chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Injection site haemorrhage, Injection site pain, Injection site reaction
Clinical narrative: Injection site haemorrhage; Injection site reaction; Injection site pain; Felt very ill; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site hemorrhage in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DUPILUMAB (DUPIXENT) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of DUPIXENT (subcutaneous) 300 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: Injection site haemorrhage), injection site reaction (Verbatim: Injection site reaction), injection site pain (Verbatim: Injection site pain) and illness (Verbatim: Felt very ill). The action taken with DUPIXENT was unknown. The outcome of the injection site hemorrhage, injection site reaction, injection site pain and illness were resolved.   It was unknown if the reporter considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2023 The reporter was a patient. The reporter reported that she had a most recent injection and had little mark where needle went in, pain at injection site, felt very ill after receiving second dose of Shingrix and also had little amount of blood at the injection site while being treated with Dupilumb (Dupixent) and Varicella zoster vaccine and with the use of Dupixent single dose pre filled pen. Dupixent had been identified with device issue. The patient past medical history, vaccination, medical treatment, family history were not provided. It was not reported if the patient received a corrective treatment for all event. At the time of reporting all events were recovered. It was unknown if the reporter considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Dupixent. It was unknown if the company considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Dupixent. The reporter requested to consent the follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I have a patient who has waited 8 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I have a patient who has waited 8 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The reporter reported that the he or she needed verification and documentation that the first Shingrix dose did not have to be repeated if given more than 6 months after the first dose. The reporter reported that he or she had a patient who had waited for 8th months. At the time of reporting the patient initial and birth of date was not provided. The follow-up could not be possible as the as no contact details were available. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which lead to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: broke out with the shingles.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: broke out with the shingles.). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter stated he/she had the vaccine 6 months ago and was ready to  go back for the second dose and he/she broke out with the shingles. It was awful stuff to the reporter. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Fever; Chills; Headache; Malaise; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included Never had shingles..   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), headache (Verbatim: Headache) and malaise (Verbatim: Malaise). The outcome of the fever, chills, headache and malaise were not reported.   It was unknown if the reporter considered the fever, chills, headache and malaise to be related to Shingles vaccine.     It was unknown if the company considered the fever, chills, headache and malaise to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by patient via interactive digital media. The reporter reported that it was a worst vaccine. The reporter reported that he or she never had shingles, so he or she did not know what that's like. The reporter reported that 8 hours into each vaccine he or she was out for over 24 hours and experienced fever, chills, headache, malaise. The reporter reported that he or she did not get the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that two shingles shots made the patient so sick.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she received first dose of Shingle vaccine and 6 days later got shingles. The reporter reported that the physician never told him or her that could happen and the reporter even asked physician if that was a side affect of vaccine  The reporter advised that did not listen to the vaccine pushers.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: Irritation in small areas of medical left arm deltoid; Irritation in small areas of left calf; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site irritation in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site irritation (Verbatim: Irritation in small areas of medical left arm deltoid) and skin irritation (Verbatim: Irritation in small areas of left calf). The outcome of the injection site irritation and skin irritation were not resolved.   It was unknown if the reporter considered the injection site irritation and skin irritation to be related to Shingrix.     It was unknown if the company considered the injection site irritation and skin irritation to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter stated that she was at a health fair day before reporting giving education on the Shingrix vaccination and a patient came up to her afterwards describing the irritation she had. The patient stated that she received the Shingrix vaccine 3 weeks ago (unsure of date) and had now developed irritation in 2 small areas in the medical left arm deltoid ( this is the area the patient received her vaccination) and her left calf.  This irritation is described as no peeling, no pain, no itching, no ill effects.  The patient was unsure if events related to the vaccine or not. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate Reconstitution Technique (Non-Approved Diluent); patient was given a Menveo vaccine reconstituted with an unapproved diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique (Non-Approved Diluent)) and inappropriate dose of vaccine administered (Verbatim: patient was given a Menveo vaccine reconstituted with an unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-JUN-2023 Nurse did not want to give information as she stated it was a violation of law. The reporter did not consent to follow up. The patient was administered with Menveo vaccine reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: Maladministration of Bexsero SC instead of IM; Bexsero administer with a 5.8 inches needle instead of 1 inches needle; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   On 08-JUN-2023, the patient received Bexsero (subcutaneous). On 08-JUN-2023, an unknown time after receiving Bexsero, the patient experienced intramuscular formulation administered by other route (Verbatim: Maladministration of Bexsero SC instead of IM) and wrong technique in product usage process (Verbatim: Bexsero administer with a 5.8 inches needle instead of 1 inches needle). The outcome of the intramuscular formulation administered by other route and wrong technique in product usage process were 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: 09-JUN-2023 Healthcare professional declined to have an account on Medical Information database. The reporter consented to follow up via email. The patient received the Bexsero via subcutaneous route using 5.8 inches needle instead of 1 inch's needle, which led to Intramuscular formulation administered by other route and wrong technique in product usage process.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Patient got most of the vaccine but some did bead up and roll down his arm; Roll down his arm; Some did bead up and roll down his arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   On 08-JUN-2023, the patient received the 1st dose of Shingrix. On 08-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Patient got most of the vaccine but some did bead up and roll down his arm), exposure via skin contact (Verbatim: Roll down his arm) and inadvertent exposure to vaccine (Verbatim: Some did bead up and roll down his arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The reporter reported that he or she was giving a patient the first dose of Shingrix on day before reporting and had a syringe failure. The patient got most of the vaccine, but some did bead up and roll down patient's arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The vaccine administration facility was the same as primary reporter. The health care provider declined to provide patient's initials and date of birth. The reporter consent to follow up via postal.
