No adverse effects were reported; HCP called to report inadvertent administration of an expired dose of VAQTA to a pediatric patient. Expiration date of 12/26/2024, administered on 1/20/2025. Potency supported by Post Expiry Memo. See Request case 02738592. No adverse effects wer; This spontaneous report was received from a nurse referring to a 8-year-old female patient. The patient’s historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 20-JAN-2025, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # X020849, expiration date 26-DEC-2024, 0.5 milliliter (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.

No additional AE/PQC.; Pharmacy student called and reported an adult patient who received two doses of GARDASIL 9 in 2018 and received a third dose of GARDASIL 9 in 2024.; This spontaneous report was received from a pharmacy student and refers to a 26-year-old adult patient with unknown gender. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates in 2018, the patient received first dose and second dose (two doses) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strengths, doses, lots #, expiry dates, and routes of administration were not provided). On an unknown date in 2024, the patient received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional information was known by reporter. No additional adverse event (AE) (No adverse event). Lots is being requested and will be submitted if received.

Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being administered the expired dose of PROQUAD.; Nurse calling with a report of an adverse event regarding an expired dose of PROQUAD that was administered to a patient. Nurse stated that the dose of PROQUAD had a labeled expiration date of 1/6/2025 and was administered to the patient on 1/20/2025; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient’s medical history, concurrent conditions and concomitant therapies were not reported. On 20-JAN-2025, an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5 ml / two dose series, lot #X018729, expiration date: 06-JAN-2025 (administered for prophylaxis, strength, and route of administration were not provided) was administered to the patient (Expired product administered). Operator of device was health professional. Nurse confirmed the patient involved had not reported any medical concerns or symptoms after being administered the expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (No adverse event). No additional information provided.

