| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2840608 | F | MI | 05/13/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y014307 |
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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patient did not report any adverse issues or side effect from the administered dose; temperature exc...
patient did not report any adverse issues or side effect from the administered dose; temperature excursion on 01/02/2025 with a "short-dated" expiration date of 04/02/2025.; This spontaneous report was received from a medical assistant referring an approximately 5-year-old female patient. Her medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 02-Jan-2025, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) underwent a temperature excursion of 69 degrees Fahrenheit (F) for 4 hours, 20 minutes and 0 seconds with no additional excursions. On 04-Apr-2025, the patient inadvertently received an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), injection (batch/lot number Y014307 has been verified to be a valid batch/lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported as "short-dated" expiration date of 04-Apr-2025 and 18-Feb-2026, but upon internal validation established as 18-Feb-2026) 0.5 mL (dosage regimen, anatomical location and route of administration were not reported) administered as prophylaxis (product storage error), which was diluted with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (expiration date, and lot # were not reported.) The patient did not report any adverse issues or side effect from the administered dose (no adverse event.) This was one of two reports received from the same reporter.
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| 2840609 | KS | 05/13/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y014094 Y014094 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse event; HCP called to report that an extra (second) dose of MMR II was inadvertently admin...
No adverse event; HCP called to report that an extra (second) dose of MMR II was inadvertently administered to a 15 month old patient on the same day (4/21/2025), at the same office visit within 2 minutes of the first dose. HCP stated it was not product confusion. T; This spontaneous report was received from a registered nurse and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 21-APR-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (valid lot #Y014094, expiration date reported and confirmed as 19-AUG-2026) at a dose 0.5 mL as prophylaxis, reconstituted with a sterile diluent (indication, dose, expiration date, and lot # were not reported). On the same day, after 2 minutes, an extra dose of the suspect vaccine (as described above [however it was not clear of the same lot number of Y014094 corresponded to both doses]) was inadvertently administered to the patient (accidental overdose). It was confirmed that it was not product confusion. The nurse simply picked up the wrong syringe on the tray. There were several vaccinations that were being administered to a set of twins, and the wrong one was selected from the ones that were out and prepped. No adverse effects were reported (no adverse event).
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| 2840610 | 12 | F | GA | 05/13/2025 |
HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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17-hydroxyprogesterone, Adrenal insufficiency, Adrenogenital syndrome, Amenorrho...
17-hydroxyprogesterone, Adrenal insufficiency, Adrenogenital syndrome, Amenorrhoea, Asthenia; Autoimmune thyroiditis, Blindness unilateral, Blood glucose increased, Confusional state, Fatigue; Head discomfort, Headache, Loss of personal independence in daily activities, Muscle spasms, Thirst; Type 1 diabetes mellitus, Weight decreased; 17-hydroxyprogesterone, Adrenal insufficiency, Adrenogenital syndrome, Amenorrhoea, Asthenia; Autoimmune thyroiditis, Blindness unilateral, Blood glucose increased, Confusional state, Fatigue; Head discomfort, Headache, Loss of personal independence in daily activities, Muscle spasms, Thirst; Type 1 diabetes mellitus, Weight decreased
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type 1 diabetes (blood sugar level was 534 and she was admitted to hospital, excessive weight loss a...
