chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: myo/pericarditis; pericardial effusion; pericardial rub; This is a spontaneous report received from a Consumer or other non HCP.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON taken for contraception. Vaccination history included: j&j (DOSE 1, SINGLE, Batch/Lot No: 201A211A, Anatomical location: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 07Apr2021, when the patient was 21-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2 (BOOSTER), SINGLE, Batch/Lot No: FE3594, Anatomical location: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 15Dec2021, when the patient was 22-year-old, for COVID-19 immunization; influenza (DOSE NUMBER UNKNOWN, SINGLE, influenza quadrivalent Pfizer, vaccine location: arm), administration date: 06Oct2022, when the patient was 23-year-old, for Influenza immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant) with onset 11Nov2022 at 17:30, outcome "recovered with sequelae", described as "myo/pericarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant) with onset 11Nov2022 at 17:30, outcome "recovered with sequelae"; PERICARDIAL RUB (hospitalization) with onset 11Nov2022 at 17:30, outcome "recovered with sequelae". The patient was hospitalized for myopericarditis, pericardial effusion, pericardial rub (start date: 11Nov2022, discharge date: Nov2022, hospitalization duration: 1 day(s)). The events "myo/pericarditis", "pericardial effusion" and "pericardial rub" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (11Nov2022) myo/pericarditis, notes: pericardial effusion, abnormal ECG and pericardial rub; SARS-CoV-2 test: (11Nov2022) Negative, notes: Nasal Swab; Troponin: (11Nov2022) elevated. Therapeutic measures were taken as a result of myopericarditis, pericardial effusion, pericardial rub. Clinical course: Patient had no signs of infection or illness other than chest pain and tachycardia. Treatment included: Colchicine, ibuprofen, and 1 year of Arcalyst. Patient had no known allergies.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Dyspnoea, Respiratory pathogen panel
Clinical narrative: Shortness of breath
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: slight soreness on arm; tired; The Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1 (toppac), single (Lot number: HG4677) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: intermittent O2 use; "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "alcohol use disorders" (unspecified if ongoing), notes: etoh use disorder/alcohol use disorder; "long term smoking history/Active smoking of cigarettes" (unspecified if ongoing), notes: long term smoking history/Active smoking of cigarettes, 50 plus pack year. The patient's concomitant medications were not reported. Past drug history included: Albuterol inhaler, notes: inhaler; Steroid inhaler, notes: inhaler. Vaccination history included: COVID-19 vaccine name: pfizer (DOSE 1, SINGLE, Batch/Lot number: EN6203), administration date: 26Feb2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 2, SINGLE, Batch/Lot number: ER2613), administration date: 18Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: FF2587), administration date: 12Oct2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: FF4984), administration date: 20Apr2022, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: moderna (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: AS7143C), administration date: 24Sep2022, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "tired".  Additional information: Only side effect to vaccine was slight soreness on arm and at 24th or so hour, got really tired.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400096881 same patient, different vaccine dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: slight soreness on arm; tired; The Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1 (toppac), single (Lot number: HG4677) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: intermittent O2 use; "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "alcohol use disorders" (unspecified if ongoing), notes: etoh use disorder/alcohol use disorder; "long term smoking history/Active smoking of cigarettes" (unspecified if ongoing), notes: long term smoking history/Active smoking of cigarettes, 50 plus pack year. The patient's concomitant medications were not reported. Past drug history included: Albuterol inhaler, notes: inhaler; Steroid inhaler, notes: inhaler. Vaccination history included: COVID-19 vaccine name: pfizer (DOSE 1, SINGLE, Batch/Lot number: EN6203), administration date: 26Feb2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 2, SINGLE, Batch/Lot number: ER2613), administration date: 18Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: FF2587), administration date: 12Oct2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: FF4984), administration date: 20Apr2022, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: moderna (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: AS7143C), administration date: 24Sep2022, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "tired".  