HCP did not report any side effects; female patient was administered an expired dose of the VARIVAX vaccine on 01/20/2025. HCP stated that the VARIVAX vaccine expired on 01/19/2025; This spontaneous report was received from a certified medical assistant (CMA) concerning to a female patient of unspecified age. The patient’s medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 20-JAN-2025, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X002100 (expiration date: 19-JAN-2025), administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided) (Expired vaccine used). However, the health care professional (HCP) did not report any side effects related to the administration of the expired dose of the vaccine and added that it did not have any prior temperature excursions (T.Es). HCP provided limited pertinent information and had no further clarifications to provide.

HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with PEDVAXHIB instead of the STERILE DILUENT, and administered to the same patient. HCP stated this occurred between January 7, 2025 and January 13, 2025. Exact date was; No adverse effects were reported; HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with PEDVAXHIB instead of the STERILE DILUENT, and administered to the same patient. HCP stated this occurred between January 7, 2025 and January 13, 2025. Exact date was; This spontaneous report was received from a nurse regarding a 12-month-old male patient. The patient’s medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On an unknown date in January 2025 (reported as between 07-JAN-2025 and 13-JAN-2025), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter, lot #x024178, expiration date: 14-JUL-2025, and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #y004554, expiration date: 20-FEB-2026 (strengths, doses, anatomical locations, and routes of administration were not reported), that were accidentally reconstituted with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (strength, lot #, expiry date, and route of administration were not provided) instead of sterile diluent; all were given as prophylaxis (Product preparation error) (Wrong product administered). No adverse effects were reported. Lot # was being requested and will be submitted if received.

Physician reported that he received Gardasil 9 off label years ago outside of age indication; No additional AE; This spontaneous report was received from Physician via Company representative, referring to himself. The patient’s concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter. On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). Physician reported that he received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) off label years ago, outside of age indication (Off label use in unapproved age group). No additional AE.

The being after I got Moderna vaccine I had a severe headache like I?ve never had before. It was more than just a headache, it was severe stabbing pain in the back of my head on both sides. Pain level was 10/10, it felt like I got shot 3 times in the back of my head. Turns out the vaccine for some odd reason attacked the nerves in the back of my head and I?ve had occipital neuralgia (nerve damage) severe pain in my head ever since, non stop.

Localized injection site pain for a few days, then the pain continued into the muscle of the shoulder/deltoid/upper arm. Pain continues to this day and is constant, 24/7. Went to Urgent Care, another doctor and ultimately this Dr. Celecoxib 200MG given for pain (which didn’t help much). Strength in the left arm, flexibility and range of motion all limited since the shot. Dr called me a few days ago, Thursday 1.23.25, after the MRI/X-ray and confirmed my suspicion of SIRVA.

Immediate pain after the needle was being taken out of arm. The pain radiated down her arm to her hand. She said she’s been experiencing nerve pain for the last two months.

On 1/24/25 at approximately 1:00 pm patient received Shingrix shot in her left arm and Fluad (top) and Comirnaty (bottom) in right arm. I discussed with patient about seperating Shingrix from Fluad and Comirnaty. Patient said she was not going to come back out to get another shot and wanted to get all 3 today. She insisted in 2023 on getting 4 shots together in one day due to the same reason. She stated she was fine with 4 shots and would be fine with 3 shots. I explained that the Shingrix shot had more side effects than the other. She asked did the side effects last forever? I said no it is commonly soreness, achy, fever etc for a couple days. She said she would be fine. Patient received all 3 shots. After receiving the Shingrix shot first she made a comment to the effect of if things keep going this way I was going to be her gal as in the shot didn’t hurt. I administered all 3 shots and she did not have any issues while in store. Patient called back after lunch saying she had lost her prescription that she picked up. She did not mention her arm at that time. She called back around 5pm and spoke to the pharmacist on duty, about pain in her arm. Pt stated she had been putting hot compresses on and had taken either IBU or Tylenol. Pharmacist on duty advised her to put cold compress and if not better possibly go to the doctor. Pharmacist on duty asked patient to call back in an hour if not better. Patient did not call back. Around 6:56pm Heatlh System called and spoke to technician, about shots patient received. They requested what immunizations patient received, what arm, manufacture, lot number and expiration date. Dr. electronically sent in prescriptions after we closed for Hydrocodone 5/325 and Lidoderm 5% patch. I spoke with patient around 9:57am on 1/25/25. Right after dialing her number the patients neighbor came to the counter to pick up her prescriptions. Neighbor stated that patient could not move her arm. That doctor last night told her it did not hit a bone, blood vessel or shoulder joint. Neighbor stated she gave her a 5% lidocaine patch and patient stated it did not help any. Patient chose to get OTC 4% patches and the hydrocodone pills. I spoke with patient and she stated she began to hurt after she got home approximately 30 minutes after shot. She stated she has pain in her arm and some in her shoulder. She went to Health System and they told her it was not uncommon to have reactions to Shingrix and that it takes 3-5 days for the pain to go away. She stated she was not going to make it that long and she was going to go to the ER. Patient stated she could move her arm any way she wanted but that it hurt a lot. I repeated about the doctor stating that it wasn’t uncommon to have side effects and she stated that he said it wasn’t common to have side effects. I asked if she was going to the ER and she stated she would take the medication when her neighbor delivered them and see if they helped. I asked her to contact me later today to let me know how she was or that I can call her and check up. She stated she would give me a call.

Patient received 2 doses of RSV. 1st dose administered was Arexvy 2023 and 2nd dose was Abrysvo 2025. Patient reports no adverse effects

Within 24 hours developed nausea, headache, chills, myalgia, and injection site pain. In 48 hours noted raised, warm, painful rash below ( not encompassing) injection site and traces of non-painful rash on lateral left breast. Headache and nausea persisted for 48 hours. Went to urgent care at 5 pm on 1/24 as rash had increased in size and intensity (pain, redness). Diagnosed with probable cellulitis and prescribed cephalexin 500 mg TID. Physician did not discuss possibility of shingles. I?ve received 2 zoster vaccines within the last 5 years. On 1/25 8:00 am rash is slightly larger and now itchy and moderately painful. It begins 1-2 inches below injection site in deltoid and covers upper bicep. No vesicles noted.

Eczema like rash on arm by 1/5/25. Skin irritation/pain on vulva 1/8 that lasted days. Rash around both eyes started 1/9. Urinary hesitancy lead to complete inability to void. Catheter placed. Urologist reports inflammation to vulva swelled ureter. Unknown cause