| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2836363 | 84 | F | IN | 04/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3x97j |
Haematemesis
Haematemesis
|
Patient reported repeated vomiting after vaccination--this reaction did not happen after ger first d...
Patient reported repeated vomiting after vaccination--this reaction did not happen after ger first dose.
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| 2836364 | 67 | M | IN | 04/16/2025 |
FLU3 |
SANOFI PASTEUR |
U8532AA |
Injection site discharge, Paraesthesia
Injection site discharge, Paraesthesia
|
Patient stated that after a couple days the shot never healed had a clear discharge for over a month...
Patient stated that after a couple days the shot never healed had a clear discharge for over a month. Then about a month ago the upper arm started tingling. He spoke to his MD and he told him to contact the pharmacy where received. Patient also stated that he was seeing a physical therapist for another issue and mentioned the tingling to him. The therapist said it may be a tight muscle in the neck that could be causing the tingling so he said he would work on that area also.
More
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| 2836365 | 50 | F | WI | 04/16/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y004116 Y007176 |
Erythema, Pain, Pruritus, Swelling; Erythema, Pain, Pruritus, Swelling
Erythema, Pain, Pruritus, Swelling; Erythema, Pain, Pruritus, Swelling
|
Itching, redness, swelling and pain
Itching, redness, swelling and pain
|
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| 2836366 | 72 | F | OK | 04/16/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LK6650 9L944 |
Erythema, Swelling; Erythema, Swelling
Erythema, Swelling; Erythema, Swelling
|
Pt has redness/swelling 6 days after vaccination
Pt has redness/swelling 6 days after vaccination
|
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| 2836367 | 45 | M | MS | 04/16/2025 |
COVID19 |
PFIZER\BIONTECH |
FD8448 |
Atrial fibrillation, Cardiac ablation, Chest pain, Electrocardiogram abnormal, S...
Atrial fibrillation, Cardiac ablation, Chest pain, Electrocardiogram abnormal, Supraventricular tachycardia
More
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Within two hours of receiving vaccine, patient experienced chest pain with associated SVT and had to...
Within two hours of receiving vaccine, patient experienced chest pain with associated SVT and had to be seen in the local ER for medication. He then had to see another hospital within the next two weeks and was admitted for a fib and uncontrolled SVT. This resulted in having to undergo cardiac ablation. Now patient continues to have heart problems and likely will need a pacemaker.
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โ | โ | โ | |||
| 2836368 | 104 | F | MN | 04/16/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Extra dose administered
Extra dose administered
|
Vaccine offered per CDC recommendations to residents present in facility that are eligible, resident...
Vaccine offered per CDC recommendations to residents present in facility that are eligible, resident received as eligible on 3/28/2025 but unfortunately was not processed correctly on paperwork as administered so was re-administered on 4/9/2025 as though it was recommended to receive (duplicate spring booster administered).
More
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| 2836369 | 86 | F | MN | 04/16/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Extra dose administered
Extra dose administered
|
Resident received 2nd booster dose for spring 2025 from nurse error in order review that was the nur...
Resident received 2nd booster dose for spring 2025 from nurse error in order review that was the nurse that administered vaccine
More
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| 2836370 | 9 | M | MI | 04/16/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y012508 Y012508 |
Abdominal pain, Diarrhoea, Injection site mass, Injection site pain, Injection s...
Abdominal pain, Diarrhoea, Injection site mass, Injection site pain, Injection site swelling; Nausea, Pain in extremity
More
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He received the HPV vaccination at his appointment last week, 04/07/25. He had left arm soreness for...
He received the HPV vaccination at his appointment last week, 04/07/25. He had left arm soreness for a few days after the vaccination on 4/7/25. Yesterday, his arm started hurting again. No erythema, but the site was swollen and tender. There is a knot under the skin. Yesterday, he also had abdominal pain and diarrhea. Abdominal pain is generalized. He feels nauseated, but no vomiting. Older brother is also reporting abdominal pain, but no diarrhea. He has been alternating tylenol and ibuprofen which does help.
