| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843633 | 1 | F | NY | 06/03/2025 |
HEPA MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y013274 Y018703 Z002625 |
Infant irritability, Pyrexia, Rash; Infant irritability, Pyrexia, Rash; Infant i...
Infant irritability, Pyrexia, Rash; Infant irritability, Pyrexia, Rash; Infant irritability, Pyrexia, Rash
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Subjective fever, fussiness & generalized rash starting 5/29/25
Subjective fever, fussiness & generalized rash starting 5/29/25
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โ | |||||
| 2843634 | 4 | M | IN | 06/03/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
Y49B2 R027447 Y014868 |
Crying, Rash, Rash erythematous; Crying, Rash, Rash erythematous; Crying, Rash, ...
Crying, Rash, Rash erythematous; Crying, Rash, Rash erythematous; Crying, Rash, Rash erythematous
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Patient was receiving his 4-year vaccines that included Kinrix (Dtap+IPV). I administered that vacci...
Patient was receiving his 4-year vaccines that included Kinrix (Dtap+IPV). I administered that vaccine in his left deltoid, then moved on and gave another 2 vaccines in his right deltoid area, 11:50am. He was crying and hugging his mom. I left the room, came over to my desk, set my vaccines down, and went and picked him some stickers out. When I returned, patient was a rash coming from under his left Band-Aid and long his left side, 11:52am. I went out and got my provider. I informed her I believed he was having a reaction to the Kinrix vaccine. She immediately came in and did an evaluation, and gave me a verbal order for diphenhydramine 5ml and 6ml of Prednisolone. I administered those medications and gave patient some water and a toy to play with while we waited 30 minutes for observation. I checked on him a few times over the 30 minutes and noted the redness was clearing up. At the 25-minute mark, I went in and rechecked his BP and Heart rate. Gave provider the notice to clear patient so he may leave.
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| 2843635 | 50 | F | 06/03/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
lg55nn 47n3y / 92nn2 |
Injection site erythema, Injection site pruritus; Injection site erythema, Injec...
Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus
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Pt called and said they were experiencing redness at injection site and itching. Patient did state t...
Pt called and said they were experiencing redness at injection site and itching. Patient did state they took Tylenol & Ibuprofen for pain. Patient did say they would go to doctor's office for evaluation.
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| 2843682 | 10 | F | NJ | 06/03/2025 |
FLU3 IPV UNK |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR UNKNOWN MANUFACTURER |
4LM54 XC891H X022411 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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No adverse event; Improper storage of product in use; This spontaneous report was received from a nu...
No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner and refers to a 8-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. Historical vaccines included Havrix (Hepatitis a vaccine inact), Fluzone (Fluconazole), and Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (vaccinated at 02-FEB-2025). On 12-Mar-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X022411, expiration date: 05-Jun-2025), administered by Intramuscular route, reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported); the first dose of Flulaval (Influenza vaccine inact split 3v) (lot #4LM54, expiration date: 30-Jun-2025) (1 dose), administered by Intramuscular route; Ipol (Polio vaccine inact 3v (Vero)) (lot #XC891H, expiration date: 31-Oct-2024) (1IPOL- B POV), administered by Intramuscular route. All for prophylaxis. On 09-Apr-2025, at compliance visit, upon review by state, temperature excursion was noted from 03-Mar-2025 to 10-Mar-2025 (product storage error). Upon further investigation and review by the DDL manufacturer, it was noted as a "glitch" "most likely caused by an electronical interference". The VFC program advised revaccination and that process was currently in progress with the patients involved. No adverse event was reported. This is one of several cases from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (redacted)@merck.com , Index date : 2025-05-14 , MNSC number : 02785949 , CLIC number : , ESTAR number : , IRMS number : Patient, Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2843683 | 11 | F | 06/03/2025 |
HPV9 |
MERCK & CO. INC. |
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Syncope
Syncope
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syncope; This spontaneous report was received from a Nurse via company employee and refers to a(n) 1...
syncope; This spontaneous report was received from a Nurse via company employee and refers to a(n) 11-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 23-May-2025, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), administered for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On 23-May-2025 (also reported as after her first dose of the GARDASIL 9 vaccine), the patient experienced syncope. At the reporting time, the outcome of syncope was unknown. The action taken with suspect vaccine was not applicable. The causal relationship between the event of syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) was unknown/not reported/not provided. Upon internal review, the event of syncope was determined to be medically significant. Additional information were not expected.
