chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: ANTH
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Headache; Pain; Muscle soreness; Fatigue; This spontaneous case report received on 30-Oct-2024 from other health care professional regarding adult patient (patient one, age 20s- 70s) of unknown gender who had "pain" (PT: Pain), "muscle soreness" (PT: Myalgia), "fatigue" (PT: Fatigue), and "headache" (PT: Headache).   The patient's medical history, concurrent conditions and allergies were not reported.   On an unknown date, the patient was administered two doses of Cyfendus (AVA + CPG 7909, lot number: unknown) and doxycycline for postexposure prophylaxis   The patient experienced pain, muscle soreness, fatigue, and headache. All events were considered as mild. The vaccine was tolerated well.   There was no labs/imaging reported.   The outcome of the reported events was unknown.  Company comment: A consumer received two doses of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient also received doxycycline along with Cyfendus. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment.; Sender's Comments: A consumer received two doses of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient also received doxycycline along with Cyfendus. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment. US-EMERGENT BIOSOLUTIONS-24000180:Study- same reporter US-EMERGENT BIOSOLUTIONS-24000181:Study- same reporter US-EMERGENT BIOSOLUTIONS-24000182:Study- same reporter US-EMERGENT BIOSOLUTIONS-24000184:Study- same reporter GB-EMERGENT BIOSOLUTIONS-24000184:Study- same reporter US-EMERGENT BIOSOLUTIONS-24000183:Study- same reporter
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report that PROQUAD was administered following TE.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, Concomitant therapies, past drug reactions and allergies were not reported.  On 22-OCT-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, (lot number Y009348 has been verified to be a valid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [PROQUAD], expiration date 11-NOV-2025 (dose, vaccination scheme frequency, route of administration and anatomical site of injection were not provided). The dose was administered following a temperature excursion (Product storage error).   No additional adverse event was reported for the patient.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2411USA001575
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported. No additional AE; VARIVAX that was expired and administered to patients; This spontaneous report has been received from a Nurse referring a 12-month-old patient of an unknown gender.  The patient's pertinent medical history, previous drug reactions and allergies were not provided. Concomitant medications included sterile diluent (BAXTER STERILE DILUENT).   On 22-OCT-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose administered, route and anatomical location of administration were not provided; lot # reported as W018830, which has been verified to be a valid lot # for this vaccine, expiration date provided and validated to be on 14-JUN-2024) (expired product administered). No adverse side effects were reported. No additional AE (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Asthma
Clinical narrative: asthama; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of asthma 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 asthma (Verbatim: asthama). The outcome of the asthma was not reported.   It was unknown if the reporter considered the asthma to be related to Shingles vaccine.     It was unknown if the company considered the asthma to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-OCT-2024 This case was reported by a patient via interactive digital media. Patient reported that the Shingles vaccine gave him/her asthma.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Impaired work ability, Sleep study
Clinical narrative: Idiopathis Hypersomnia, 29 months missed from job by order of agency
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Patient came to pharmacy and stated pharmacist had administered her RSV shot in  toward the back of her arm instead of the center.  Pt stated as a result she experienced pain that she's never experienced with the previous immunizations she'd received at this pharmacy. VAERS completed
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Dizziness, Injection site pain, Nausea, Pain
Clinical narrative: Injection site pain started approximately 2-3 hours following vaccination, primarily in right arm.  Fever, chills, body aches started approximately midnight the night of vaccination. Had nausea the following morning causing emesis of breakfast.  Had intermittent lightheartedness until at least 0900 (possibly secondary to dehydration from emesis and fever). On 11/7 (two days following vaccination), noted a single ulcer on the bottom of the tongue near a vein, no known associated oral trauma. Unknown if this was related. Injection site pain still present on 11/7 but significantly improved.