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| 2836371 | 70 | M | NC | 04/16/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
M4B34 |
Injury associated with device, Occupational exposure to product
Injury associated with device, Occupational exposure to product
|
ACCIDENTAL NEEDLE STICK TO ASSOCIATE ADMINISTERING THE SHOT
ACCIDENTAL NEEDLE STICK TO ASSOCIATE ADMINISTERING THE SHOT
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| 2836372 | 67 | F | IA | 04/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
F9X4P |
Rash, Varicella
Rash, Varicella
|
Patient developed rash - NP, believes it is chicken pox.
Patient developed rash - NP, believes it is chicken pox.
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| 2836373 | 62 | M | NY | 04/16/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Chest X-ray normal, Culture, Oropharyngeal pain, Pharyngeal swelling
Chest X-ray normal, Culture, Oropharyngeal pain, Pharyngeal swelling
|
Patient stated he received the Capvaxive vaccine and then woke up with a sore, swollen throat the fo...
Patient stated he received the Capvaxive vaccine and then woke up with a sore, swollen throat the following day. He stated he feels find other wise and was seen by an urgent care provider, who thinks it is most likely an upper respiratory infections and not pneumonia. Cultures were sent out for testing.
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| 2836374 | 1.25 | F | TN | 04/16/2025 |
HEPA MMRV VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
lm99n y003883 x018952 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
Pt received both MMRV (MMR with Varicella) and another vaccine of Varicella so she received 2 doses ...
Pt received both MMRV (MMR with Varicella) and another vaccine of Varicella so she received 2 doses of varicella
More
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| 2836375 | 16 | M | PA | 04/16/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LF5302 U8558BA |
Feeling hot, Hyperhidrosis, Presyncope; Feeling hot, Hyperhidrosis, Presyncope
Feeling hot, Hyperhidrosis, Presyncope; Feeling hot, Hyperhidrosis, Presyncope
|
Vasovagal episode after vaccinations, 10-15 minutes later. Sweaty, felt warm. Kept supine then sitti...
Vasovagal episode after vaccinations, 10-15 minutes later. Sweaty, felt warm. Kept supine then sitting for 20 minutes drinking apple juice and water till felt better and B/P returned to his normal.. Observed while recovering, seen by his doctor before leaving.
More
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| 2836376 | 63 | M | MO | 04/16/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, C-reactive protein, Full blood count, Joint stiffness, Metabolic fun...
Arthralgia, C-reactive protein, Full blood count, Joint stiffness, Metabolic function test; Red blood cell sedimentation rate
More
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Diffuse joint pain and stiffness, past 4-5 days.
Diffuse joint pain and stiffness, past 4-5 days.
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| 2836377 | 64 | F | MA | 04/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9L944 |
Injection site erythema
Injection site erythema
|
Redness at injection site
Redness at injection site
|
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| 2836378 | 55 | F | VA | 04/16/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
D4J9L EK225 |
Limb mass, Pruritus, Skin exfoliation, Urticaria; Limb mass, Pruritus, Skin exfo...
Limb mass, Pruritus, Skin exfoliation, Urticaria; Limb mass, Pruritus, Skin exfoliation, Urticaria
More
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Per patient, skin on her nose started to peel off 2 days after the vaccines, then bumps developed o...
Per patient, skin on her nose started to peel off 2 days after the vaccines, then bumps developed on arms and hands. Finally, welts showed up on her neck and they've caused lots of itchiness, especially at night.
More
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| 2836379 | 17 | M | AR | 04/16/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
X4T99 |
Wrong product administered
Wrong product administered
|
Patient was given the incorrect vaccination. He was given a Meningococcal ACWY instead of the Mening...
Patient was given the incorrect vaccination. He was given a Meningococcal ACWY instead of the Meningococcal B vaccine that he was due for.
More
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| 2836380 | 11 | M | NY | 04/16/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y012864 U8361AA 3RE73 |
Hypoaesthesia, Mobility decreased, Muscular weakness; Hypoaesthesia, Mobility de...