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| 2843684 | TX | 06/03/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
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Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Caller stated patient has not reported any symptoms.; HCP calling to report a patient inadvertently ...
Caller stated patient has not reported any symptoms.; HCP calling to report a patient inadvertently received and PROQUAD vaccine instead of MMRII and VARIVAX.; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 02-JUN-2025, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) and reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported), instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (Wrong product administered). The patient had not reported any symptoms after the administration.
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| 2843685 | M | 06/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Bone marrow transplant
Bone marrow transplant
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Bone marrow transplant; This serious case was reported by a pharmacist via patient support programs ...
Bone marrow transplant; This serious case was reported by a pharmacist via patient support programs and described the occurrence of bone marrow transplant in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced bone marrow transplant (Verbatim: Bone marrow transplant) (serious criteria clinically significant/intervention required). The outcome of the bone marrow transplant was unknown. It was unknown if the reporter considered the bone marrow transplant to be related to Arexvy. The company considered the bone marrow transplant to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 17-APR-2025 The patient received Arexvy vaccine previously, but recently had a bone marrow transplant. Their doctor recommended to repeat vaccines. The patient tried to check to readminister Arexvy per doctor order but came back denied. The reporter asked about a prior authorization for this situation and would like a call back for assistance. The Quality Auditor located the note in this case from the email and advised that this was an adverse event that needs to be reported.; Sender's Comments: Bone marrow transplant is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
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| 2843686 | F | AZ | 06/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
k2bb7 |
Injection site induration, Injection site mass, Product administered at inapprop...
Injection site induration, Injection site mass, Product administered at inappropriate site, Tendonitis
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spot in arm which was visibly lumpy and harder; spot in arm which was visibly lumpy and harder; susp...
spot in arm which was visibly lumpy and harder; spot in arm which was visibly lumpy and harder; suspected tendinitis; The pharmacist thought that the vaccine was administered lower than it should have been; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) (batch number k2bb7, expiry date 30-JAN-2027) for prophylaxis. In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site lump (Verbatim: spot in arm which was visibly lumpy and harder), injection site induration (Verbatim: spot in arm which was visibly lumpy and harder), tendonitis (Verbatim: suspected tendinitis) and vaccine administered at inappropriate site (Verbatim: The pharmacist thought that the vaccine was administered lower than it should have been). The outcome of the injection site lump and tendonitis were unknown and the outcome of the injection site induration was not reported and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the injection site lump, injection site induration and tendonitis to be related to Shingrix. It was unknown if the company considered the injection site lump, injection site induration and tendonitis to be related to Shingrix. Additional Information: GSK receipt date: 27-MAY-2025 The pharmacist stated that a patient received her first dose of Shingrix in February 2025. After her dose, she developed a spot in her arm which was visibly lumpy and harder than normal. The pharmacist thought that the vaccine was administered lower than it should have been which led to vaccine administered at inappropriate site. It may be tendinitis.
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| 2843688 | 06/03/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Fatigue, Headache, Herpes zoster, Vaccination failure; Fatigue, Headache, Herpes...
Fatigue, Headache, Herpes zoster, Vaccination failure; Fatigue, Headache, Herpes zoster, Vaccination failure
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Suspected vaccination failure; outbreak of shingles; This serious case was reported by a consumer vi...
Suspected vaccination failure; outbreak of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received single vaccine 20 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: outbreak of shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had been fortunate not to ever get a severe case of shingles, but the reporter chronically get shingles. The patient had an ongoing prescription for Valtrex and begin taking them at first sign. The patient guessed that in the past 3 years the patient had gotten the at least 20 times. The reporter has had the single vaccine about 20 years ago, and also the double vaccine a few years ago. Usually before an outbreak, the reporter felt run down, headache for a few days. Then surprise, the patient got another breakout. The reporter was on a trial to take a Valtrex every day and see if that helps. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
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| 2843689 | 06/03/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Arthralgia, Herpes zoster, Injection site pain, Injection site swelling, Pyrexia...