Additional information: Only side effect to vaccine was slight soreness on arm and at 24th or so hour, got really tired.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400096881 same patient, different vaccine dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: slight soreness on arm; tired; The Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1 (toppac), single (Lot number: HG4677) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: intermittent O2 use; "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "alcohol use disorders" (unspecified if ongoing), notes: etoh use disorder/alcohol use disorder; "long term smoking history/Active smoking of cigarettes" (unspecified if ongoing), notes: long term smoking history/Active smoking of cigarettes, 50 plus pack year. The patient's concomitant medications were not reported. Past drug history included: Albuterol inhaler, notes: inhaler; Steroid inhaler, notes: inhaler. Vaccination history included: COVID-19 vaccine name: pfizer (DOSE 1, SINGLE, Batch/Lot number: EN6203), administration date: 26Feb2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 2, SINGLE, Batch/Lot number: ER2613), administration date: 18Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: FF2587), administration date: 12Oct2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: pfizer (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: FF4984), administration date: 20Apr2022, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "slight soreness on arm", "tired"; COVID-19 vaccine name: moderna (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: AS7143C), administration date: 24Sep2022, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "tired".  Additional information: Only side effect to vaccine was slight soreness on arm and at 24th or so hour, got really tired.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400096881 same patient, different vaccine dose/event;
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Hypersensitivity, Rash, Swelling, Swelling face
Clinical narrative: 16 y.o. male who has a past medical history of Developmental speech disorder presents for evaluation of significant rash and swelling to the face as well as the neck that the patient has been experiencing over the past day in the setting of having had meningitis vaccine. Patient is complaining of pruritus to the affected area. Denies difficulty swallowing/breathing/throat swelling. Denies fever, chills, CP/SOB, abdominal pain/nausea/vomiting/diarrhea/constipation, dysuria. No recent sick contacts. No travel history. No known COVID-19 exposures. No other complaints.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: 16 y.o. male who has a past medical history of Developmental speech disorder presents for evaluation of significant rash and swelling to the face as well as the neck that the patient has been experiencing over the past day in the setting of having had meningitis vaccine. Patient is complaining of pruritus to the affected area. Denies difficulty swallowing/breathing/throat swelling. Denies fever, chills, CP/SOB, abdominal pain/nausea/vomiting/diarrhea/constipation, dysuria. No recent sick contacts. No travel history. No known COVID-19 exposures. No other complaints.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Patient received expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-JUN-2024 The patient received expired vaccine which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered after temperature excursion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: vaccine administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-JUN-2024 The vaccine was administered after temperature excursion which led to incorrect storage of drug. The caller said she already reported this to GlaxoSmithKline. Confirmed no other adverse event occurred. No PQC reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pain, Rash
Clinical narrative: some pain; Incomplete course of vaccination; shingles; shingles rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On 15-JUN-2024, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and rash (Verbatim: shingles rash). On an unknown date, the patient experienced pain (Verbatim: some pain) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The patient was treated with valacyclovir. The outcome of the shingles and rash were not reported and the outcome of the pain was not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix.     It was unknown if the company considered the shingles, rash and pain to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUN-2024 The reporter was patient that stated that she recieved 1 dose only of Shingrix about 5 years ago, which led to incomplete course of vaccination.  The patient reported that she was diagnosed by a doctor with Shingles on 16th June 2024.  The patient reported that she got the shingles rash and the patient had been prescribed Valacyclovir.  The patient also reported she was in some pain.  The patient had reported all that was provided about this adverse event. Consent to follow up with HCP was obtained.