Sex: M
Vaccine: MENB
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Circumstance or information capable of leading to medication error; was planning to administer one dose of Bexsero, which could be a potential 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (on March 2020 received 1st dose) and Bexsero (on an unknown date received 2nd dose).   On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and extra dose administered (Verbatim: was planning to administer one dose of Bexsero, which could be a potential 3rd dose). The outcome of the circumstance or information capable of leading to medication error and extra dose administered were 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: 09-JUN-2023 The pharmacist called to inform that a patient that began the scheme of Bexsero back in March 2020 was not sure if the 2nd dose had been received or not due to lack of records. On the day of reporting, the pharmacist was planning to administer one dose, which could be a potential 3rd dose if the 2nd dose had already received and not recorded. On the day of reporting the pharmacist was planning to administer a dose to the patient, which led to extra dose administered and circumstance or information capable of leading to medication error. The reporter did not consent to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JAN-2023, the patient received the 1st dose of Shingrix. In JAN-2023, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.   It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The case was reported by patient's wife. Member called on behalf of patient.  The reporter confirmed spouse not available to speak.  The reporter stated spouse received the Shingrix and a week to 10 days later the patient got shingles.  The reporter mentioned that the shingles resolved quickly, was not a bad case and spouse was not really in pain.  The reporter stated that she guessed the Shingrix must have helped. The reporter enquired that if patient get the second Shingrix vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in March 2023).   In JUN-2023, the patient received the 2nd dose of Twinrix. In JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long 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: 09-JUN-2023 Exact date of vaccinations were unknown. Lot and expiration of vaccinations were unknown. The reporter consented to follow up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient; adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-month-old female patient who received HBV (Engerix B adult) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 12-JUN-2023, the patient received the 1st dose of Engerix B adult. On 12-JUN-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient) and adult product administered to child (Verbatim: adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter declined to provide patient initials. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a staff member administered an adult dose of Engerix-B to a patient, which led to overdose and adult product administered to child.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received Boostrix expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 05-JUN-2023, the patient received Boostrix. On 05-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received Boostrix expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-JUN-2023 The reporter consented to follow up via email. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 26th November 2022).   On 11-APR-2023, the patient received the 2nd dose of Twinrix. On 11-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long 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: 12-JUN-2023 The reporter reported that late second dose of Twinrix was administered to a patient and an early third dose was being considered. No consent to follow up because hcp declined to store information. The reporter reported that the patient got late second dose and at the time of reporting attended the pharmacy requesting a third dose, healthcare professional called to ask medical information to make a decision.  No details on patient or vaccine were reported. The reporter did not consent to follow-up. The patient received the 2nd dose of Twinrix late than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Malaise, Nausea, Syncope
Clinical narrative: Fainted; Clammy; Nauseated; Felt sick all over; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 2HC4L, expiry date 09-JUL-2024) for prophylaxis.   On 19-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular). On 19-MAY-2023, 6 hrs after receiving Shingrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), clamminess (Verbatim: Clammy), nausea (Verbatim: Nauseated) and feeling unwell (Verbatim: Felt sick all over). On 20-MAY-2023, the outcome of the fainting, clamminess, nausea and feeling unwell were resolved.   It was unknown if the reporter considered the fainting, clamminess, nausea and feeling unwell to be related to Shingrix.     It was unknown if the company considered the fainting, clamminess, nausea and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter was the patient. The patient stated that she received her 1st Shingrix vaccine on 19-MAY-2023 and within 6 hours started having this reactions such as Clammy, Nauseated, fainted, and felt sick all over.  Patient stated this lasted until the morning of 20-MAY-2023 and everything was completely resolved.