Arthralgia, Herpes zoster, Injection site pain, Injection site swelling, Pyrexia; Rash
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the site is raised red and hurts a lot; the site is raised red and hurts a lot; I feel feverish; joi...
the site is raised red and hurts a lot; the site is raised red and hurts a lot; I feel feverish; joint soreness / my ankle on the side I had shingles rash really really hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Had shingles over 2 years ago). In MAY-2025, the patient received the 1st dose of Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced fever (Verbatim: I feel feverish), injection site erythema (Verbatim: the site is raised red and hurts a lot), injection site pain (Verbatim: the site is raised red and hurts a lot) and soreness of joint (Verbatim: joint soreness / my ankle on the side I had shingles rash really really hurts). The outcome of the fever, injection site erythema, injection site pain and soreness of joint were not resolved. It was unknown if the reporter considered the fever, injection site erythema, injection site pain and soreness of joint to be related to Shingles vaccine. It was unknown if the company considered the fever, injection site erythema, injection site pain and soreness of joint to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine less than 24 hours ago. The first one. The patient have had shingles over 2 years ago. Today the site was raised red and hurts a lot & feel feverish. Now the patient's ankle on the side he/she had shingles rash really really hurted. The reporter wanted to know if this was common that the joint soreness a side effect of shingles vaccine.
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| 2843690 | 06/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Chills, Ear pain, Headache, Lacrimation increased, Pain; Paranasal sinus discomf...
Chills, Ear pain, Headache, Lacrimation increased, Pain; Paranasal sinus discomfort, Sinusitis
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headache; sinus pressure; watery eyes; bodyaches; ears pain; chills; sinus infection; This non-serio...
headache; sinus pressure; watery eyes; bodyaches; ears pain; chills; sinus infection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis. In MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, less than a week after receiving Shingrix, the patient experienced headache (Verbatim: headache), sinus pressure (Verbatim: sinus pressure), watering eyes (Verbatim: watery eyes), general body pain (Verbatim: bodyaches), ear pain (Verbatim: ears pain), chills (Verbatim: chills) and sinus infection (Verbatim: sinus infection). The outcome of the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection were not resolved. It was unknown if the reporter considered the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection to be related to Shingrix. It was unknown if the company considered the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection to be related to Shingrix. Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The reporter stated that he/she had first dose of Shingrix vaccine two days ago and experienced side effects headache, sinus pressure, watery eyes, body aches, chills, no fever, headache and ears pain. The patient stated he/she do not know if it is sinus infection or injection side effect its been 2 days since received first dose The patient enquired how long do side effect last
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| 2843691 | 06/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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Knocked me on my butt; This non-serious case was reported by a consumer via interactive digital medi...
Knocked me on my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (patient received 1st dose on unknown date). On 01-JUN-2025, the patient received the 2nd dose of Shingles vaccine. In JUN-2025, less than a day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Knocked me on my butt). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 02-JUN-2025 This case was reported by a patient via interactive digital media. Patient stated that just got second shot a day before reporting, patient stated that it knocked on butt. 1st one didn't. Glad it was only once.
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| 2843692 | 06/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I have the shingles in my ride side of my head; This serious case was...
Suspected vaccination failure; I have the shingles in my ride side of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have the shingles in my ride side of my head). The patient was treated with valacyclovir. The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the Shingles shot but just found out he/she had the shingles in his/her ride side of head so patient guessed that the shot did not work, the physician put him/her on valacyclovir for 7 days. The reporter was hoping since he/she had the shot, he/she would have a mild case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2843693 | 0.42 | M | PA | 06/03/2025 |
DTAP |
SANOFI PASTEUR |
3ca20c1 |
Injection site urticaria, Urticaria
Injection site urticaria, Urticaria
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Hives on abdomen and hives at vaccine site
Hives on abdomen and hives at vaccine site
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| 2843694 | 1.83 | M | PR | 06/03/2025 |
DTAP DTAP HEPA HEPA HIBV HIBV PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH |
Y97N7 Y97N7 DN273 DN273 UK2001AC UK2001AC 4G5574 4G5574 |
Erythema, Injection site pain, Laboratory test, Lip swelling, Pyrexia; Skin warm...