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Tongue ulceration, Vomiting
Clinical narrative: Injection site pain started approximately 2-3 hours following vaccination, primarily in right arm.  Fever, chills, body aches started approximately midnight the night of vaccination. Had nausea the following morning causing emesis of breakfast.  Had intermittent lightheartedness until at least 0900 (possibly secondary to dehydration from emesis and fever). On 11/7 (two days following vaccination), noted a single ulcer on the bottom of the tongue near a vein, no known associated oral trauma. Unknown if this was related. Injection site pain still present on 11/7 but significantly improved.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: she has tinnitus in the ear; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 48-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2XK44, expiry date 13-JUN-2025) for prophylaxis.   On 07-OCT-2024, the patient received FluLaval 2024-2025 season. In OCT-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced tinnitus (Verbatim: she has tinnitus in the ear). The outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the tinnitus to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   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-OCT-2024  The pharmacist did the vaccine to a patient couple days before reporting. The patient had tinnitus in the ear, it's gotten worse. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Product complaint, Syringe issue, Underdose
Clinical narrative: syringe broke; Product Complaint; States the vaccine was partially administered to the patient; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 6-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 94J52, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On 08-OCT-2024, the patient received Fluarix 2024-2025 season. On 08-OCT-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incomplete dose administered (Verbatim: States the vaccine was partially administered to the patient). On an unknown date, the patient experienced syringe broken (Verbatim: syringe broke) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe broken and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe broken to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the syringe broken to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   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: 10-OCT-2024 and 10-OCT-2024 The physician office staff member reported that they had an incident on 8th October 2024, she was giving a shot of the Fluarix vaccine and the glass, the pre filled syringe broke. The reported she was administering pre-filled syringe suspect vaccine to a patient and the neck of the LLA broke.  The reporter stated that the vaccine was partially administered to the patient.  The reported that she has been preparing vaccines for 10 years and she has never had the glass break on a Pre-filled syringe. The product still present in the syringe The reporter consented to follow up. GlaxoSmithKline had completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends, an examination of the complaint sample, a testing of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. Nothing atypical was identified while the product was under GlaxoSmithKline control which would explain the reported quality defect. Given the outcome of its investigation, GlaxoSmithKline considers the complaint that is the object of this report as unsubstantiated. Summary of Changes: Narrative updated.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects/symptoms reported. No additional AE details.; she administered expired PNEUMOVAX 23 to one patient on 11/4/2024; This spontaneous report was received from a medical assistant referring to a 63-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 04-NOV-2024, the patient was vaccinated with expired pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (0.5 mL, lot#: X018273, expiration date: 07-OCT-2024; strength and route of administration were not reported) by a healthcare professional for prophylaxis (expired product administered). The vaccine did not experience any temperature excursions through the date of administration. No side effects/symptoms were reported. No additional adverse events (AE) details were reported (no adverse event).
Sex: M
Vaccine: RVX
Symptoms: Cough, Paranasal sinus hypersecretion
Clinical narrative: Sinus drainage; cough; This non-serious case was reported by a consumer and described the occurrence of postnasal drip in a 81-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included losartan.   On 04-OCT-2024, the patient received RSV vaccine. On 07-OCT-2024, 3 days after receiving RSV vaccine, the patient experienced postnasal drip (Verbatim: Sinus drainage) and cough (Verbatim: cough). The outcome of the postnasal drip and cough were not resolved.   It was unknown if the reporter considered the postnasal drip and cough to be related to RSV vaccine.     It was unknown if the company considered the postnasal drip and cough to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 11-OCT-2024 This report was submitted via the online direct entry reporting system. The other health professional reported that male patient received RSV vaccine and developed sinus drainage and cough.