| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2839793 | TN | 05/06/2025 |
RSV |
PFIZER\WYETH |
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Drug ineffective, Foetal exposure during pregnancy, Respiratory syncytial virus ...
Drug ineffective, Foetal exposure during pregnancy, Respiratory syncytial virus infection, Term baby
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Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had ...
Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.; Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.; This is a spontaneous report received from a Physician from a sales representative. An infant patient born to a mother who, while pregnant received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant), outcome "unknown" and all described as "Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.". The patient was hospitalized for drug ineffective, respiratory syncytial virus infection (start date: 2024). It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection. Clinical course: It was reported that 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500094055 same product/event, different patient;
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| 2839794 | TN | 05/06/2025 |
RSV |
PFIZER\WYETH |
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Drug ineffective, Foetal exposure during pregnancy, Respiratory syncytial virus ...
Drug ineffective, Foetal exposure during pregnancy, Respiratory syncytial virus infection, Term baby
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Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' wh...
Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' who had received the RSV maternal vaccine at 35-36 weeks gestation.; Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' who had received the RSV maternal vaccine at 35-36 weeks gestation.; This is a spontaneous report received from a Physician from a sales representative. An infant patient born to a mother who, while pregnant received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) other for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization), outcome "unknown" and all described as "Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' who had received the RSV maternal vaccine at 35-36 weeks gestation.". It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection. Clinical course: It was reported that 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with ABRYSVO in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202500093960 same product/event, different patient;
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| 2839795 | M | MD | 05/06/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood chromogranin A, Blood thyroid stimulating hormone, Borrelia test, C-reacti...
Blood chromogranin A, Blood thyroid stimulating hormone, Borrelia test, C-reactive protein, Cardiovascular examination; Echocardiogram, Electrocardiogram, Epstein-Barr virus antibody, Full blood count, Heart rate; Histamine level, Investigation, Leukotriene test, Magnetic resonance imaging head, Metabolic function test; Neurological examination, Postural orthostatic tachycardia syndrome, Red blood cell sedimentation rate, Serum ferritin, Tryptase; Vestibular function test, Vitamin B12, Vitamin D
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Postural orthostatic tachycardia syndrome; This is a literature report for the following literature...
Postural orthostatic tachycardia syndrome; This is a literature report for the following literature source(s). Postural orthostatic tachycardia syndrome (POTS) is a condition primarily affecting females between the ages of 12 and 50 years; it is most commonly triggered by viral infections, pregnancy, fever, surgery, or trauma.1 Symptoms of POTS include dizziness/lightheadedness, fatigue, palpitations, visual disturbance, headache, nausea, and difficulty concentrating. While there are likely several underlying mechanisms and etiologies of POTS, an autoimmune basis of POTS has been postulated.2,3 Since the start of the COVID-19 pandemic, several case reports have documented the onset of POTS following SARS-CoV-2 infection4-6; in fact, our group published one of the first documented cases of POTSfollowing SARS-CoV-2 infection in a pediatric patient.7 The development of POTS following SARSCoV-2 is not entirely surprising considering that prior to the pandemic, roughly 50% of patients reported a history of infection closely preceding the onset of their POTS symptoms. The authors report a case of POTS in combination with another cause of dizziness, persistent postural perceptual dizziness (PPPD), following mRNA COVID-19 vaccination; to our knowledge, this is one of the first documented cases of POTS and PPPD co-occurring. The authors aim to bring more attention to both POTS and PPPD as 2 distinct causes of chronic dizziness that can coexist. The co-occurrence of POTS and PPPD may indicate a common etiology of the 2 conditions, or, perhaps, one may directly or indirectly cause the other. Case Report A 15-year-old male reported general malaise in the hours following administration of his second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine. He went on to develop symptoms of dizziness, headache, fatigue flushing, and nausea over the next few days. Prior to vaccination, he had been running daily and was overall healthy, with no chronic medical problems besides mild anxiety and depression, which had been well controlled on 20 mg of fluoxetine daily. Interestingly, the patient tolerated the first vaccine without incident. Over the next year and a half, his symptoms fluctuated but persisted, with dizziness being his most debilitating symptom. His dizziness, described as if the room were spinning, was exacerbated by standing up quickly, motion, and exertion, and was often accompanied by nausea, visual changes, and worsening headache. In light of persistent symptoms, the patient was evaluated by several pediatric neurologists; multiple neurological examinations were documented as reassuring and nonfocal. Magnetic resonance imaging of the brain revealed a few faint punctate foci scattered in cerebral white matter, deemed a normal variant, and was otherwise unremarkable. Of note, punctate foci are more often seen in patients with migraine headaches than in the general population.9 A complete blood count and complete metabolic panel were unremarkable, with a C-reactive protein = 0.1, erythrocyte sedimentation rate = 5, vitamin D = 45, vitamin B12 = 987, thyroid-stimulating hormone = 0.8, Epstein-Barr virus (EBV) IgM antibody = 0.2, EBV IgG antibody = <0.2, Borrelia burgdorferi antibody test negative, and ferritin = 60. Trials of meclizine 25 mg as needed, sumatriptan 50 mg as needed, zonisamide 5 mg daily, and topiramate 50 mg twice daily (BID) for headaches did not result in symptomatic improvement. Six months after the onset of symptoms, the patient underwent cardiac testing; his cardiac examination, echocardiogram,and electrocardiogram (ECG) were unremarkable. A 10-minute passive standing test revealed an increase in heart rate (HR) of 45 beats per minute (bpm) from 54 bpm supine to a peak of 99 bpm standing, associated with worsening orthostatic symptoms, and in the absence of orthostatic hypotension, consistent with the criteria proposed by the 2019 agency to diagnose POTS.1 He was subsequently trialed on various interventions commonly used to treat POTS, including both non-pharmacological and pharmacological measures. Initially, he saw some improvement in symptoms after increasing his daily fluid and salt intake, but the improvement was not sustained. He also tried several medications commonly used for POTS; some, like fludrocortisone 1 mg daily and propranolol 10 mg 3 times daily (TID), appeared to exacerbate his symptoms, while others, like midodrine 7.5 mg TID and pyridostigmine 60 mg BID, resulted in only very mild improvement. He also started physical therapy (PT) twice weekly; he followed a POTS protocol, focusing on recumbent physical activity, and was able to work up to 50minutes at a time on a recumbent bike. At the same time, he was working with a pediatric psychologist twice a month on pain-coping strategies for headaches. After completing several months of PT and therapy services, he noted some improvement in functioning but not in symptom burden. Due to the presence of flushing, mild dermatographia, and pruritus upon standing, the possibility of mast cell activation syndrome (MCAS) was investigated; testingwas ordered and revealed a normal tryptase, urine N-methylhistamine, chromogranin A, and PGF2 alpha, but elevated plasma histamine level of 3.7 (<1.8) and urine leukotriene E4 level of 193 (<104). Based on these results, the patient met Consensus-2 criteria for MCAS, including 1 major criterion (clinical complaints) and 2 minor criteria (presence of elevated mast cell mediators: histamine and leukotriene E4).10 Various pharmacological agents aimed at MCAS, including a combination of H1 (cetirizine 10 mg daily) and H2 blockers (famotidine 20 mg BID), cromolyn sodium 200 mg 4 times daily, and quercetin 500 mg daily, proved ineffective. Considering the patient's lack of response to multiple MCAS-targeted treatments, it is possible that MCAS was an overdiagnosis in this case.11 Despite various interventions for chronic headaches, POTS, and MCAS, the patient saw little improvement and remained functionally impaired over a year following the onset of his symptoms. He was unable to return to in-person school and struggled to complete even asynchronous virtual school due to his symptom burden. Finally, the patient underwent vestibular testing, which showed gaze-evoked right-beating nystagmus and left unilateral weakness on caloric testing. These results were interpreted as mild left vestibular hypofunction, possibly resulting from vestibular neuritis. Persistent postural perceptual dizziness is a condition typically precipitated by another event or disorder that causes dizziness or vertigo, which can include vestibular neuritis. Patients with PPPD therefore sometimes have abnormalities on vestibular testing related to the precipitating or comorbid disorder. The authors' patient's clinical picture, in particular the severity and chronicity of his symptoms, was overall consistent with a diagnosis of PPPD, possibly triggered by vestibular neuritis.12 Treatment recommendations for PPPD included cognitive behavioral therapy (CBT), vestibular PT, and migraine diet and lifestyle modifications. The patient was then referred and accepted into a monthlong pediatric day rehabilitation program, which provides daily, intensive rehabilitation services consisting of PT, occupational therapy (OT), and CBT services. After completing the program, the patient's symptoms improved enough that he was able to start a gradual return to in-person school. Two months later, he described himself as 100% functional albeit not completely symptom-free. He remains on target to graduate on time with his classmates. Discussion Although several case reports have suggested a temporal relationship between vaccination and POTS, a causal association has never been established.13,14 According to the Vaccine Adverse Event Reporting System (VAERS), a total of 29 case reports worldwide from June 1, 2006, through August 31, 2015, described the onset of POTS following administration of the human papillomavirus (HPV) vaccine.15 The VAERS review concluded that POTS following HPV vaccination was relatively rare, accounting for just 0.4% of all HPV reports during the study period. As the incidence of POTS is highest in teens and young adults, which is the predominant demographic receiving the HPV vaccination series, it was hypothesized that the occurrence of POTS following HPV vaccination is most likely due to chance alone. Two recent review articles, including one from the Society, have similarly concluded that there is insufficient evidence to support a causal relationship between POTS and the HPV vaccine. With regard to the COVID-19 mRNA vaccine specifically, a recent cohort study of 284,592 COVID-19 -vaccinated individuals demonstrated that the odds of developing POTS were higher in the 90 days after vaccination compared with the 90 days prior.18 Nevertheless, the authors caution that these results should not be interpreted as a causal link due to the observational design of the study. While there are several case reports describing a temporal association between POTS and COVID vaccination in adults,19-21 the only published pediatric case report describing this association is convoluted by several factors, including an imprecise timeline and a concomitant diagnosis of myocarditis.22 Although autoimmunity is a potential key mechanism underlying vaccine-induced and infection-induced POTS, it is important to note that very little conclusive evidence has emerged for autoimmune mechanisms in POTS.23 Persistent postural perceptual dizziness (PPPD) is a newly recognized disorder by the World Health Organization, caused by chronic dysfunction of the vestibular system and characterized by at least 3 months of persistent dizziness, nonspinning vertigo, and/or unsteadiness.24,25 PPPD typically develops in response to an insult or other condition(s) that cause dizziness; this insult is thought to induce an overreliance on postural control strategies and visual stimuli for spatial orientation. 