Hypoaesthesia, Mobility decreased, Muscular weakness; Hypoaesthesia, Mobility decreased, Muscular weakness; Hypoaesthesia, Mobility decreased, Muscular weakness
More
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Shortly after administration of 3 vaccines (2 in right deltoid, 1 in left deltoid) as above, patient...
Shortly after administration of 3 vaccines (2 in right deltoid, 1 in left deltoid) as above, patient complained of numbness and weakness of the entire right arm. No other deficits on neurologic exam but patient was unable to voluntarily lift arm or maintain arm in raised position. mild withdrawal to pain noted.
More
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| 2836381 | 55 | F | AR | 04/16/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Pain in extremity, Peripheral swelling
Pain in extremity, Peripheral swelling
|
Swollen arm for more than 5 days and severe arm pain
Swollen arm for more than 5 days and severe arm pain
|
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| 2836382 | 17 | F | CA | 04/16/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
XL223 |
Extra dose administered, Injection site pain
Extra dose administered, Injection site pain
|
patient was given an extra dose of the MCV vaccine. Provider was made while documenting for the vacc...
patient was given an extra dose of the MCV vaccine. Provider was made while documenting for the vaccine. Parent was called and made aware of the error. Per provider ,parent made aware of no adverse reaction are to be expected with the extra dose of the MCV other than pain at the injection site.
More
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| 2836383 | 68 | M | 04/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Pain in extremity, Product administered at inappropriate site
Pain in extremity, Product administered at inappropriate site
|
Pharmacist administered vaccine to high and caused severe pain for the patient that lasted over 2 da...
Pharmacist administered vaccine to high and caused severe pain for the patient that lasted over 2 days.
More
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| 2836525 | 36 | F | TX | 04/16/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
T5D73 |
Breath sounds abnormal, Eye movement disorder, Hypotonia, Loss of consciousness,...
Breath sounds abnormal, Eye movement disorder, Hypotonia, Loss of consciousness, Unresponsive to stimuli
More
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2-3 MINUTES AFTER HER HBS SHOT THE DONOR SLUMPED BACKWARDS IN THE CHAIR IN PS OFFICE #2 LOST CONSCIO...
2-3 MINUTES AFTER HER HBS SHOT THE DONOR SLUMPED BACKWARDS IN THE CHAIR IN PS OFFICE #2 LOST CONSCIOUSNESS FOR 90 SECONDS, HAD NOISY BREATHING, DONOR WAS UNAROUSABLE BY LOUD VOICE, DONOR EYES ROLLED BACK INTO HER HEAD, SHE HAD ABNORMAL UPPER LIMBS POSITIONING BUT NOT RHYTHMIC JERKY MOVEMENTS, WHEN DONOR REGAINED CONSCIOUSNESS SHE WAS AWARE OF WHERE SHE WAS AND RECALLED RECENT EVENTS.
More
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| 2836526 | 64 | M | OK | 04/16/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4n222 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
|
No adverse event, reporting incorrect Administration (administered IM instead of SQ)
No adverse event, reporting incorrect Administration (administered IM instead of SQ)
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| 2836527 | 76 | M | FL | 04/16/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0589 |
Injection site rash, Rash
Injection site rash, Rash
|
Patient reports rash at injection site that has migrated to the back of his arm, as of today 4/16/25...
Patient reports rash at injection site that has migrated to the back of his arm, as of today 4/16/25 he said the condition is improving.
More
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| 2836528 | 25 | F | CA | 04/16/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
|
Arthralgia, Back pain, Immediate post-injection reaction, Injected limb mobility...