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: a pediatric dose of Havrix was given to an adult patient; a pediatric dose of Havrix was given to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 63-year-old male patient who received HAV (Havrix pediatric) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix in April 2024).   On 09-OCT-2024, the patient received the 2nd dose of Havrix pediatric. On 09-OCT-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: a pediatric dose of Havrix was given to an adult patient) and adult use of a child product (Verbatim: a pediatric dose of Havrix was given to an adult patient). The outcome of the underdose and adult use of a child product 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-OCT-2024  The nurse reported that a pediatric dose of Havrix was given to an adult patient which led to underdose and adult use of a child product.  The nurse reported that dose was second Havrix dose for the patient.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Vaccine not stable administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis.   On 08-OCT-2024, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Vaccine not stable administered). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2024 The pharmacist reported that an Arexvy vaccine was reconstituted on 4th October 2024 for a patient that decided they did not needed it, so they stored the vaccine in the fridge until 8th October 2024 when it was administered to a patient, which led to incorrect storage of drug.  This had been the first and only Arexvy vaccine for that patient so far. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Possible administration of liquid portion only; Possible administration of liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis.   On 01-OCT-2024, the patient received Hiberix. On 01-OCT-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Possible administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Possible administration of liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The nurse reported that a patient received the diluent portion only of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not knew which patient was the one receiving the non-reconstituted vaccine and asked how to proceed. The Vaccine Administration Facility was the same as Primary Reporter The case is 1 of the 5 linked case, by same reporter; Sender's Comments:  US-GSK-US2024125036:Same reporter/Diffrent patient US-GSK-US2024125018:Same reporter/Diffrent patient US-GSK-US2024125010:Same reporter/Diffrent patient US-GSK-US2024125012:Same reporter/Diffrent patient
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 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 44-year-old male patient who received HBV (Engerix B) (batch number MD9SL, expiry date 12-AUG-2026) for prophylaxis.   Previously administered products included Engerix B (received 1st dose of Engerix B vaccine on 12th October 2022, with batch number 74EM4  and lot expiry 20th December 2022).   On 10-OCT-2024, the patient received the 2nd dose of Engerix B. On 10-OCT-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 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: 11-OCT-2024 The pharmacist reported that a patient received the first dose of Engerix-B on 12th October 2022 and did get the second dose until before one of reporting. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: FLUX
Symptoms: Skin lesion, Swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction; interaction between vaccine antigens and pre-existing IgG antibodies; large, localized swelling within hours of her annual influenza vaccine; Initial information received on 30-Oct-2024 via Health Care Professional regarding an unsolicited valid serious case issued from a literature article:    This Case was linked to US-SA-2024SA318348.  This case involves a 5-year-old female patient (Patient 2) who experienced Arthus reaction (type iii immune complex mediated reaction) while receiving vaccine Influenza Vaccine (Latency: unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed large, localized swelling within hours of her annual influenza vaccine (vaccination site swelling) since infancy. Lesions resolved after two weeks.   Author stated that: Arthus reaction is a type III hypersensitivity reaction, triggered by interaction between vaccine antigens and pre-existing (immunoglobulin) IgG antibodies (vaccine interaction). Symptoms peak at 12 to 36 hours post-immunization and include injection-site swelling, induration, and pain. Though classically associated with tetanus toxoid boosters, limited literature addresses this phenomenon with other vaccines. This case emphasizes the need for providers to recognize Arthus reactions with vaccines beyond tetanus toxoid. Strategies like dose splitting may not prevent reactions. Recognizing these reactions is crucial for diagnosis, patient management, and counseling. Documenting and reporting these cases will enhance understanding of vaccine safety profiles and inform future clinical guidelines. While current guidelines advise avoiding tetanus vaccines for at least ten years following this reaction, the ideal timing with influenza vaccine is unknown.  Seriousness criteria: medically significant. Action taken: not applicable Corrective treatment: not reported for the event. Outcome: Recovered / Resolved Reporter's causality: Related; Sender's Comments: Sanofi company comment on dated 06-NOV-2024: This case involves a 5-year-old female patient (Patient 2) who experienced Arthus reaction (type iii immune complex mediated reaction) while receiving vaccine Influenza Vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely. US-SA-2024SA318348:
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt stated itchiness traveling up her arm to her neck. Pt had erythema around the injection site and some small patches of redness above and below the injection site. Pt was given 50 mg of benedryl orally and observed. Pt symptoms did remain the same for next 10 mins then improved after 30 mins.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: Severe HSV-2 outbreak
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebral artery embolism, Cerebrovascular accident, Fatigue, Hemiparesis
Clinical narrative: I had a stroke and was in the hospital for 3 days following.  No symptoms prior to the day it happened. Then the right side of my body went numb and weak.  My foot dragged. My right  arm was weak and my fingers were not working properly. I felt very fatigued. My blood pressure spiked to 195/100. I was told I had a blood clot that went to my brain for no apparent reason.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal disorder, Peroneal nerve palsy
Clinical narrative: I had a stroke and was in the hospital for 3 days following.  No symptoms prior to the day it happened. Then the right side of my body went numb and weak.  My foot dragged. My right  arm was weak and my fingers were not working properly. I felt very fatigued. My blood pressure spiked to 195/100. I was told I had a blood clot that went to my brain for no apparent reason.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance impaired, Hypothyroidism, Iron deficiency anaemia, Vitamin B12 deficiency
Clinical narrative: Patient pregnant with LMP 3/5/2024, 27 weeks gestation at time of vaccine. Problem list includes hypothyroid in pregnancy, pre-diabetes, Vitamin B12 deficiency, iron deficiency anemia Patient received COVID vaccine on 9/10/2024 and again on 11/4/2024
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Loss of consciousness, Pallor, Vomiting
Clinical narrative: Within one minute after shots, she passed out, loss her color, 10 minutes later she vommitted. It took about an hour for her to recover. Weak for a total of 3 hours.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 38.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Chills, Computerised tomogram normal, Dizziness
Clinical narrative: Overnight I started to have the rigors accompanied by profuse sweating that felt better by 5:30 am. At that time I decided to get up and go to the bathroom ( just to urinate, not have a bowel movement). While seated I felt dizzy and knew I was going to pass out. Once I passed out my husband heard me fall and came in the bathroom. He stated that it was difficult for him to get me to sit up and speak so he called EMS.  By the time the ambulance arrived I was awake but I could hardly talk, I couldn't open my eyes or stand on my own.  I was taken to ER by the Fire Department.  While in the ambulance the paramedic started an IV on me and by the time I got to the hospital I was able to keep my eyes open but still felt extremely weak.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Fall, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Overnight I started to have the rigors accompanied by profuse sweating that felt better by 5:30 am. At that time I decided to get up and go to the bathroom ( just to urinate, not have a bowel movement). While seated I felt dizzy and knew I was going to pass out. Once I passed out my husband heard me fall and came in the bathroom. He stated that it was difficult for him to get me to sit up and speak so he called EMS.  By the time the ambulance arrived I was awake but I could hardly talk, I couldn't open my eyes or stand on my own.  I was taken to ER by the Fire Department.  While in the ambulance the paramedic started an IV on me and by the time I got to the hospital I was able to keep my eyes open but still felt extremely weak.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan with contrast normal, Urine analysis normal