Sex: F
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number C7747, expiry date 20-JUN-2026) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong technique in drug usage process (Verbatim: Inappropriate Reconstitution Technique). The outcome of the wrong technique in drug usage process 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: 17-JUN-2024 The reporter was a Healthcare Provider (Medical Assistant).  When asked how the mixing/shaking of the vaccine was performed, the reporter replied gently, however as per preparation for administration in prescribing information it is instructed to shake vigorously which led to wrong technique in drug usage process.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: no second dose has been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received one dose on 15th May 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: no second dose has been administered yet). The outcome of the incomplete course of vaccination 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: 17-Jun-2024 Pharmacist called to report that no second dose has been administered yet. Lot number was asked and declined. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Four doses administered instead of two; Four doses administered instead of two; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number K72R2, expiry date 24-JAN-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number KK3JM, expiry date 25-SEP-2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th July 2021 (lot number and expiry date were unknown)) and Shingrix (received 2nd dose on 22nd October 2021 (lot number and expiry date were unknown)).   On 16-MAR-2024, the patient received the 4th dose of Shingrix. On 22-OCT-2022, the patient received the 3rd dose of Shingrix. On 22-OCT-2022, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Four doses administered instead of two). On 16-MAR-2024, the patient experienced extra dose administered (Verbatim: Four doses administered instead of two). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 17-JUN-2024 The patient was not immunocompromised. The patient already received four Shingrix doses and want to receive a 5th dose at the time of reporting. The patient received third and fourth dose of Shingrix, which led extra dose administered. The reporter mentioned he was not comfortable giving it, and there was no prescription from a physician for any additional doses, but patients just want to get a booster to be protected. This case was linked with US2024075152, reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2024075152:Same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th October 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: second dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JUN-2024 Pharmacist called to report a patient received the first dose of Shingrix and had not received the second dose yet. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix vaccine, which led to an incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Feeding disorder, Pyrexia, Sleep disorder
Clinical narrative: abdominal cramps; unable to eat; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of abdominal cramp in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 11-JUN-2024, less than a day after receiving Shingrix, the patient experienced low grade fever (Verbatim: fever). On 12-JUN-2024, the patient experienced abdominal cramp (Verbatim: abdominal cramps) and unable to eat (Verbatim: unable to eat). On 12-JUN-2024, the outcome of the low grade fever was resolved. The outcome of the abdominal cramp and unable to eat were not resolved.   The reporter considered the abdominal cramp, low grade fever and unable to eat to be related to Shingrix.     The company considered the abdominal cramp, low grade fever and unable to eat to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2024 The patient reported that she received her 2nd Shingrix dose on June 12, 2024. That night, she was awoken from sleep with a low-grade fever. The fever lasted until midday the following day. The following day, June 13, 2024, she began having abdominal cramps and was unable to eat anything but a bland diet.
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 1st dose on 15-Apr-2024 and next on 12-Jun-2024 with no reported adverse event; Initial information received on 13-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15-year-old male patient who received 1st dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] on 15-apr-2024 and next on 12-jun-2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Jun-2024, the patient received a 0.5 ml dose (dose 2) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U7938AA and expiry date: 28-Feb-2026 via intramuscular route in unknown administration site and on 15-Apr-2024 he received an unknown dose (dose 1) of same vaccine with an unknown batch number via intramuscular route in unknown administration site as meningitis immunization (immunization) and on same day 12-Jun-2024 leading to event of (extra dose administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HEP
Symptoms: Blood fibrinogen decreased, Fibrin D dimer increased, Haemangioma, Haemangioma-thrombocytopenia syndrome, Injection site bruising
Clinical narrative: Within 2 weeks of immunization, a small blue/purple bruise appeared at immunization site and over a 30 day period grew exponentially in size. In January 2023, patient was diagnosed with a Tufted Angioma with Kasabach Merritt Phenomenon.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Photophobia, Rash, Rash pruritic, Vision blurred