Arthralgia, Back pain, Immediate post-injection reaction, Injected limb mobility decreased, Joint noise; Joint swelling, Limb discomfort, Mobility decreased, Multiple sclerosis, Muscle spasticity; Muscle tightness, Musculoskeletal stiffness, Myofascial pain syndrome, Neck pain, Pain; Pain in extremity, Swelling; Arthralgia, Back pain, Immediate post-injection reaction, Injected limb mobility decreased, Joint noise; Joint swelling, Limb discomfort, Mobility decreased, Multiple sclerosis, Muscle spasticity; Muscle tightness, Musculoskeletal stiffness, Myofascial pain syndrome, Neck pain, Pain; Pain in extremity, Swelling
More
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I described them. Pediatric onset Multiple Sclerosis never ever had upper shoulder pain/upper extrem...
I described them. Pediatric onset Multiple Sclerosis never ever had upper shoulder pain/upper extremity and neck pain until the second dose of moderna vaccine My upper body and shoulders were completely fine until I had the second Moderna vaccine. It started in my left shoulder with swelling, pain, stiffness, difficulty lifting, and a heavy feeling. I thought it was just an initial reaction, but the symptoms persisted, then spread to my right shoulder, shortly after to my neck, and upper back. I now experience chronic pain, crunching, grinding, stiffness, myofascial pain syndrome (MPS), severe neck tightness, and spasticity. I had none of these symptoms before. I only started getting TPI (trigger point injection) therapy in 2023, which helps relieve the pain. However, I have had this pain for four years, and it was unbearable before starting TPI treatment. I now have chronic pain in both shoulders, my upper back, and my neck. Lot number: 017C21A (please do not share Lot # info unless asked)- Site: Left Deltoid dosage: 0.5 NDC can be provided upon request. Vaccine time 9-11 am. All records saved. Please do not share my lot number unless specifically requested. I prefer that this information remain confidential, as I receive ongoing care and do not want it to affect me. Thank you.
More
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โ | |||||
| 2836529 | 14 | F | MD | 04/16/2025 |
HPV4 HPV4 HPV4 MNQ MNQ MNQ VARCEL VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Abdominal pain, Abdominal pain upper, Blood bilirubin increased, Cholecystectomy...
Abdominal pain, Abdominal pain upper, Blood bilirubin increased, Cholecystectomy, Cholecystitis; Cholelithiasis, Crohn's disease, Gastrointestinal disorder, Gastrointestinal motility disorder, Imaging procedure abnormal; Irritable bowel syndrome; Abdominal pain, Abdominal pain upper, Blood bilirubin increased, Cholecystectomy, Cholecystitis; Cholelithiasis, Crohn's disease, Gastrointestinal disorder, Gastrointestinal motility disorder, Imaging procedure abnormal; Irritable bowel syndrome; Abdominal pain, Abdominal pain upper, Blood bilirubin increased, Cholecystectomy, Cholecystitis; Cholelithiasis, Crohn's disease, Gastrointestinal disorder, Gastrointestinal motility disorder, Imaging procedure abnormal; Irritable bowel syndrome
More
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Gardasil doses were administered on 7/10/2008, 09/12/2008, and 01/30/2009. Following the initial dos...
Gardasil doses were administered on 7/10/2008, 09/12/2008, and 01/30/2009. Following the initial dose, severe abdominal pain began resulting in a visit to the Emergency room on 7/15/2008. I was admitted for observation overnight where lab work was drawn. I was discharged the morning of 7/16/2008 and my parents were contacted by the doctor that same evening that my doctor that we needed to return to the hospital due to elevated bilirubin levels and suspected inflamed gallbladder. I was readmitted to the hospital on 7/16/2008 for further testing as well as continued abdominal pain. Imaging was done that evening which showed my gallbladder was full of gallstones. I was scheduled for gallbalder removal on 7/17/2008. Following the removal of my gallbladder, I continued having extreme stomach pain and devloped bowel issues. Over the course of the next few months I recieved a Crohn's disease, IBS, and eventually colonic inertia. Up until 7/10/2008 I had no bowel issues, now pain or stomach problems or other autoimmune issues.
More
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โ | โ | ||||
| 2836530 | 50 | F | NV | 04/16/2025 |
PNC21 PNC21 PNC20 PNC20 |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
LC5484 LC5484 |
Headache, Swelling face, Urticaria; Urticaria; Headache, Swelling face, Urticari...