type 1 diabetes (blood sugar level was 534 and she was admitted to hospital, excessive weight loss and thirst, fatique); adrenal insufficiency (weight loss, spasms throughout her body; Hashimoto's thyroiditis/autoimmune injury (fatique, confusion); non-classical congenital adrenal hyperplasia (abnormal bloodwork for 17-hydroxyprogesterone); amenorrhea (headache); legally blind in one eye/blindness; fluttering feeling in brain; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt) of an unknown age. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, at the age of 12 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On an unknown date, at the age of 14, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. Vaccination date was reported as 12-DEC-2017, but it was unknown if that was the first or second dose. On an unspecified date, following second vaccination with quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt experienced excessive weight loss in a short timeframe, extreme thirst, and headaches. Her blood sugar level was 534 and she was admitted to the hospital. Pt was diagnosed with type-1 diabetes, adrenal insufficiency, nonclassical congenital adrenal hyperplasia, Hashimoto's thyroiditis, amenorrhea, and has been declared legally blind in one eye. She also experienced headaches, a fluttering feeling in her brain, confusion, fatigue, spasms throughout her body, and abnormal bloodwork for 17-hydroxyprogesterone. The pt must have taken insulin injections several times per day and currently has an insulin pump. She has been taking hydrocortisone steroids three times per day and thyroid medication daily. She also took hormones to regulate menstruation. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities. On unknown dates, based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to type-1 diabetes, adrenal insufficiency, non-classical congenital adrenal hyperplasia, Hashimoto's thyroiditis, amenorrhea, and blindness. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to type-1 diabetes, adrenal insufficiency, non-classical congenital adrenal hyperplasia, Hashimoto's thyroiditis, amenorrhea, and blindness, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The pt suffered and at the time of report continued to suffer severe and permanent physical injuries, and permanent emotional injuries, including pain and suffering. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and at the time of report continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events was considered not recovered. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All events were considered disabling. This is one of several reports received from the same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : (redacted)@merck.com , Index date : 2025-05-07 , MNSC number : , CLIC number : , ESTAR number : LEGCLAPOL , IRMS number : 68710, 68707 , Central date : 2025-05-05 , Classification : DMC, Attachment description : Legal , Safety case number :
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| 2840611 | 05/13/2025 |
HEP |
UNKNOWN MANUFACTURER |
UNK |
Ear infection, Meningitis
Ear infection, Meningitis
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found I had MENINGITIS within 2 weeks of hep B 2nd shot; ear infections; This serious case was repor...
found I had MENINGITIS within 2 weeks of hep B 2nd shot; ear infections; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, 2 weeks after receiving Hepatitis B vaccine, the patient experienced meningitis (Verbatim: found I had MENINGITIS within 2 weeks of hep B 2nd shot) (serious criteria GSK medically significant) and ear infection (Verbatim: ear infections). The outcome of the meningitis and ear infection were not reported. It was unknown if the reporter considered the meningitis and ear infection to be related to Hepatitis B vaccine. The company considered the meningitis to be unrelated to Hepatitis B vaccine. It was unknown if the company considered the ear infection to be related to Hepatitis B vaccine. Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that look at records and found had meningitis within 2 weeks of hepatitis B 2nd shot. Not to mention multiple ear infections following shots.; Sender's Comments: Meningitis is a listed event which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications, age of patient, relevant lab results, investigation details) is considered unrelated to GSK Hepatitis B vaccine.
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| 2840618 | 1.17 | F | TX | 05/13/2025 |
HIBV PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
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Abnormal behaviour, Dark circles under eyes, Tremor; Abnormal behaviour, Dark ci...
Abnormal behaviour, Dark circles under eyes, Tremor; Abnormal behaviour, Dark circles under eyes, Tremor
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Parents noted some tremors in the evening after vaccine (denies true seizure). No fever. Parents als...
Parents noted some tremors in the evening after vaccine (denies true seizure). No fever. Parents also report that patient had behavior change for 6-7 days after vaccine. Was not talking, had dark circles under eyes. Returned to baseline after ~1 week. Information about symptoms noted by parents not reported to provider until May 2025.
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| 2840619 | 34 | F | 05/13/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Blood cholesterol, Dyspnoea, Influenza, Loss of personal independence in daily a...
Blood cholesterol, Dyspnoea, Influenza, Loss of personal independence in daily activities, Pulmonary pain; Pyrexia, Ventilation/perfusion scan
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Day after for a week I had normal Flu symptoms, Fever etc. A week Later, both bottom lungs had cons...
Day after for a week I had normal Flu symptoms, Fever etc. A week Later, both bottom lungs had constant Pain, the following days after about 3-4 days after, I had problems breathing when doing any exerting activity, walking to far. A week later, it became worse that when I drove in the car if it was too warm I had to open all windows so i could try breath, Showering has become and issue, the steam aggravates the breathing too. I did go to my GP, he was not sure what was causing the issues, I however through reading about the vaccination and allergic reactions, realized I had a lot of these symptoms.
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| 2840620 | 67 | F | HI | 05/13/2025 |
PNC20 |
PFIZER\WYETH |
LX4484 |
Injection site pain, Injection site reaction, Injection site warmth, Pain in ext...