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: inadvertently given a dose of expired Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 31-MAY-2023, the patient received Havrix. On 31-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: inadvertently given a dose of expired Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter reported that a patient was inadvertently given a dose of expired Havrix vaccine which led to expired vaccine used.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: developed hives on her stomach and right leg 3 hours after administration; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 hrs after receiving Shingrix, the patient experienced hives (Verbatim: developed hives on her stomach and right leg 3 hours after administration). The outcome of the hives was resolved (duration 4 weeks).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The patient self-reported this case. In 2023, the patient developed hives in her stomach and right leg 3 hours after administration of the vaccine and it was resolved. The reporter did not consent to follow-up.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ActHib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event; Initial information received on 09-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who had acthib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event after receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for immunisation; rotavirus vaccine (rotavirus vaccine) for immunisation; and hepatitis b vaccine (hepatitis b vaccine) for Immunisation.  On 09-Jun-2023, the patient received a  dose of suspect hib (prp/t) vaccine, Powder and solvent for solution for injection lot UJ794AA, 08-Oct-2023 via intramuscular route in unknown administration site for Immunization.  On 09-Jun-2023 the patient developed a non-serious acthib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event (product preparation error) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event acthib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event.  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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pulmonary embolism
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Hypotension, Hypoxia, Neuropathy peripheral, Symptom recurrence
Clinical narrative: NEUROPATHY ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOTENSION HYPOXIA 12/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breakthrough COVID-19, COVID-19, COVID-19 pneumonia, Chronic sinusitis, Computerised tomogram head
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER by Pfizer, COVID POSITIVE. She is Admitted to the Hospital for COVID19, Headache, Malaise,  Hypokalemia, Hyponatremia, Hypocalcemia, Hypertension, Hypertension, and Hyperlipidemia. Pt treated with dexamethasone and Zithromax for covid pneumonia and hyponatremia.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hyperlipidaemia, Hypertension, Hypocalcaemia, Hypokalaemia
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER by Pfizer, COVID POSITIVE. She is Admitted to the Hospital for COVID19, Headache, Malaise,  Hypokalemia, Hyponatremia, Hypocalcemia, Hypertension, Hypertension, and Hyperlipidemia. Pt treated with dexamethasone and Zithromax for covid pneumonia and hyponatremia.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyponatraemia, Malaise, SARS-CoV-2 test positive
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER by Pfizer, COVID POSITIVE. She is Admitted to the Hospital for COVID19, Headache, Malaise,  Hypokalemia, Hyponatremia, Hypocalcemia, Hypertension, Hypertension, and Hyperlipidemia. Pt treated with dexamethasone and Zithromax for covid pneumonia and hyponatremia.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Sleep apnoea syndrome
Clinical narrative: SLEEP APNEA ACUTE ST ELEVATION MI, ANTERIOR WALL
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hepatic steatosis, Laboratory test abnormal
Clinical narrative: I got really sick after receiving the vaccine with nausea and unable to stand up straight for a couple of days. In 03/2023, I had a doctor's appointment regarding a hernia. The test they gave me was the incorrect one and they found I have severe fatty liver.  Now I am on a diet to try to reverse this diagnose.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiogenic shock, Hypoxia, Myocardial ischaemia
Clinical narrative: DEMAND ISCHEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA CARDIOGENIC SHOCK
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling, pain at injection site, large red raised area at injection site that is hot to the touch, fever. I am already on tramadol, took 600 mg ibuprofen which had no effect on pain. Applied ice in 20 min intervals, though touching with wrapped ice bag hurts as does any touching, not sure it helped at all.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY 1/6/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Hypoxia
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOXEMIA
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Cardiomyopathy
