| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2837869 | F | CA | 04/24/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
2345B |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatr...
Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 12-month-old female patient who received HAV (Havrix 1440 adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. On 22-APR-2025, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient) and overdose (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the adult product administered to child and overdose 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: 22-APR-2025 Medical Assistant called to report a twelve month old female patient that suffered the maladministration of an adult dose of a Havrix Vaccine, which led to adult product administered to child and overdose. Medical Assistant wanted to know if there are any safety (adverse event) and guidance (revaccination advise) on this situation. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2837870 | 54 | F | IA | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladmi...
Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number YY22P, expiry date 20-JUL-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 1st November 2024). On 28-FEB-2025, the patient received the 2nd dose of Shingrix. On 28-FEB-2025, 119 days after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)) and inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 The registered nurse stated that they were not 100 percent sure if the patient had received the full dose or only the diluent. If the patient had received three doses of Shingrix, what concerns would have needed to be addressed. Patient received maladministration of AS01B Adjuvant of Shingrix, which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication.
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| 2837871 | NJ | 04/24/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Syringe issue
Syringe issue
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they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble o...
they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.; they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5ml single (Lot number: LK6650, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.". Additional information: Transferring agent started, "I just have a customer that called, and it was the Prevnar 20, they had an air bubble. She said for Prevnar 20 they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.". When paraphrased the concern, reporter stated, "Yes, it broke completely." Product Quality Group provided investigational results on 22Apr2025 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): The complaint for "they had a air bubble in the medication" of Prevenar 20 was investigated.The investigation included reviewing the involved batch records, deviation investigation, the evaluation of a retain sample, an analysis of the complaint history for the involved scope and Annual Product Review. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot LK6650. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Site Investigation (Puurs):Container Broken/Cracked During Prep/Use. The complaint for "the nurse was tapping the needle to get the air bubble out and it broke." of Prevenar 20 was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain sample, an analysis of the complaint history for the involved scope and Annual Product Review. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot LK6650. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Site Investigation: Bubbles/Foamy - Liquid. The complaint reported "air bubble" for a Prevnar 20V syringe.?The Fill Lot is LE1000. The final scope was limited to the Fill Lot and its component lots (Aluminium phosphate and Buffer lot) as a trend was not identified and no evidence was found to indicate that manufacturing activities contributed to the reported complaint. The investigation included a review of batch records and process records, a lot history review and a reserve review for the lot(s) in scope. An evaluation of the complaint history confirms that this is the first complaint for the Fill Lot for this complaint subclass. A Lot specific trend was not identified. Controls are in place to prevent/detect the reported complaint; EISAI inspection for particulate matter, In process testing of turbidity, AQL inspection for abnormal colour (low/high turbidity) and product appearance release testing. A sample or photo was not received. A review of the latest APQR (Annual Product Quality Review) reports was performed - RPT-193056 (2019-2022) and RPT-218189 (2023). No trends were identified for subclass Adverse Event MD/MDCP. Review of Reserve APQR reports: A review of the APQR (Annual Product Quality Review) reserve chapters were performed - RPT-215231 (2023 Section 9.0) and RPT-194694 (2019-2022 Section 9). No issues were identified.There were no issues identified during the investigation impacting product quality. The complaint is not confirmed and is not process related. A root cause was not identified, and no corrective/preventative actions are required.? The reported defect is not representative of the quality of the batch, and lot LE1000 remains acceptable for further distribution.? An issue escalation was not raised and regulatory notification is not required. No further action is required. Site Investigation: Container Broken/Cracked During Prep/Use. The complaint reported "the needle broke completely" for a Prevenar 20V syringe.?The Fill Lot is LE1000. The final scope was limited to the Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities contributed to the reported complaint. The investigation included a review of batch records and process records, a lot history review and a reserve review for the lot(s) in scope. No complaint sample or photo was returned for this complaint. Therefore, this complaint is not confirmed. An evaluation of the complaint history confirms that this is the first complaint for the Fill Lot for this complaint subclass. A lot specific trend was not identified. A trend was not identified for the syringe barrel lots associated with the Fill Lot for this class/subclass. A review of the latest APRR (Annual Product Record Review) reports for Prevenar 20V Drug Product was performed for 'Product Complaints' and 'Reserve Samples'. No trends or issues were identified in relation to this complaint. Refer to RPT-246679 (2024), RPT-215256 (2023) and RPT-194382 (2019-2023). Controls are in place to prevent/detect the reported complaint; The EISAI inspection machine has 100% detection for underfilled/empty syringes and also detects a missing tip cap and cracked barrel. There were no issues identified during the investigation impacting product quality. The complaint is not confirmed and is not process related. A root cause was not identified, and no corrective/preventative actions are required. Following completion of the investigation it is determined that a regulatory notification is not required for this complaint. The reported defect is not representative of the quality of the batch, and lot LE1000 remains acceptable for further distribution.Device Investigation: This investigation is based on the information captured in the Complaint Description and Argus Report. Two distinct Complaint Issues of "Cartridge/Syringe Barrel Broken During Prep/Use" and "Product Appearance - Bubbles/Foamy Liquid" were reported. However, these two distinct Complaint Issues map to the same Hazards/Hazardous Situations. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis (INX100323906, Version 7.0). All complaint investigations are trended. There is no current trend alert documented.
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| 2837872 | F | CA | 04/24/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Autoimmune disorder, Biopsy skin, Blood thyroid stimulating hormone, Chronic gas...