25 Symptoms of PPPD are exacerbated by upright posture, active or passive movement (eg, walking or riding in a vehicle), and exposure to complex visual stimuli (eg, wallpaper with an intricate pattern). 24,25 Symptoms tend to cause the patient significant distress, especially in the modern world with its increasing fascination with multimedia stimulation.24 While there are similarities between POTS and PPPD, for example, in both conditions, patients experience dizziness that increases upon standing, there are also differences. An important distinction is that sensitivity to complex or moving visual stimuli from a seated position is specific to PPPD as POTS is a purely orthostatic condition. Furthermore, PPPD does not cause abnormal changes in HR as seen in POTS. It is important to distinguish between these two conditions as medications targeted to POTS are unlikely to be useful in PPPD (see Table). Our patient remained debilitated for over a year following vaccination despite trying various treatments for POTS, MCAS, and chronic daily headache; he finally experienced significant improvement in symptoms and functioning when his treatment plan was targeted to PPPD. In his case, the PPPD may have been triggered by vestibular neuritis, headache syndrome, anxiety, and/or POTS itself, which can all occur after vaccination and cause dizziness.26,27 Alternatively, it is possible that the patient first developed PPPD, which caused dizziness upon standing; this dizziness, in turn, may have produced discomfort and/or anxiety, resulting in a tachycardia mimicking POTS.While it is known that benign paroxysmal positional vertigo and vestibular migraines can trigger PPPD and then coexist with it,24 our literature search found no reports linking POTS with PPPD; thus, this is one of the first reported case describing POTS co-occurring with PPPD. The co-occurrence of POTS and PPPD may indicate a common etiology of the 2 conditions or, perhaps, as we suggest, one may directly or indirectly cause the other. Our primary aim is to bring attention to both POTS and PPPD as distinct and, importantly, treatable causes of chronic dizziness that may co-occur. The authors believe further research is needed to determine the prevalence of both POTS and PPPD as separate but also coexisting conditions in adult and pediatric patients alike.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 2839796 | M | 05/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Oral lichen planus
Oral lichen planus
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got Oral Lichen Planus after 3 vaccinations; This is a spontaneous report received from a Consumer o...
got Oral Lichen Planus after 3 vaccinations; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019096 (BioNTech). A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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 (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: ORAL LICHEN PLANUS (non-serious), outcome "unknown", described as "got Oral Lichen Planus after 3 vaccinations". Additional information: Reporter's brother (patient) got Oral Lichen Planus after 3 vaccinations. Asked to find a cure for this disease.
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| 2839806 | ID | 05/06/2025 |
MMR |
MERCK & CO. INC. |
Y015834 |
Device connection issue, Underdose
Device connection issue, Underdose
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No additional AE; Patient only received a partial dose.; when administering MMR II and the needle at...
No additional AE; Patient only received a partial dose.; when administering MMR II and the needle attached to the luer lock on the diluent pre-filled syringe was loose; The nurse reports leaking occurred through the threaded part of the needle; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (lot #Y015834 was verified to be a valid number, expiration date: 20-Sep-2026) (product quantity: 1 vial) diluted with sterile diluent (BAXTER STERILE DILUENT) (product quantity: 1 prefilled syringe) (lot # and expiration date were not reported) (dose, scheme, strength, formulation injection site and route of administration were not provided). It was reported that when administering Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) the needle attached to the luer lock on the diluent pre-filled syringe was loose (device connection issue). The nurse reported that leaking occurred through the threaded part of the needle and the needle was twisted on tight (needle issue). Patient only received a partial dose (incorrect dose administered). Product has been discarded and is not available for return. Pictures are not available. No additional adverse event was reported.
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| 2839808 | 05/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Lymphatic system neoplasm, Wound
Lymphatic system neoplasm, Wound
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tumor in my lymph node; an open wound; This is a spontaneous report received from a Consumer or othe...
tumor in my lymph node; an open wound; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WOUND (non-serious) with onset 2021, outcome "not recovered", described as "an open wound"; LYMPHATIC SYSTEM NEOPLASM (medically significant) with onset 2021, outcome "not recovered", described as "tumor in my lymph node". Clinical course: Patient got the COVID vaccine shot from Pfizer in 2021. It caused an open wound, and a tumor in the lymph node. Patient have had this for 4 years now and finally decided it was enough. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2839809 | 41 | M | CA | 05/06/2025 |
COVID19 |
MODERNA |
3043030 |
Dizziness, Hypoaesthesia
Dizziness, Hypoaesthesia
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Participant received Covid-19 injection at 1531 on 5/2/25, participant was observed for 15 minutes. ...
Participant received Covid-19 injection at 1531 on 5/2/25, participant was observed for 15 minutes. After obnservation period, participant went and got up to walk and stated, "I feel lightheaded, and I have a left numb arm, but the lightheadedness started earlier in the day". RN offered snacks, water, and Gatorade to participant. RN performed vitals on participant, all within normal limits (BP: 130/90, HR 98, 96% oxygen saturation on room air, 97.8 temporal temperature.) Participant stated "my numb arm and lightheadendness has resolved" about ten minutes after vitals were taken and participant left building.
