| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2822723 | 59 | F | FL | 01/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3959s |
Extra dose administered
Extra dose administered
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Patient received a 3rd dose on accident. Patient did not recall getting the whole series in 2020.
Patient received a 3rd dose on accident. Patient did not recall getting the whole series in 2020.
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| 2822772 | 4 | M | NY | 01/24/2025 |
MMRV |
MERCK & CO. INC. |
Y009108 |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP calling to report an AE regarding the PROQUAD vaccine. HCP stated that an improperly stored PROQ...
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).
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| 2822773 | U | VA | 01/24/2025 |
HPV9 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No additional AE. No PQC.; HCP reports patient did not get her second GARDASIL 9 dose until today, 1...
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.
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| 2822774 | 18 | F | 01/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 HPV9 HPV9 HPV9 HPV9 HPV9 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Adverse reaction, Anxiety, Arthralgia, Arthritis, Arthropod bite; Blood thyroid ...
Adverse reaction, Anxiety, Arthralgia, Arthritis, Arthropod bite; Blood thyroid stimulating hormone increased, Bursal fluid accumulation, Chondromalacia, Depression, Fibromyalgia; Gait inability, Gastroenteritis, Hypermobility syndrome, Hypertriglyceridaemia, Hyperuricaemia; Immunisation reaction, Mental disorder, Panic attack, Rash, Serum ferritin increased; Skin papilloma, Sleep disorder due to a general medical condition, Tonsillitis; Adverse reaction, Anxiety, Arthralgia, Arthritis, Arthropod bite; Blood thyroid stimulating hormone increased, Bursal fluid accumulation, Chondromalacia, Depression, Fibromyalgia; Gait inability, Gastroenteritis, Hypermobility syndrome, Hypertriglyceridaemia, Hyperuricaemia; Immunisation reaction, Mental disorder, Panic attack, Rash, Serum ferritin increased; Skin papilloma, Sleep disorder due to a general medical condition, Tonsillitis
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couldn't walk; isolated, depressed; Hypertriglyceridemia; mosquito bite over leg and subsequent...
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:
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| 2822775 | U | KS | 01/24/2025 |
MMRV |
MERCK & CO. INC. |
X018729 |
Expired product administered
Expired product administered
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Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being a...
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.
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| 2822776 | U | NY | 01/24/2025 |
HPV9 |
MERCK & CO. INC. |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No additional AE/PQC.; Pharmacy student called and reported an adult patient who received two doses ...
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.
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| 2822777 | 8 | F | GA | 01/24/2025 |
HEPA |
MERCK & CO. INC. |
X020849 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse effects were reported; HCP called to report inadvertent administration of an expired dose...
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.
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| 2822778 | 36 | M | GA | 01/24/2025 |
HEPA |
MERCK & CO. INC. |
X020849 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse event; HCP called to report inadvertent administration of an expired dose of VAQTA to an ...
No adverse event; HCP called to report inadvertent administration of an expired dose of VAQTA to an adult patient.; Dose .5ML; This spontaneous report was received from a nurse regarding a 36-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 20-JAN-2025, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, 0.5 milliliter, administered for prophylaxis (lot number X020849 has been verified to be a valid number for hepatitis a vaccine, inactivated [VAQTA], expiration date 26-DEC-2024) (anatomical site of injection and route of administration were not provided) (Expired product administered, Incorrect dose administered). No additional adverse event was reported for the patient.
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| 2822779 | U | OH | 01/24/2025 |
HPV9 |
MERCK & CO. INC. |
W029724 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse effects reported; HCP calling to report that patient inadvertently received expired dose ...
No adverse effects reported; HCP calling to report that patient inadvertently received expired dose of GARDASIL 9 on 1/20/2025 that expired on 1/8/2025. Per post expiry sheet, product is supported. No adverse effects reported. No additional AE. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 20-JAN-2025 the patient was inadvertently vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # W029724, expiration date 08-JAN-2025, Single Dose; strength, route were not reported) for prophylaxis (expired product administered). No adverse event was reported.
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| 2822780 | U | IL | 01/24/2025 |
VARCEL |
MERCK & CO. INC. |
Y006522 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional adverse event; HCP called to report a Temperature Excursion on case number 02740636. ...
No additional adverse event; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te; This spontaneous report was received from Other Health Professional and refers to a. The patient's medical history was not reported. The patient's concurrent conditions included medication dilution. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown). On 06-DEC-2024, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #Y006522, expiration date: 25-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient experienced No additional adverse event. On 06-DEC-2024, the patient experienced HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te. At the time of reporting, the outcome of the event HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te was not known, the outcome of the event No additional adverse event was not known. The action taken with VARIVAX regarding HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te was reported as Not Applicable. The action taken with VARIVAX regarding No additional adverse event was reported as Not Applicable.