Clinical narrative: Overnight I started to have the rigors accompanied by profuse sweating that felt better by 5:30 am. At that time I decided to get up and go to the bathroom ( just to urinate, not have a bowel movement). While seated I felt dizzy and knew I was going to pass out. Once I passed out my husband heard me fall and came in the bathroom. He stated that it was difficult for him to get me to sit up and speak so he called EMS.  By the time the ambulance arrived I was awake but I could hardly talk, I couldn't open my eyes or stand on my own.  I was taken to ER by the Fire Department.  While in the ambulance the paramedic started an IV on me and by the time I got to the hospital I was able to keep my eyes open but still felt extremely weak.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient received the GSK Flulaval trivalent influenza vaccine LOT# 5554G in her left deltoid on 11/04/2024 at approximately 0940. Patient denied any immediate reaction after the vaccine. She reports that she noticed her left arm begin to develop pain and swelling from her left upper arm to her hand on 11/05/2024. The pain and swelling increased throughout the day and worsened by 11/06/2024. She approached a physician at the family practice that she works at, and the physician administered an injection of steroids. The patient noted that by 11/07/2024, her pain/swelling decreased significantly. She noted that her left arm today (11/08/2024) is almost back to 100% normal.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Red rash, pain & a bruise at injection site.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction, red, swollen, hard area, treated with ice pack for comfort. Seizure requiring emergency medication at 0130 on 11/8/24 and resident seizures are infrequent and very rarely require intervention.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Injection site reaction, red, swollen, hard area, treated with ice pack for comfort. Seizure requiring emergency medication at 0130 on 11/8/24 and resident seizures are infrequent and very rarely require intervention.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, painful, warm at injection site approximately 3? long x 2? wide lasting currently 5 days       On  day 3 developed cellulitis left lower leg
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: pt received flu in left arm first and then novavax in right arm after.  She complained of dizziness and then lost consciousness and convulsed.  total time to regain consciousness was about 5 seconds.  emts were dispatched to treat pt
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received an additional dose of RSV vaccine. Although patient reported not receiving an RSV in the past updated EHR records showed he had received at a local pharmacy on 11/17/2023. Pt tolerated procedure well with no complications after administration. Monitored for 15 minutes after injection.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: After receiving Covid booster shot (not sure of booster name or lot number) I noticed itching on my left foot. I then started itching on the left side of my chest and noticed raised red hives all over my chest, back, lower neck, groin area and top of both feet, about 6 hours after receiving Covid booster shot. I took 25mg of Benadryl to help the itching. I contacted the Outpatient Clinic and the nurse set up a tele urgent care appointment for 1:30pm on 11/07/2024.
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Abdominal pain, Blood thyroid stimulating hormone, Cough, Dyspnoea, Nausea
Clinical narrative: Neck pain, neck mass, difficulty breathing, body aches, cough, congestion, abdominal pain, nausea, vomiting, subjective fever that required ED visit 5 days after vaccination. Treated conservatively with gradual improvement in symptoms. Per visit 11/06/2023, Neck mass improved spontaneously but not resolved completely per patient, however, unable to palpate on exam.
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Neck mass, Neck pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Neck pain, neck mass, difficulty breathing, body aches, cough, congestion, abdominal pain, nausea, vomiting, subjective fever that required ED visit 5 days after vaccination. Treated conservatively with gradual improvement in symptoms. Per visit 11/06/2023, Neck mass improved spontaneously but not resolved completely per patient, however, unable to palpate on exam.
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Thyroid mass, Thyroxine free normal, Ultrasound thyroid abnormal, Vomiting
Clinical narrative: Neck pain, neck mass, difficulty breathing, body aches, cough, congestion, abdominal pain, nausea, vomiting, subjective fever that required ED visit 5 days after vaccination. Treated conservatively with gradual improvement in symptoms. Per visit 11/06/2023, Neck mass improved spontaneously but not resolved completely per patient, however, unable to palpate on exam.
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Arthralgia, Blood thyroid stimulating hormone normal, Fatigue, Goitre, Malaise
Clinical narrative: Neck pain, neck mass, difficulty breathing, body aches, cough, congestion, abdominal pain, nausea, vomiting, subjective fever that required ED visit 5 days after vaccination. Treated conservatively with gradual improvement in symptoms. Per visit 11/06/2023, Neck mass improved spontaneously but not resolved completely per patient, however, unable to palpate on exam.
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Neck pain, Odynophagia, Oropharyngeal pain, Pain, Thyroid mass
Clinical narrative: Neck pain, neck mass, difficulty breathing, body aches, cough, congestion, abdominal pain, nausea, vomiting, subjective fever that required ED visit 5 days after vaccination. Treated conservatively with gradual improvement in symptoms. Per visit 11/06/2023, Neck mass improved spontaneously but not resolved completely per patient, however, unable to palpate on exam.