Injection site pain, Injection site reaction, Injection site warmth, Pain in extremity, Rash erythematous
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Patient received the prevnar-20 vaccine on 5/6/25 around 1:20pm. She reported feeling achiness in ...
Patient received the prevnar-20 vaccine on 5/6/25 around 1:20pm. She reported feeling achiness in the vaccinated arm around evening time. On 5/11/25, patient developed a red rash around the vaccinated area that is tender and warm to the touch. Redness was partially relieved with the use of a cold compress. Patient will continue to monitor rash.
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| 2840682 | F | LA | 05/13/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y013009 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; This spontaneous report was received from FDA and ...
INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; This spontaneous report was received from FDA and refers to an 81-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 29-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in left arm for an unknown indication. On 04-Feb-2025, the patient experienced redness (injection site erythema) and itching (injection site pruritus) at injection site. At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
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| 2840683 | AK | 05/13/2025 |
MMR |
MERCK & CO. INC. |
X011431 |
Expired product administered
Expired product administered
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HCP called stating that she gave MMR-II to a pediatric student on 4/24/2025 and the vaccine had expi...
HCP called stating that she gave MMR-II to a pediatric student on 4/24/2025 and the vaccine had expired 4/19/2025.; This spontaneous report was received from a nurse and refers to a pediatric student (child) patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, lot #X011431, with expiration date reported as and upon internal validation confirmed to be: 19-Apr-2025) (route of administration and vaccination site were not reported) administered for prophylaxis (expired product administered). The reporter was submitting a medical information request to ensure it was okay and stated "I don't have much time because I have kids coming in and out of the office. I just need to process the medical information request." and was unable to provide further information about the adverse event or patient.
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| 2840684 | HI | 05/13/2025 |
MMR |
MERCK & CO. INC. |
X026330 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms. No additional AE; HCP reported improperly stored administered MMR II; This spontaneous ...
No symptoms. No additional AE; HCP reported improperly stored administered MMR II; This spontaneous report was received from a Physician Assistant (Medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 21-APR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, 0.5 mL, administered as prophylaxis (lot number X026330 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date 07-NOV-2025; route of administration, anatomical site of injection and vaccination scheme frequency were not provided), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (expiration date, and lot number were not reported). The dose was administered after a temperature excursion (TE) at 8.5 degree Celsius (C) for 4 minutes, with no previous TE (Product storage error). No symptoms and no additional adverse events (AE) were reported for the patient.
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| 2840686 | NE | 05/13/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
X011441 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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No additional AE; Caller reported expired vaccine administered. No other information provided. No ...
No additional AE; Caller reported expired vaccine administered. No other information provided. No additional AE/PQC reported.; This spontaneous report was received from a Medical Assistant and refers to a identifiable 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 22-APR-2025, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X011441, which had expired on 19-APR-2025 (expired vaccine administered) for prophylaxis. The patient experienced No additional AE.
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| 2840687 | F | MD | 05/13/2025 |
HPV9 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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The patient received the first and second dose but never recived her 3rd dose.; No additional AE rep...
The patient received the first and second dose but never recived her 3rd dose.; No additional AE reported.; This spontaneous report has been received from an other health professional, regarding to a 27-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date in December 2017, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), then on an unspecified date in March 2018, she received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), both doses administered as prophylaxis (doses, routes of administration, anatomical sites of injection, vaccination schemes frequency, lot numbers and expiration dates were not reported). Also, it was reported that the patient never received her 3rd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Inappropriate schedule of product administration). No additional adverse events were reported in the patient.
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| 2840688 | M | 05/13/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site irritation, Injection site nodule, Injection site pain
Injection site irritation, Injection site nodule, Injection site pain
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The caller stated that yesterday in the shower, her son noticed a "nodule" on his arm. The...
The caller stated that yesterday in the shower, her son noticed a "nodule" on his arm. The nodule is on the same arm (deltoid area) where the vaccine was administered; he has pain/irritation if the nodule is pressed on; he has pain/irritation if the nodule is pressed on; This spontaneous report was received from a consumer regarding a 13-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On approximately 21-APR-2025 (also reported as about 3 weeks ago), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) administered on the deltoid area (unspecified) for prophylaxis (strength, dose, vaccination scheme, route of administration, lot number, and expiration date were not reported). On 11-MAY-2025, the patient noticed a "nodule" on his arm. The nodule was on the same arm where the vaccine was administered (Vaccination site nodule). The patient also had pain/irritation if the nodule was pressed on (Vaccination site pain, Vaccination site irritation). The outcome of the events was unknown. The reporter considered the events to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9).