Autoimmune disorder, Biopsy skin, Blood thyroid stimulating hormone, Chronic gastritis, Coeliac disease; Colonoscopy, Endoscopy upper gastrointestinal tract, Faecal calprotectin, Graves' disease, HLA marker study; Intrinsic factor antibody, Proctitis ulcerative, Serology test, Thyroid stimulating immunoglobulin, Thyroxine free
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Vaccine-induced autoimmunity; new-onset autoimmune conditions following vaccination with mRNA-based ...
Vaccine-induced autoimmunity; new-onset autoimmune conditions following vaccination with mRNA-based vaccines; Primary hyperthyroidism in setting of Graves disease; Celiac disease; Autoimmune gastritis; Ulcerative proctitis; This is a literature report for the following literature source(s). Vaccine-induced autoimmunity has been previously described with many protein subunit vaccines. Many mechanisms have been proposed, though it is largely thought to occur via molecular mimicry. In the wake of the COVID-19 pandemic that saw the rapid development and distribution of several new vaccines using novel technology, there are emerging reports of new-onset autoimmune conditions following vaccination with mRNA-based vaccines. Per case description or methods, the patient is a 47-year-old woman with a history of iron-deficiency anemia and atopic dermatitis. Her family history is notable for 2 children with biopsy-proven Celiac disease, one of whom additionally has Graves' disease. She initially presented for an intermittent, pruritic lower extremity rash that developed after her second mRNA-based COVID-19 vaccine. Celiac serologies were negative (she was gluten-free at the time) but her HLA-DQ2 haplotype was positive. Punch biopsy of her rash was notable for intra- and subepidermal splitting with granular IgA deposition at the dermal/ epidermal junction, consistent with dermatitis herpetiformis. Several months later, she received a booster and shortly thereafter, she presented to the emergency room with acute palpitations, tremor, and diarrhea. TSH was undetectable with elevated free T4 and TSI consistent with primary hyperthyroidism in setting of Graves' disease; she was started on treatment with methimazole and beta blockade. Due to ongoing evidence of malabsorption, she underwent upper endoscopy that was consistent with treated Celiac disease (increased duodenal lymphocytes with preserved villous architecture) as well as atrophic gastritis and elevated IF antibody suggestive of autoimmune gastritis. She later developed hematochezia; colonoscopy had evidence of chronic active proctitis, and in conjunction with a mildly elevated fecal calprotectin, she was additionally diagnosed with ulcerative proctitis and started on mesalamine with resolution of symptoms. Per discussion, the case highlights a striking example of vaccine-induced autoimmunity, wherein the patient developed several new-onset autoimmune conditions, particularly gastrointestinal disorders, upon receiving mRNA-based vaccines. Given only a small subset of patients experience this phenomenon, it suggests there may exist a genetic predisposition for autoimmunity triggered by vaccination. The case underscores the need to use mRNA-based vaccines with caution in patients at high risk for autoimmunity.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of autoimmune diseases might not be fully excluded, considering the temporal relationship. However, the patient had underlying atopic dermatitis with family history/2 children positive for autoimmune disorders (Celiac disease and Graves' disease), the genetic predispositions could be major contributors towards these occurrences. 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. Linked Report(s) : US-PFIZER INC-PV202500046529 Same article, drug, and patient; different event and dose;
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| 2837873 | 52 | F | LA | 04/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0151 EW0151 EW0151 EW0151 EW0151 EW0151 EW0151 EW0151 EW0151 EW0151 |
COVID-19, SARS-CoV-2 test, Vaccination failure; Amnesia, Blood test, Body temper...
COVID-19, SARS-CoV-2 test, Vaccination failure; Amnesia, Blood test, Body temperature, Coma, Constipation; Gait inability, Hypersensitivity, Illness, Laboratory test, Lymph nodes scan normal; Rash, Restless legs syndrome, Sepsis, Uterine leiomyoma, Viral test; Vomiting, West Nile virus test; COVID-19, SARS-CoV-2 test, Vaccination failure; Amnesia, Blood test, Body temperature, Coma, Constipation; Gait inability, Hypersensitivity, Illness, Laboratory test, Lymph nodes scan normal; Rash, Restless legs syndrome, Sepsis, Uterine leiomyoma, Viral test; Vomiting, West Nile virus test
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tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months ...
tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months after second Covid injection; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955) and on 10Apr2021 as dose 2, single (Lot number: EW0151) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, latency 3 months after the suspect product(s) administration, outcome "unknown" and all described as "tested positive for Covid 3 months after second Covid injection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.
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| 2837874 | M | FL | 04/24/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Autism spectrum disorder, Fibromyalgia, Insomnia, Mental disorder, Neoplasm mali...
Autism spectrum disorder, Fibromyalgia, Insomnia, Mental disorder, Neoplasm malignant; Nerve injury
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Autism; Cancer; fibromyalgia; mental issues; insomnia; nerve damage; The initial case was missing th...