Erythema, Injection site pain, Laboratory test, Lip swelling, Pyrexia; Skin warm, Urticaria; Erythema, Injection site pain, Laboratory test, Lip swelling, Pyrexia; Skin warm, Urticaria; Erythema, Injection site pain, Laboratory test, Lip swelling, Pyrexia; Skin warm, Urticaria; Erythema, Injection site pain, Laboratory test, Lip swelling, Pyrexia; Skin warm, Urticaria
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Mother refers that the baby has hives on the face, high fever, swollen lips and one side of the face...
Mother refers that the baby has hives on the face, high fever, swollen lips and one side of the face is red and hot to the touch. A lot of pain at the site of administration.
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| 2843695 | 57 | F | NC | 06/03/2025 |
PNC20 |
PFIZER\WYETH |
LN4929 |
Anaphylactic reaction, Swelling face, Throat tightness, Urticaria
Anaphylactic reaction, Swelling face, Throat tightness, Urticaria
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INCIDENT 1- 5/28: Full- blown hives on entire body, throat closing up - anaphylaxis -- Went to ER &a...
INCIDENT 1- 5/28: Full- blown hives on entire body, throat closing up - anaphylaxis -- Went to ER & received EPI-Pen and IV with Benadryl, steroid, Pepcid and etc. Held for observation. INCIDENT 2 - 5/31: Hives on entire body, throat closing up, face swollen, and lips extremely swollen - anaphylaxis. Gave myself Epi-Pen and went to ER. Had same treatment as Incident 1.
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| 2843696 | 33 | M | ID | 06/03/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y014181-P Y014181-P |
Depressed mood, Feeling hot, Injection site erythema, Injection site pruritus, I...
Depressed mood, Feeling hot, Injection site erythema, Injection site pruritus, Injection site warmth; Malaise
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Varicella- states he felt warm (low grade fever) did not measure temperature because he did not have...
Varicella- states he felt warm (low grade fever) did not measure temperature because he did not have a thermometer. Site was warm, itchy, red, states it felt like he was very sick. No nausea/vomiting. States he felt so down he almost called out x 2 d/t this. Symptoms lasted x 7 days
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| 2843697 | 06/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Illness
Illness
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sick; This non-serious case was reported by a consumer via interactive digital media and described t...
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that the first one made them so sick that they asked their doctor if they had to take the second because they had shingles previously and reaction to the shot was worse than the Shingles.
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| 2843698 | 80 | F | SC | 06/03/2025 |
PNC21 |
MERCK & CO. INC. |
y019158 |
Erythema, Mass, Pain, Pyrexia
Erythema, Mass, Pain, Pyrexia
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redness, fever, soreness, and knot in arm appeared a week after receiving vaccine
redness, fever, soreness, and knot in arm appeared a week after receiving vaccine
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| 2843699 | 17 | F | AZ | 06/03/2025 |
HEP TDAP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
4D333 3CA22C1 |
Syncope; Syncope
Syncope; Syncope
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After the client received her vaccines, she was walking back to the lobby when she fainted. Client w...
After the client received her vaccines, she was walking back to the lobby when she fainted. Client was slowly lowered to the ground to avoid injury. Respirations were even and shallow. Ammonia inhalant applied, client responded immediately, was able to answer questions and walk to a chair in the waiting room. 911 had been contacted and arrived on scene, client mother elected for client to go to the hospital for further treatment and evaluation.
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| 2843700 | 1.08 | M | WA | 06/03/2025 |
DTPPVHBHPB MMRV VARCEL |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U8267AA Y015991 Y017915 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient was seen by Dr. on 6/2/2025 for his 1 year WCC. He was scheduled to receive MMR, Varicella a...
Patient was seen by Dr. on 6/2/2025 for his 1 year WCC. He was scheduled to receive MMR, Varicella and Vaxelis vaccines. He was inadvertently given MMRV, Varicella and Vaxelis vaccines by staff who was working with Dr. this day. Staff noted the error and immediately informed the clinical supervisor. Clinical services, Program Manager and Dr. were also notified. Telephone call to family to explain incident done as recommended by provider. No adverse effects noted at this time. Family will reach out with any questions, concerns or needs.
