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.

Patient received RSV vaccine at 35w6d and 12 days later reported for induction of labor with platelets of 51 10×3/uL. Platelets previously normal on 11/13/2024.

Extensive Erythema and Swelling at the site of injection, extending down the left arm

Headache, nausea, vomiting

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

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.

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.

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.

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.

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.