Headache, Swelling face, Urticaria; Urticaria; Headache, Swelling face, Urticaria; Urticaria
More
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hives and swelling of the face, headache
hives and swelling of the face, headache
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| 2836552 | 2.75 | M | OH | 04/16/2025 |
MMRV |
MERCK & CO. INC. |
Y013572 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Patient was due to receive a Varicella vaccine but unintentionally received a MMR-Varicella vaccine,...
Patient was due to receive a Varicella vaccine but unintentionally received a MMR-Varicella vaccine, no reaction to vaccine. This was the patient's 2nd MMR vaccine and 1st Varicella vaccine.
More
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| 2836951 | 4 | M | IN | 04/16/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U7908AB Y012076 |
Cellulitis; Cellulitis
Cellulitis; Cellulitis
|
Cellulitis of R leg / thigh after administration of MMRV + Quadracel.
Cellulitis of R leg / thigh after administration of MMRV + Quadracel.
|
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| 2836041 | 53 | F | MA | 04/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
K2BB7 K2BB7 |
Arthralgia, Asthenia, Erythema, Myalgia, Nausea; Skin lesion
Arthralgia, Asthenia, Erythema, Myalgia, Nausea; Skin lesion
|
Red indurated lesions like erythema on both cheeks (especially right side); generalized myalgias and...
Red indurated lesions like erythema on both cheeks (especially right side); generalized myalgias and weakness; pain in joints (no visible inflammation); some nausea
More
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| 2836042 | 37 | F | CA | 04/15/2025 |
COVID19 |
MODERNA |
|
Coma, Myocardial infarction, Syncope
Coma, Myocardial infarction, Syncope
|
Booster shot taken. She fainted while taking dog for a walk. Nearly died of heart attack. Was in com...
Booster shot taken. She fainted while taking dog for a walk. Nearly died of heart attack. Was in coma for a few days.
More
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โ | โ | ||||
| 2836131 | NJ | 04/15/2025 |
RV5 |
MERCK & CO. INC. |
X023474 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; ROTATEQ was administered after a temperature excursion; Information has been recei...
No additional AE; ROTATEQ was administered after a temperature excursion; Information has been received from Business Partner/CRO on 21-Mar-2025. This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Feb-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #X023474, expiration date: 11-Jul-2025) administered by Oral route for prophylaxis. Tis vaccine underwent temperature excursion in 52.2 degree Fahrenheit for 1 hour. No additional adverse event was reported.
More
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| 2836132 | 14 | PA | 04/15/2025 |
HPV9 |
MERCK & CO. INC. |
|
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
14 year-old patient may have received less than recommend; No additional AE; This spontaneous report...
14 year-old patient may have received less than recommend; No additional AE; This spontaneous report was received from an Other health professional and referred to a 14-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient may have received less than recommend first dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), (may have received 0.01mL of vaccine), (lot # and expiration date were not reported) for prophylaxis (underdose). No additional AE. Lot # is being requested and will be submitted if received.
More
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| 2836133 | MD | 04/15/2025 |
VARCEL |
MERCK & CO. INC. |
Y011712 |
No adverse event, Product storage error
No adverse event, Product storage error
|
no adverse event; improper storage of product in use; This spontaneous report was received from a/an...
no adverse event; improper storage of product in use; This spontaneous report was received from a/an Consumer or other non-health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-Mar-2025, the patient was vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), formulation: injection, lot #Y011712, expiration date: 02-Jul-2026, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On 29-Jan-2025, administered dose of vaccine was exposed to the temperature excursion of 14.65 degrees Fahrenheit for 13 hours and 15 minutes (product storage error). No previous temperature excursion has occurred. No additional adverse event reported (no adverse event).
More
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| 2836134 | AL | 04/15/2025 |
VARCEL |
MERCK & CO. INC. |
X006981 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No adverse event; HCP called to report that an expired dose of VARIVAX was administered to a patient...