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| 2839810 | 60 | F | MI | 05/06/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9L944 9L944 |
Erythema, Headache, Pain, Pain in extremity, Skin warm; Tenderness
Erythema, Headache, Pain, Pain in extremity, Skin warm; Tenderness
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Patient complained of soreness and redness on arm. Was warm and tender to the touch. Redness was swe...
Patient complained of soreness and redness on arm. Was warm and tender to the touch. Redness was swelling. Also described headache like/shingle pain. She had no issues with the first shot. Advised to contact Dr if it got worse. Counseled on icing it and taking Benadryl. Patient was already taking ibuprofen for the swelling.
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| 2839811 | 1.5 | M | CO | 05/06/2025 |
DTAP HEPA PNC13 RV1 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
2CA77C1 9R5LC GK5782 YL9YN |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event
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This is not adverse reaction event. HAVRIX was administered by 11/04/2024, the Hep-A vaccine expired...
This is not adverse reaction event. HAVRIX was administered by 11/04/2024, the Hep-A vaccine expired by 11/02/2024. It's administered 2 days later after expired. And we already report to GSK and authority on 11/05/2024. But report in VAERS, because it reported by GSK, so we report it again. We already followed the results from GSK and authority. This is duplicated report. There is no adverse reaction by vaccination and no treatment at all. Informed to patient's parents right a way.
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| 2839817 | 55 | M | 05/06/2025 |
MMR TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
10670574 5k6mbs5 |
Arthralgia, Mobility decreased, Pain in extremity, Shoulder injury related to va...
Arthralgia, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration; Arthralgia, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
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Patient developed SIRVA and experienced pain in shoulder and arm and could not move his arm
Patient developed SIRVA and experienced pain in shoulder and arm and could not move his arm
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| 2839818 | 66 | M | GA | 05/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Biopsy skin, Rash
Biopsy skin, Rash
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rash whole body
rash whole body
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| 2839819 | 28 | F | CA | 05/06/2025 |
TDAP |
SANOFI PASTEUR |
u8389aa |
Injection site bruising, Injection site inflammation, Injection site pain, Injec...
Injection site bruising, Injection site inflammation, Injection site pain, Injection site swelling
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patient complaining of swelling and inflammation and bruising at the injection site that was going a...
patient complaining of swelling and inflammation and bruising at the injection site that was going away and a week later she is experiencing pain and swelling again and noticed that the arm below the injection site is getting bruised again.
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| 2839820 | 44 | F | TX | 05/06/2025 |
COVID19 |
PFIZER\BIONTECH |
59267-1000-1 |
Coronary artery thrombosis, Myocardial infarction
Coronary artery thrombosis, Myocardial infarction
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Heart attack with blood clot.
Heart attack with blood clot.
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✓ | ✓ | ||||
| 2839821 | 45 | M | KS | 05/06/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
1822809 1822809 1822809 |
Amnesia, Brain fog, Confusional state, Derealisation, Dizziness; Fatigue, Hand-e...
Amnesia, Brain fog, Confusional state, Derealisation, Dizziness; Fatigue, Hand-eye coordination impaired, Magnetic resonance imaging, Pain, Primary stabbing headache; Slow response to stimuli
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Approximately an hour after receiving the vaccine, I experienced a stabbing (ice pick) headache and ...
Approximately an hour after receiving the vaccine, I experienced a stabbing (ice pick) headache and have experienced the same headache daily since the vaccine (aprox. 3 1/2 years). I have never experienced this type of headache in my life prior to the vaccine. The intensity of the headache varies but has been consistent and persistent since receiving the vaccine on 10/21/2021. Other symptoms include, dizziness, brain fog, confusion, memory loss, feelings of derealization, fatigue, body aches, hand eye coordination difficulties and my reaction time and awareness of my surroundings have been impaired dramatically.
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| 2839822 | 72 | F | FL | 05/06/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Pain in extremity
Pain in extremity
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Patient reported sore arm post vaccination. Patient was prescribed a Medrol Dosepak 11 days post vac...
Patient reported sore arm post vaccination. Patient was prescribed a Medrol Dosepak 11 days post vaccination but did not immediately take it. Patient was also told to take over the counter pain relieving medication, but refused to initially take these as well. Patient was told to be evaluated by a physician if soreness continued, and was seen on 4/28 at a local urgent care. Urgent care recommended patient follow up with orthopedic specialist to be evaluated for potential gabapentin therapy. Urgent care also instructed patient to use Voltaren Gel and Salon Paas topically as well as heating pad to relieve pain. It is unknown if the patient has contacted an ortho.
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| 2839824 | 59 | F | CA | 05/06/2025 |
PNC20 |
PFIZER\WYETH |
LK6655 |
Injection site erythema, Injection site inflammation
Injection site erythema, Injection site inflammation
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6 x 6 inches of redness and inflammation in the injection site
6 x 6 inches of redness and inflammation in the injection site
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| 2839986 | 27 | F | NC | 05/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
B4J4B |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
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huge red, hot circle around injection site lot of pain, bruising
huge red, hot circle around injection site lot of pain, bruising
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| 2839987 | 1 | F | MN | 05/06/2025 |
HEPA MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y019318 Y015022 Y013074 |
Rash; Rash; Rash
Rash; Rash; Rash
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Rash.