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| 2840689 | 05/13/2025 |
HPVX TDAP |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
2CA82C2 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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During the call the clinic sister mentioned that she administered Tdap (Adacel - batch number 2CA82C...
During the call the clinic sister mentioned that she administered Tdap (Adacel - batch number 2CA82C2; exp date June 2026) instead of HPV vaccine (Gardasil); This spontaneous report was received from a consumer or other non-health professional, via vendor and refers to a 9-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Diphtheria vaccine toxoid;Pertussis vaccine acellular 5-component;Tetanus vaccine toxoid (ADACEL) (lot number2CA82C2, expiration date: on an unknown date in June 2026), instead of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, dose number, frequency, vaccination scheme, route of administration, anatomical location, lot number and expiration date were not reported) (Wrong product administered).
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| 2840690 | 53 | F | CT | 05/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Eye pruritus, Incomplete course of vaccination, Ophthalmic herpes zoster, Visual...
Eye pruritus, Incomplete course of vaccination, Ophthalmic herpes zoster, Visual impairment
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shingles in her eye; Blindness/ went blind in eye/woke up to shadows, like a curtain over her eye; e...
shingles in her eye; Blindness/ went blind in eye/woke up to shadows, like a curtain over her eye; eye is itchy; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 09-NOV-2023, the patient received the 1st dose of Shingrix (left arm). In NOV-2023, less than a month after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: shingles in her eye) (serious criteria GSK medically significant) and blindness (Verbatim: Blindness/ went blind in eye/woke up to shadows, like a curtain over her eye) (serious criteria GSK medically significant). On an unknown date, the patient experienced eye pruritus (Verbatim: eye is itchy). The patient was treated with valaciclovir (Valacyclovir). In NOV-2023, the outcome of the ophthalmic herpes zoster and blindness were resolved. The outcome of the eye pruritus was not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, blindness and eye pruritus to be related to Shingrix. The company considered the ophthalmic herpes zoster, blindness and eye pruritus to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-MAY-2025 and 06-MAY-2025 The reporter reported that she woke up to shadows, like a curtain over her eye, blind in her eye (unknown eye) around 18-November-2023. The patient reported that she had shingles in her eye (unknown eye). The patient reported that blindness lasted for a good week (no specific date provided). The patient did see an Ophthalmologist, and received prescriptions from her pharmacy on 19-November-2023 for several eye drops (unknown products information), and Valacyclovir 500mg, 1 Tablet three times a day (might be) for 10 days, quantity 30. The patient also reported that she never received the second dose of Shingrix because what she experienced after the first dose was scary. The patient also reports that her eye was itchy at the time of reporting, and she thought she had shingles in her eye again. The patient reported received vaccination for shingles. The patient went blind in eye now the repercussions were could get shingles at any time for the rest of life. The patient was 53 and company does not even take responsibility for that and why did not even pay the eye doctor bills that's ridiculous.; Sender's Comments: Ophthalmic herpes zoster, Blindness and Eye pruritus are unlisted events which are considered unrelated to GSK vaccine Shingrix.
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| 2840691 | 66 | F | LA | 05/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Condition aggravated, Discomfort, Fungal infection, Lichen sclerosus
Condition aggravated, Discomfort, Fungal infection, Lichen sclerosus
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Lichen Sclerosus Flare; Lichen Sclerosus Flare; Yeast infection; Uncomfortable; This non-serious cas...