Clinical narrative: A few days after receiving the vaccine, I had developed an itchy rash/bumps on my lower back. with medication it was a bit less itchy but would a around the beginning of December it would flare up and now it would itch when my body got hot. Around the end of December my rash looked different and would get worse now. Then around spring  the rash would now itch at room temperature and my back would flare up and I had red spots from the torso  up. The itching was almost unbearable, I noticed that I could not feel cold anymore, I could lay down in the snow in normal T shirt and pants and I could not feel cold.  Around January  that I noticed that slowly my vision would get worse. It was an Increasing amount of floaters in my vision, I had dark spots in the upper parts of my vision. Around spring time my vision got worse, I noticed my vision was like television static, tiny black dots flashing in my vision. A couple of months later and it slowly got worse, Now I saw a large amount of floaters in my vison, my vision had a subtle dark spot in the middle that would pulse, and it was the same beat as my heartbeat. My eyes would lose focus if I stared at something for too long, like a couple of seconds, and when the sun hit my eye I saw a white circle in my vision. Now when light hits my eye the afterimage stays for much longer than usual like around a minute or two. The eye symptoms were noticeably worse when I looked at something bright like the color white or when I'm outside at a sunny day. These symptoms affect both eyes and leave me feel quite disoriented as at times its quite difficult to see. as of 6/27/2024 the rash on my lower back has come back but now it only itches when I scratch it and it doesn't feel as severe as it used to.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: A few days after receiving the vaccine, I had developed an itchy rash/bumps on my lower back. with medication it was a bit less itchy but would a around the beginning of December it would flare up and now it would itch when my body got hot. Around the end of December my rash looked different and would get worse now. Then around spring  the rash would now itch at room temperature and my back would flare up and I had red spots from the torso  up. The itching was almost unbearable, I noticed that I could not feel cold anymore, I could lay down in the snow in normal T shirt and pants and I could not feel cold.  Around January  that I noticed that slowly my vision would get worse. It was an Increasing amount of floaters in my vision, I had dark spots in the upper parts of my vision. Around spring time my vision got worse, I noticed my vision was like television static, tiny black dots flashing in my vision. A couple of months later and it slowly got worse, Now I saw a large amount of floaters in my vison, my vision had a subtle dark spot in the middle that would pulse, and it was the same beat as my heartbeat. My eyes would lose focus if I stared at something for too long, like a couple of seconds, and when the sun hit my eye I saw a white circle in my vision. Now when light hits my eye the afterimage stays for much longer than usual like around a minute or two. The eye symptoms were noticeably worse when I looked at something bright like the color white or when I'm outside at a sunny day. These symptoms affect both eyes and leave me feel quite disoriented as at times its quite difficult to see. as of 6/27/2024 the rash on my lower back has come back but now it only itches when I scratch it and it doesn't feel as severe as it used to.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Discomfort, Inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid with palpable tenderness, swelling 8x8 cm and warmth. Generalized malaise, no fever. Acetaminophen for Ibuprofen ad vised for discomfort, local cool pack to area of inflammation. Improvement reported at 48 hours .No complaints of local pain at follow up for her other health conditions the following 10 days.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Malaise
Clinical narrative: Left deltoid with palpable tenderness, swelling 8x8 cm and warmth. Generalized malaise, no fever. Acetaminophen for Ibuprofen ad vised for discomfort, local cool pack to area of inflammation. Improvement reported at 48 hours .No complaints of local pain at follow up for her other health conditions the following 10 days.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Peripheral swelling, Pharyngeal swelling, Swelling face, Throat tightness
Clinical narrative: Reported Symtpoms: 10042700:SWELLING OF LEGS; 10043528:THROAT TIGHTNESS;  Narrative: Patient is a 68 y/0 male with PMHx of seizure, PTSD, osteoporosis, depression, obesity who was seen by primary care on 3/12/24 where he received a shingles vaccine. He stated he was told to not get any pneumococcal or influenza vaccines. Patient reported he had severe swelling of face, throat, and lower extremities about 20 years ago from last influenza vaccine. He has one documented influenza vaccine, which was given on 10/31/2001. Per nursing note, there were no mention of side effects including swelling of face, throat or lower extremities. His next note was 1/15/2002 where he asked for a refill of medications. No mention of side effects from vaccine. Other Relevant HX: Patient is a 68 y/0 male with PMHx of seizure, PTSD, osteoporosis, depression, obesity who was seen by primary care on 3/12/24 where he received a shingles vaccine.. He stated he was told not to get an pneumococcal or influenza vaccines. Patient reported he had severe swelling of face, throat, and lower extremities about 20 years ago from last influenza vaccine. He has one documented influenza vaccine, which was given on 10/31/2001. Per nursing note, there were no mention of side effects including swelling of face, throat or lower extemities. His next note was 1/15/2002 where he asked for a refill of medication. No mention of side effects from vaccine. Other: SWELLING OF THROAT; LEG SWELLING