No adverse event; HCP called to report that an expired dose of VARIVAX was administered to a patient. VARIVAX expired on 3/7/2025, administered 3/24/2025. Potency of the dose was supported by the Post Expiry Memo. No symptoms reported. Consent to contact is Yes. No a; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 24-MAR-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X006981, expiration date: 07-MAR-2025) 0.5 mL administered by unknown route (exact dose and anatomical location were not provided), which was diluted with a sterile diluent (expiration date and lot # were not reported) as prophylaxis. No symptoms reported (no adverse event).
More
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| 2836135 | F | 04/15/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Y013009 Y013009 |
Headache, Injection site erythema, Injection site inflammation, Injection site p...
Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus; Injection site warmth
More
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headache; Injection site erythema; Injection site pain; Injection site pruritus; Injection site infl...
headache; Injection site erythema; Injection site pain; Injection site pruritus; Injection site inflammation; Injection site warmth; This spontaneous report was received from a Regulatory Authority and refers to a 65-year-old female patient. The patient's medical history was headache, injection site erythema, injection site inflammation, injection site pain, injection site pruritus and injection site warmth. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in Left Arm for prophylaxis. On 16-Jan-2025, the patient experienced headache. On 16-Jan-2025, the patient experienced Injection site erythema. On 16-Jan-2025, the patient experienced Injection site pain. On 16-Jan-2025, the patient experienced Injection site pruritus. On 16-Jan-2025, the patient experienced Injection site inflammation. On 16-Jan-2025, the patient experienced Injection site warmth. At the reporting time, the patient had not recovered from headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site inflammation and Injection site warmth. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of all adverse events and Pneumococcal 21-valent Conjugate Vaccine was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2821300-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
More
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| 2836136 | IA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
T025509 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
no adverse event; expired vaccine administered; This spontaneous report was received from an Other h...
no adverse event; expired vaccine administered; This spontaneous report was received from an Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-Feb-2022, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #T025509, expiration date: 23-Jan-2022, also reported as 23-JAN-2025, discrepancy) (1 dose) reconstituted with sterile diluent (DSM STERILE DILUENT), (lot # and expiration date were not reported)(expired vaccine administered) No adverse event was reported.
More
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| 2836137 | F | PA | 04/15/2025 |
HPV9 |
MERCK & CO. INC. |
X002626 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE; Vaccine expired 02/12/2025 and administered today (03/28/2025).; This spontaneous ...
No additional AE; Vaccine expired 02/12/2025 and administered today (03/28/2025).; This spontaneous report has been received from a medical assistant referring to a female patient of unspecified age. The patient's concurrent conditions, pertinent medical history, previous drug reactions/allergies, and concomitant therapies were not provided. On 28-MAR-2025, the patient was vaccinated with HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) SYRINGE with valid lot # X002626 and expiration date 12-FEB-2025 (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) as prophylaxis (Expired product administered). There was confirmed no temperature excursion (TE), nor additional adverse event (AE).
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| 2836138 | ID | 04/15/2025 |
VARCEL VARCEL VARCEL VARCEL HIBV HIBV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
y013350 y013350 X022981 X022981 |
No adverse event, Product storage error; Product storage error; No adverse event...
No adverse event, Product storage error; Product storage error; No adverse event, Product storage error; Product storage error; No adverse event, Product storage error; Product storage error
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No additional aes were reported; The nurse is reporting that a patient received improperly stored va...
No additional aes were reported; The nurse is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VARIVAX (y013350 8/2/2026) Temperature: 14.92F Time frame:; Information has been received from Business Partner/CRO on 31-Mar-2025. This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Mar-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #y013350, expiration date: 02-Aug-2026), dose number 1, for prophylaxis. On 28-Mar-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccine underwent temperature excursion (Product storage error). No additional adverse event.
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| 2836139 | PA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y018156 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ...
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 05-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 5.9 degree Fahrenheit for 13 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
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| 2836140 | F | SD | 04/15/2025 |
PPV |
MERCK & CO. INC. |
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Cellulitis
Cellulitis
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HCP reports patient had "severe cellulitis" after receiving PNEUMOVAX 23 "years ago&q...
