| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2818540 | 62 | M | OH | 12/30/2024 |
FLU3 FLU3 FLU3 VARZOS VARZOS VARZOS FLU3 FLU3 FLU3 VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
72RF2 72RF2 72RF2 KJ3N3 KJ3N3 KJ3N3 72RF2 72RF2 72RF2 KJ3N3 KJ3N3 KJ3N3 |
Allergic respiratory symptom, Computerised tomogram abnormal, Computerised tomog...
Allergic respiratory symptom, Computerised tomogram abnormal, Computerised tomogram head, Ear congestion, Eye pruritus; Facial discomfort, Facial pain, Mucosal hypertrophy, Nasal congestion, Nasal obstruction; Paranasal sinus hypersecretion, Rhinorrhoea; Allergic respiratory symptom, Computerised tomogram abnormal, Computerised tomogram head, Ear congestion, Eye pruritus; Facial discomfort, Facial pain, Mucosal hypertrophy, Nasal congestion, Nasal obstruction; Paranasal sinus hypersecretion, Rhinorrhoea; Computerised tomogram head, Epistaxis, Eye pruritus, Facial pain, Headache; Nasal congestion, Oral herpes, Respiratory tract congestion, Rhinorrhoea, Secretion discharge; Sinonasal obstruction, Sinus pain, Sinusitis; Computerised tomogram head, Epistaxis, Eye pruritus, Facial pain, Headache; Nasal congestion, Oral herpes, Respiratory tract congestion, Rhinorrhoea, Secretion discharge; Sinonasal obstruction, Sinus pain, Sinusitis
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Approximately 1 week after the two shots, I had symptoms consistent with allergies consisting of stu...
Approximately 1 week after the two shots, I had symptoms consistent with allergies consisting of stuffy/runny nose. itchy eyes, ear congestion, and sinus drainage in the rear of my mouth. The drainage became worse at night upon sleeping. As instructed by previous doctors, I attempted home remedies consisting of a combination of Oral Sudafed, Zyrtec, Coricidn HBP Cold and Flu, Saline, and Store Brand Phenylephrine Hydrochloride 1% nasal sprays. My symptoms worsened so I scheduled an appointment on 4 Dec 24 with Health Group to check for a sinus infection. She thought I might need a course of Prednisone if the Amoxicillin Clauvulnate 875-125 mg x2 for 7 days did not work to clear up the issue. The symptoms continued to stay the same and I scheduled a second appointment with Dr same practice. He prescribed Azeltine 137mg x 2, Doxycycline Hycate 100mg x 2 x 10 days (still taking), and a 15-day supply of Prednisone 10 mg x 30 tablets varied dosage. I was to take the Prednisone first which I did with no help to symptoms. Dr. also ordered a sinus CT Scan taken on 12/24/24. The findings of Dr, stated mucosal thickening with an occlusion of the frontoemethoid on both sides of the face leading to chronic sinus drainage, facial pressure, and pain. Dr. is subsequently referring me to an ENT specialist still inwork.
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| 2824051 | 0.5 | U | OK | 02/01/2025 |
PPV |
MERCK & CO. INC. |
X027348 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
HCP reported no side effects; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP re...
HCP reported no side effects; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a 6 month and 26 days old child was inadverntly administered the PNEUMOVAX 23 vaccine. HCP stated that the patient was supposed to receive the PREVNAR 20 vaccine but wa; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a 6 month and 26 days old child was inadverntly administered the PNEUMOVAX 23 vaccine. HCP stated that the patient was supposed to receive the PREVNAR 20 vaccine but; This spontaneous report was received from a Medical assistant and refers to a 6-month-old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. 22-JAN-2025, the patient was inadvertently administered pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, prefilled syringe, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided) (Wrong product administered, Product confusion). No additional adverse event was reported.
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| 2824065 | 34 | M | CT | 02/01/2025 |
COVID19 |
PFIZER\BIONTECH |
ER3736 |
Injection site inflammation, Injection site irritation
Injection site inflammation, Injection site irritation
|
Long term inflammation and irritation in the injection site.