Autism; Cancer; fibromyalgia; mental issues; insomnia; nerve damage; The initial case was missing the following minimum criteria: as Unspecified product. Upon receipt of follow-up information on 18Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "Autism"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer"; FIBROMYALGIA (non-serious), outcome "unknown"; MENTAL DISORDER (non-serious), outcome "unknown", described as "mental issues"; INSOMNIA (non-serious), outcome "unknown"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage". Clinical course: Events: Autism, cancer, fibromyalgia, mental issues, insomnia and several others. Not from pharmaceuticals being blamed but mass hypnosis contracted/monitored, non-FDA electronic emission devices. Although Health Provider admitted the Hypnosis is causing damage other things like Vaccines are being blamed for. Took Covid vaccine and oh. (illegible) hypnosis is causing nerve damage/autism from frequencies being emitted from hypnosis devices. Lawyers and criminals also using these to commit & cover up crimes. Spectrum and analyzers scientifically prove this and other detection. Several corporations & even small businesses have also employed these devices not regulated by the FDA or FCC causing the harm, again scientifically verifiable with spectrum analyzers and medical studies that prove this frequencies/emission cause cancer, autism, and many other medical issues with unknown & misdiagnosed cases because it's not the. Hypnosis Devices emitting frequencies causing nerve damage / development also causing cancer, then the radiation issues. Formulation (e.g., tablet, cream, drops): Electronic devices. Reason for use: Multiple, many criminals. What was the final action taken with the product: No action yet. Your vaccine is being blamed for the criminal use and damage of hypnosis devices being used, resulting in mass medical & mental health issues. There is substantial proof & data substantiating this. You can verify yourself with spectrum analyzers and other Optical sensor detection equipment, with medical studies and data. I can also explain the mode and provide specific information. I would love to come to your facility to present all my evidence for potential litigation that's mutually beneficial and put the blame of harm on the proper cause. This hypnosis is also used by law enforcement at will on public and attorneys affecting courts and witnesses including your or your experts to sabotage corporations & win cases. It's used to commit and cover up crimes. You can verify many types for commercial purpose on (website name) patent search. It used in mass by (Name) at rallys, courts, used to steal elections and go after anyone who catches on. Its (illegible) and in mass use causing mass harm. And you (illegible) I have been being blamed for results of other action/products. I have a lot of evidence to provide to help save pharmaceuticals that help people but being blamed for damage, including autism. Hypnosis is causing such as use rates increase so do the medical issues. Prior case law, events and scientific data. Withheld government uses it in mass and criminally. I can come to your location and caution (illegible) here but is used nationally (globally). I believe I have more than sufficient evidence to prevail in court.
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| 2837875 | 45 | F | 04/24/2025 |
COVID19 FLU3 |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
LP1776 UT8485MA |
Chills, Hallucination, Headache, Tremor; Chills, Hallucination, Headache, Tremor
Chills, Hallucination, Headache, Tremor; Chills, Hallucination, Headache, Tremor
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hallucinations; reaction of chills, shakes; reaction of chills, shakes; extreme headache; Initial in...
hallucinations; reaction of chills, shakes; reaction of chills, shakes; extreme headache; Initial information received on 16-Apr-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This was a courtesy case received via Pfizer. This case involves a 45 years old female patient who experienced hallucinations, reaction of chills, shakes, reaction of chills, shakes and extreme headache after receiving Covid-19 Vaccine (Comirnaty) and Influenza usp trival a-b subvirion no preservative vaccine [Fluzone]. The patient's past medical history included Dyspepsia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Ergocalciferol (Vitamin d); Ethinylestradiol, Levonorgestrel (Simpesse); Omeprazole; Hepatitis b vaccine rHBsAg (yeast) (Heplisav b); Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap); and Typhoid vaccine (Typhoid) for Immunisation. On 08-Apr-2025, the patient received a dose 1 of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot UT8485MA via unknown route in the left arm (route, strength and expiration date: not provided) for prophylactic vaccination and received a dose 1 of suspect COVID-19 Vaccine (Comirnaty) not produced by Sanofi Pasteur lot LP1776 via unknown route in the left arm (route, strength and expiration date: not provided) for prophylactic vaccination. On 09-Apr-2025 the patient developed hallucinations (hallucination), reaction of chills, shakes (chills), (tremor) and headache (latency- 1 day). Reportedly, patient stated that she had her normal reaction of chills, shakes, etc, but after that stopped an extreme headache has settled that has lasted since 4/9. Was having mild hallucinations the first couple days, not being fully aware of where she was. Action taken- not applicable (for both suspects). The patient was treated with Butalbital, Caffeine, Paracetamol (Fioricet) for Symptomatic treatment. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness criteria- medically significant for hallucination.; Sender's Comments: Sanofi Company Comment dated 23-Apr-2025: This case involves a 45 years old female patient who experienced hallucinations, reaction of chills, shakes, reaction of chills, shakes and extreme headache after receiving Covid-19 Vaccine (Comirnaty) and Influenza usp trival a-b subvirion no preservative vaccine [Fluzone]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
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| 2837885 | 13 | F | OH | 04/24/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y005835 W007025 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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The patient did not report any adverse issues or side effects from any of the administered doses; A ...
The patient did not report any adverse issues or side effects from any of the administered doses; A patient who is currently 13 years old received their first dose on 06/19/2023 (lot: W007025 expiration: unknown) and a second dose today, 04/15/2025 (lot: Y005835 e; This spontaneous report was received from a nurse referring to a 13-year-old female patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On 19-JUN-2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) injection, for prophylaxis (dose, route of administration, strength and anatomical location were not provided; valid lot number W007025, with expiration date not provided but upon internal validations established as 04-DEC-2024). On 15-APR-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) injection as a dose of 0.5 ml, for prophylaxis (route of administration, strength and anatomical location were not provided; valid lot number Y005835, with expiration date on 06-JUN-2026). (Inappropriate schedule of product administration). There was no adverse effect reported.