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| 2843701 | 16 | F | 06/03/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LL0641 U8493AA |
Injection site rash, Rash erythematous, Rash pruritic; Injection site rash, Rash...
Injection site rash, Rash erythematous, Rash pruritic; Injection site rash, Rash erythematous, Rash pruritic
More
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Red rash that started at right deltoid approx 36 hours after vaccine administration. Rash has contin...
Red rash that started at right deltoid approx 36 hours after vaccine administration. Rash has continued to spread over 48 hours down anterior and medial bicep. Rash is itchy. Deltoid muscle is sore. No joint involvement. Encouraged Ibuprofen, antihistamine, continued observation, and follow up if worsening/failing to improve over the next 48 hours.
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| 2843702 | 25 | F | CO | 06/03/2025 |
HEPA TDAP YF |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y017625 3CA22C1 UK134AA |
Dizziness, Injection site erythema, Injection site pruritus, Injection site swel...
Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling; Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling; Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
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Client called 5 hours after receiving vaccines and reported redness, swelling, itchiness at site of ...
Client called 5 hours after receiving vaccines and reported redness, swelling, itchiness at site of yellow fever administration, left arm subcutaneous. Client also reported feeling dizzy intermittently. Client denied any respiratory symptoms. Client was instructed to take oral benadryl and apply ice to the site and to call if symptoms worsened or changed. This writer reached out to client following day at 0830, approximately 22 hours after vaccine administration, client reported benadryl helped, swelling decreased. Client reports site is still slightly swollen and itchy. Client instructed to continue to monitor and call back if anything changes.
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| 2843703 | 4 | M | CO | 06/03/2025 |
IPV |
SANOFI PASTEUR |
W1C751M |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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There was no adverse event. Child's parent did not have any issues with Child after receiving e...
There was no adverse event. Child's parent did not have any issues with Child after receiving extra dose of IPV.
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| 2843704 | 0.17 | F | PA | 06/03/2025 |
HIBV |
SANOFI PASTEUR |
uk042aa |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Vaccine expired on 3/20/25. Vaccine given 5/15/25. Discovered event on reporting 6/3/25. No adverse...
Vaccine expired on 3/20/25. Vaccine given 5/15/25. Discovered event on reporting 6/3/25. No adverse effects noted.
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| 2843705 | 19 | F | GA | 06/03/2025 |
MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
x028353 x028353 y006523 y006523 |
Dyspnoea, Lethargy, Lip swelling, Pruritus, Tachypnoea; Urticaria; Dyspnoea, Let...
Dyspnoea, Lethargy, Lip swelling, Pruritus, Tachypnoea; Urticaria; Dyspnoea, Lethargy, Lip swelling, Pruritus, Tachypnoea; Urticaria
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shortly after vaccination, pt was found sitting on ground outside of clinic complaining of hives, it...
shortly after vaccination, pt was found sitting on ground outside of clinic complaining of hives, itching and shortness of breath. pt was assisted into building for assessment and treatment. pt appeared lethargic, tachypneic, lips appeared swollen. based on symptoms and history, IM Epinephrine autoinjector pin was administered into the right thigh through the pts clothing. vitals assessed, lung sounds auscultated as clear in all fields. medical provider on site came and assessed and determined that the pt was stable for transport POV to the nearest hospital for further evaluation and treatment (no EMS was needed). pt was assisted into POV and accompanied by clinic staff (EMT/RN and MD) to the hospital were the pt was registered and triaged by hospital staff and care was transferred to facility staff.
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| 2843706 | 0.17 | F | PA | 06/03/2025 |
HIBV |
SANOFI PASTEUR |
uk042aa |
Expired product administered
Expired product administered
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Vaccine expired 3/1/25. Vaccine administered 5/15/25. Event found after running administration repor...
Vaccine expired 3/1/25. Vaccine administered 5/15/25. Event found after running administration report 6/3/25.
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| 2843707 | 18 | F | PA | 06/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
7MN4C |
Blindness, Dizziness, Hypotonia, Posture abnormal
Blindness, Dizziness, Hypotonia, Posture abnormal
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About 10 minutes after receiving Bexsero patient was sitting in waiting room and began to feel ligh...