Rash.
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| 2839988 | 78 | NC | 05/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8515CA |
Diplopia, Dizziness, Vision blurred
Diplopia, Dizziness, Vision blurred
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pt left clinic after vaccine admin, went to local pharmacy to pick up meds. Had episode of dizziness...
pt left clinic after vaccine admin, went to local pharmacy to pick up meds. Had episode of dizziness and double vision, presented back to clinic. Vital signs stable. Neuro check by NP normal. Pt c/o continued dizziness & blurred vision. EMS called and pt transported to ER for further evaluation.
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| 2839379 | F | IL | 05/05/2025 |
HPV4 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Incomplete course of vaccination, No adverse event; Incomplete course of vaccina...
Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event
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HCP called regarding GARDASIL and/or GARDASIL 9. It's reported that the patient was "in he...
HCP called regarding GARDASIL and/or GARDASIL 9. It's reported that the patient was "in her 20's at the time of the first vaccination" and missed her 2nd and 3rd dose in the GARDASIL series (HCP unclear whether it was GARDASIL or GARDASIL 9) and on; No other AE/No PQC.; This spontaneous report was received from a/an Pharmacist and refers to a(n) Adult female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date between 2014 and 2016 also reported when the patient was in her 20's, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), administered by Unknown route (lot # and expiration date were not reported) however, the reporter was unclear whether it was GARDASIL or GARDASIL 9. On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), administered by Unknown route (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), for the treatment of Prophylaxis. The HCP stated that they would be administering the remaining Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) series "starting where they left off", they had not yet received the 2nd and 3rd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9). No adverse event reported. Lot # is being requested and will be submitted if received.
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| 2839380 | NV | 05/05/2025 |
HEPA |
MERCK & CO. INC. |
X024966 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No other information provided. No additional AEs/PQC reported.; Caller reported VAQTA administered ...
No other information provided. No additional AEs/PQC reported.; Caller reported VAQTA administered after expiration date.; Information has been received from Business Partner/CRO on 08-Apr-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and 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 date, the patient started therapy with . On an unknown date, the patient started therapy with Hepatitis A Vaccine, Inactivated (lot #X024966, expiration date: 23-Mar-2025) 1 mL administered by Intramuscular route. The patient started therapy with Hepatitis A Vaccine, Inactivated for the treatment of Prophylaxis. On 25-Mar-2025, the patient experienced Caller reported VAQTA administered after expiration date.. On an unknown date, the patient experienced No other information provided. No additional AEs/PQC reported.. At the reporting time, the outcome of Caller reported VAQTA administered after expiration date. and No other information provided. No additional AEs/PQC reported. was unknown. The action taken with Hepatitis A Vaccine, Inactivated was reported as not applicable.
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| 2839381 | 05/05/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Post herpetic neuralgia, Therapeutic response unexpected, Vaccina...
Herpes zoster, Post herpetic neuralgia, Therapeutic response unexpected, Vaccination failure
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Suspected vaccination failure; had it twice; Postherpetic neuralgia; This serious case was reported ...
Suspected vaccination failure; had it twice; Postherpetic neuralgia; 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. The patient's past medical history included psoriasis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had it twice) and post herpetic neuralgia (Verbatim: Postherpetic neuralgia). The outcome of the vaccination failure was not reported and the outcome of the shingles and post herpetic neuralgia were resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient had it twice after the shot also had Postherpetic neuralgia which was twice as bad as the shingles, but when it all went away no longer had psoriasis on elbows ever again. The patient reported this observation to the because was not an physician they were not interested. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2839382 | 3 | M | WI | 05/05/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
Wrong product administered
Wrong product administered
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Kinrix out of the recommended age administration; Kinrix as fourth instead of fifth DTaP-IPV dose ad...
Kinrix out of the recommended age administration; Kinrix as fourth instead of fifth DTaP-IPV dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. On 16-APR-2025, the patient received Kinrix. On 16-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix out of the recommended age administration) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as fourth instead of fifth DTaP-IPV dose administration). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-APR-2025 Certified Medical Assistant wanted to know if a Kinrix administration in a 3 years-old patient was considered an error and how to proceed, inappropriate age at vaccine administration. Also, agent asked in which number dose in the series for DTaP-IPV immunization Kinrix was given and the health care provider mentioned that was the fourth (instead of being the fifth, as recommended in the prescribing information), which led to inappropriate schedule of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
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| 2839388 | F | NJ | 05/05/2025 |
PNC21 TTOX |
MERCK & CO. INC. UNKNOWN MANUFACTURER |
|
Abdominal pain, Injection site pain, Musculoskeletal stiffness; Abdominal pain, ...
Abdominal pain, Injection site pain, Musculoskeletal stiffness; Abdominal pain, Injection site pain, Musculoskeletal stiffness
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Experienced sore, tight/stiff arm, and inject site soreness; Experienced sore, tight/stiff arm, and ...
