis, hypoxemic respiratory failure, and stroke due to #3 and #4.   Patient had received four doses of the COVID vaccine series.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, Cardiac arrest, Circulatory collapse, Critical illness, Death
Clinical narrative: Patient brought to the ED by EMS on 1/1/23 for evaluation of a stroke. Per EMS, the patient received a COVID vaccine on 12/27/22 and has been endorsing left arm soreness and lethargy. His wife reported he went to the bathroom and back to bed around 1pm, his last known time at normal baseline. His wife checked on him around 6pm and the patient was not responding, so EMS was called. On MRI, he was noted to have several embolic strokes. Additionally, a COVID PCR test returned positive. Patient was admitted 1/1/23. Within 24 hours after admission, he developed progressive unresponsiveness, possible seizure, profound and progressive circulatory collapse, hemoconcentration and worsening metabolic acidosis. Additionally he had a cardiac arrest. The patient was resuscitated initially however given his progressive organ failure and extreme critical illness, family elected to move toward comfort care. The patient passed away on 1/2/23. Discharge diagnoses include:  1. COVID infection; 2. h/o recent COVID vaccine; 3. probable idiopathic capillary leak syndrome due to #1 or #2; 4. profound circulatory shock due to #3; and 5. multisystem organ failure including metabolic acidosis, hypoxemic respiratory failure, and stroke due to #3 and #4.   Patient had received four doses of the COVID vaccine series.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Embolic stroke, Haemoconcentration, Lethargy, Magnetic resonance imaging head abnormal, Metabolic acidosis
Clinical narrative: Patient brought to the ED by EMS on 1/1/23 for evaluation of a stroke. Per EMS, the patient received a COVID vaccine on 12/27/22 and has been endorsing left arm soreness and lethargy. His wife reported he went to the bathroom and back to bed around 1pm, his last known time at normal baseline. His wife checked on him around 6pm and the patient was not responding, so EMS was called. On MRI, he was noted to have several embolic strokes. Additionally, a COVID PCR test returned positive. Patient was admitted 1/1/23. Within 24 hours after admission, he developed progressive unresponsiveness, possible seizure, profound and progressive circulatory collapse, hemoconcentration and worsening metabolic acidosis. Additionally he had a cardiac arrest. The patient was resuscitated initially however given his progressive organ failure and extreme critical illness, family elected to move toward comfort care. The patient passed away on 1/2/23. Discharge diagnoses include:  1. COVID infection; 2. h/o recent COVID vaccine; 3. probable idiopathic capillary leak syndrome due to #1 or #2; 4. profound circulatory shock due to #3; and 5. multisystem organ failure including metabolic acidosis, hypoxemic respiratory failure, and stroke due to #3 and #4.   Patient had received four doses of the COVID vaccine series.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Organ failure, Pain in extremity, Respiratory failure, Resuscitation, SARS-CoV-2 test positive
Clinical narrative: Patient brought to the ED by EMS on 1/1/23 for evaluation of a stroke. Per EMS, the patient received a COVID vaccine on 12/27/22 and has been endorsing left arm soreness and lethargy. His wife reported he went to the bathroom and back to bed around 1pm, his last known time at normal baseline. His wife checked on him around 6pm and the patient was not responding, so EMS was called. On MRI, he was noted to have several embolic strokes. Additionally, a COVID PCR test returned positive. Patient was admitted 1/1/23. Within 24 hours after admission, he developed progressive unresponsiveness, possible seizure, profound and progressive circulatory collapse, hemoconcentration and worsening metabolic acidosis. Additionally he had a cardiac arrest. The patient was resuscitated initially however given his progressive organ failure and extreme critical illness, family elected to move toward comfort care. The patient passed away on 1/2/23. Discharge diagnoses include:  1. COVID infection; 2. h/o recent COVID vaccine; 3. probable idiopathic capillary leak syndrome due to #1 or #2; 4. profound circulatory shock due to #3; and 5. multisystem organ failure including metabolic acidosis, hypoxemic respiratory failure, and stroke due to #3 and #4.   Patient had received four doses of the COVID vaccine series.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient brought to the ED by EMS on 1/1/23 for evaluation of a stroke. Per EMS, the patient received a COVID vaccine on 12/27/22 and has been endorsing left arm soreness and lethargy. His wife reported he went to the bathroom and back to bed around 1pm, his last known time at normal baseline. His wife checked on him around 6pm and the patient was not responding, so EMS was called. On MRI, he was noted to have several embolic strokes. Additionally, a COVID PCR test returned positive. Patient was admitted 1/1/23. Within 24 hours after admission, he developed progressive unresponsiveness, possible seizure, profound and progressive circulatory collapse, hemoconcentration and worsening metabolic acidosis. Additionally he had a cardiac arrest. The patient was resuscitated initially however given his progressive organ failure and extreme critical illness, family elected to move toward comfort care. The patient passed away on 1/2/23. Discharge diagnoses include:  1. COVID infection; 2. h/o recent COVID vaccine; 3. probable idiopathic capillary leak syndrome due to #1 or #2; 4. profound circulatory shock due to #3; and 5. multisystem organ failure including metabolic acidosis, hypoxemic respiratory failure, and stroke due to #3 and #4.   Patient had received four doses of the COVID vaccine series.
Age: 0.5
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent vaccine given instead of monovalent for second dose in the infant series