About 10 minutes after receiving Bexsero patient was sitting in waiting room and began to feel lightheaded and said "everything was going black". Provider responded and patient become limp with some inward turning of right hand and foot. Episode lasted approximately 5 seconds and patient opened eyes, pupils were dilated but responding to provider movement, able to locate where she was and state her name. Pulse ox was applied to finger which revealed normal pulse ox level of 97% and HR of 48. Two minutes later she felt nauseous and was helped to the bathroom but did not have any emesis. Five minutes after the event she was helped to an exam room, laid flat and elevated legs. After 2 minutes of legs elevated patient stated she was feeling better. She was given water and laid flat for 15 minutes. She sat up and BP was checked and found to be 98/58 (BP upon arrival to office before vaccine was 108/60). She sat up for another 15-20 minutes, BP was rechecked and found to be 100/60. Her color returned to normal, she stated she felt better, and was able to ambulate self to parent's private vehicle and go home.
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| 2843708 | 12 | F | VA | 06/03/2025 |
HPV9 |
MERCK & CO. INC. |
Y012864 |
Dizziness, Headache, Tremor
Dizziness, Headache, Tremor
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She became dizzy, developed headache, and was shaky starting 4 hr after vaccination and this continu...
She became dizzy, developed headache, and was shaky starting 4 hr after vaccination and this continued until this morning though symptoms are now improving.
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| 2843709 | 51 | F | FL | 06/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
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felt burning at time of injection and had burning redness pain at site of injection
felt burning at time of injection and had burning redness pain at site of injection
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| 2843710 | 17 | F | FL | 06/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
7MN4C |
Dizziness, Pallor, Syncope
Dizziness, Pallor, Syncope
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APPROXIMATELY 5 MINUTES AFTER INJECTION, PATIENT BECAME PALE AND FAINTED. SHE VERBALIZED FEELING DI...
APPROXIMATELY 5 MINUTES AFTER INJECTION, PATIENT BECAME PALE AND FAINTED. SHE VERBALIZED FEELING DIZZY JUST PRIOR TO EPISODE. SHE RETURNED TO BASELINE 1 MINUTE LATER. SHE REMAINED IN THE OFFICE 30 MINUTES AFTER EPISODE.
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| 2843711 | 39 | F | FL | 06/03/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9K34M |
Haemorrhage, Injection site swelling
Haemorrhage, Injection site swelling
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Severe swelling at injection site. Patient was bleeding more than normal after administration. Patie...
Severe swelling at injection site. Patient was bleeding more than normal after administration. Patient was given a cold pack to apply. After 10 to 15 minutes the swelling was noticeably reduced.
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| 2843712 | 11 | M | TX | 06/03/2025 |
MENB TD VARCEL |
NOVARTIS VACCINES AND DIAGNOSTICS MASS. PUB HLTH BIOL LAB MERCK & CO. INC. |
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Headache, Injection site swelling, Pyrexia; Headache, Injection site swelling, P...
Headache, Injection site swelling, Pyrexia; Headache, Injection site swelling, Pyrexia; Headache, Injection site swelling, Pyrexia
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Hight temperature 104, bad headache and swollen areas around the shots. They did not know which shot...
Hight temperature 104, bad headache and swollen areas around the shots. They did not know which shot he had a reaction from so they could not give him anymore of those shots if needed.
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| 2843713 | 06/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; diagnosed this week with shingles.; This serious case was reported by...
Suspected vaccination failure; diagnosed this week with shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed this week with shingles.). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 30-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that they got the shots a couple years ago and patient was diagnosed this week with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2843714 | 56 | F | FL | 06/03/2025 |
COVID19 HEP PNC20 |
PFIZER\BIONTECH DYNAVAX TECHNOLOGIES CORPORATION PFIZER\WYETH |
md3414 945663 lx4482 |
Extra dose administered, Pain in extremity; Extra dose administered, Pain in ext...
Extra dose administered, Pain in extremity; Extra dose administered, Pain in extremity; Extra dose administered, Pain in extremity
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Pt was given two pneumonia vaccines within the last two weeks. Pt has a sore arm, but otherwise fine...
Pt was given two pneumonia vaccines within the last two weeks. Pt has a sore arm, but otherwise fine.