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| 2822781 | F | 01/24/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Dysstasia, Mobility decreased, Muscular weakness, Myalgia
Dysstasia, Mobility decreased, Muscular weakness, Myalgia
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intermittent muscle pains /leg muscle pain; weakness in legs; difficult to climb stairs/rise from si...
intermittent muscle pains /leg muscle pain; weakness in legs; difficult to climb stairs/rise from sitting position; No longer have muscle pains in arms and body; This non-serious case was reported by a consumer and described the occurrence of myalgia of lower extremities in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included hypertension (Treated with Ramipril and Carvedilol), transient ischemic attack (Patient had Transient ischaemic attack in 1999), blood cholesterol increased (Treated with Crestor) and cardiovascular risk (Treated with Jardiance). Concomitant products included carvedilol, ramipril, clopidogrel bisulfate (Plavix), rosuvastatin calcium (Crestor) and empagliflozin (Jardiance). On 23-OCT-2024, the patient received Arexvy. On 28-OCT-2024, 5 days after receiving Arexvy, the patient experienced myalgia of lower extremities (Verbatim: intermittent muscle pains /leg muscle pain), lower extremities weakness of (Verbatim: weakness in legs), activities of daily living impaired (Verbatim: difficult to climb stairs/rise from sitting position) and generalized muscle aches (Verbatim: No longer have muscle pains in arms and body). The outcome of the myalgia of lower extremities, lower extremities weakness of and activities of daily living impaired were not resolved and the outcome of the generalized muscle aches was resolved. It was unknown if the reporter considered the myalgia of lower extremities, lower extremities weakness of, activities of daily living impaired and generalized muscle aches to be related to Arexvy. It was unknown if the company considered the myalgia of lower extremities, lower extremities weakness of, activities of daily living impaired and generalized muscle aches to be related to Arexvy. Additional Information: GSK Receipt Date: 27-DEC-2024 A 87 year female patient received Arexvy vaccine and experienced intermittent muscle pain and weakness in leg. The patient no longer had muscle pains in arms and body but leg pains still persist which was severe at time, worse at night. Leg weakness still persists making it difficult to climb stairs and rise from sitting position. The patient reported that the symptoms was not treated. The patient current condition includes hypertension, Transient ischaemic attack, High cholesterol and Cardiovascular risk
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| 2822782 | M | 01/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Feeling abnormal
Feeling abnormal
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put me out for a full day; This non-serious case was reported by a consumer and described the occurr...
put me out for a full day; This non-serious case was reported by a consumer and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: put me out for a full day). The outcome of the feeling abnormal was resolved (duration 1 day). It was unknown if the reporter considered the feeling abnormal to be related to Shingrix. It was unknown if the company considered the feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 26-DEC-2024 The patient self-reported this case for himself. The patient said that he just got his first Shingles vaccine and that put him out for a full day. He did not want to get the full real shingles. He got to get the second vaccine too, and further said everyone else should too.
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| 2822783 | U | 01/24/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient just finished shots about a year ago and like a month ago came down with shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
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| 2822784 | U | 01/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Fatigue, Malaise, Mobility decreased
Fatigue, Malaise, Mobility decreased
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couldnt move my arm; also felt sick for; wiped me out; This non-serious case was reported by a consu...
couldnt move my arm; also felt sick for; wiped me out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased 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 mobility decreased (Verbatim: couldnt move my arm), feeling unwell (Verbatim: also felt sick for) and fatigue (Verbatim: wiped me out). The outcome of the mobility decreased was resolved and the outcome of the feeling unwell and fatigue were not reported. It was unknown if the reporter considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine. It was unknown if the company considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The- patient received shingles vaccine and it was wiped out, could not move my arm for days also felt sick for that same period of time. The patient said it was a piece of cake compared to getting shingles, get vaccinated.; Sender's Comments: US-GSK-US2025AMR009137:same reporter
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| 2822785 | F | CO | 01/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
K72R2 |
Occupational exposure to product, Product complaint, Syringe issue
Occupational exposure to product, Product complaint, Syringe issue
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solution squirted on face; Vial leak; Pharmaceutical product complaint; This non-serious case was re...
solution squirted on face; Vial leak; Pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Herpes zoster (Shingrix) (batch number K72R2, expiry date 24-JAN-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: solution squirted on face), product leakage (Verbatim: Vial leak) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, product leakage and pharmaceutical product complaint were unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The nurse stated she attempted to insert needle into adjuvant component of Shingrix and the needle bounced off the rubber stopper and the solution squirted onto the health care professional face, which led occupational exposure via skin contact with product.. The reporter something was wrong with the stopper on that vial as she used another adjuvant and was able to successfully withdraw the medication. The patient did receive the dose of Shingrix using another adjuvant vial. The nurse refused to send a picture stating she does not have time to do so. The information received from QA department on 22-JAN-2025 GlaxoSmithKline had completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends and 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. The GlaxoSmithKline considered the complaint that was the object of this report as unsubstantiated.
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| 2822786 | F | TN | 01/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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incomplete course of vaccination; This non-serious case was reported by a other health professional ...
incomplete course of vaccination; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in 2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 28-DEC-2024 Reporter stated that patient received Shingrix vaccine one dose only in 2022 and asked if patient require 1 or 2 doses now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2822787 | 56 | M | MN | 01/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GA99K |
Product preparation issue
Product preparation issue
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patient received only the liquid adjuvant portion of Shingrix; patient received only the liquid adju...
patient received only the liquid adjuvant portion of Shingrix; patient received only the liquid adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number GA99K) for prophylaxis. On 15-JAN-2025, the patient received Shingrix. On 15-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 21-JAN-2025 The nurse reported that a patient received only the liquid adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered At the time of reporting a repeat dose had not yet been administered.
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| 2822788 | U | HI | 01/24/2025 |
COVID19 |
JANSSEN |
Unknown |
Adverse event
Adverse event
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deadly vaccine; This spontaneous report received from a consumer by a company representative concern...
deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. After taking COVID-19 shot. (dose series is 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with product quality complaints: Product Complaint 90000347962; 90000347798. Investigation Results: Undetermined. Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. Verified signals are assessed as per TV-WI-14276. No further action is required at this time. This report was non-serious.
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| 2822797 | U | HI | 01/24/2025 |
COVID19 |
JANSSEN |
|
Adverse event
Adverse event
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Deadly vaccine; This spontaneous report received from a consumer by a company representative concern...
Deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with product quality complaints: Product Complaint 90000347798; 90000347962. Investigation Results: Undetermined, Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. Verified signals are assessed as per TV-WI-14276. No further action is required at this time. This report was non-serious.
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| 2822798 | U | HI | 01/24/2025 |
COVID19 |
JANSSEN |
|
Adverse event
Adverse event
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Deadly vaccine; This spontaneous report received from a consumer by a company representative concern...
Deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series:1, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347797. Investigation Results: Undetermined-Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. This report was non-serious.
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| 2822799 | U | ID | 01/24/2025 |
COVID19 |
JANSSEN |
Unknown |
Adverse event
Adverse event
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deadly vaccine; This spontaneous report received from a consumer by a company representative concern...
deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid 19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. (dose series 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347801. Investigation Results: Undermined: Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. This report was non-serious.
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| 2822800 | U | NM | 01/24/2025 |
COVID19 |
JANSSEN |
|
Adverse event
Adverse event
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DEADLY VACCINE; This spontaneous report received from a consumer by a company representative concern...
DEADLY VACCINE; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. after taking COVID-19 shot. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347802. Investigation Results: Undetermined: Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. This report was non-serious.
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| 2822801 | U | HI | 01/24/2025 |
COVID19 |
JANSSEN |
Unknown |
Adverse event
Adverse event
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deadly vaccine; This spontaneous report received from a lawyer concerned a patient of unspecified ag...
deadly vaccine; This spontaneous report received from a lawyer concerned a patient of unspecified age and sex. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347799. This report was non-serious.
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| 2822802 | M | 01/24/2025 |
COVID19 |
MODERNA |
008B21A |
Influenza like illness
Influenza like illness
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he felt "flu-ish" for a day or two; This spontaneous case was reported by a patient family...
he felt "flu-ish" for a day or two; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (he felt "flu-ish" for a day or two) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he felt "flu-ish" for a day or two). At the time of the report, INFLUENZA LIKE ILLNESS (he felt "flu-ish" for a day or two) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-467516 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-467516:Reporter's case
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| 2822804 | 67 | M | 01/24/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
8058877 |
COVID-19; COVID-19
COVID-19; COVID-19
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he got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-...
he got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he got COVID) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Stroke (25 years ago). Concurrent medical conditions included Disability. On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In May 2024, the patient experienced COVID-19 (he got COVID). At the time of the report, COVID-19 (he got COVID) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was reported that patient was supposed to get a second dose of the 2023 booster which he had never heard about. On May-2024, patient got COVID and it lasted about a week. There was lots of coughing , and his mucus was abnormal, it was clear and bubbly. He could breathe okay but he knew something was wrong. He stated he self-isolated for 5 days after he returned from his trip.He could not self-test as he is disabled and that he could only use one arm. Treatment information was not provided.
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| 2822805 | U | NC | 01/24/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Needle issue
Needle issue
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once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the ...
once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe; needle broke off the diluent syringe; This is a spontaneous report received from an Other HCP from product quality group, Program ID: A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe"; NEEDLE ISSUE (non-serious), outcome "unknown", described as "needle broke off the diluent syringe". Causality for "once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe" and "needle broke off the diluent syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: Has a caller on the line who is a pharmacy intern calling about Abrysvo vaccine and stated that once the pharmacy tried to reconstitute it, it broke. She is reporting that and requests replacement product. The presentation is the diluent and the lyophilized antigen component. She is not fully aware what happened regarding it breaking but the pharmacist told her that while trying to reconstitute it, the needle broke off the diluent syringe and she has no manufacturer name or lot number to provide for the needle. Caller clarified she is now not sure if the needle broke or if something went wrong with the component of the diluent syringe. Carton/box: lot number KC7884, expiry date Sep2025, NDC 0069034401; Antigen vial: lot number KC7884, expiry date Oct2025, NDC 0069020701, and it says lyophilized antigen component. Diluent syringe: lot number HM8389, expiry date Sep2025, NDC 0069025001. Vial adaptor: Asks is that the white portion and she sees the connector piece on the diluent and antigen vial. Confirmed no patient involvement.
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| 2822806 | 24 | F | MS | 01/24/2025 |
RSV |
PFIZER\WYETH |
5469 |
Exposure during pregnancy, Injection site erythema, Injection site pain
Exposure during pregnancy, Injection site erythema, Injection site pain
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vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread a...
vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful; it was red, it is all at the injection site/ redness has started to spread; This is a spontaneous report received from a Consumer or other non HCP. A 24-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2025 as dose 1, single (Lot number: 5469) at the age of 24 years, in arm for maternal immunisation. The patient was 34 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 34 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Jan2025, outcome "not recovered", described as "vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jan2025, outcome "not recovered", described as "it was red, it is all at the injection site/ redness has started to spread". The events "vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful" and "it was red, it is all at the injection site/ redness has started to spread" required emergency room visit. It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema. Causality for "vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful" and "it was red, it is all at the injection site/ redness has started to spread" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Clinical course: office manager called to reported: they gave the patient Abrysvo for maternal and the vaccine hurt pretty bad as she got it, but Sunday she called the doctor's office to report and she has pictures of everything. Arm was really sore, and it was red, it was all at the injection site but it was red and it got worse over the days. So, she ended up going to the ER, because of the soreness and the redness. She said it looked like, she was the patient told her own, told her off the doctor, on Sunday. It was a patient, a pregnant patient came in on 02Jan2025. A 24-year-old female, on 02Jan2025 to get, she was 34 weeks pregnant, she got a gestational age. She got a Abrysvo vaccine and then she said that it got her really bad when she got the vaccine, at the time but later on, a couple of days later she called the office on Sunday and left them a message saying that she was in pain, that she went to the ER because of soreness and the redness has started to spread, from just being at the injection site and it was just starting to spread and it was very painful. The event stared within a next couple of days. Patient went to the emergency room and did not know what they gave her.