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| 2837886 | 68 | M | FL | 04/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
2N795 |
Incorrect route of product administration
Incorrect route of product administration
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wrong route of administration; 68 years patient received a priorix vaccine; This non-serious case wa...
wrong route of administration; 68 years patient received a priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 68-year-old male patient who received MMR (Priorix) (batch number 2N795, expiry date 13-SEP-2026) for prophylaxis. On 17-APR-2025, the patient received Priorix (intramuscular). On 17-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: wrong route of administration) and inappropriate age at vaccine administration (Verbatim: 68 years patient received a priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration 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: 18-APR-2025 The pharmacist reported a patient received a dose of Priorix via intramuscular injection instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. The 68 year old patient received a dose of Priorix vaccine which led to inappropriate age at vaccine administration.; Sender's Comments: US-GSK-US2025047931:same reporter
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| 2837887 | 66 | F | 04/24/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
m4b34 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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received the third dose 10 days earlier than recommended/early dose; This non-serious case was repor...
received the third dose 10 days earlier than recommended/early dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 66-year-old female patient who received HAB (Twinrix) (batch number m4b34, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (Patient received second dose on 24-NOV-2024). On 15-APR-2025, the patient received the 3rd dose of Twinrix. On 15-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: received the third dose 10 days earlier than recommended/early dose). The outcome of the drug dose administration interval too short was 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: 18-APR-2025 Reporter asked how to proceed with the schedule of Twinrix when the patient received the third dose 10 days earlier than recommended. The patient received third dose of Twinrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
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| 2837889 | 04/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Abdominal pain upper; Abdominal pain, Alanine aminotransferase abnormal, Asparta...
Abdominal pain upper; Abdominal pain, Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Blood test normal, Borrelia test negative; Cholecystectomy, Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resonance imaging normal; Metabolic function test normal, Nausea, Thyroid function test normal; Abdominal pain upper; Abdominal pain, Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Blood test normal, Borrelia test negative; Cholecystectomy, Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resonance imaging normal; Metabolic function test normal, Nausea, Thyroid function test normal
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abdominal stomach pain; This is a spontaneous report received from a Nurse. An adult patient receiv...
abdominal stomach pain; This is a spontaneous report received from a Nurse. An adult patient received BNT162b2 (BNT162B2), 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "abdominal stomach pain". The event "abdominal stomach pain" required physician office visit. Additional information: The patient has been sick since the patient received shots from Pfizer, and the patient has been to 8 doctors and a surgeon and no one could figure out what was wrong with the patient, the patient had abdominal stomach pain that seemed to not be related to anything that they could find and they only thing that changed was the patient had the Pfizer vaccine (Pfizer COVID-19 Vaccine). The patient stated "for four years and I have been treated by 8 doctors." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2837890 | F | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Back pain, Nausea, Pulmonary thrombosis
Back pain, Nausea, Pulmonary thrombosis
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pulmonary thrombosis; nausea; lower back pain; This is a spontaneous report received from an Other H...
pulmonary thrombosis; nausea; lower back pain; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024SA301951 (Sanofi). A 34-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), 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: PULMONARY THROMBOSIS (hospitalization, medically significant), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain". The patient was hospitalized for pulmonary thrombosis (start date: 04Oct2024, discharge date: 06Oct2024, hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of pulmonary thrombosis, nausea. Clinical course: Patient is taking Apixaban (Eliquis) for pulmonary thrombosis; Prochlorperazine edisylate (Prochlorperazine) and Ondansetron hydrochloride (Zofran) for Nausea and not reported for rest of the events. Hospitalization for 2 days from 04Oct2024 to 06Oct2024 for pulmonary thrombosis. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pulmonary thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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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| 2837891 | 04/24/2025 |
COVID19 COVID19 COVID19 COVID19 |
JANSSEN MODERNA PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Injury; Injury; Injury; Injury
Injury; Injury; Injury; Injury
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patient experienced INJURY; This is a spontaneous report received from a Consumer or other non HCP. ...
patient experienced INJURY; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-784929 (ModernaTX, Inc.), MOD-2025-783177 (ModernaTX, Inc.). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single) intramuscular for covid-19 prophylaxis; COVID-19 vaccine nrvv ad (chadox1 ncov-19) (ASTRAZENECA COVID-19 VACCINE), as dose 1, single) for product used for unknown indication; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single) for product used for unknown indication. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INJURY (medically significant), outcome "unknown", described as "patient experienced INJURY". Therapeutic measures were not taken as a result of injury. Batch/lot number is not provided, and it cannot be obtained.
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| 2837892 | 1.42 | M | 04/24/2025 |
DTAP |
SANOFI PASTEUR |
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Urticaria
Urticaria
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Broke out in full body hives
Broke out in full body hives
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| 2837893 | 0.33 | M | NC | 04/24/2025 |
DTAPHEPBIP DTAPHEPBIP HIBV HIBV PNC20 PNC20 RV5 RV5 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
B532G B532G Y008355 Y008355 LK6653 LK6653 2091232 2091232 |
Chest X-ray normal, Influenza virus test negative, Lethargy, Pyrexia, Respirator...