Sex: M
Vaccine: COVID19
Symptoms: Jaundice
Clinical narrative: Reported Symptoms:  10023126:JAUNDICE;  Narrative:  The patient is a 38yo male with PMH of Hand Sprain Feb. 19, 2023, Hyperlipidemia -May 28, 2021,, Abnormal results of Liver Function studies -May 28, 2021, L. Knee pain and Exposure to potentially Hazardous Substance- March 11, 2024. On March 11, 2024 Chief Ambulatory Care Attending Physician reported the patient had a historical ADR of Covid-19 vaccine induced Jaundice, in response to first Covid -19 vaccination and has not taken another since. The patient doesn't recall what type it was. Patient's PMH also showed the patient had abnormal results of liver function sturdies May 28, 2021. Unable to find Medical Center Immunization record. Oher Relevant HX:  Other: JAUNDICE
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Guillain-Barre syndrome, Immunisation reaction, Paraesthesia
Clinical narrative: Reported Symtpoms: 10018767:GUILLIAN-BARRE SYNDROME; Narrative: A 38yo patient with PMH of HTN, IBS, Anxiety, Severe Obesity - BMI 48+. February 21, 2024 the patient presented to the ER with CC of dizziness, Chest pain and tingling in both legs. On March 25, 2024, PCC staff RN reported the patient had a historical ADR of Covid-19 vaccine induced Guillain Barre syndrome. No other detailed information was provided regarding the vaccine. (i.e. maunfacturer, lot #, expiration date, product specificity, when, where and by who it was administered etc) Other Relevant HX: Other: GUILLAIN BARRE
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram, Hypertension, Immunisation reaction
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; 10020772:HYPERTENSION; Narrative: Per RN note 4/14/21: Patient had a reaction to the vaccine within 2 minutes of receiving the  injection. Chest pain,with tightness and heat feeling. Patient was taken to  the treatment room and PA and RN was at bed side. EKG was performed O2 was placed on the Patient at 2 liters. vital sign were taken  and blood pressure was 159/102;67 resp 18 and RA was 99%. EKG was reviewed by provider and the patient states that he is feeling somewhat better. Blood  pressure was rechecked and the 133/94. Patient was stable and per PA okay  to go home. Other Relevant HX: Other: CHEST PAIN; HYPERTENSION
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Per RA provider RN's note cosigned by attending physician, A 57yo female communicated she developed rash few days after she received Moderna Covid - 19 vaccine and for which she went to urgent care and was treated with a Steroid shot. The patient also reported she has had Flu vaccine and Pfizer's Covid- 19 vaccine in the past without any problems. The attending physician reported the historical ADR. No detailed information regarding the the Moderna covid-19 vaccine was provided (i.e Product Lot #, Exp. date, who administered the vaccine and where etc). Other Relevant HX: Other: RASH
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation, Tongue oedema
Clinical narrative: Reported Symptoms: 10014257:EDEMA TONGUE;  Narrative: Patient is a 54 y/o male with PMHx of OA, prediabetes, obesity who was contacted by primary care nurse for due immunizations. Patient reported he had the covid vaccine once and had tongue swelling and never received any other covid vaccine. He was administered a covid vaccine on 4/19/21 into left deltoid. Per immunizer note, there were no documented issues. On 4/27/21, patient was seen at ED for scratchy throat. Denied tongue or lip swelling at the time and there was no mention of covid vaccine per ED note. Patient reported that he had seasonal allergies and had not been able to get allergy shots or nasal steroid spray since he had not been able to get in to see his community allergist. He was discharged home that same day with a refill of nasal fluticasone. No further information provided. Other Relevant HX: Patient is a 54 y/o male with PMHX of OA, prediabetes, obesity who was contated by primary care nure for due immunizations. Patient reported he had the covid vaccine once and had tongue swelling and never received any other covid vaccine. He was administered a covid vaccine on 4/19/21 into left deltoid. Per immunizer note, there were no documented issues. On 4/27/21, patient was seen at ED for scratchy throat. Denied tongue swelling at the time and there was no metnion of covid vaccine per ED note. He was discharged home that same day with a refill of nasal fluticasone. No further information provifed. Other: SWELLING OF TONGUE
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death, Dementia
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10012267:DEMENTIA; Narrative: death d/t advanced dementia Other Relevant HX: Other: advanced dementia
Age: 98.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; Narrative: Other Relevant HX:
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death, Fall
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10016178:FALLING DOWN; Narrative: death post fall Other Relevant HX: Other: fall
Sex: M
Vaccine: COVID19
Symptoms: Blister, Immunisation reaction