couldn’t walk; isolated, depressed; Hypertriglyceridemia; mosquito bite over leg and subsequently had bug bites like reaction all over body; anxiety; chondromalacia in the left knee; gabapentin; this apparently worsened his pain and cause psychiatric side effects; gastroenteritis; tonsillitis; Inflammatory arthritis; hypermobility in joints especially ankles, wrists, and hands.; ferritin levels are high; that pain in bilateral knee had been waking up over night even through pain meds; supplement that he had a rare adverse reaction to; ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE; THS 4.23 (h); uric 8.7 (H), hyperuricemia; Small fluidfjoint effusion in the suprapatellar bursa/e.; body rashes/ nodular rash on the right foot and lower leg,; fibromyalgia, chronc fatigue and chronic joint pain, ANA 1:640 (A), levated ANA; athralgia in multiple joints; Candida albicans skin antigen injections for warts; panic attack; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning male patient (pt). Patient’s current conditions, medical history and concomitant therapy was not reported. On 18-SEP-2020, (at 18 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prophylaxis. Within weeks after receiving the vaccination, on or around 04-OCT-2020, the pt began to experience body rashes, chronic fatigue, and chronic joint pain symptoms. Petitioner went and bought knee braces at his local pharmacy and started to wear them, but the pain kept getting worse. By the end of October 2020, the pain in his left knee had gotten so bad that he was seen a few times at urgent care wherein they prescribed anti-inflammatory medications and more restrictive braces for both knees, neither of which helped. On or around 30-OCT-2020, in addition to the pain he was experiencing in both knees, the pt began to experience severe pain in his left foot. He could no longer bear any weight on it so was taken to the emergency room, where he had to be carried out by his father, because he couldn’t walk. Within the next few days, he also began experiencing severe pain in his hands, fingers, and ankles. He has been in severe pain ever since, the pt had seen countless specialists such as rheumatologists, sports medicine, orthopedics, allergy/immunology, infectious disease, endocrinologists, pain management, and neurologists. The pt had many blood tests and imaging studies performed and has been left with no answers or given an explanation of the origin of his symptoms. The pt was officially diagnosed with Fibromyalgia on 26-AUG-2022, by rheumatologist. He was then sent to pain management, and they tried several treatments, none of which helped him long term, Petitioner has been told that there is no cure and most treatments have been ineffective, including prescription pain medication, nerve medication, psychiatric medication, steroid injections, extensive physical therapy (both regular and aquatic), high dose anti-inflammatory medication, and steroids. As far as future treatments are concerned, the options are limited. Currently, the pt continues to suffer with chronic pain, chronic fatigue and was ultimately diagnosed with fibromyalgia. Petitioner’s pain has gotten so bad in his lower extremities he is no longer able to walk without assistance. Petitioner needs to use a walker inside his home and a wheelchair when he leaves his home. The pt can’t even take a shower without the use of his shower chair. The pt had been diagnosed with fibromyalgia as well as arthralgia in multiple joints. The outcome of the events were not recovered. Causality of the events was reported as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). F/U information was received on 21-JAN-2025 from a from medical records regarding a case in litigation referring a 18 years old male patient (transgender). Pt medical history included tonsillectomy, appendectomy, hernia repair, bilateral mastectomy with free nipple graft, bilateral liposuction flank, pt current condition included lactose intolerance, right ovarian cyst, skin scar and gender dysphoria; non smoker and non-alcohol use, no-drug usser. Familial medical history included Lupus-Mother; Hyperlipidemia Father; Lupus Matemal Grandmother; Hypertension Matemal Grandmother; Stroke Matemal Grandmother, Coronary Artery Disease Matemal Grandmother; Hypertension Paternal Grandmother; Hyperlipidemia Patemal Grandmother; Lymphoma paternal grandfather. Historical vaccination included: diphtheria vaccine toxoid, pertussis vaccine acellular (DTAP); Hepatitis B vaccine (Recombinant) (RECOMBIVAX) (MARRS# 2501USA007027); Hepatitis A Vaccine, Inactivated (VAQTA); Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II); unspecified polio vaccine and polio vaccine inact (IPV). 18-SEP-2020, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly on the left deltoid as prophylaxis (lot#, expiration date, dose description were not provided). 08-OCT-2020 at medical visit, the pt complaint of body rash for days started on hands/feet, spreading- possibly triggered by panic attack treated with BENADRYL w/no relief. Was started on Buspar 2 weeks ago for anxiety, stopped it recently because of increased anxiety and suicidal ideation, additionally, pt complaied of rash on whole body started on hands then spread to legs, reports itchiness, but no pain, denies any significant changes that may had caused it and cannot associated with specific foods or contacts, no systemic symptoms, it was advised to start topical Lidex BID, and cold compresses, Zyrtec up to TID, avoid scratching. XR knees (28-OCT-2020): Alignment unremarkable. Joint spaces are preserved. No erosions are detected. No osteophyte formation. On 30-OCT-2020, pt Antinuclear antibody tested positive. XR left foot (01-NOV-2020): No fracture, subluxation, periosteal reaction or bone destruction is detected. Joint spaces are preserved. XR left foot (30-NOV-2020): No radiographic evidence of significant arthritis. On TAV on 05-MAY-2021. The pt presented with trouble with multiple joint pains on and off without signs of inflammatory arthritis/tophaceous disease referred for worsening of polyarthralgia, several non-inflammatory painful episodes each responsive with medicines (lower Effexor dose), negative MRI in past for any hand/wrist inflammation and not responsive to steroids or sulfasalazine by rheumatologist, was recommended to continue conservative pain management with oral APAP with NSAID only for breakthrough, additionally it was referred that Around October 2020, began to have severe sharp pain involving the knees, ankles, wrists and fingers. Not associated with itching, redness, swelling, or warmth. Pain is intermittent and worse with movement, pt