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| 2843715 | 12 | MI | 06/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Wrong product administered
Wrong product administered
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Dtap vaccine given instead of Tdap.
Dtap vaccine given instead of Tdap.
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| 2843716 | 65 | F | AL | 06/03/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
PG3RP F95YS |
Injection site erythema, Injection site pruritus, Injection site warmth, Pain in...
Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity; Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
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Day of- arm soreness, Day 2- began to get red, Day 3- redness diameter spreading and began to itch a...
Day of- arm soreness, Day 2- began to get red, Day 3- redness diameter spreading and began to itch and have warmth to the injection site
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| 2843717 | 53 | F | WV | 06/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Peripheral swelling, Pyrexia, Swelling face
Peripheral swelling, Pyrexia, Swelling face
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Patients' daughter called stating patient had fever and swelling of face, hands and feet .Advis...
Patients' daughter called stating patient had fever and swelling of face, hands and feet .Advised to go directly to ER.
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| 2843718 | 65 | F | NC | 06/03/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Chills, Injection site erythema, Oral herpes, Pyrexia
Chills, Injection site erythema, Oral herpes, Pyrexia
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Patient presented to office for visit on 6/3/25 for "allergic reaction to injection" follo...
Patient presented to office for visit on 6/3/25 for "allergic reaction to injection" following Capvaxive administration on 5/30/25. Vaccine was administered in Left deltoid and patient reported redness at the site which was endorsed by the provider but denied pain at the site. No warmth at the site noted by the provider. Provider stated injection site was not concerning for cellulitis. Pt reported subjective fever and chills the evening after receiving vaccination, though she never took her temperature at home to confirm fever and was afebrile during her appointment. She also presented with fever blisters around her mouth. No other symptoms of concern reported by patient. Provider treated Herpes labialis with Valacyclovir 2000 mg BID for one day. Provider recommended warm moist compress to the area, Tylenol and Ibuprofen PRN, and reviewed red flag warning signs and emergency precautions for injection site reaction per note.
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| 2843719 | 18 | F | AK | 06/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
More
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Patient had pain in the injection site next day and still is experiencing pain and redness, some swe...
Patient had pain in the injection site next day and still is experiencing pain and redness, some swelling and a small lump in the right deltoid where medication was administered.
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| 2843721 | 30 | M | LA | 06/03/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FM0173 FM0173 FM0173 |
Aortic valve sclerosis, Chest discomfort, Chest pain, Echocardiogram abnormal, E...
Aortic valve sclerosis, Chest discomfort, Chest pain, Echocardiogram abnormal, Ejection fraction normal; Electrocardiogram ambulatory abnormal, Mitral valve incompetence, Palpitations, Pulmonary valve incompetence, Supraventricular extrasystoles; Tricuspid valve incompetence, Ventricular extrasystoles
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Chest Pain/ pressure, palpitations (PVC) started in FEB 2023. Slight chest pains/ pressure still exi...
Chest Pain/ pressure, palpitations (PVC) started in FEB 2023. Slight chest pains/ pressure still exists 2-3 times weekly. PVCs occur multiple times daily. Symptoms can increase in severity with ingestion of high salt/ sugar content foods.
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| 2843722 | 41 | F | TX | 06/03/2025 |
COVID19 |
MODERNA |
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Aphasia, Dyspnoea, Erythema
Aphasia, Dyspnoea, Erythema
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Before the vaccine I was speaking fine. After vaccine couldnt speak at all, face and neck was red, h...
Before the vaccine I was speaking fine. After vaccine couldnt speak at all, face and neck was red, had some breathing difficulty. Sent right to ER.
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| 2843723 | 73 | M | MO | 06/03/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM2222 U8489AA |
Limb mass, Pruritus; Limb mass, Pruritus
Limb mass, Pruritus; Limb mass, Pruritus
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Patient states that 2 months after receiving Fluzone HD and Comirnaty that he developed a bump on h...
Patient states that 2 months after receiving Fluzone HD and Comirnaty that he developed a bump on his arm that has progressively become larger and itchy. He stated that initially it resembled a pimple. Patient denies treating with any medication or attempting to lance. He affirmed that he would occasionally scratch the area. Patient stated that he felt that someone should pay for him to see a provider to look at his arm.