Experienced sore, tight/stiff arm, and inject site soreness; Experienced sore, tight/stiff arm, and inject site soreness; tight/stiff arm; This spontaneous report was received from a consumer, referring to herself, a 50-year-old female patient. The patient's concomitant drugs included breast cancer medication. The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21v conj vaccine (CRM197) (CAPVAXIVE) (dose, strength, route of administration, lot#, and expiration date were not reported) for prophylaxis by a Health Professional; together with Tetanus vaccine (dose, strength, route of administration, lot#, and expiration date were not reported). On 29-APR-2025, the patient experienced sore, tight/stiff arm, and inject site soreness. At the time of reporting, the outcome of the events above was unknown. The causal relationship between the events above and the suspected vaccines was not reported. Lot# is being requested and will be submitted if received.
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| 2839389 | 60 | F | FL | 05/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Diarrhoea, Eye haemorrhage, Injection site pain, Vomiting
Diarrhoea, Eye haemorrhage, Injection site pain, Vomiting
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Vomiting; Diarrhea; Pain injection site; broke an eye blood vessel/ my left eye broke a blood vessel...
Vomiting; Diarrhea; Pain injection site; broke an eye blood vessel/ my left eye broke a blood vessels in the eye and the white part is totally red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In APR-2025, less than a week after receiving Shingrix, the patient experienced broken blood vessel in eye (Verbatim: broke an eye blood vessel/ my left eye broke a blood vessels in the eye and the white part is totally red). On 25-APR-2025, the patient experienced injection site pain (Verbatim: Pain injection site). On 26-APR-2025, the patient experienced vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site pain was unknown and the outcome of the vomiting and diarrhea were resolved and the outcome of the broken blood vessel in eye was not resolved. It was unknown if the reporter considered the injection site pain, vomiting, diarrhea and broken blood vessel in eye to be related to Shingrix. It was unknown if the company considered the injection site pain, vomiting, diarrhea and broken blood vessel in eye to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 The patient self reported this case for herself. The patient reported an adverse event for the Shingrix vaccine on 30th April 2025. She stated that she had received the first dose of Shingrix on 24th April 2025, in her left arm at a local pharmacy. The lot/expiration details were unknown. She mentioned that she had experienced pain at the injection site on the next day. On 26th April 2025, she reported vomiting and diarrhea. The patient stated that she had recovered from these symptoms but noted, the vomiting was so bad that her left eye broke a blood vessel, and the white part was totally red.
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| 2839434 | 42 | NY | 05/05/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y013347 |
Product storage error; Product storage error
Product storage error; Product storage error
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no additional AE; HCP calling to report T/E. HCP stated VARIVAX was administered.ved (including lot/...
no additional AE; HCP calling to report T/E. HCP stated VARIVAX was administered.ved (including lot/exp): VARIVAX Y013347 8/08/2026; This spontaneous report was received from a nurse and refers to a 42-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unspecified dates, varicella virus vaccine live (oka-merck) (VARIVAX) lot #Y013347 underwent temperature excursions (13 minutes in -14.0 degrees Celsius and 36 minutes in -7.8 degrees Celsius). On 07-APR-2025, the patient was vaccinated with varicella virus vaccine live (oka-merck) (VARIVAX), injection, lot #Y013347, expiration date was reported as 08-AUG-2026, however upon internal validation determined as 02-AUG-2026, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiry date were not reported). The vaccine underwent temperature excursion described above (Product storage error). No additional adverse event was reported.
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| 2839435 | 24 | NY | 05/05/2025 |
VARCEL |
MERCK & CO. INC. |
Y013347 |
No adverse event, Product storage error
No adverse event, Product storage error
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. No additional AE /PQC reported; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated V...
. No additional AE /PQC reported; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered. Permission was given to contact HCP. No additional AE /PQC reported. ? Names of vaccines involved (including lot/exp): VARIVAX Y013347 8/08/20; This spontaneous report was received from an other health professional and refers to a(n) 24-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-MAR-2025, the patient was vaccinated with improperly stored dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Injection, lot #Y013347, expiration date 02-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The excursion lasted for 36 minutes in temperature -7.8 Celsius degrees. There was previous excursion that lasted 13 minutes in temperature -14.0 Celsius degrees (-14.4�C up to -10.4�C) (improper storage of product in use). No additional adverse events were reported.
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| 2839436 | 55 | NY | 05/05/2025 |
VARCEL |
MERCK & CO. INC. |
Y013347 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VA...
No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered. Permission was given to contact HCP. No additional AE /PQC reported. ? Names of vaccines involved (including lot/exp): VARIVAX Y013347 8/08/20; This spontaneous report was received from an other health professional and refers to a(n) 55-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-MAR-2025, the patient was vaccinated with improperly stored dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Injection, lot #Y013347, expiration date 02-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The excursion lasted for 36 minutes in temperature -7.8 Celsius degrees. There was previous excursion that lasted 13 minutes in temperature -14.0 Celsius degrees (-14.4�C up to -10.4�C) (improper storage of product in use). No additional adverse events were reported.
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| 2839437 | 10 | NY | 05/05/2025 |
VARCEL |
MERCK & CO. INC. |
Y015557 |
Product storage error
Product storage error
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HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX were administered. Permiss...
HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX were administered. Permission was given to contact HCP. No additional AE/PQC reported. ? Names of vaccines involved (including lot/exp): VARIVAX Y015557 09/1; no adverse event; This spontaneous report was received from a nurse and regarding a 10-year-old patient of unknown gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection, as prophylaxis (lot #Y015557, expiration date: 16-Sep-2026) (dose, anatomical location, and route of administration were not reported), reconstituted with sterile diluent (MERCK STERILE DILUENT), solution for injection (dose, indication, route of administration, expiration date, and lot # were not reported). It was stated that this vaccine, underwent a temperature excursion (TE) at -7.8 �C, during 36 minutes. A previous temperature excursion had occurred at -14.4�C (up to -10.4�C) and 14.0 �C during 13 minutes.