Chest X-ray normal, Influenza virus test negative, Lethargy, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Tremor; Chest X-ray normal, Influenza virus test negative, Lethargy, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Tremor; Chest X-ray normal, Influenza virus test negative, Lethargy, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Tremor; Chest X-ray normal, Influenza virus test negative, Lethargy, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Tremor
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FEVER, LETHARGY, SHAKING
FEVER, LETHARGY, SHAKING
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| 2837894 | 37 | F | PA | 04/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N22 |
Incorrect route of product administration
Incorrect route of product administration
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Pt was given the vaccine IM and not SC
Pt was given the vaccine IM and not SC
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| 2837895 | 14 | F | MI | 04/24/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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no reaction. out of age recommendation
no reaction. out of age recommendation
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| 2837896 | 38 | F | MO | 04/24/2025 |
DT |
SANOFI PASTEUR |
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Injection site paraesthesia, Paraesthesia, Raynaud's phenomenon
Injection site paraesthesia, Paraesthesia, Raynaud's phenomenon
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Tingling in the arm from site to pinky, comes and goes. Also have Raynauds phenomenon in the left pi...
Tingling in the arm from site to pinky, comes and goes. Also have Raynauds phenomenon in the left pinky after administration
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| 2837897 | 51 | F | 04/24/2025 |
HEP MMR VARZOS |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
4BX39 Y008592 7ZM55 |
Hypersensitivity, Influenza like illness; Hypersensitivity, Influenza like illne...
Hypersensitivity, Influenza like illness; Hypersensitivity, Influenza like illness; Hypersensitivity, Influenza like illness
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Patient reported "allergic reaction" to vaccine administration on Monday 4/21. States star...
Patient reported "allergic reaction" to vaccine administration on Monday 4/21. States starting Monday night, discomfort in arm began. When removing band aid following shower, site of injection swollen, red, reports pain at site, reports "flu like" symptoms. Confirmed with patient and vaccine administration record, arm affected Left side, Shingrix vaccine Advised OTC pain relief, Tylenol and or Ibuprofen, advised antihistamine such as Benadryl for swelling. Cold compress to injection site on/off 15 minute intervals with paper towel between to avoid direct skin contact, avoid lotions/perfumes to site. Offered same day visit with provider for follow up d/t sx not improving in 2-3 days, scheduled for same day of reporting for evening appointment. Advised calling office back for worsening symptoms and or Urgent care. Disclosed to patient vaers report to be filed.
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| 2837898 | 14 | F | MN | 04/24/2025 |
COVID19 |
MODERNA |
3043836 |
Hypoaesthesia oral
Hypoaesthesia oral
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Received the vaccine at a visit on the morning of 4/8/25. About 8-9 hours, she developed numbness o...
Received the vaccine at a visit on the morning of 4/8/25. About 8-9 hours, she developed numbness of her lower lip. Felt "like after you go to the dentist and they give you the numbing shot in your mouth." Numbness was localized to the exterior surface of the lower lip, bilaterally from left commissure to right commissure. No other numbness elsewhere. No muscle weakness or asymmetry. No facial palsy. Otherwise felt well. Was able to talk normally, drink and eat normally. maybe some mild swelling, per parent. this sensation lasted unchanged until April 10th, evening. At this time she noticed that the lip numbness was only felt on the left side ( from left commissure to midline). otherwise felt well. No cold sores
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| 2837899 | 1.25 | M | 04/24/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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Injection site rash
Injection site rash
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Local rash at immunization.
Local rash at immunization.
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| 2837900 | 11 | M | LA | 04/24/2025 |
TDAP |
SANOFI PASTEUR |
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Erythema, Swelling
Erythema, Swelling
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2.5 X 1 CM AREA OF ERYTHEMA AND SWELLING
2.5 X 1 CM AREA OF ERYTHEMA AND SWELLING
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| 2837901 | 15 | F | VA | 04/24/2025 |
HPV9 |
MERCK & CO. INC. |
Y012921 |
Amnesia, Dizziness, Dyskinesia, Loss of consciousness, Presyncope
Amnesia, Dizziness, Dyskinesia, Loss of consciousness, Presyncope
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orders placed for patient to receive GARDASIL 9 VACCINE. Vaccine obtained and dual verified with LPN...
orders placed for patient to receive GARDASIL 9 VACCINE. Vaccine obtained and dual verified with LPN prior to administration, vaccination given per provider order. Pre-vaccination counseling provided and patient agreeable to vaccination administration. Verbal consent and confirmation obtained. Patient and father present both deny previous adverse reactions to vaccination administration and patient denies contraindications to vaccination. Vaccine provided via IM route to R deltoid w/o complication, patient tolerated well and conversational with her father and RN during administration. During post-vaccination observation patient noted to become pale and while seated began to experience a suspected vasovagal response, patient began jerking arms and legs and lost consciousness for ~3 seconds before recovering. On waking, patient reported no recollection of event. Pallor improved after event. GCS of 15, responds appropriately to all commands, pupils equal and reactive. Patient passed Neuro Exam w/o issue. PCP notified and in room to assess patient, similar findings. Patient provided with 8oz of juice and crackers and vitals rechecked. No further events. Vitals rechecked after 15 minutes and WDL. Patient reports no further feeling of lightheadedness and reports resolution of symptoms.
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| 2837902 | 0.17 | F | OK | 04/24/2025 |
DTAPIPVHIB DTAPIPVHIB DTAPIPVHIB PNC15 PNC15 PNC15 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
UK023AA UK023AA UK023AA X022479 X022479 X022479 |
Blood glucose normal, Brief resolved unexplained event, Crying, Cyanosis, Electr...
Blood glucose normal, Brief resolved unexplained event, Crying, Cyanosis, Electroencephalogram normal; Infantile apnoea, Infantile back arching, Oxygen saturation decreased, Pallor, Screaming; Staring; Blood glucose normal, Brief resolved unexplained event, Crying, Cyanosis, Electroencephalogram normal; Infantile apnoea, Infantile back arching, Oxygen saturation decreased, Pallor, Screaming; Staring
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At approximately 10:30pm on 4/16 she was being held by grandma with her owelette sock in place. Th...