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| 2822807 | U | MO | 01/24/2025 |
PNC20 |
PFIZER\WYETH |
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Drug reaction with eosinophilia and systemic symptoms
Drug reaction with eosinophilia and systemic symptoms
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DRESS; This is a spontaneous report received from a Consumer or other non HCP from medical informati...
DRESS; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (medically significant), outcome "unknown", described as "DRESS". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2822808 | F | WI | 01/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Scan, Vaccination failure
COVID-19, Scan, Vaccination failure
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Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours; H...
Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours; Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours; This is a spontaneous report received from a Physician. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "aortic dissection", start date: 23Dec2015 (unspecified if ongoing), notes: medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient.; "memory issues", start date: Mar2016 (unspecified if ongoing), notes: memory issues came three months around that, then became more progressive, right now patient is stable. There were no concomitant medications. Vaccination history included: comirnaty 12 plus (DOSE 7, SINGLE), administration date: 03Jul2024, for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 3, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 4, SINGLE), for Covid-19 Immunization; Moderna bvln bstr (DOSE 5, SINGLE, Moderna BVLN BSTR), for Covid-19 Immunization; Spikevax 12 plus (DOSE 6, SINGLE, Spikevax 12 plus), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours". The patient underwent the following laboratory tests and procedures: Scan: Unknown results. BNT162b2 omicron (kp.2) administered on Sep2024 or Oct2024 and hospitalization occurred for two nights or for four nights.; Sender's Comments: Based on the information currently available, a lack of efficacy with 62b2 omicron (kp.2) in this patient cannot be completely excluded. The patient's predispositions such as old age, underlying disease/ concomitant medications leading to immunity insufficiency may contribute to suboptimal response after vaccination.
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| 2822809 | U | MN | 01/24/2025 |
IPV |
SANOFI PASTEUR |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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patient might have received an expired dose with no reported adverse event; Initial information rece...
patient might have received an expired dose with no reported adverse event; Initial information received on 17-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient to whom received an expired dose of IPV (Vero) [IPOL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient might have received a expired dose unknown dose of suspect IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization (circumstance or information capable of leading to medication error) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. 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.
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| 2822810 | M | WA | 01/24/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number No batch number No batch number |
Arthralgia, Back pain, Condition aggravated, Discomfort, Ear pain; Eye pain, Fee...
Arthralgia, Back pain, Condition aggravated, Discomfort, Ear pain; Eye pain, Feeling abnormal, Genital herpes, Headache, Herpes zoster oticus; Loss of personal independence in daily activities, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity; Pain of skin, Tendon pain, Tinnitus
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Severe outbreak of gential herpes / outbreak was very mild / immediately followed by another severe ...
Severe outbreak of gential herpes / outbreak was very mild / immediately followed by another severe outbreak; Health has plummeted and the quality of life is dramatically reduced; Pain in my buttocks; Pain in Hamstring; Lower back pain / back pain; Calves pain; Discomfort; Pain in eardrums / pain in my ears; Ringing in my ears; Pain on the sides of my head / he has so much pain on the unaffected side of his head / frequent headaches now; Pain in my eyes; Pinching of my skin / pinching on my torso / pinching in my legs; Pain on my torso; Pains throughout my body especially at the site of old injuries; Neck pain; Pain in the bottoms of his feet; Pain in the palms of his hands / Odd pains in his forearms; Unable to work out; With odd and scary feelings in my muscles; Often nauseas now; Miserable symptoms / terrifying symptoms; Tried a workout two days ago and it has resulted in a worsening of symptoms; This spontaneous case, initially received on 17-Jan-2025, was reported by a non health professional and concerns an adult male patient. Past medical history included genital herpes, Ramsay Hunt Syndrome, Some autoimmune dysfunction. No concomitant medications were reported Administration of company suspect drug: On 17-Nov-2024, the patient received Afluria (TIV) for influenza immunization, dose regimen, route of administration and anatomical location: not reported, Lot number: not reported but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Nov-2024, 2 days after vaccination, the patient experienced Severe outbreak of gential herpes / outbreak was very mild / immediately followed by another severe outbreak (outcome: Unknown), Health has plummeted and the quality of life is dramatically reduced (outcome: Unknown), Pain in my buttocks (outcome: Unknown), Pain in Hamstring (outcome: Unknown), Lower back pain / back pain (outcome: Unknown), Calves pain (outcome: Unknown), Discomfort (outcome: Unknown), Pain in eardrums / pain in my ears (outcome: Unknown), Ringing in my ears (outcome: Unknown), Pain on the sides of my head / he has so much pain on the unaffected side of his head / frequent headaches now (outcome: Unknown), Pain in my eyes (outcome: Unknown), Pinching of my skin / pinching on my torso / pinching in my legs (outcome: Unknown), Pain on my torso (outcome: Unknown), Pains throughout my body especially at the site of old injuries (outcome: Unknown), Neck pain (outcome: Unknown), Pain in the bottoms of his feet (outcome: Unknown), Pain in the palms of his hands / Odd pains in his forearms (outcome: Unknown), Unable to work out (outcome: Unknown), With odd and scary feelings in my muscles (outcome: Unknown), Often nauseas now (outcome: Unknown), Miserable symptoms / terrifying symptoms (outcome: Unknown), Tried a workout two days ago and it has resulted in a worsening of symptoms. On 17-Nov-2024 