Clinical narrative: Reported Symptoms: 10005216:BLISTERS;     Narrative:  A 36 yo Male patient who received his Covid- 19 vaccination in Sept of 2021, was reported with a historical ADR of Moderna Covid -19 vaccine induced blister by PCC attending physician.. No other detailed information was provided by the attending Physician or the patient regarding the vaccine, including where it was administered or by whom.    Other Relevant HX:   Other: BLISTER
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Reported Symptoms:   10037087:PRURITUS;  10037844:RASH;     Narrative:  Other Relevant HX:   Other:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; Narrative: Other Relevant HX:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tachycardia
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10028411:MYALGIA; 10043071:TACHYCARDIA; Narrative: Patient received first Shingrix vaccine. That evening woke up with reported fever, myalgia and tachycardia. Tachycardia and fever resolved within a few hours. Myalgia remained for an additional 24 hours. Patient hesitent to receive second dose and likely will not per report to provider d/t symptoms. Other Relevant HX: Other:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myasthenia gravis, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth to the area with occasional itching.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction report from parent of patient. Patient was given the wrong vaccination.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Pale, sweating, dizziness, and nausea.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Patient's left arm keeps going numb from inner forearm down to pinky and ring finger. At times he feels numb down the left side of his ribs, eft leg and up to his left jaw. It happens often when he stands up or lays down.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: MOC STATES SHE NOTICIED RASH ON PATIENTS LEFT ARM AND BEGAN TO GET SWOLLEN, STARTED ON 06/20/24. PATIENT WAS SEEN WITH PCP ON 06/21/24 DUE TO ARM LOOKING WORSE. MOC WAS ADVISED BY PCP TO TAKE PATIENT TO EMERGENCY ROOM IF PATIENT'S RASH/SWOLLENNESS GETS WORSE. PATIENT WAS TAKEN TO EMERGENCY ROOM ON 06/22/24. PATIENT HAS FOLLOW UP APPT WITH PCP ON 06/24/24/
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: 11 yr old female due for Tdap, HPV, and MenQuadfi. The office is in the process of switching to new EMR; there was no option to scan vaccines. The RN checked the vaccines prior to entering the patient's room, but mistook Bexsero for MenQuadfi and patient ended up receiving Tdap, HPV, and Bexsero. Once mistake was realized, the provider, patient, and parent was made aware. Patient then received her scheduled dose of MenQuadfi.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Patient started to break out in hives all of her body including her face about 36 hours after injection.  Pt came in and talked to me, reporting pharmacist, and her rash was small (sulfa allergy looking) and emitting heat.  Pt shared that she had a horrible case of chicken pox when she was little(she was hospitalized) and caught it twice in two years.  She didn't have any s/sx of breathing issue.  I recommended benadryl OTC and to monitor and if rash got worse or other additional respiratory symptom occurs to reach out to physician.   Her rash got worse over night, she followed up with her physician and she was prescribed with Prednisone.  Couple days has passed, her rash is getting better and has no other additional  symptoms
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reported to NP 2 weeks after receiving the vaccine that within 30 minutes of receiving the MMR vaccine in their left tricep, the patient states they had soreness that radiates down towards the elbow. Reports it as a constant, dull ache. It is relieved with ibuprofen, but they have been advised by their cardiologist to "use it sparingly".
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine, Arthralgia, Chills, Headache, Injection site erythema
Clinical narrative: Patient received an MMR vaccine on 6/10/2024- she reports the following day she became extremely nauseated, had a fever, body aches, severe arm pain and a firm lump and expanding redness at injection site and down arm.  She reports yesterday she had severe joint and neck pain, a headache and chills.  Today she admits to feeling 'fine'.  Arm redness is receding and softening. No further fever, chills or headache, mild joint pain. Discussed reaction to MMR.  Advised to monitor for any bleeding as ITP has been associated with vaccine.  Follow up for any bleeding or additional concerns. Completed item.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient received an MMR vaccine on 6/10/2024- she reports the following day she became extremely nauseated, had a fever, body aches, severe arm pain and a firm lump and expanding redness at injection site and down arm.  She reports yesterday she had severe joint and neck pain, a headache and chills.  Today she admits to feeling 'fine'.  Arm redness is receding and softening. No further fever, chills or headache, mild joint pain. Discussed reaction to MMR.  Advised to monitor for any bleeding as ITP has been associated with vaccine.  Follow up for any bleeding or additional concerns. Completed item.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Patient received an MMR vaccine on 6/10/2024- she reports the following day she became extremely nauseated, had a fever, body aches, severe arm pain and a firm lump and expanding redness at injection site and down arm.  She reports yesterday she had severe joint and neck pain, a headache and chills.  Today she admits to feeling 'fine'.  Arm redness is receding and softening. No further fever, chills or headache, mild joint pain. Discussed reaction to MMR.  Advised to monitor for any bleeding as ITP has been associated with vaccine.  Follow up for any bleeding or additional concerns. Completed item.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Patient during first dose of the series complains of fever, general malaise, and soreness that will not improve with Morton or Tylenol. During the first dose this last up to a week of these symptoms. Now, after the second dose in the series patient complains of same symptoms lasting up to 4 days.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Urine analysis, Vertigo