Lichen Sclerosus Flare; Lichen Sclerosus Flare; Yeast infection; Uncomfortable; This non-serious case was reported by a consumer via call center representative and described the occurrence of lichen sclerosus in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included lichen sclerosus (patient was diagnosed with Lichen Sclerosus in her genital area a year ago). On 11-NOV-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced lichen sclerosus (Verbatim: Lichen Sclerosus Flare), condition aggravated (Verbatim: Lichen Sclerosus Flare), yeast infection (Verbatim: Yeast infection) and discomfort (Verbatim: Uncomfortable). The outcome of the lichen sclerosus, condition aggravated and discomfort were not resolved and the outcome of the yeast infection was resolved. The reporter considered the lichen sclerosus and condition aggravated to be possibly related to Shingrix. It was unknown if the reporter considered the yeast infection and discomfort to be related to Shingrix. The company considered the lichen sclerosus and condition aggravated to be possibly related to Shingrix. It was unknown if the company considered the yeast infection and discomfort to be related to Shingrix. Additional Information: GSK receipt date: 06-MAY-2025 The reporter was female patient that was diagnosed with Lichen Sclerosus in her genital area a year ago, pre-existing receiving the first dose of Shingrix. The patient reported that after she received the first dose of Shingrix (no specific date provided), she had a flare of her Lichen Sclerosus, and this flare had been going on for a couple of months now (no specific dates provided). The patient reported that the flare was very uncomfortable. The patient reported that after the flare of her Lichen Sclerosus occurred, she also experienced a yeast infection (no specific date provided, which had cleared up at the time of reporting. The patient reported that she used Clobetasol Ointment 0.01% topically twice a day on the rash in the area of the flare on her genitals. The patient reported that her physician told her that the Lichen Sclerosus flare could be related to receiving the first dose of Shingrix. The patient did not had a Lot/Expiry/NDC/or route of administration for the Shingrix first dose.
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| 2840692 | 51 | M | MI | 05/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
33473 |
Vitreous floaters
Vitreous floaters
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floaters in his left eye; This non-serious case was reported by a nurse via call center representati...
floaters in his left eye; This non-serious case was reported by a nurse via call center representative and described the occurrence of eye floaters in a male patient who received Herpes zoster (Shingrix) (batch number 33473, expiry date 29-OCT-2026) for prophylaxis. On 18-APR-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced eye floaters (Verbatim: floaters in his left eye). The outcome of the eye floaters was unknown. It was unknown if the reporter considered the eye floaters to be related to Shingrix. It was unknown if the company considered the eye floaters to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 The reporter had been the healthcare professional (nurse) who had stated that a patient had experienced floaters in his left eye after receiving his first dose of Shingrix.
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| 2840693 | 59 | F | OH | 05/13/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Pain in extremity, Ultrasound scan, X-ray
Pain in extremity, Ultrasound scan, X-ray
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Received flu vaccine and within 2-3 days had intense arm pain on side of vaccine.
Received flu vaccine and within 2-3 days had intense arm pain on side of vaccine.
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| 2840694 | 67 | F | NJ | 05/13/2025 |
PNC21 |
MERCK & CO. INC. |
y019157 |
Injection site rash, Injection site swelling
Injection site rash, Injection site swelling
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patient said she had rash and swelling around injection site. it was still there after a week
patient said she had rash and swelling around injection site. it was still there after a week
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| 2840695 | 59 | F | VT | 05/13/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945660 |
Injection site pain, Nausea
Injection site pain, Nausea
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Patient reported nausea for 24 hours following immunization, soreness at injection site.
Patient reported nausea for 24 hours following immunization, soreness at injection site.
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| 2840696 | 4 | F | WA | 05/13/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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Allergy test positive, Food allergy, Hypersensitivity, Lip swelling, Swelling of...
Allergy test positive, Food allergy, Hypersensitivity, Lip swelling, Swelling of eyelid; Urticaria
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Mild reaction to first dose of vaccine- mild rash. Second dose woke up with eyes swollen almost una...
Mild reaction to first dose of vaccine- mild rash. Second dose woke up with eyes swollen almost unable to open and lips swollen with massive hives all over body- back, belly, face etc, proceeded to then continue with allergic reactions for months until we had extensive allergy testing and discovered her new allergies to soybeans and peas and wheat! She also became sensitive to things in general including food dyes. Her vaccines were delayed on a modified schedule due to her mothers similar reaction to mmr vaccine as a child and again in nursing school.
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| 2840697 | 33 | M | PA | 05/13/2025 |
VARCEL |
MERCK & CO. INC. |
Y020586 |
Erythema, Swelling
Erythema, Swelling
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woke up the next day with the area red and swollen.
woke up the next day with the area red and swollen.
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| 2840698 | 27 | F | FL | 05/13/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
051E21A 051E21A |
Blood test, Brain fog, Dyspnoea, Exercise tolerance decreased, Inappropriate sin...