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| 2843724 | 4 | M | NM | 06/03/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
7NA4T |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Made an honest mistake and pulled Pediarix vaccine (Dtap/ HepB/IPV) instead of Kinrix vaccine (Dtap/...
Made an honest mistake and pulled Pediarix vaccine (Dtap/ HepB/IPV) instead of Kinrix vaccine (Dtap/IPV) given to patient on 05-30-25 - Patient tolerated vaccine well with no adverse reactions. No redness or swelling at injection site post discharge from clinic. Patient has had these vaccines prior to this with no adverse reactions.
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| 2843725 | 12 | F | WI | 06/03/2025 |
HPV9 |
MERCK & CO. INC. |
Y017907 |
Hypotension, Syncope
Hypotension, Syncope
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Patient came in to receive HPV vaccine today. Patient tolerated vaccine well during injection. Patie...
Patient came in to receive HPV vaccine today. Patient tolerated vaccine well during injection. Patient did eat breakfast this morning. Patient reports they have never had a syncopal episode or have reacted to a vaccine in the past. Patient's father was in the room for vaccination and mother came in afterwards. About 5 minutes after the vaccine was given, patient asked Dad for some water, he went to the cupboard in the room to find a cup. Patient then fainted while she was sitting in the chair. Dad opened the door for help and myself, and 2 MA's came into the room to assist. Patient was alert when we came into the room and was getting up with help from Dad to the chair. It was unclear if patient hit her head, her head was lying near the exam table. She did have a red mark, start of a bruise on the back of her right shoulder about the size of a dollar coin from where she fell. Patient looked pale/green and was feeling dizzy when she was sitting back in the chair. Patient wanted to lay down, we helped her to the table and put her feet up, with cold wash cloth on her forehead. Blood pressures were initially low at 78/50 but came up to 91/60 before she left. Dr. did come into the room to examine the patient and answered all parents questions. After 30 minutes, patient recovered well and was able to return to her other appointment . Parents did say that she is very active, in dance and track and did not get home until late last night. Parents denied further questions or concerns and thanked us for the care. Mother will stay home with patient today, making sure she stays hydrated and is eating and is instructed to call us if any questions or concerns arise.
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| 2843726 | 55 | M | NC | 06/03/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Injection site cellulitis
Injection site cellulitis
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Cellulitis at site of injection, treated with antibiotics doxycycline.
Cellulitis at site of injection, treated with antibiotics doxycycline.
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| 2843727 | 53 | F | 06/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4b227 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt was signed up for RSV vaccine and received it however turned out patient was not 60 years old yet...
Pt was signed up for RSV vaccine and received it however turned out patient was not 60 years old yet and received vaccine. Pt had no symptoms or side effects.
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| 2843728 | 12 | M | UT | 06/03/2025 |
MNQ |
SANOFI PASTEUR |
U8194AA |
Cyanosis, Electrocardiogram normal, Foaming at mouth, Loss of consciousness
Cyanosis, Electrocardiogram normal, Foaming at mouth, Loss of consciousness
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patient was given vaccine and left clinic, went across the street to artic circle for ice cream and ...
patient was given vaccine and left clinic, went across the street to artic circle for ice cream and passed out in the car. Parents said patient turned blue and was foaming at the mouth for a short period. Parents brought patient to the ER next door to the clinic and was seen and vitals quickly became stable.
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| 2843729 | 06/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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itching at the injection site; redness at the injection site; This non-serious case was reported by ...
itching at the injection site; redness at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site itching (Verbatim: itching at the injection site) and injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site itching and injection site erythema were not reported. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingles vaccine. It was unknown if the company considered the injection site itching and injection site erythema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via (Shingrix chatbot) interactive digital media. Reporter asked whether it was normal to experience itching and redness at the injection site.
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| 2843730 | 1.33 | F | IL | 06/03/2025 |
HIBV |
SANOFI PASTEUR |
UK092AA |
Expired product administered
Expired product administered
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Pt was given an ActHIB vaccine. Expiration date of vaccine was noted after administration (5/31/25)....
Pt was given an ActHIB vaccine. Expiration date of vaccine was noted after administration (5/31/25). Dr. and nurse manager notified of expired vaccine.
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