At approximately 10:30pm on 4/16 she was being held by grandma with her owelette sock in place. The owelette alarmed for low oxygen. The infant became pale, then blue then let out a weak cry and stopped. She was not breathing for about 15-20 seconds then she regained color and 30 seconds later this occurred again. Mom reports this continued for 15-20 minutes. During these episodes she had a blank stare. She was taken via private vehicle to ER after EMS was called. It was determined it would be quicker to take her than to wait for EMS. When they arrived at ER she started to come out of it, but had a couple of more episodes while there. She was transferred by ambulance to Hospital. She had another couple of episodes while there. EEG was performed and it was normal. Blood glucose was reportedly normal per mom. No other labs or tests were performed. She was admitted for observation for 24 hours then released with diagnosis of Brief Resolved Unexplained Event. Mom reports earlier on the day this occurred she would scream and arch her back in an extreme way while lying on her tummy or side causing her to roll over to her back. She had not done this previously and reports she did it 13 times that day. She has not done it since.
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| 2837903 | 57 | F | OH | 04/24/2025 |
PNC21 |
MERCK & CO. INC. |
Y019152 |
Injection site erythema, Injection site warmth, Muscle twitching, Rash macular
Injection site erythema, Injection site warmth, Muscle twitching, Rash macular
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Redness and blotching down left arm. Left arm is sore. The redness and blotching are not at the inje...
Redness and blotching down left arm. Left arm is sore. The redness and blotching are not at the injection site but more distal. 4-23-25 was warm to the touch. Pt is also having muscle twitching in left arm. NP encourage the the pt to apply ice, take ibu/tylenol for pain, and take an antihistamine. Discussed red flag symptoms and when to seek further evaluation.
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| 2837904 | 19 | F | FL | 04/24/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
DA7P5 |
Injected limb mobility decreased, Injection site erythema, Injection site swelli...
Injected limb mobility decreased, Injection site erythema, Injection site swelling, Nerve compression, Skin discolouration
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Given fluvarix vaccine on 4/21/25 in right deltoid muscle. Patient called office on Tuesday 4/22/25...
Given fluvarix vaccine on 4/21/25 in right deltoid muscle. Patient called office on Tuesday 4/22/25 to note swelling at site and redness. Patient called office again on Wednesday 4/23/25 to report "being unable to move right arm, sensitivity to touch, discoloration in comparison to other arm, pain that feels like pin and needles" Patient directed to ER and did not go on 4/23/25. Patient walked into office on Thursday 4/24/25 got examined by physician and instructed to go to ER.
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| 2837905 | 1.5 | F | GA | 04/24/2025 |
HEPA |
MERCK & CO. INC. |
Y014585 |
Injection site urticaria, Urticaria
Injection site urticaria, Urticaria
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Chief Complaint In office 4/22 for 18 mo WB; Hep A vaccine given (early am). Around 1430 developed ...
Chief Complaint In office 4/22 for 18 mo WB; Hep A vaccine given (early am). Around 1430 developed hives on R outside thigh around vaccine injection site Hives progressed on torso and taken to facility. Never respiratory symptoms Dose of Benadry given and sent home temp 99-100 Discharged home with instructions for Benadryl Q 6-8 and Zyrtec once daily No further rash since last night
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| 2837906 | 62 | F | FL | 04/24/2025 |
PNC20 PNC20 TDAP TDAP |
PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Asthenia, Back pain, Eye pain, Gait inability, Neurological symptom; Pain in ext...
Asthenia, Back pain, Eye pain, Gait inability, Neurological symptom; Pain in extremity, Paraesthesia; Asthenia, Back pain, Eye pain, Gait inability, Neurological symptom; Pain in extremity, Paraesthesia
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Patient reported GBS symptoms. She said she had pain in her eyes, arms, back, legs. She had tingli...
Patient reported GBS symptoms. She said she had pain in her eyes, arms, back, legs. She had tingling and weakness. She could not walk. She went to hospital. She had to have plasma treatments to repair her nerve endings. She was in an inpatient rehab and is currently doing out patient rehab.
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✓ | ✓ | ||||
| 2837907 | 63 | M | UT | 04/24/2025 |
DTAP DTAP |
SANOFI PASTEUR SANOFI PASTEUR |
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Discomfort, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, P...
Discomfort, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Pain; Sleep disorder
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Vaccination in upper left arm. First day, some noticeable discomfort, but common to this type of vac...
Vaccination in upper left arm. First day, some noticeable discomfort, but common to this type of vaccine. second day discomfort became slightly more noticeable, and by day three it had become a deeper more intense pain. Called the physicians office on day five, as pain increased and mobility of the left arm lessened and became more pronounced. Advised to use ice, ibuprofen and acetaminophen (alternating) every 3 to 6 hours. Lateral motion of the arm very difficult and painful. Sleeping (any position) is difficult. Pain radiates upward into the neck and downward toward the elbow. some pain also in the mid to upper scapula.
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| 2837908 | 11 | F | TX | 04/24/2025 |
MENB MENB |
PFIZER\WYETH PFIZER\WYETH |
Meninggococcal Meninggococcal |
Inappropriate schedule of product administration, Malaise, Pyrexia, Tremor, Vomi...
Inappropriate schedule of product administration, Malaise, Pyrexia, Tremor, Vomiting; Wrong product administered
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Wrong Vaccine was given at age 11, when it should have been the Tdap. They gave her the Meninggoccoc...