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER BY PFIZER, COVID POSITIVE.   79-year-old gentleman who presented with complaint of cough, shortness of breath.  Found to have pulmonary edema.  Echo revealed cardiomyopathy.  Patient had elevated troponins consistent with NSTEMI.  He was started on heparin drip, IV diuresis.  Cardiology was consulted.  They recommend ischemic workup outpatient in light of patient's positive COVID status.  Regarding COVID viral pneumonia, patient placed on oral Decadron and Albuterol, Symbicort, anticoagulation.  Fortunately he had no significant hypoxia during his stay.   Pt now has an ejection fracture of 20%-25%.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Diuretic therapy, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER BY PFIZER, COVID POSITIVE.   79-year-old gentleman who presented with complaint of cough, shortness of breath.  Found to have pulmonary edema.  Echo revealed cardiomyopathy.  Patient had elevated troponins consistent with NSTEMI.  He was started on heparin drip, IV diuresis.  Cardiology was consulted.  They recommend ischemic workup outpatient in light of patient's positive COVID status.  Regarding COVID viral pneumonia, patient placed on oral Decadron and Albuterol, Symbicort, anticoagulation.  Fortunately he had no significant hypoxia during his stay.   Pt now has an ejection fracture of 20%-25%.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia viral, Pulmonary oedema, SARS-CoV-2 test positive, Troponin increased, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER BY PFIZER, COVID POSITIVE.   79-year-old gentleman who presented with complaint of cough, shortness of breath.  Found to have pulmonary edema.  Echo revealed cardiomyopathy.  Patient had elevated troponins consistent with NSTEMI.  He was started on heparin drip, IV diuresis.  Cardiology was consulted.  They recommend ischemic workup outpatient in light of patient's positive COVID status.  Regarding COVID viral pneumonia, patient placed on oral Decadron and Albuterol, Symbicort, anticoagulation.  Fortunately he had no significant hypoxia during his stay.   Pt now has an ejection fracture of 20%-25%.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: LEFT FACIAL PALSY
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angina unstable, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE UNSTABLE ANGINA ANGINA, UNSPECIFIED 12/8/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired drug given ( Expiration 6/7/23, given 6/12/23)
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No Adverse Event- Patient was given Intial Pfizer dose instead of the Bivalent Booster
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No Adverse effect- Patient was given intial pfizer dose instead of the Pfizer Bivalent booster
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Dyspnoea
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. presents to the ED complaining of shortness of breath and cough.  Patient started with URI symptoms, associated with cough dry, sore throat for last 3 weeks.  Patient states despite taking multiple medications has not got any better.  Per the patient just finished a course of antibiotics/Z pack. Apparently patient has lost 13 lb since this started. TREATMENT MEDICATIONS ARE Cefepime, Solu-Medrol, AND Protonix.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Lung disorder, Lung opacity, Oropharyngeal pain, Platelet count decreased
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. presents to the ED complaining of shortness of breath and cough.  Patient started with URI symptoms, associated with cough dry, sore throat for last 3 weeks.  Patient states despite taking multiple medications has not got any better.  Per the patient just finished a course of antibiotics/Z pack. Apparently patient has lost 13 lb since this started. TREATMENT MEDICATIONS ARE Cefepime, Solu-Medrol, AND Protonix.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary mass, Respiratory symptom, SARS-CoV-2 test positive, Vaccine breakthrough infection, Weight decreased
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. presents to the ED complaining of shortness of breath and cough.  Patient started with URI symptoms, associated with cough dry, sore throat for last 3 weeks.  Patient states despite taking multiple medications has not got any better.  Per the patient just finished a course of antibiotics/Z pack. Apparently patient has lost 13 lb since this started. TREATMENT MEDICATIONS ARE Cefepime, Solu-Medrol, AND Protonix.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. presents to the ED complaining of shortness of breath and cough.  Patient started with URI symptoms, associated with cough dry, sore throat for last 3 weeks.  Patient states despite taking multiple medications has not got any better.  Per the patient just finished a course of antibiotics/Z pack. Apparently patient has lost 13 lb since this started. TREATMENT MEDICATIONS ARE Cefepime, Solu-Medrol, AND Protonix.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse effects- patient was given initial Pfizer dose instead of the Pfizer Bivalent dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse effects- patient was given initial Pfizer dose instead of Pfizer Bivalent booster
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Epilepsy, Pulmonary embolism
Clinical narrative: EPILEPSY, UNSPECIFIED ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reaction. Patient given 3 doses instead of 2 per manufacturer insert
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient did not come back to clinic or call us about reaction.  Patient was in the clinic today for a different vaccine and reported swelling  at injection site and a mild rash lasting 4 days after last vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dehydration, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Vasovagal syncope approximately 5 minutes after receiving immunization. Became unresponsive for about 2 minutes with no abnormal movements, loss of bowel or bladder control or vomiting. BP 66/38 HR 57 while unconscious, recovered to 91/59 HR 75 when awake. Had not eaten prior to immunization that morning and likely slightly dehydrated. Drank water and ate a cookie upon awakening and was able to walk out of clinic unassisted approximately 15 minutes later.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/27/2023 HEMATEMESIS