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Thyroxine normal, Ultrasound thyroid abnormal
Clinical narrative: Neck pain, neck mass, difficulty breathing, body aches, cough, congestion, abdominal pain, nausea, vomiting, subjective fever that required ED visit 5 days after vaccination. Treated conservatively with gradual improvement in symptoms. Per visit 11/06/2023, Neck mass improved spontaneously but not resolved completely per patient, however, unable to palpate on exam.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia
Clinical narrative: When attempting to get out of bed, patient was unable to stand (usually able to stand without issue). Unable to raise or turn his feet to sit down in the wheelchair.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was scheduled for a nurse visit on 11/7/2024 to receive Meningococcal B vaccine. LPN pulled an expired vaccine and gave vaccine to pt. Pt's parent was present at the time of vaccination and has been informed of the incident. Staff doctor was also notified of the incident and assessed pt. Pt showed no s/s of distress. Pt's parent has agreed to come back at a later time to be revaccinated per CDC guidelines.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Mom reports that she had a fever, and had a rash on her legs.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC20, VARZOS
Symptoms: Asthenia, Blood creatine phosphokinase, Blood glucose, Blood iron, Blood thyroid stimulating hormone
Clinical narrative: One week after vaccinations started to experience shortness of breath, fatigue, decreased stamina and strength, right calf pain and edema, 10-pound weight gain. Calf pain lasted several months. treated with doxycycline, oral steroid. Slowly improved or stabilized but remains fatigued and short of breath.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC20, VARZOS
Symptoms: C-reactive protein, Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Electrophoresis protein
Clinical narrative: One week after vaccinations started to experience shortness of breath, fatigue, decreased stamina and strength, right calf pain and edema, 10-pound weight gain. Calf pain lasted several months. treated with doxycycline, oral steroid. Slowly improved or stabilized but remains fatigued and short of breath.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC20, VARZOS
Symptoms: Exercise tolerance decreased, Fatigue, Fibrin D dimer, Full blood count, Influenza virus test
Clinical narrative: One week after vaccinations started to experience shortness of breath, fatigue, decreased stamina and strength, right calf pain and edema, 10-pound weight gain. Calf pain lasted several months. treated with doxycycline, oral steroid. Slowly improved or stabilized but remains fatigued and short of breath.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC20, VARZOS
Symptoms: Metabolic function test, N-terminal prohormone brain natriuretic peptide, Oedema peripheral, Pain in extremity, Reticulocyte count
Clinical narrative: One week after vaccinations started to experience shortness of breath, fatigue, decreased stamina and strength, right calf pain and edema, 10-pound weight gain. Calf pain lasted several months. treated with doxycycline, oral steroid. Slowly improved or stabilized but remains fatigued and short of breath.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC20, VARZOS
Symptoms: SARS-CoV-2 test, Serum ferritin, Vitamin B12, Vitamin D, Weight increased
Clinical narrative: One week after vaccinations started to experience shortness of breath, fatigue, decreased stamina and strength, right calf pain and edema, 10-pound weight gain. Calf pain lasted several months. treated with doxycycline, oral steroid. Slowly improved or stabilized but remains fatigued and short of breath.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient reports  shoulder pain and stiffness, with tingling that travels from shoulder to fingers on left side. Also reports pain to neck during rotation and extension.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two doses of the flu vaccines one day apart. Patient lives in an residence home and was given a flu shot (11/6/24) as part of a flu clinic coordinated by residence nurse. When putting in vaccinations in the pharmacy noticed patient had received flu shot on 11/5/24. I contacted the nurse and they confirmed they were not aware the resident had previously received the vaccine the day prior. Nurse assessed patient and reports seems to be doing fine.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Face injury, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient walked out of consultation room after receiving a vaccination with no symptoms. He walked approximately 20 feet and fainted, falling forward into a metal display hitting the front of his face and then backward onto the floor hitting the back of his head. He immediately regained consciousness and was aware of his surroundings. He was put in a chair where he was given an ice pack for his head until EMTs arrived. EMTs decided it was appropriate to take him to a hospital.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Arexvy vaccine on 1/6/24. Readministered on 11/8/24
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 27.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Cellulitis at injection site.  Injection site red, swollen, hot,  itchy.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Patient started with pain and swelling in deltoid of Right arm the day after the vaccination clinic. The pain persists and limits ADLs. She does have full ROM in shoulder (but with discomfort). Pain appears confined to area of injection and not in the shoulder joint. She has spoken with MD who believes it is inflammatory and advised ibuprofen. encouraged patient to follow up again with MD since this started 3 weeks ago.