is unable to ambulate sometimes due to the pain, symptoms did not improve on prednisone and did not worsen after coming off, Effexor discontinued January 2021 and pain severity improved afterwards one week after discontinuation, pt was unable to touch thumb to wrist, unable to wrap opposite wrist with thumb and pinky finger. On 09-AUG-2022, pt reported that he recently had a physician who believes that he may fit a diagnosis of fibromyalgia. He has a follow-up with a fibromyalgia specialist in two weeks. On 20-SEP-2022, pt reported that his pain levels have been more variable, but the lower pain levels are better, although the severe pain was worse. He was still able to walk independently, but severe pain limited his endurance and activity tolerance. Pt was still undergoing testing to confirm his diagnoses of polyarthralgia and fibromyalgia. On 27-OCT-2022, Pt reported he uses walker, walking sticks, and manual W/C. Pt reports he started a flare about 3-4 months ago that had not improved significantly with L knee pain>R knee pain and other diffuse pain throughout extremities. On 02-NOV-2022, at endocrinology telephone appointment visit (TAV), the pt complained of joint pain, swelling and Recent onset of migratory arthritis, positive ANA and assured has follow up appt with rheumatology, the pt stated appt in 2 days and continued pain and inability to walk due to LE arthritis. Rheumatology appt made after ED visit Reinforced importance of low fat, low sugar diet, no concentrated sweets, no fruit juice or any sweetened beverage. On 04-NOV-2020, the pt complained of pain began in knees ( front and back), wrists and feet pain ( tops), sometimes looks swollen, he had been taking otc Advil 2 tabs or Tylenol 2 tabs every 4 hours and when severe takes Norco, he has also been taking meloxicam 2 tabs/day with not much relief, pt had difficulty walking due to knees and feet pain and has not been able to work, he was not able to even walk to the bathroom due to pain. Review of systems (ROS) within normal limits, it was recommended to stop NSAIDs and take prednisone as prescribed. On 17-NOV-2022, pt received new lightweight W/C, hands are hurting but likely due to using new art device, pt reported knees are worse overall. Pt felt like he sees a short-term improvement of about 1-1.5 days before symptoms increase again. On 17-JAN-023, pt reported fewer episodes of knee buckling but also notes using assistive devices more frequently. On 06-FEB-2023, pt reports has not been able to walk and has used W/C for about 1.5 weeks. Pt trialed aquatic therapy but had to quit after 20 minutes due to excruciating pain. Pt went to urgent and was given steroids which has helped a little bit with full body joint, muscle pain. Pt had episode of knee instability and had a near fall. Pt reports position does not affect pain especially in knees. Pt reports reducing number of medications from 6 to 3 which has made it difficult to manage pain. On 29-JUN-2023, Pt reports that he was able to walk about 0.5 mile with mod Increase in pain that decreased within day. Pt reports wearing OTC ankle braces bilaterally. On 06-AUG-2023, Pt reports that he has been feeling much better off and on for about 1 month. He has been on medication Naltrexone and magnesium as recommended by a pain management specialist. Pt reports no instability with walking, pain at 3/10 on average L>R knee, ankle, hands. Pt reports some breakthrough muscular and tendon pain since been more active as when walking more. Pt noted no assistive device usage in last month. Pt notes he continues to experience fatigue especially at the end of the day. On 31-MAR-2023, the pt consulted for ANA elevated, and lot of pain in the Knees. Steroids helped at first Now ankles, wrists hurt, hurts all over, Joints hurt more than muscles, Uses walker for a year, Recent knee injections with Pain Management, 4/2022, without significant benefit, had been In physical therapy for the past 1.5 years, mostly for the knees, did not have significant hypermobility on exam, some benefit from meloxicam, not much benefit from prior ibuprofen tramadol did help. He had been taking cymbalta since early august 2022, for suspected fibromyalgia, unfortunately no significant benefit for pain (has helped anxiety however), pain has actually been getting worse. On doctors visit on 25-AUG-2023, the pt complaint of Feeling unstable in ankle and wrist. Knee has pain below. Had increased pain for a day following last sessions exercises. Pt reports he had significant increase in pain day after last visit which coincided with taking a supplement that he had a rare adverse reaction to. Pt reports he stopped supplement and symptoms have been improving overall though ankles are most painful currently. Pt also notes had imaging on ankles that revealed tissue on lateral dorsum of feet with MRI pending. The outcome of the event rash was updated to unknown, causality assessment for the events fibromyalgia, rash, arthralgia, gait inability was updated to unknown. Information received on 21-JAN-2025, contained the following adverse events: Hypertriglyceridemia (onset, outcome and causality unknown, tx: gemfibrozil), Arthropod bite (onset, outcome and causality unknown), Bursal fluid accumulation (28-OCT-2020, outcome and causality unknown, tx aspiration), Hyperuricaemia (01-NOV-2020, outcome and causality unknown), Blood thyroid stimulating hormone increased (09-DEC-2020, outcome and causality unknown), anxiety (onset, outcome and causality unknown, tx: gabapentin), Immunisation reaction (07-MAR-2021, related to COVID vaccine, outcome and causality unknown), hypermobility (10-AUG-2023, outcome and causality unknown), Adverse reaction to product (??-???-2023, outcome and causality unknown, related to unspecify supplements), ferritin high (onset, outcome and causality unknown), Sleep disorder due to a general medical condition (??-???-2023, outcome and causality unknown), Skin papilloma (??-SEP-2020, outcome and causality unknown, tx: Candida albicans skin antigen injections), Psychiatric disorder NOS (onset, outcome and causality unknown), gastroenteritis (onset, outcome and causality unknown), Tonsillitis(onset, outcome and causality unknown), panic attack (??-???-2020, outcome and causality unknown) Upon internal review, the events fibromyalgia, gait disturbance and arthralgia were considered to caused disability since pt was no longer able to walk without assistance and must rely on a walker or wheelchair to move around due the pain. All available medical records will be provided upon request. This is 1 of 2 reports from the same patient. ; Sender’s Comments: US-009507513-2501USA007027:

No additional AE. No PQC.; HCP reports patient did not get her second GARDASIL 9 dose until today, 1/17/2025 and her first dose was “years ago, like 11 years”.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient’s pertinent medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (reported as “years ago, like 11 years”), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) Injection administered as prophylaxis (strength, lot #, expiry date, route of administration and anatomical location were not provided) and then on 17-JAN-2025, the patient received the second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe also administered as prophylaxis, lot number: 1965044, expiration date: 07-JAN-2026 (strength, route of administration and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse event.

HCP calling to report an AE regarding the PROQUAD vaccine. HCP stated that an improperly stored PROQUAD was administered to a patient. HCP provided limited pertinent information and demographic data. Permission to follow-up with the HCP is unspecifie; No additional AE/PQC reported; This spontaneous report was received from a physician and refers to a 4-year-old male. No information on patient’s medical history, current conditions and concomitant medication was provided. On 30-DEC-2024, the patient was vaccinated with improperly stored dose (temperature excursion) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Subcutaneous Injection (albumin status: rHA) lot #Y009108, expiration date: 06-NOV-2025, administered subcutaneously in the left arm for prophylaxis (strength, exact dose, and dose number were not provided) (product storage error). The vaccine was determined to be viable. No additional adverse events and product quality complaints was reported (no adverse event).

Patient received a 3rd dose on accident. Patient did not recall getting the whole series in 2020.

At around 10:30 am on 01/24/2025 patient approached Team (PHN Team) – (RN, PHN and RN, PHN and requested a Hepatitis A vaccine. RN, PHN reviewed patient eligibility and confirmed vaccine history in the Immunization Registry database. Patient denied having a history of allergies or adverse reactions to vaccines. Patient denied syncope after receiving vaccines in the past. At 10:55 am, RN, PHN administered Havrix (Lot # 772YT, Expiration date 9/23/2025) in the right deltoid, intramuscularly. At 11:00 am patient reported she ?felt dizzy?. Patient appeared sitting calmly in the chair, RN, PHN provided patient with a juice box. RN, PHN, offered to lie patient down on the yoga mat. Patient denied moving and requested to stay sitting. Patient began drinking the juice box. Patient’s skin was dry and appropriate color for Ethinicy. At 11:05 am patient gave verbal consent for RN, PHN to measure vitals. Vital signs measured as follows: blood pressure 102/68 mm Hg, heart rate 75 beats per minute, respiratory rate 18 breaths per minute, oxygen saturation 98%. Patient stated she was “feeling better”. At 11:08 am patient reported symptom had resolved completely. PHN, educated patient about risk for syncope with vaccinations. PHN, referred patient to primary care clinic for follow up and future vaccines. Patient stood up at 11:10 am to go to her appointment at clinic. Patient denied any return of symptoms and walked away with a steady gait and balance to the next resource tent.

During the administration of the Pfizer COVID-19 vaccine, it was noted that the vaccine was diluted with 1.8 mL of diluent instead of the recommended 1.1 mL.

induration, swelling, warmth and redness of injection site, fever up to 101F