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| 2839438 | 0.33 | F | AL | 05/05/2025 |
RV5 |
MERCK & CO. INC. |
|
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No additional AE; the patient was administered this dose via a feeding tube (nasogastric); patient r...
No additional AE; the patient was administered this dose via a feeding tube (nasogastric); patient received their first dose of ROTATEQ on 4/11/2025 at the age of 18 weeks and 4 days.; This spontaneous report was received from a Nurse (registered nurse [RN]) and refers to an 18-week-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-Apr-2025 (at the age of 18 weeks and 4 days), the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral solution, dose number 1, administered via a feeding tube (nasogastric) (exact dose, lot # and expiration date were not reported) for prophylaxis at Clinic (inappropriate schedule of product administration, incorrect route of product administration). No additional adverse event (AE) was reported (no adverse event). Lot # is being requested and will be submitted if received.
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| 2839439 | PA | 05/05/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
y010373 Y015108 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE/PQC.; temperature excursion evaluation and stated that the product was administered...
No additional AE/PQC.; temperature excursion evaluation and stated that the product was administered.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers Y010373, which had been verified to be valid, expiration date was reported as 06-Jun-2026 and validated as 05-Jun-2026; and Y015108 which had been verified to be valid, expiration date was reported and validated as 06-Sep-2026), as prophylaxis. The vaccine administered was stored at temperature of 12.9 degrees Celsius (C) for a time frame of 5 hours and 12 minutes (improper storage of product in use). There was no previous temperature excursion. No additional AE details were reported.
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| 2839440 | KY | 05/05/2025 |
VARCEL |
MERCK & CO. INC. |
Y014939 |
Product storage error
Product storage error
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administrations of VARIVAX following a temperature excursion; No other AE/PQC; This spontaneous repo...
administrations of VARIVAX following a temperature excursion; No other AE/PQC; This spontaneous report was received from a consumer or other non health professional and refers to a(n) patient of unknown age and 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 date, the patient was vaccinated with unknown number of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y014939, expiration date: 04-Sep-2026, administered for prophylaxis (strength, dose and route of administration were not provided) following a temperature excursion (5.5�F up to 14.4�F (-14.4�C up to -10.4�C) 0 hours 50 minutes; 14.5�F up to 46.4�F (-10.5�C up to 8.4�C) 11 hours 30 minutes; 46.5�F to 77.4�F (8.5�C to 25.4�C) 0 hours 40 minutes; 77.5�F/25.5�C or warmer 0 hours 0 minutes) (Improper storage of product in use). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot and expiration date were not provided). No previous temperature excursion. No symptoms reported and no additional details provided. No other adverse event (AE) (No adverse event). This is an invalid case due to lack of patient's identifiers.; Reporter's Comments:
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| 2839442 | 18 | F | PA | 05/05/2025 |
MMRV |
MERCK & CO. INC. |
|
Wrong product administered
Wrong product administered
|
Patient given MMRV instead of MMR.
Patient given MMRV instead of MMR.
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| 2839443 | 15 | F | PA | 05/05/2025 |
MMRV |
MERCK & CO. INC. |
|
Wrong product administered
Wrong product administered
|
Received MMRV instead of MMR
Received MMRV instead of MMR
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| 2839444 | 57 | F | AR | 05/05/2025 |
VARCEL |
MERCK & CO. INC. |
Y013347 |
Headache, Injection site swelling, Oedema peripheral, Tenderness
Headache, Injection site swelling, Oedema peripheral, Tenderness
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Employee states after receiving vaccination she got a headache within a few hours. The next morning ...
Employee states after receiving vaccination she got a headache within a few hours. The next morning she woke up with swelling to injection site, her underarm area and her breast were swollen as well and sore to the touch.
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| 2839445 | M | MN | 05/05/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U8313AA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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N/A
N/A
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| 2839446 | 63 | M | IA | 05/05/2025 |
COVID19 |
MODERNA |
3043159 |
Death
Death
|
passed away
passed away
|
✓ | |||||
| 2839447 | 1.33 | F | GA | 05/05/2025 |
DTAP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
Y97N7 Y005366 LK6655 |
Injection site erythema, Injection site pain, Injection site warmth; Injection s...
Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth
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Most of L anterior thigh erythematous, warm, tender (14cm x 9.5cm). Rx Keflex issued, Benadryl PRN, ...
Most of L anterior thigh erythematous, warm, tender (14cm x 9.5cm). Rx Keflex issued, Benadryl PRN, warm sitz baths, cool compresses. Improvement noted within 24-48hrs.
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| 2839448 | 76 | M | IA | 05/05/2025 |
COVID19 |
MODERNA |
3043332 |
Death
Death
|
passed away
passed away
|
✓ | |||||
| 2839449 | 2 | F | NJ | 05/05/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Diarrhoea, Eye swelling, Periorbital swelling, Pyrexia, Rash
Diarrhoea, Eye swelling, Periorbital swelling, Pyrexia, Rash
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On day 6, It started with a small rash on the neck. By Day 8-9 it became a full body rash. Day 10 pa...