Wrong Vaccine was given at age 11, when it should have been the Tdap. They gave her the Meninggoccocal B vaccine which is due when she is 16. She was very sick that night after the vaccine. Shaking, dizzy, fever, throwing up.
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| 2837909 | 49 | F | CA | 04/24/2025 |
HEP HEP MMR MMR TDAP TDAP VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
T5D73 T5D73 Y004114 Y004114 3RE73 3RE73 Y014181 Y014181 |
Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site pai...
Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site reaction, Injection site swelling, Pyrexia, Rash papular; Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site reaction, Injection site swelling, Pyrexia, Rash papular; Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site reaction, Injection site swelling, Pyrexia, Rash papular; Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site reaction, Injection site swelling, Pyrexia, Rash papular
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Patient began experiencing an adverse reaction the day following vaccination (04/22/2025). She prese...
Patient began experiencing an adverse reaction the day following vaccination (04/22/2025). She presented to our clinic an additional day following (04/23/2025). Patient had a swollen, red area about 4 inches in length and 2 inches in width at the site of the varicella vaccine (back of left arm). The area was red with small, raised bumps. Patient stated that the area was painful and pulsating. She stated that she experienced a fever the day following the vaccine but was unable to report her exact temperature. She also experienced fatigue, headache, and tightness in her chest. Patient has a history of asthma, but did not feel the need to use her inhaler. At the time she presented to our clinic (04/23/2025 at 4:10pm) she was still experiencing tightness in her chest, fatigue, and pain, but stated that symptoms were starting to feel better. Patient had not had the varicella vaccine before but stated she had the chickenpox as a child. At that time her vitals were as follows: Temperature 97.5F, Blood Pressure 112/81, Pulse 79 bpm, O2 sat on right arm 99%. Patient was instructed to go to urgent care and was given a note explaining what has been stated above, which vaccines she received and where they were given, and vital signs at 4:10pm that she could take to urgent care.
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| 2837910 | 31 | F | AZ | 04/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
Injected limb mobility decreased, Injection site erythema, Injection site pain, ...
Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
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Client called in stating she was experiencing soreness, redness, and swelling at the injection site ...
Client called in stating she was experiencing soreness, redness, and swelling at the injection site and found it difficult to raise her arm. Client stated the symptoms began the day after receiving her Tdap booster and have not improved. Client stated she will continue to apply ice to the injection site and has found relief with over the counter pain relievers. Client shared she will continue to monitor and seek medical attention if symptoms don't improve or worsen.
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| 2837911 | 6 | M | MO | 04/24/2025 |
DTAP DTAP HEPA HEPA MMR MMR |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
YJ7C3 Y7JC3 DN273 DN273 Y007615 |
Injection site erythema, Injection site urticaria, Injection site warmth; Inject...
Injection site erythema, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site urticaria, Injection site warmth
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Pts mother noted patient scratching at his right Deltoid on 04/23/25. Pts mother noted a large wheal...
Pts mother noted patient scratching at his right Deltoid on 04/23/25. Pts mother noted a large wheal approx 3 inches across under injection site. Initially hot to the touch ,today at office visit, redness till present but no swelling noted. MOP states it has improved. No treatment necessary
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| 2837912 | 4 | F | WA | 04/24/2025 |
MMRV |
MERCK & CO. INC. |
Y013579 |
Product storage error
Product storage error
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Invalid dose. Vaccine had 2 temp excursions.
Invalid dose. Vaccine had 2 temp excursions.
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| 2837913 | 11 | F | 04/24/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site urticaria
Injection site urticaria
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Roughly 3 days after receiving first dose of HPV and Meningicoccal vaccine given in Left deltoid, pa...
Roughly 3 days after receiving first dose of HPV and Meningicoccal vaccine given in Left deltoid, patient started developing hives on L arm surrounding injection sites that continued to spread with antihistamines
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| 2837914 | 10 | M | WA | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered
Expired product administered
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Pt given cov vaccine 7 days past BUD of vaccine. Grace period post-BUD is 2 days. Vaccine not otherw...
Pt given cov vaccine 7 days past BUD of vaccine. Grace period post-BUD is 2 days. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
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| 2837915 | 12 | F | TN | 04/24/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
u7950aa 9935h |
No adverse event; No adverse event
No adverse event; No adverse event
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none at the time of the visit
none at the time of the visit
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| 2837916 | 5 | M | WA | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered
Expired product administered
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Pt given cov vaccine 7 days past BUD of vaccine. Vaccine not otherwise expired. Vaccine info: Pfizer...
Pt given cov vaccine 7 days past BUD of vaccine. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
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| 2837917 | 17 | F | OH | 04/24/2025 |
HEP HEP HEP HEPA HEPA HEPA HPV9 HPV9 HPV9 IPV IPV IPV MENB MENB MENB MMR MMR MMR MNQ MNQ MNQ TDAP TDAP TDAP VARCEL VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
K4JH7 K4JH7 K4JH7 X2233 X2233 X2233 X024727 X024727 X024727 W1C831M W1C831M W1C831M ES49H ES49H ES49H Y015995 Y015995 Y015995 U8193AB U8193AB U8193AB U8352BA U8352BA U8352BA Y010373 Y010373 Y010373 |
Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood so...
Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting; Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count; Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea; Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting
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Vaccinations administered 04/23/2025, on the morning of 04/24/2025, the person c/o being lightheaded...
