she passed a few months ago; hurting all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (she passed a few months ago) and PAIN (hurting all over) in a 9-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (she passed a few months ago) (seriousness criteria death and medically significant) and PAIN (hurting all over) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. The patient was in 80s and received the Moderna COVID shot when came out and was “hurting all over” and stated that the shots were messed whole body up and passed a few months ago. No other details were reported. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-110011 (E2B Linked Report).; Reporter’s Comments: The benefit-risk relationship of the product is not affected by this report.; Sender’s Comments: US-MODERNATX, INC.-MOD-2021-110011:Reporter’s case; Reported Cause(s) of Death: She passed a few months ago

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

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.

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.

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.

I was told he would have no reaction as this is his 3rd time getting the vaccine have waited two years to get this vaccine since the last one he had he got a staff infection as well. His shot was January 17th he had itched at it for 3 days the night on January 20th it started to appear extremely swollen and by the morning of January 21st his arm was 5x the size I called office to be seen the refused to see him so that?s when I rushed to the emergency room where they gave him his first round a Benadryl and perscribed him cephalexin he has currently had 3 doses of if and the swelling and irritation has not reduced at all

7 days after the injection husband noticed a red patch on pts arm. The next day seen at the clinic with a rash below the injection site, red, warm, indurated, 6 x 4 cm, and tender to touch.

Patient is a 25-year-old G4P2103 with EDD 2/17/25, who was admitted to the hospital on 1/20/25 at 36w0d due to 1-week of petechiae and easy bleeding/bruising. She was found to have new profound thrombocytopenia on admission, with platelet count of 5k. The presumed diagnosis is ITP, either as a primary autoimmune condition or as a vaccine adverse event. She remains admitted today (1/22/25) and work-up for alternative causes of thrombocytopenia, but no other cause has been identified thus far. She is receiving steroids and IVIg with the goal to improve her platelet count prior to delivery.

Pt reported red patch and pain, hot to touch, at injection area

Patient started to have strong lower back pain 4 hours after receiving the vaccine and it stays. She has gone to a chiropractor and got treatment for 5 times.