Long term inflammation and irritation in the injection site.
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| 2824066 | 72 | F | SC | 02/01/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Blood thyroid stimulating hormone normal, Electrocardiogram normal, Fatigue, Ful...
Blood thyroid stimulating hormone normal, Electrocardiogram normal, Fatigue, Full blood count normal, Heart rate irregular; Metabolic function test normal, Pyrexia
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Fever the night of 1/18 and 1/20, fatigue 1/19, irregular heart beat intermittently beginning approx...
Fever the night of 1/18 and 1/20, fatigue 1/19, irregular heart beat intermittently beginning approximately 1/23 or 1/24
More
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| 2824067 | 0.08 | F | DC | 02/01/2025 |
DTPPVHBHPB DTPPVHBHPB PNC15 PNC15 RV5 RV5 |
MSP VACCINE COMPANY MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
u7296aa u7296aa x027947 x027947 y005877 y005877 |
Diaphragmatic hernia, Dysphagia, Rotavirus infection, Stool analysis, Swallow st...
Diaphragmatic hernia, Dysphagia, Rotavirus infection, Stool analysis, Swallow study abnormal; Vomiting, Weight gain poor; Diaphragmatic hernia, Dysphagia, Rotavirus infection, Stool analysis, Swallow study abnormal; Vomiting, Weight gain poor; Diaphragmatic hernia, Dysphagia, Rotavirus infection, Stool analysis, Swallow study abnormal; Vomiting, Weight gain poor
More
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Pt diagnosed with Rotavirus infection with persistent vomiting 2 months after vaccination on Decembe...
Pt diagnosed with Rotavirus infection with persistent vomiting 2 months after vaccination on December 16, 2024. It is potentially believed by her GI specialists that the infection caused her seemingly mild diaphragmatic hernia to push through further and cause an inability to gain weight well due to excess vomiting and inability to eat well.
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โ | โ | ||||
| 2824068 | 46 | M | VA | 02/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Condition aggravated, Hypertension, Psoriasis
Condition aggravated, Hypertension, Psoriasis
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Adverse effect was increase in uncontrollable hypertension & psoriasis. Began taking water pill...
Adverse effect was increase in uncontrollable hypertension & psoriasis. Began taking water pills to control hypertension, and terrible psoriasis of the scalp. My PCP has been following me. A dermatologist has to step in to control the scalp psoriasis which never occurred until after this was taken.
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โ | |||||
| 2824069 | 31 | F | CO | 02/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Fatigue, Headache, Pain
Chills, Fatigue, Headache, Pain
|
Fatigue, severe body aches, chills, headache
Fatigue, severe body aches, chills, headache
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| 2824070 | 68 | F | GA | 02/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received an additional dose of Arexvy - above the recommended single dose. Reports no advers...
Patient received an additional dose of Arexvy - above the recommended single dose. Reports no adverse reactions or side effects.
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| 2824071 | 61 | F | PA | 02/01/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3043836 |
Axillary mass, Axillary pain, Contusion; Axillary mass, Axillary pain, Contusion
Axillary mass, Axillary pain, Contusion; Axillary mass, Axillary pain, Contusion
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I do not know which flu vaccine I received. The morning after the vaccine, I flew to another city...
I do not know which flu vaccine I received. The morning after the vaccine, I flew to another city. When I woke on the 18th I had a hard very painful approx three-quarter inch oval lump below my right armpit. The pain extended beyond the localized lump. My guess is the lump was a lymph node. A few days later when I woke, the lump was gone, and I had a bruise extending from my right armpit to the bottom of my right breast and the pain had changed from severe to minor. Prior to this, I just had mild or no reaction to a vaccine.
More
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| 2824072 | 11 | F | AZ | 02/01/2025 |
COVID19 FLU3 HPV9 MNQ TDAP |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
|
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Pfizer covid vaccine for age 12 years and up was administered to this 11 year old.
Pfizer covid vaccine for age 12 years and up was administered to this 11 year old.