patient was vaccinated with the Afluria 24-25 TIV LA/RA flu vaccine. Prior to being vaccinated he was in excellent health. Since the vaccine, his health has plummeted, and the quality of my life was dramatically reduced. When he said "excellent health" he was not exaggerating. He was routinely hiking ten miles with dogs, strenuously working out, working hard around property and much more physically fit than most 30-year-olds but he was older than that. Two days after being vaccinated he had a severe outbreak of genital herpes, which he had not occurrences of for at least three years prior and at that time (three years prior), the outbreak was very mild. He had not for many years had any significant genital herpes outbreaks. The outbreak which started on 19-Nov-2024 was immediately followed by another severe outbreak, as this subsided, it was followed by yet another outbreak and then another outbreak after that. He now had pain in his buttocks, hamstrings, lower back and calves which come along with herpes outbreaks. In addition to the extreme discomfort this had had a devastating effect on my relationship with my partner. He had shingles as Ramsay Hunt Syndrome in 2019 which had been in remission but following the vaccination on 17-Nov-2024 now had the symptoms of that again. This included pain in eardrums, pain in ears, ringing in ears, pain on the sides of head, pain in eyes, pinching of skin, pain on torso, pinching on torso, pinching in legs. It was extremely disturbing that he had so much pain on the unaffected side of his head and he was very concerned that would be stricken with Ramsay Hunt on that side, which would destroy his health. Additionally he had some autoimmune dysfunction in the mid 2000s, which was of unknown origin and which spent a lot of money and time to lift himself out of with rest, careful diet and exercise and medication. He had been symptom free of that since about 2012 and stopped taking any medication for those symptoms in about 2017, but now the symptoms of that had returned. He had pains throughout his body, especially at the site of old injuries. He had neck pain, back pain, pain in the bottoms of his feet, pain in the palms of his hands, odd pains in his forearms. He had frequent headaches now, and he almost never have had headaches in his life. Prior to 17-Nov-2024, when received the Afluria vaccination, he was extremely physically fit. He worked out twice each week in the gym, doing very strenuous workouts and rarely missing that exercise. He performed three sets of ten pullups, five sets of squats, hip thrusts, leg curls, calf raises, barbell rowing on one day and bench presses, shoulder presses, bar dips, planks, upright rows, dumbell raises on the other day. Now, exactly two months later, he was unable to work out. He tried a workout two days before and it had resulted in a worsening of symptoms. The normal post exercise pain that one might experience after a workout was replaced with odd and scary feelings in his muscles. He had to visit health care provider for additional anti-virals to try to keep these herpes infections at bay and he was forced to take double and triple the dosage. He had often nauseas now and did not know if it was a side effect from all the anti-virals or a side effect of the Afluria vaccination. He was an adult and recently started a new job which was critical for his family's wellbeing. The job required travel, which had had to do with the miserable symptoms. He had to put on a happy face in meetings while experience these pains and other terrifying symptoms Afluria (TIV) action taken: Not Applicable Reporter assessment: the reporter did not provide a seriousness and causality assessment for the events.; Reporter's Comments: Causality: Related for all the events. Due to the spontaneous nature of the case, it is considered related for the reporting purpose. Close temporal relationship, onset after 2 days after vaccination. However, medical histories could be a possible risk factors for the events to occur.
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| 2822811 | 66 | F | AK | 01/24/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Blood test, Body temperature decreased, Dizziness, Electrocardiogram, Eye moveme...
Blood test, Body temperature decreased, Dizziness, Electrocardiogram, Eye movement disorder; Fear, Injection site erythema, Injection site swelling, Injection site warmth, Palpitations
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all was normal for the first 6 days, slight swelling and redness at injection site. Woke in the morn...
all was normal for the first 6 days, slight swelling and redness at injection site. Woke in the morning of the 7th day with dizziness and when I opened my eyes they were jumping back and forth and stopped after about 30 -45 seconds,and my palpitations which I have been dealing with for a while now were bad and my temp was very low, 93. I went to the Er and they found nothing obviously wrong. I had not even considered it had been my vaccination as my arm looked totally clear the night before and there was no redness or swelling, so I did not think of mentioning it. On arriving home I ran my hand up my arm and discovered it was hot and upon inspection discovered it swollen and bright red! It is better today, the swelling has gone way down and the redness is subsiding. I have been applying topical Benadryl to the site. I do believe it was a late reaction to the vaccine. Unexpected and scary. I have not had a reaction to other vaccinations in the past but am concerened about future vaccinations
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| 2822816 | 36 | F | UT | 01/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Headache, Nausea, Vomiting
Headache, Nausea, Vomiting
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Headache, nausea, vomiting
Headache, nausea, vomiting
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| 2822817 | 10 | M | 01/24/2025 |
TDAP |
SANOFI PASTEUR |
3CA22C1 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Extensive Erythema and Swelling at the site of injection, extending down the left arm
Extensive Erythema and Swelling at the site of injection, extending down the left arm
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| 2822818 | 34 | F | WA | 01/24/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Exposure during pregnancy, Labour induction, Platelet count decreased, Thrombocy...
Exposure during pregnancy, Labour induction, Platelet count decreased, Thrombocytopenia
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Patient received RSV vaccine at 35w6d and 12 days later reported for induction of labor with platele...
Patient received RSV vaccine at 35w6d and 12 days later reported for induction of labor with platelets of 51 10x3/uL. Platelets previously normal on 11/13/2024.