Blood test, Brain fog, Dyspnoea, Exercise tolerance decreased, Inappropriate sinus tachycardia; Palpitations, SARS-CoV-2 antibody test
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Inappropriate sinus tachycardia upon standing, palpitations, brain fog, exercise intolerance, shortn...
Inappropriate sinus tachycardia upon standing, palpitations, brain fog, exercise intolerance, shortness of breath
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| 2840699 | 61 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
No adverse event
No adverse event
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The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840700 | 5 | F | PA | 05/13/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Z003311 Z003311 |
Papule, Pyrexia, Rash, Rash papular, Rash pruritic; Scab, Skin lesion, Varicella...
Papule, Pyrexia, Rash, Rash papular, Rash pruritic; Scab, Skin lesion, Varicella virus test
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Patient developed post vaccination fever day after vaccination along with a pruritic erythematous pa...
Patient developed post vaccination fever day after vaccination along with a pruritic erythematous papular rash on side of face, rash subsequently spread to other parts of face, arms and trunk and continued to have low grade fever. No other viral like symptoms developed. On exam noted to have 20-30 erythematous papules and 2 crusted over lesions.
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| 2840701 | 47 | M | IN | 05/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac disorder, Condition aggravated, Diabetes mellitus, Hypoaesthesia, Moveme...
Cardiac disorder, Condition aggravated, Diabetes mellitus, Hypoaesthesia, Movement disorder
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After i got the first one i went and sat for 15 mins and everything was fine and then same for the s...
After i got the first one i went and sat for 15 mins and everything was fine and then same for the second one. After the second one i started having issues with my heart and it got worse and worse and i had trouble moving and lose feeling in my arm and it cause a TIA. but that cant be proved. I was in and out of the hospital a number of times over the heart issues and my diabetes. I was even transferred over to (redacted) because it was too packed at the hospital and after a while i finally got with the doctor i am with now and i started to get better and got me on medication that help improved everything and i am hoping that i will get to the point where i don't need to take the medication any more.
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| 2840702 | 38 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
No adverse event
No adverse event
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The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
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| 2840703 | 41 | M | AZ | 05/13/2025 |
SMALL VARZOS |
EMERGENT BIOSOLUTIONS GLAXOSMITHKLINE BIOLOGICALS |
FDP00015 LL5C2 |
No adverse event; No adverse event
No adverse event; No adverse event
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The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840704 | 0.5 | M | OK | 05/13/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7374BA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient accidentally given a dose that had expired on 5/6/25. No adverse reaction reported after dos...
Patient accidentally given a dose that had expired on 5/6/25. No adverse reaction reported after dose.
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| 2840705 | 41 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00017 |
No adverse event
No adverse event
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The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs or reactions reported.
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| 2840706 | 39 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00015 |
No adverse event
No adverse event
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The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
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| 2840707 | 74 | F | TN | 05/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Abdominal discomfort, Headache, Nausea, Pyrexia
Abdominal discomfort, Headache, Nausea, Pyrexia
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Nausea; Head aching; temperature; felt like a rock in her stomacht; This non-serious case was report...
Nausea; Head aching; temperature; felt like a rock in her stomacht; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 06-MAY-2025, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Head aching), fever (Verbatim: temperature) and stomach feeling heavy (Verbatim: felt like a rock in her stomacht). The outcome of the nausea, headache and fever were not resolved and the outcome of the stomach feeling heavy was unknown. It was unknown if the reporter considered the nausea, headache, fever and stomach feeling heavy to be related to Shingrix. It was unknown if the company considered the nausea, headache, fever and stomach feeling heavy to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 and 07-MAY-2025 The consumer was the primary reporter. The reporter stated that she received her second dose of Shingrix on in her left arm. The reporter stated that the next morning she felt like a rock was in her stomach, nausea, head aching, and a temperature of 98.9 degree Fahrenheit and her temperature usually runs around 97.6 degree Fahrenheit. On 7 May 2025, The reporter stated that she does not have the power even to say whether aspirin Tylenol or ibuprofen are contraindicated when somebody was having a headache or something like that from the shot The reporter stated it would be awfully nice if patient had at least that much authority.