HCP reports patient had "severe cellulitis" after receiving PNEUMOVAX 23 "years ago". Per HCP, reaction was "localized to the deltoid area". Unknown if any treatment was provided. No other information provided. No additional AE. No PQC.; This spontaneous report was received from the Health Care professional and refers to a 60-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, reported as "years ago", the patient was administered Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection, administered by unknown route as vaccination (dose, anatomical location, lot # and expiration date were not reported). On an unspecified date, after receiving the suspect vaccine, the patient had severe cellulitis localized to the deltoid area. Unknown if any treatment was provided. No other information provided. At the reporting time, the outcome of severe cellulitis was not known. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not reported, but established as not applicable. The causal relationship between the severe cellulitis and the suspect vaccine was not provided.
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| 2836141 | ID | 04/15/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y009589 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; HBP calling reporting that a patient received an improperly stored PROQUAD. Refer...
No additional AE; HBP calling reporting that a patient received an improperly stored PROQUAD. Reference TE case #02780764. HBP reported that the PROQUAD underwent a TE on 03/06/2025. HBP reported that the date of the administration was 03/27/2025. No symptoms or side; Information has been received from Business Partner/CRO on 01-Apr-2025. This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-Mar-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y009589, expiration date: 17-Nov-2025) 0.5 mL for prophylaxis. On 27-Mar-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccination underwent temperature excursion in 39.44 Fahrenheit for 1 hour 35 minutes (Product storage error). No additional adverse event was reported.
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| 2836142 | CA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y019465 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No symptomatic adverse events were reported. No additional information is available. No additional A...
No symptomatic adverse events were reported. No additional information is available. No additional AE; HCP called to report that the patient inadvertently received an extra dose of PROQUAD.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-APR-2025, the patient was inadvertently vaccinated with an extra dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 milliliters (mL), lot #Y019465; which has been verified to be valid for of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, with an expiration date reported and establish as 24-MAY-2026, administered for prophylaxis (strength, route and anatomical site of administration were not provided), with the sterile diluent (BAXTER STERILE DILUENT), lot #1973306; which has been verified to be valid, with an expiration date reported and establish as 30-OCT-2026 (Extra dose administered). No symptomatic adverse events were reported (No adverse event).
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| 2836143 | F | 04/15/2025 |
PNC21 |
MERCK & CO. INC. |
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Pain, Swelling
Pain, Swelling
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some swelling; Pain; This spontaneous report was received from field-based employee (FBE) and refers...
some swelling; Pain; This spontaneous report was received from field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced some swelling and pain. The primary reporter could not confirm if swelling and pain started before or after patient was administered Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). The patient went to a hospital to seek treatment for pain and swelling about one week ago and unknown if patient was admitted. At the reporting time, the outcome of some swelling and Pain was unknown. The causal relationship between both events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.
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| 2836144 | F | VA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y019464 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No side effects or symptoms have been reported.; 41-year-old female received a dose of PROQUAD; This...
No side effects or symptoms have been reported.; 41-year-old female received a dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 41-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 04-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) Injection (lot #Y019464, expiration date: 24-MAY-2026) 0.5 mL as prophylaxis. The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date was not provided) (inappropriate age at vaccine administration). No adverse event was reported.
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| 2836145 | PA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y018156 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ...
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 08-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 5.7 degree Fahrenheit for 30 hours 30 minutes. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
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| 2836146 | PA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y018156 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ...
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 10-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 5.7 degree Fahrenheit for 30 hours 30 minutes. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
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| 2836147 | PA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y018156 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ...
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 18-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.6 degree Fahrenheit for 81 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
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| 2836148 | PA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y018156 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ...
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 19-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.6 degree Fahrenheit for 90 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
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| 2836149 | PA | 04/15/2025 |
MMRV |
MERCK & CO. INC. |
Y018156 |
No adverse event
No adverse event
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No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ...
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 20-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.6 degree Fahrenheit for 90 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
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