On day 6, It started with a small rash on the neck. By Day 8-9 it became a full body rash. Day 10 patient woke up with puffy/swollen eyes, a fever and diarrhea.
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| 2839450 | 52 | M | CO | 05/05/2025 |
COVID19 |
PFIZER\BIONTECH |
lp1780 |
No adverse event
No adverse event
|
none noted
none noted
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| 2839451 | 05/05/2025 |
MMRV |
MERCK & CO. INC. |
|
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event, Underdose
More
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No additional AE/no; received half a dose of PROQUAD; This spontaneous report was received from a fi...
No additional AE/no; received half a dose of PROQUAD; This spontaneous report was received from a field-based employee (FBE) via physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-APR-2025, the patient was vaccinated with half a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) due to the child screaming and squirming and they lost control of the child, and the product was wasted during that time (underdose). The FBE states the physician wanted to know if the dose given was sufficient or is revaccination required. No adverse events reported.
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| 2839452 | 1.25 | M | MN | 05/05/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK19AA |
Cyanosis, Irritability, Peripheral coldness, Pyrexia
Cyanosis, Irritability, Peripheral coldness, Pyrexia
|
Later in the evening after receiving his vaccine, mother says he "reacted" and developed f...
Later in the evening after receiving his vaccine, mother says he "reacted" and developed fever, his hands looked "cold and purple" and he was fussy. This was better, it sounds like, by the next day. No ongoing concerns. Family is concerned that this could have been related to the vaccines he had received, and wants this "reaction marked in his chart.".
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| 2839453 | 62 | F | OH | 05/05/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3042913 3042913 |
Discomfort, Fatigue, Hyperhidrosis, Immediate post-injection reaction, Pain in e...
Discomfort, Fatigue, Hyperhidrosis, Immediate post-injection reaction, Pain in extremity; Peripheral coldness, Peripheral swelling, Pyrexia
More
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She immediately felt discomfort as the vaccine was being administered. Her arm remained sore throug...
She immediately felt discomfort as the vaccine was being administered. Her arm remained sore throughout the day and she began "freezing" later that night. The next morning (Friday) she woke up drenched in sweat as if her fever broke and she was extremely fatigued that day. The fever and fatigue remained through Sunday (72 hours). Her arm is still sore and swollen today, Monday. She is taking ibuprofen to try and manage the symptoms.
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| 2839454 | 35 | F | MI | 05/05/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y018398 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Dose provided was # 4 of 3 dose course. Extra dose administered. Given by Medical Assistant. No ...
Dose provided was # 4 of 3 dose course. Extra dose administered. Given by Medical Assistant. No adverse event was noted (no signs or symptoms of reaction)
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| 2839455 | 67 | F | OH | 05/05/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
ab499 |
Headache, Heart rate increased
Headache, Heart rate increased
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Was not informed she was given Tdap instead of Td. No VIS given. Has severe headache and rapid heart...
Was not informed she was given Tdap instead of Td. No VIS given. Has severe headache and rapid heart rate but not as severe as yesterday.
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| 2839456 | 21 | M | TN | 05/05/2025 |
HPV9 VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y018398 X000532 |
Expired product administered; Expired product administered
Expired product administered; Expired product administered
|
It was noted when charting the Varivax that the vaccine given was expired as of 1/4/25. Contacted Me...
It was noted when charting the Varivax that the vaccine given was expired as of 1/4/25. Contacted Merck to inquire about potency and was told that they have in house data that supports the potency of the vaccine and they do not give recommendations on whether or not dose needs to be repeated. NP states that she will have titers drawn in a few months to see if he has immunity. patient notified and voiced understanding. Incident report filled out.
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| 2839457 | 51 | F | NY | 05/05/2025 |
PNC13 PNC13 |
PFIZER\WYETH PFIZER\WYETH |
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Arthralgia, Chills, Fatigue, Headache, Injection site erythema; Myalgia, Pain in...
Arthralgia, Chills, Fatigue, Headache, Injection site erythema; Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
More
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redness below the area of injection- red banding around the arm-pooling of the serum? arm swelling a...
redness below the area of injection- red banding around the arm-pooling of the serum? arm swelling and soreness. fever (102.6), chills, muscle/joint aches, tiredness, headache.
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| 2839458 | 69 | F | AZ | 05/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E754F |
Injection site erythema, Injection site induration, Injection site warmth
Injection site erythema, Injection site induration, Injection site warmth
|
SITE OF INJECTION: RED/HARD/HOT. NO ADDITIONAL SYMPTOMS
SITE OF INJECTION: RED/HARD/HOT. NO ADDITIONAL SYMPTOMS
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| 2839459 | 1.33 | F | MI | 05/05/2025 |
HEPA MMR PNC20 |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
Y013274 X026222 LJ5282 |
Product preparation error; Product preparation error; Product preparation error
Product preparation error; Product preparation error; Product preparation error
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Patient was due for Pentacel, they received 2 of 2 with was reconstituted with dilutian instead if b...
Patient was due for Pentacel, they received 2 of 2 with was reconstituted with dilutian instead if being reconstituted with the Dtap- IPV component. Patients mouther was contacted and informed. We are bringing the patient back to get a repeat of the Pentacel Vaccines
More
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