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| 2824073 | 61 | M | VA | 02/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Facial pain, Muscle spasms, Pain, Pain in extremity, Paraesthesia
Facial pain, Muscle spasms, Pain, Pain in extremity, Paraesthesia
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2 and a half hours after vaccine both feet, toes and legs began to tingle and severe pain that radia...
2 and a half hours after vaccine both feet, toes and legs began to tingle and severe pain that radiated to the arms and left side of face. Toes on right foot cramped and curled.
More
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โ | โ | ||||
| 2824074 | 78 | F | KY | 02/01/2025 |
PNC20 RSV |
PFIZER\WYETH PFIZER\WYETH |
LG5575 LN5496 |
Injection site erythema, Peripheral swelling, Pruritus, Skin warm; Injection sit...
Injection site erythema, Peripheral swelling, Pruritus, Skin warm; Injection site erythema, Peripheral swelling, Pruritus, Skin warm
More
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Patient reports redness, swelling, warmth, and itching in her left arm that began the following morn...
Patient reports redness, swelling, warmth, and itching in her left arm that began the following morning after receiving the immunizations (about 24 hours later). She says it peaked around 48-72 hours after administration. She self-treated with diphenhydramine and said that did help. She was mostly recovered by the time she reported it to us on 2/1/25, but still had some minor redness around the injection sites.
More
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| 2824075 | 15 | M | PA | 02/01/2025 |
PPV |
MERCK & CO. INC. |
x027348 |
Erythema, Local reaction, Myalgia, Pain, Pyrexia
Erythema, Local reaction, Myalgia, Pain, Pyrexia
|
+large erythematous local reaction and high fevers, soreness and myalgias 24 hours after getting vac...
+large erythematous local reaction and high fevers, soreness and myalgias 24 hours after getting vaccine
More
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| 2824076 | 67 | M | CA | 02/01/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Asthenia, Back pain, Chills, Dizziness; Fatigue, Headache, Sleep dis...
Arthralgia, Asthenia, Back pain, Chills, Dizziness; Fatigue, Headache, Sleep disorder
More
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Approximately 9 hours after injection, I started to get chills. They were not terrible, but sent me ...
Approximately 9 hours after injection, I started to get chills. They were not terrible, but sent me to bed at 9:00PM. Rough night sleeping, as I was waking every hour or so due to pain in my knee, back, head. I was still having chills. At about 2:00 AM, I got up because of a pain in my right ankle. I do tend to have an inflammatory response there from vaccines. It also happened with Covid shots. Other vulnerable areas that were painful was my lower back (dull pain), as well as another area I have post vaccine issues with, the ball of my left foot. However, I could deal with this, and probably not file this report, if it wasn't for the next issue. When I got up at around 4:30AM, I stood up, feeling weak, and moved to and moved towards my bedroom door. As I did, I started to faint. Fortunately, I was able to get back on the bed and avoid injury from fainting. I tried again an hour or so later, and the same thing happened. I had been close to completely passing out 3 times. I read things on the CDC site that said that fainting side effects were generally thought to be associated with the procedure itself, rather than the vaccine. The fact that I was fainting many hours later, calls that into question. I had a fever of 100 degrees at 4:30 AM. It's 9:15 AM on 2/1/12025, and I'm feeling better, to be sure. Back is still quite sore, and I am very fatigued. The last time my back got this sore was after my first Covid shot back in 2020.
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| 2824077 | 70 | F | AR | 02/01/2025 |
RSV |
PFIZER\WYETH |
LL8391 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received Abrysvo on 11-13-2023 and again on 01-29-2025. Shot was duplicated. Spoke to pati...
Patient received Abrysvo on 11-13-2023 and again on 01-29-2025. Shot was duplicated. Spoke to patient on 01-29-25 and 01-30-25 and she reported NO adverse events.
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| 2824078 | 65 | F | FL | 02/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n77j2 |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
|
red, warn injection site
red, warn injection site
|
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| 2824079 | 63 | M | NV | 02/01/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LG5579 235d2 |
Pain, Sleep disorder, Tremor; Pain, Sleep disorder, Tremor
Pain, Sleep disorder, Tremor; Pain, Sleep disorder, Tremor
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Pt states he has uncontrollable shaking and can't sleep and has body aches.