Vaccinations administered 04/23/2025, on the morning of 04/24/2025, the person c/o being lightheaded and almost vomited at school, father took daughter to the Local ER for evaluation and treatment, after treatment daughter was discharged to home. Case was diagnosed with #1 - myalgias, #2 - Nausea. While in the ER - she was given 1 liter of fluid before being discharged home
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| 2837918 | 72 | F | CT | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Unevaluable event
Unevaluable event
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Got Shingrix at pharmacy
Got Shingrix at pharmacy
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| 2837919 | 7 | M | MI | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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no sx's but Covid 12+ was given instead of 5-11 age COVID
no sx's but Covid 12+ was given instead of 5-11 age COVID
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| 2837920 | 69 | F | CA | 04/24/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LX4482 MG5S9 |
Erythema, Hypersensitivity, Incontinence, Peripheral swelling; Erythema, Hyperse...
Erythema, Hypersensitivity, Incontinence, Peripheral swelling; Erythema, Hypersensitivity, Incontinence, Peripheral swelling
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04/14/2025-"Patient called in and stated after receiving the shingles vaccine she had an allerg...
04/14/2025-"Patient called in and stated after receiving the shingles vaccine she had an allergic reaction. I asked patient if she had called us to report the allergic reaction, patient stated she did not and "would let it take it's course". Patient stated she was experiencing redness, arm swelling, caused incontinence that causes her to wake up 3-4 times a night x10 days. Patient stated she was not experiencing any symptoms today." Pt is scheduled to f/u for her reaction today at 2:15pm
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| 2837921 | 53 | F | OH | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Abdominal pain, Dizziness, Headache
Abdominal pain, Dizziness, Headache
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strong abdominal pain, headache, dizziness reported via Mychart on 4/24
strong abdominal pain, headache, dizziness reported via Mychart on 4/24
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| 2837922 | 16 | M | DE | 04/24/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LF5303 U8494AA |
Conjunctival haemorrhage, Nausea, Pyrexia, Vomiting; Conjunctival haemorrhage, N...
Conjunctival haemorrhage, Nausea, Pyrexia, Vomiting; Conjunctival haemorrhage, Nausea, Pyrexia, Vomiting
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Patient started about 14 hours after his vaccines with significant nausea and vomiting; he forcefull...
Patient started about 14 hours after his vaccines with significant nausea and vomiting; he forcefully vomited at least 6 times and had to be seen in an urgent care for SL Zofran. No LOC or other SE's. His vomiting cause bilateral subconjunctival hemorrhages. He had no other symptoms of anaphylaxis. He had no diarrhea or other symptoms of gastroenteritis. He did have a fever 101.
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| 2837923 | 12 | M | NC | 04/24/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y007991 U8193AA U7983AA |
Injection site cellulitis, Injection site nodule, Injection site pain, Injection...
Injection site cellulitis, Injection site nodule, Injection site pain, Injection site reaction, Rash papular; Injection site cellulitis, Injection site nodule, Injection site pain, Injection site reaction, Rash papular; Injection site cellulitis, Injection site nodule, Injection site pain, Injection site reaction, Rash papular
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mother states that the day after receiving vaccines, child woke up with rash, raised area, with knot...
mother states that the day after receiving vaccines, child woke up with rash, raised area, with knot on the left arm at injection site. Was taken to PCP due to area worsening and was prescribed antibiotics to rule out infection. Site was marked and mother advised to return if area worsens or spreads. Mother returned child to PCP the next day d/t area worsening. Was prescribed another antibiotic and dx with cellulitis. Mother denies child running a fever or complaining of itching. Mother states the only pain felt by child is pain/soreness at the actual injection site.
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| 2837924 | 6 | M | WA | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered
Expired product administered
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Pt given cov vaccine 8 days past BUD of vaccine. Grace period post-BUD is 2 days. Vaccine not otherw...
Pt given cov vaccine 8 days past BUD of vaccine. Grace period post-BUD is 2 days. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
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| 2837925 | 1.42 | M | VA | 04/24/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
39KS9 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient received the DTAP/HEPB/IPV Vaccine second dose too early. The dose was received at 17 m...
The patient received the DTAP/HEPB/IPV Vaccine second dose too early. The dose was received at 17 months.
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| 2837926 | 8 | F | WA | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered
Expired product administered
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Pt given cov vaccine 7 days past BUD of vaccine. Vaccine not otherwise expired. Vaccine info: Pfizer...
Pt given cov vaccine 7 days past BUD of vaccine. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
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| 2837927 | 76 | F | KS | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
52F7M |
Pain in extremity
Pain in extremity
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PATIENT HAS HAD A VERY SORE ARM SINCE THE TIME OF INJECTION. 2ND SHINGRIX VACCINE IN THE LEFT DELTO...
PATIENT HAS HAD A VERY SORE ARM SINCE THE TIME OF INJECTION. 2ND SHINGRIX VACCINE IN THE LEFT DELTOID DID NOT CAUSE ANY ISSUES. PATIENT REPORTS HAVING HAD A VACCINE PREVIOUSLY AT ANOTHER CLINIC IN THE RIGHT DELTOID THAT REQUIRED PHYSICAL THERAPY. PATIENT WAS NOT IN PT AT THE TIME OF THIS INJECTION.
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| 2837928 | 53 | F | ME | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3x97j |
Cellulitis
Cellulitis
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patient presented to pharmacy 4/23 with what looked like cellulitis confirmed by ER. Patient is cur...
patient presented to pharmacy 4/23 with what looked like cellulitis confirmed by ER. Patient is currently on antibiotics for treatment
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