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| 2822819 | 22 | F | PA | 01/24/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
jt322 |
Fall, Head injury, Loss of consciousness, Pallor
Fall, Head injury, Loss of consciousness, Pallor
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Patient received fluarix vaccine at the pharmacy while seated. She got up and walked about 10 feet. ...
Patient received fluarix vaccine at the pharmacy while seated. She got up and walked about 10 feet. Rph noticed she looked pale. Rph told her to come sit back down. Patient sat in chair then started to pass out by falling to her side. Rph tried to help guide her to the ground. Pt did slightly bump her head, but it was not a hard fall. Rph told tech to call EMS and EMS came. By the time they came patient was doing ok. Patient had her blood pressure checked by EMS when they came but refused the ambulance because she was starting to feel better. Patient explained that she has anxiety and was worked up about getting the vaccine. Rph gave her a sugary drink to bring up her blood sugar and crackers to keep her sugar up. Rph stayed with her for at least a half an hour afterward to ensure she was ok. Then Rph insisted to walk out with her to her car. She was looking and feeling much better at that time. Due to patient stating she has anxiety and was worked up about getting a vaccine and she said she did not eat anything since breakfast time this does NOT seem to be related to the vaccine itself. This seems to be a stress/anxiety response and possibly a drop in blood sugar.
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| 2822820 | 59 | F | FL | 01/24/2025 |
FLU3 |
SEQIRUS, INC. |
393341 |
Extra dose administered
Extra dose administered
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Patient got the same vaccine on 8/16/2024 then again on 01/24/25
Patient got the same vaccine on 8/16/2024 then again on 01/24/25
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| 2822821 | 96 | F | CA | 01/24/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LJ5284 LJ5284 |
Asthenia, Blood glucose normal, Differential white blood cell count, Full blood ...
Asthenia, Blood glucose normal, Differential white blood cell count, Full blood count, Glycosylated haemoglobin; Lethargy, Lipids, Mental status changes, Metabolic function test, Unresponsive to stimuli
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Event started on 1/24/2025 @ 1310- Abnormal Vital signs, Altered Mental Status, Generalized Weakness...
Event started on 1/24/2025 @ 1310- Abnormal Vital signs, Altered Mental Status, Generalized Weakness. Vital Signs @ 1310: B/P 46/30 (Right Arm), Pulse 70, Respirations 28 on Room Air, Temperature 97.1, Blood glucose 142 mg/dL. Patient had received therapy and was transferred from bed to wheelchair. As soon as patient transferred to wheelchair patient became lethargic and unresponsive. patient then placed in Trendelenburg position. Patient making eye contact and responding to simple question. EMS called. Patient taken to hospital for further evaluation.
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| 2822822 | 59 | M | AL | 01/24/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004045 |
Expired product administered
Expired product administered
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Not so much an adverse event on the patient's end, luckily, but the pharmacy dispensed an expir...
Not so much an adverse event on the patient's end, luckily, but the pharmacy dispensed an expired vaccine. It was picked up by the patient 12/12/24 and started on 1/18/25. The box states it expired November 2024. The pharmacy then instructed my mother to share her box which was in date with my father, and they would get a replacement in before their 3rd dose was due. Unfortunately, they did not get it in in time forcing both of my parents to need to restart the therapy and neither of them had boxes to do that with as the one given to my dad was expired and the one given to my mother was recommended to be shared between them meaning neither of them could complete the therapy.
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| 2822823 | 85 | M | MD | 01/24/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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Cardiac dysfunction, Death, Ejection fraction decreased, Gait inability, Joint s...
Cardiac dysfunction, Death, Ejection fraction decreased, Gait inability, Joint swelling; Pain, Poor peripheral circulation, Pyrexia, Tremor
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Patient received flu vaccine at 11 am on 10/1. He woke with fever and shakes 13 hours later at midn...
Patient received flu vaccine at 11 am on 10/1. He woke with fever and shakes 13 hours later at midnight 10/2. Patient took a tylenol and it helped, but he had another fever/shake episode 24 hours after vaccinne shot on 10/2, around noon. He had a virtual visit on 10/2. Nothing was prescribed and his fever left by evening. However, the impact led to swelling in his left ankle on 10/2. It It was so severe he went to doctor and thought he had gout on the morning of 10/3. The medicine the doctor gave on 10/3 had no impact on his swelling, in fact, it worsened. In the early morning hours (2 am) of 10/4 an ambulance was called because he could not walk and was in so much pain. He went to the Hospital and was flown to another hospital at 7 am on 10/4. He died at 11 pm on 10/4. His heart's capacity was greatly reduced and flow was not getting to his legs. We believe the reaction to the flu vaccine caused his body unnecssary stress and prompted his heart to malfunction.
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| 2822824 | 67 | M | GA | 01/24/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Urticaria; Urticaria
Urticaria; Urticaria
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Patient had returned to the pharmacy to get benadryl tablets and topical benadryl after speaking wit...
Patient had returned to the pharmacy to get benadryl tablets and topical benadryl after speaking with his provider. Patient reports having hives after receiving both vaccines.
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| 2822825 | 41 | F | MN | 01/24/2025 |
PNC13 PNC13 |
PFIZER\WYETH PFIZER\WYETH |
Unknown Unknown |
Diarrhoea, Headache, Injection site erythema, Injection site induration, Nausea;...
Diarrhoea, Headache, Injection site erythema, Injection site induration, Nausea; Pain, Pyrexia, Vomiting
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Red hardened area at injection site, fever over 101 for 3 days, body aches. Headache, nausea/vomitin...