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received flu vaccination twice, once on 9-23-2024 and 11-8-2024
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given flu vaccine twice, once on 9-23-2024 and on 11-8-2024.
Age: 87.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain
Clinical narrative: Patient reported chest pain.  EMS was called.  Patient refused transport to hospital.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Pain in the shoulder area.   Pain when I reach out, try to put a coat on.  Pain in the shoulder when I sleep. So far I have been taking some Aleve.  I use topical pain relief creams.
Age: 96.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain
Clinical narrative: Patient reported chest pain 24-48 hours after receiving vaccinations.  EMS was called.  Patient refused transport to Emergency Department.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient born 10/XX/24, however received the first dose of Hep B vaccine late apparently due to parent deferral until PCP visit on 11/8/2024.
Age: 85.0
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Chest pain
Clinical narrative: Patient reported chest pain 24-48 hours after receiving vaccinations.  EMS was called.  Patient refused transport.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was 54 years old and should have received the regular flu vaccine, but erroneously received the adjuvanted Fluad that was intended for patients 65 and older. No adverse reactions reported.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: There was no "adverse event" and mistake was made giving a third Hep B too early.  Call was made to mother, mother said "it was fine".
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Blister, Blister rupture, Hypoaesthesia, Injection site pain, Joint range of motion decreased
Clinical narrative: Pathcy erythematous rash on R forearm, small vesicles on palm of hand. Dorsal wrist with shallow ruptured blister, RUE swelling FROM fingers. Initially just had deltoid pain, however the next day she developed rash on R hand  and arm. Also with numbness/weakness in the arm and limited ROM/weakness in hand due to swelling.  Treatment: Cetirizine and hydrocortisone 1% cream.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Muscular weakness, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Pathcy erythematous rash on R forearm, small vesicles on palm of hand. Dorsal wrist with shallow ruptured blister, RUE swelling FROM fingers. Initially just had deltoid pain, however the next day she developed rash on R hand  and arm. Also with numbness/weakness in the arm and limited ROM/weakness in hand due to swelling.  Treatment: Cetirizine and hydrocortisone 1% cream.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Health maintenance in patient's chart showed that a second HPV vaccine was due. After administration of vaccine, patient's chart showed pt had already gotten two doses of HPV.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Gait disturbance, Heart rate decreased, Hypoaesthesia
Clinical narrative: Patient's written response of adverse reaction: "I believe I am having an adverse reaction of sorts that has started Monday night and became more severe over the course of that night. The core symptoms are nausea and vomiting, lightheadedness, slowed breathing/heart rate, sporadic numbness or tingling in left arm, body weakness and unstable gate, and severe head spinning that can last hours. These symptoms have continued since Monday night. I have taken Tylenol and Pepto Bismal to no avail."
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Vertigo, Vomiting
Clinical narrative: Patient's written response of adverse reaction: "I believe I am having an adverse reaction of sorts that has started Monday night and became more severe over the course of that night. The core symptoms are nausea and vomiting, lightheadedness, slowed breathing/heart rate, sporadic numbness or tingling in left arm, body weakness and unstable gate, and severe head spinning that can last hours. These symptoms have continued since Monday night. I have taken Tylenol and Pepto Bismal to no avail."
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Lip swelling, Tongue pruritus
Clinical narrative: Mom called 3 hours after the child received his HPV vaccine and he had lip swelling and his tongue was itchy. He had also had lunch and played his band instrument.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Client received two doses of DTaP out of this lot on the same visit.  No adverse side effects noted from client.