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| 2840708 | 41 | F | TX | 05/13/2025 |
VARCEL |
MERCK & CO. INC. |
X006980 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse reaction the vaccine was out of date when given. Patient was called and had no reactions...
No adverse reaction the vaccine was out of date when given. Patient was called and had no reactions. We have informed her to return 28 days after the 7th of May for repeat dose.
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| 2840709 | 43 | F | VA | 05/13/2025 |
COVID19 |
NOVAVAX |
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Unevaluable event
Unevaluable event
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Three variances of COVID Booster with production left to one of two Manufactures.
Three variances of COVID Booster with production left to one of two Manufactures.
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| 2840710 | 4 | F | KS | 05/13/2025 |
MMR MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Bacterial disease carrier, Blood brain barrier defect, Blood test, Dental operat...
Bacterial disease carrier, Blood brain barrier defect, Blood test, Dental operation, Depressed mood; Paediatric acute-onset neuropsychiatric syndrome, Pharyngitis streptococcal, Streptococcus test positive, Tonsillectomy, Tooth disorder; X-ray
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pts mothers states a few weeks after getting the vaccine, the pt had to go get some major dental wor...
pts mothers states a few weeks after getting the vaccine, the pt had to go get some major dental work done with Dr.. When she woke up from the anesthesia, the parents say she was a different child. She was melancholy and was never like this before. Her body was trying to fight off the immunization and the anesthesia from the dental work. Within a couple of weeks she developed strep throat. She had her tonsils taken out when she was 7 because her throat never went back to normal from strep. She was given penicillin shots. The anesthesiologist explained to the mother that she had pandas. This is when the strep in the body is displaced and it keeps your body from fighting it off the way that it should. It was the strep crossing the blood brain barrier. Something is keeping her body from being able to fight off infection. It was explained to her that her body wasn't able to fight off the immunization, and then the dental work and strep. It sent her body into hyper overdrive trying to fight off the immunization. She continues to have this melancholy behavior. She now has extensive dental issues and is a carrier of strep. She struggles daily and was not like this before getting her MMR vaccine at the age of 4.
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| 2840711 | 25 | F | NC | 05/13/2025 |
HPV9 |
MERCK & CO. INC. |
2002580 |
Depressed level of consciousness, Visual impairment
Depressed level of consciousness, Visual impairment
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Pt began to pass out but never lost full consciousness. She was seeing black dots. We had her lie on...
Pt began to pass out but never lost full consciousness. She was seeing black dots. We had her lie on the ground and she began to feel better. Full recovery around 45 minutes later.
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| 2840712 | 57 | F | NH | 05/13/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
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Patient received vaccine on 5/6/25, started to develop warmth and redness in the right deltoid on 5/...
Patient received vaccine on 5/6/25, started to develop warmth and redness in the right deltoid on 5/8/25. Patient tried using cool compresses at home. After 6 days and the redness is worsening, patient called this PCP office. An appointment was scheduled.
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| 2840713 | 45 | F | IA | 05/13/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Arthralgia, Cognitive disorder, Communication disorder, Fatigue, Impaired work a...
Arthralgia, Cognitive disorder, Communication disorder, Fatigue, Impaired work ability; Judgement impaired, Myalgia, Thinking abnormal
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Fatigue, cognitive impairment affecting judgment, thought processes and communication skills, pain i...
Fatigue, cognitive impairment affecting judgment, thought processes and communication skills, pain in muscles and joints throughout the body not explained by degenerative disc disease and a decreased ability to work--exhausted FMLA benefits and am now on short term disability due to the effects of the vaccines by Moderna. First dose was administered on or about 2/1/2021. I have used Ivermectin intermittently to help temper symptoms but it is not a long-term solution as it cannot be taken daily without significant risk of liver damage.
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| 2840714 | 77 | M | IL | 05/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
mg5s9 |
Needle issue
Needle issue
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I had an incident yesterday when giving a shingrix injection. I reconstituted the vaccine normally. ...
I had an incident yesterday when giving a shingrix injection. I reconstituted the vaccine normally. But when I went to inject the patient, once I inserted the needle I could not push the syringe to inject the immunization. There was pressure and I couldn?t get the syringe/medicine out. So I took the needle out and reinserted and had the same issue. I then told the patient I had an issue with the needle so I switched out the needle and that worked. The new needle/ third try went smoothly.