Red hardened area at injection site, fever over 101 for 3 days, body aches. Headache, nausea/vomiting, diarrhea
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| 2822826 | 16 | M | CO | 01/24/2025 |
FLU3 |
SANOFI PASTEUR |
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Pallor, Posture abnormal
Pallor, Posture abnormal
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I administered a Fluzone and Comirnaty vaccine to patient. He stood up and he was standing by his mo...
I administered a Fluzone and Comirnaty vaccine to patient. He stood up and he was standing by his mom in the counseling room. Suddenly, he slumped over slowly and turned very pale. We laid him on the ground gently (no injuries occurred) and he took some deep breaths. We gave him a cool cloth for his neck, some water, and a lollipop. He had no trouble breathing. After about 10 minutes in the counseling room, his color returned and he was able to walk to the waiting area. He and his mother waited for another 15 minutes and he was fine. We offered to call EMS, but mom declined.
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| 2822827 | 37 | F | 01/24/2025 |
VARCEL |
MERCK & CO. INC. |
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Injection site rash
Injection site rash
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Mild rash at injection site
Mild rash at injection site
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| 2822916 | 9 | F | CA | 01/24/2025 |
FLU3 HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
AEZJ7 Y007197 |
Injection site pain; Injection site pain
Injection site pain; Injection site pain
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Received HPV1 at L deltoid 1/3/25 severe pain same site. Presented to clinic for this issue 1/16/25....
Received HPV1 at L deltoid 1/3/25 severe pain same site. Presented to clinic for this issue 1/16/25. Suspected injection site local reaction.
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| 2822917 | 55 | F | MD | 01/24/2025 |
PNC20 PNC20 VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LK6651 LK6651 7ZM55 7ZM55 |
Anaphylactic reaction, Chest X-ray normal, Chest pain, Dyspnoea, Injection site ...
Anaphylactic reaction, Chest X-ray normal, Chest pain, Dyspnoea, Injection site pain; Laboratory test normal, Lip swelling, Swelling face, Troponin normal; Anaphylactic reaction, Chest X-ray normal, Chest pain, Dyspnoea, Injection site pain; Laboratory test normal, Lip swelling, Swelling face, Troponin normal
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Anaphylaxis including facial swelling, lip swelling, difficulty in breathing, chest pain. Patient wa...
Anaphylaxis including facial swelling, lip swelling, difficulty in breathing, chest pain. Patient was treated in the hospital with IV steroid, antihistamine and the symptoms are mostly resolved. Also has arm soreness on the injection site.
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| 2822367 | U | ID | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
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patient had pneumonia, then a couple days later tested positive for Covid-19; patient had pneumonia,...
patient had pneumonia, then a couple days later tested positive for Covid-19; patient had pneumonia, then a couple days later tested positive for Covid-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "not recovered" and all described as "patient had pneumonia, then a couple days later tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08Jan2025) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 pneumonia. Clinical course: Patient had booster shot 25Oct2024, plus all of past Covid shots. Patient asked why he/she now have Covid-19 at 74 years of age. The patient had pneumonia, then a couple days later tested positive for Covid-19. Patient have been in the hospital several times and given IV antibiotics and now he/she is on bed rest at home hoping he/she can beat this. Patient was tested 08Jan2025 and still positive today. Just wanted to share his/her fears. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2822368 | 17 | M | KS | 01/23/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013469 |
Confusional state, Device connection issue, Needle issue, Syringe issue, Underdo...
Confusional state, Device connection issue, Needle issue, Syringe issue, Underdose; Confusional state, Device connection issue, Needle issue, Syringe issue, Underdose
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Patients response: Confusion; the "needle broke off" while they were administering a dose ...
Patients response: Confusion; the "needle broke off" while they were administering a dose of GARDASIL 9 / 1/2 med went into muscle, 1/2 went out of hub; the "needle broke off" while they were administering a dose of GARDASIL 9; Paatient only received 1/2 dose; This spontaneous report was received from a physician and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions. previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, expiration date 10-OCT-2026 (strength, dose description, lot # and route of administration) as prophylaxis. On an unknown date, the needle broke off while they were administering a dose of the vaccine, No additional adverse event was reported. Follow-up information was received from a company representative on 12-DEC-2024. It was confirmed that the products were not available to be returned to the manufacturer. Follow-up information was received from a nurse on 16-JAN-2025. The report concerns to a 17-year-old male patient, his demographics were updated. On 10-DEC-2024, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via intramuscular in the left deltoid (lot number Y013469 was determined to be a valid number). The prefilled syringe experienced a malfunction, half of the dose went into the muscle, the other half came out of the hub (needle issue and poor quality device used), the patient received only half of dose (accidental underdose). It was reported that patient's response to the incident was confusion. The outcome of the event was not reported. The causal relationship between the events and the suspect vaccine was not provided.
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| 2822369 | F | VA | 01/23/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site discomfort
Injection site discomfort
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Someone received a dose of GARDASIL 9 "on Friday" and now "feels like they have a lum...
Someone received a dose of GARDASIL 9 "on Friday" and now "feels like they have a lump under their arm but when they look there is not a lump" / it felt as if there was a knot there but when I went to feel it there was no knot; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JAN-2025, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, exact quantity volume, lot #, expiry date, route and anatomical site of administration were not provided) administered for prophylaxis. On 10-JAN-2025 (also reported as "on Friday and now"), the patient felt like she had a lump under her arm but when she looked there was not a lump, also reported as "it felt as if there was a knot there but when she went to feel it there was no knot" around the injection site (Vaccination site discomfort). At the time of the report the patient had not recovered. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
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| 2822370 | M | MA | 01/23/2025 |
DTAP DTAP DTAP DTAP HIBV HIBV HIBV HIBV IPV IPV IPV IPV PPV PPV PPV PPV RV5 RV5 RV5 RV5 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase norm...
Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Biopsy skin abnormal, Blister; Condition aggravated, Dermatitis bullous, Diffuse cutaneous mastocytosis, Malaise, Nausea; Pyrexia, Rash papular, Rash pruritic, Red blood cell count normal, Tryptase increased; Vomiting, White blood cell count normal; Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Biopsy skin abnormal, Blister; Condition aggravated, Dermatitis bullous, Diffuse cutaneous mastocytosis, Malaise, Nausea; Pyrexia, Rash papular, Rash pruritic, Red blood cell count normal, Tryptase increased; Vomiting, White blood cell count normal; Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Biopsy skin abnormal, Blister; Condition aggravated, Dermatitis bullous, Diffuse cutaneous mastocytosis, Malaise, Nausea; Pyrexia, Rash papular, Rash pruritic, Red blood cell count normal, Tryptase increased; Vomiting, White blood cell count normal; Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Biopsy skin abnormal, Blister; Condition aggravated, Dermatitis bullous, Diffuse cutaneous mastocytosis, Malaise, Nausea; Pyrexia, Rash papular, Rash pruritic, Red blood cell count normal, Tryptase increased; Vomiting, White blood cell count normal; Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Biopsy skin abnormal, Blister; Condition aggravated, Dermatitis bullous, Diffuse cutaneous mastocytosis, Malaise, Nausea; Pyrexia, Rash papular, Rash pruritic, Red blood cell count normal, Tryptase increased; Vomiting, White blood cell count normal
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Severe bullous eruption; It was reported in a published article title as stated below that a life-th...
Severe bullous eruption; It was reported in a published article title as stated below that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article presented a child with generalized bullous eruption after routine vaccination. A 5-month-old child received scheduled vaccination with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Orally (dose, frequency, lot number and expiration date were not reported) and Hemophilus influenzae B, conjugated pneumococcal vaccine (PCV), poliomyelitis (inactivated), and diphtheria and tetanus toxoid (dose, route, frequency, lot number and expiration date were not reported). Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on one-at-a-time basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruption was considered to be life-threatening by the authors. Follow up information was received. A 5-month-old boy presented for evaluation of a raised apparently pruritic rash with episodic blisters. He was the product of an uncomplicated, full-term pregnancy with normal delivery. At 2 months of age, the skin of his abdomen and back became progressively rough and stiff with wheal formation surrounded by "raw" red areas of flare at the site of physical stroking. Skin biopsy was obtained from the right flank to confirm a suspected diagnosis of diffuse cutaneous mastocytosis (DCM). Review of systems was noteworthy for history of colicky abdominal pain. There was no history of wheezing, loss of consciousness, diarrhea, vomiting, or abdominal distention. He was following his growth curve and reached all age-appropriate developmental milestones. Physical examination on an unspecified date showed an alert, well-appearing boy in no evident distress, appropriately interactive. No lymphadenopathy or organomegaly was observed. Skin was notable for confluent skin-colored papules and plaques with peau d'orange appearance covering his trunk with urtication on minimal touch . Hyperpigmented patches of several centimeters in diameter were present on the extremities. On an unknown date, Laboratory results showed a 24-hour collection urinary histamine level of 873 microgram/gram creatinine. (reference range <35 microgram/gram creatinine), total serum tryptase of 64 nanogram/milliliter (ng/ml) (reference range<15 ng/mL), and mature tryptase of 3.1 ng/mL (reference range, <1 ng/mL). Blood cell counts on an unknown date were 12000 white blood cells/micro liter, 4690 red blood cells/microliter, and 473000 platelets/microliter with mild eosinophilia of 550 microliter, and otherwise normal differential. On an unknown date, Liver function tests were normal (alanine aminotransferase, 23 micro kat/Liter; aspartate aminotransferase, 34 micro kat/L). Lesional skin biopsy on an unknown date showed a patchy band-like infiltrate of mononuclear cells in the superficial dermis. lmmunostaining for tryptase and CD117 on an unknown date was positive, confirming that the infiltrate primarily consisted of mast cells. The diagnosis of DCM was made on the basis of these clinical and histopathologic findings. At 5 months of age, on an unknown date, the patient received his scheduled 4-month vaccinations with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid, poliovirus vaccine inactivated (unspecified), pneumococcal conj vaccine (unspecified) and hib conj vaccine (unspecified carrier). Within 12 hours of vaccine administration, he became colicky. A day later, he began developing blisters filled with clear fluid that became confluent. The areas most affected included the back (which was covered with extensive bullae), skin fold areas of the upper arms, and the lower abdomen distant from the area of injection. He had no fever and was in no acute distress. He was treated with a 5-day course of low-dose oral steroids and recovered with no residual skin changes. A copy of the published article is attached as further documentation of the patient's experience. Literature Report: Follow up information has been received from the authors of a published literature article, titled as stated below. It was reported that the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Orally (dose, frequency, lot number and expiration date were not reported) and Hemophilus influenzae B, conjugated pneumococcal vaccine (PCV), poliomyelitis (inactivated), and diphtheria and tetanus toxoid at one visit concomitantly. Upon internal review, the event dermatitis bullous was determined to be medically significant. Literature Report: . It has been determined that case PL-009507513-2412POL007606 is a duplicate of case # US-MERCK-1205USA04644. Therefore, case # PL-009507513-2412POL007606 is being deleted from our files and the cases are consolidated into case # US-MERCK-1205USA04644. Additional information is not expected.; Sender's Comments: , MERCK1205USA04644:Mfr number
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