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Glomerular filtration rate, Hypotension
Clinical narrative: I95.9 HYPOTENSION 3/30/2023 CKD STAGE 3A (GFR 45-59)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery stenosis, Cerebral artery occlusion, Cerebrovascular accident, Epilepsy, Hypersensitivity
Clinical narrative: G40.909 EPILEPSY, UNSPECIFIED 3/23/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 3/23/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE T78.40XA ALLERGIC REACTION, INIT 3/9/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Procedural complication
Clinical narrative: G40.909 EPILEPSY, UNSPECIFIED 3/23/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 3/23/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE T78.40XA ALLERGIC REACTION, INIT 3/9/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE NON ST ELEVATION MI CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE AND CHRONIC POSTTRAUMATIC RESPIRATORY FAILURE, UNSPECIFIED TYPE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Prinzmetal angina
Clinical narrative: PRINZMETAL ANGINA ALLERGIC REACTION, INIT
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Dyskinesia oesophageal, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/13/2023 ESOPHAGEAL DYSKINESIA
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Hypoxia, Pulmonary embolism, Respiratory failure, Sepsis
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 4/6/2023 SEPSIS UNSPECIFIED ORGANISM J96.10 CHRONIC RESPIRATORY FAILURE 4/6/2023 SEPSIS UNSPECIFIED ORGANISM J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/14/2023 SEPSIS UNSPECIFIED ORGANISM R09.02 HYPOXEMIA 3/21/2023 SEPSIS UNSPECIFIED ORGANISM
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Redness, Swollen, Hot to touch, Hard
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Fatigue, Hypersomnia, Productive cough, Sleep disorder
Clinical narrative: I had a lot of coughing that was a dry hacking cough, that would not let me sleep at night. I was coughing so hard it was causing me to urinate on myself. Although I had a lot of phlegm it would not come up. The first time I had it was three days after I received the fourth dose, it lasted until February. The cough came back in March, the cough is still lingering. I was able to sleep last night, 06/13/23 for the first time without waking to take cough syrup. The fatigue is horrible, there will be days I come home fall asleep and don't wake up until the next day. The doctor did not run any test either time I went to see her, she did prescribe benzonatate for the coughing.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urinary incontinence
Clinical narrative: I had a lot of coughing that was a dry hacking cough, that would not let me sleep at night. I was coughing so hard it was causing me to urinate on myself. Although I had a lot of phlegm it would not come up. The first time I had it was three days after I received the fourth dose, it lasted until February. The cough came back in March, the cough is still lingering. I was able to sleep last night, 06/13/23 for the first time without waking to take cough syrup. The fatigue is horrible, there will be days I come home fall asleep and don't wake up until the next day. The doctor did not run any test either time I went to see her, she did prescribe benzonatate for the coughing.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY, UNSPECIFIED
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt experienced warm, hot, erythematous, upper extremity at injection sight. Symptomatic treatment encouraged including Tylenol/ibuprophen for pain, Benadryl for itching at site, and hydrocortisone cream topically.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure acute, Hypoxia, Left ventricular failure
Clinical narrative: R09.02 HYPOXIA 4/7/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Product communication issue, Wrong product administered
Clinical narrative: Patient was given Gardasil in error. Patient was to receive Meningococcal vaccine. The Provider asked MA to administer Meningococcal the MA heard Gardasil and administered Gardasil to patient. Patient completed 2 dose series of Gardasil at 12 years old. Pt now has had 3 doses of Gardasil. Reviewed by Medical Director . Pt has not experienced any adverse reaction. No further work up needed.  Education and policy and workflow updates have been updated to prevent this from happening again in the future.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: DTaP given was expired.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to the arm int he vicinity of the vaccine administration site.
Age: 93.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 8/31/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 on June 4, 2023
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna Covid vaccine. This was the patient's second dose. They had had a Monovalent dose 3/6/2023. The dose that was given was 0.2 mL from the vial with the pink cap. The correct dose would be 0.25 ml from the Moderna with the blue cap.