Clinical narrative: Patient reported that on 6/18 after she returned home from work, she had dizziness that felt like the room was spinning around her. It occurred intermittently. She had no adverse symptoms on day of vaccine.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: She had redness and swelling, like hives at the injection site . It subsided about 2 hours after the initial reaction. On 6/23/24, there was notable redness and swelling  (2in x 2in in diameter) and (0.75in x 0.75 in) area of induration and tenderness.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Mass
Clinical narrative: Patient had a palpable lump on her left scapula 4-5 hours after administration.  The site was not warm to the touch, no signs of infection anaphylaxis, no hives, was not warm to the touch, no shortness of breath.  advised Dad to give her Benadryl every 6 hours and Tylenol as needed for her left arm being sore at the injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Sudden onset rash across neck
Age: 76.0
Sex: M
Vaccine: MNQ
Symptoms: Condition aggravated, Myasthenia gravis
Clinical narrative: Pt didn't have reaction, per RN pt had MG flare up and is the hospital
Age: 13.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There were no adverse events. Mother was just notified of an incorrect vaccine had been given.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mom got really sick after the first vaccine and it gave her major blood clots and abcesses. We told her not to get a second dose, but she snuck around behind everyone's back and got the second dose even though she was already sick with a uti and septic shock. She died within one to two days after.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received pediatric dose of engerix. No sign or symptoms of reaction/anaphylaxis.
Age: 61.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient presents herself today 6.24.2024 with a slightly reddened "Quarter" sized area of the right deltoid muscle with pain radiating to the hand.  Seen by Employee Health Physician with Ibuprofen 200mg PO ordered.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Asthenia, Cough, Dyspnoea, Pyrexia, Tachypnoea
Clinical narrative: Tachypnea, dyspnea, cough,, fever, weakness
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Viral test
Clinical narrative: Tachypnea, dyspnea, cough,, fever, weakness
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Back pain, Chest pain, Chills, Decreased appetite
Clinical narrative: Prolonged headache for two days, lethargic, rapid heart rate, fever, chills, soreness at injection site (right shoulder), throat soreness and swelling, chest & back pain, loss of appetite.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Impaired driving ability, Injection site pain
Clinical narrative: Prolonged headache for two days, lethargic, rapid heart rate, fever, chills, soreness at injection site (right shoulder), throat soreness and swelling, chest & back pain, loss of appetite.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Oropharyngeal pain, Pharyngeal swelling, Pyrexia
Clinical narrative: Prolonged headache for two days, lethargic, rapid heart rate, fever, chills, soreness at injection site (right shoulder), throat soreness and swelling, chest & back pain, loss of appetite.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, Dizziness, Nervous system disorder, Orthostatic hypotension, Palpitations
Clinical narrative: Since the day of the second vaccine I've experienced heart palpitations, dizziness, uncontrolled blood pressures. It has now been determined as of Feb 2024 that I have developed an autonomic nervous system disorder, POTs and Orthostatic hypotension with vasovagal syncope
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope, Tilt table test
Clinical narrative: Since the day of the second vaccine I've experienced heart palpitations, dizziness, uncontrolled blood pressures. It has now been determined as of Feb 2024 that I have developed an autonomic nervous system disorder, POTs and Orthostatic hypotension with vasovagal syncope
Age: 45.0
Sex: F
Vaccine: TYP, YF
Symptoms: Paraesthesia
Clinical narrative: Client states minutes after vaccines given reports tingling in fingers and googled that can happen with YF vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Product storage error
Clinical narrative: Datalogger report review on 5/29/2024 showed a temperature excursion. Vaccines were placed on hold after this was noticed. All manufacturers were contacted to notify of temperature excursions and obtain stability data and whether vaccinations stored in this refrigerator were supported to be used or if they needed to be discarded. The wasted-do not use/not supported vaccinations included the Rotavirus vaccine (RotaTeq) that the patient previously received.