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| 2840715 | 1.25 | M | KS | 05/13/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
DN273 |
Rash, Rash maculo-papular
Rash, Rash maculo-papular
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2 days following administration of Havrix Ped/Adol to LVL, pt broke out in full body macular-papular...
2 days following administration of Havrix Ped/Adol to LVL, pt broke out in full body macular-papular rash to head and face, torso, trunk, all 4 extremities.
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| 2840716 | 44 | F | MI | 05/13/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
47XP4 |
Underdose
Underdose
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Patient received pediatric dose instead of adult dose of the hep b vaccine
Patient received pediatric dose instead of adult dose of the hep b vaccine
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| 2840717 | 35 | F | CA | 05/13/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Discomfort, Injected limb mobility decreased, Injection site pain, Product admin...
Discomfort, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Sleep disorder
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Injection site high up on left arm near edge of shoulder area. Pain scale 8 out of 10 for 6 days (st...
Injection site high up on left arm near edge of shoulder area. Pain scale 8 out of 10 for 6 days (started 1 day post vaccine). Area is tender and pain inhibits range of motion. Cannot sleep and discomfort continues even at rest.
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| 2840718 | 38 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP000016 |
No adverse event
No adverse event
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The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
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| 2840719 | 9 | F | TX | 05/13/2025 |
HPV9 |
MERCK & CO. INC. |
Y012865 |
Abdominal pain upper, Dizziness
Abdominal pain upper, Dizziness
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Felt dizzy and had stomachache the evening of vaccine administration and next morning, motrin helped...
Felt dizzy and had stomachache the evening of vaccine administration and next morning, motrin helped, felt better by time of doctor's visit
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| 2840720 | 47 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00016 |
No adverse event
No adverse event
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The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840721 | 05/13/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Muscle disorder
Muscle disorder
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muscle in right leg has never been the same/it affected the muscle in right leg; This non-serious ca...
muscle in right leg has never been the same/it affected the muscle in right leg; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle disorder in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In JUL-2024, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced muscle disorder (Verbatim: muscle in right leg has never been the same/it affected the muscle in right leg). The outcome of the muscle disorder was not resolved. It was unknown if the reporter considered the muscle disorder to be related to RSV vaccine. It was unknown if the company considered the muscle disorder to be related to RSV vaccine. Additional Information: GSK receipt date: 03-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that they got this vaccine last July and the muscle in right leg had never been the same. Patient indicated that they would never do it again. Also stated that they got vaccine and it affected the muscle in right leg.
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| 2840722 | 9 | F | TX | 05/13/2025 |
HPV9 |
MERCK & CO. INC. |
1965079 |
Axillary pain, Pain, Pain in extremity, Tremor, Ultrasound scan abnormal
Axillary pain, Pain, Pain in extremity, Tremor, Ultrasound scan abnormal
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R arm/axilla pain daily since administration, > 1 year. Awakens from sleep sometimes. Mother will...
R arm/axilla pain daily since administration, > 1 year. Awakens from sleep sometimes. Mother will massage. Seen for symptoms 12/7/2024, ibuprofen recommended. Presented again 4/22/2025. Reports pain in R arm/armpit, especially when raises arm. Also R hand will shake when tries to hold something.
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| 2840723 | 47 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
9686 |
No adverse event
No adverse event
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The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840724 | 35 | F | VA | 05/13/2025 |
HPV9 |
MERCK & CO. INC. |
Y014510 |
Injectable contraception, No adverse event, Pregnancy test urine negative, Wrong...
Injectable contraception, No adverse event, Pregnancy test urine negative, Wrong product administered
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pt came into the office to get her 2nd Gardasil vaccine as scheduled. Pt was given wrong injection. ...
pt came into the office to get her 2nd Gardasil vaccine as scheduled. Pt was given wrong injection. She was given Depo Provera (birth control) Pt did also still receive the Gardasil vaccine with no issues.
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| 2840725 | 62 | F | WA | 05/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Computerised tomogram, Magnetic resonance imaging, Transient global amnesia
Computerised tomogram, Magnetic resonance imaging, Transient global amnesia
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First TGA 8 days after second injection. I?ve had 3 more since then.
First TGA 8 days after second injection. I?ve had 3 more since then.
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