Pt states he has uncontrollable shaking and can't sleep and has body aches.
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| 2824080 | 62 | F | TX | 02/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
X5T42 |
Chest discomfort, Chills, Headache, Myalgia, Pain
Chest discomfort, Chills, Headache, Myalgia, Pain
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January 24 around 1:00 PM - vaccine January 25 around 2:00 AM - chills, body aches, headache, chest ...
January 24 around 1:00 PM - vaccine January 25 around 2:00 AM - chills, body aches, headache, chest tight and muscle like pain on the right side of my body continued throughout the day even taking 600 mg ibuprofen every six hours. That evening fever was 101.4. Extreme fatigue during the day also. January 26 - Symptoms continued, especially severe headache and weakness. January 27 - Doctor s appointment. Fever that morning 102 and now experiencing nausea with severe headache, body aches. Fever blisters started appearing on the outside of mouth. Doctor did flu and Covid test, both negative. Said to alternate ibuprofen and Tylenol every 4 hours and told me to take Valacyclovir for fever blisters. If not better call her on Wednesday. January 28 - Seemed to feel a little better but weak and still had headache. Fever blisters on outside of mouth and sores on inside of mouth. About 4:00 PM chills started again and brought fever, extreme headache, and bodyache. Tylenol and ibuprofen were not helping much. Temp got up to 105 at one point. Unable to sleep and new pain developed under my right breast and radiated to my back. January 29 - Extremely weak by the ordeal and a little short of breath. Called doctor and she scheduled bloodwork for the next day. Did not miss Tylenol and ibuprofen and symptoms did improve. Pain under right breast returning when I laid down. Ate better today but very little. January 30 - No fever or body aches and better appetite. Still had a noticeable headache and was weak but otherwise much better. Pain under right breast woke me up several times in the night and had a little shortness of breath. January 31 - Doctor reported that bloodwork showed potassium was low and anemia. She suggested I have a CT Scan about pain to check for blood clot. Everything much improved, including headache. Throughout night pain under right breast still persisted but not as pronounced. February 1 - Mouth is healing, normal appetite and more energy.
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| 2824081 | 66 | F | TX | 02/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y011819 |
Chills, Erythema, Myalgia, Pyrexia
Chills, Erythema, Myalgia, Pyrexia
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Got the Capvaxive shot,that night patient got fever,muscle pain and chill,fever gone in 2 days but t...
Got the Capvaxive shot,that night patient got fever,muscle pain and chill,fever gone in 2 days but the muscle pain and redness on the skin still there
More
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| 2824082 | 15 | F | MI | 02/01/2025 |
HPV9 |
MERCK & CO. INC. |
Y012776 |
Pain in extremity
Pain in extremity
|
PATIENT'S CAREGIVER ( DAD) REPORTED PATIENT HAD PAIN IN LEFT ARM FOR PAST FEW DAYS AFTER RECE...
PATIENT'S CAREGIVER ( DAD) REPORTED PATIENT HAD PAIN IN LEFT ARM FOR PAST FEW DAYS AFTER RECEIVING VACCINE. HE ALSO ADDED WITH PAINFUL ARM PATIENT PRACTICED VOLLEYBALL GAME FOR PAST FEW DAYS, WHICH ELEVATED HER PAIN LEVEL. SHE WAS SEEN BY CLINIC TODAY. SHE WAS PRESCRIBED MUSCLE RELAXANTS , NSAIDS BY THE CLINIC.
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| 2824083 | 35 | F | MI | 02/01/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM7786 UT8506JA |
Headache, Injection site erythema, Injection site swelling, Injection site warmt...
Headache, Injection site erythema, Injection site swelling, Injection site warmth; Headache, Injection site erythema, Injection site swelling, Injection site warmth
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Vaccines administered 1/29/25, patient called the pharmacy 2/1/25 with c/c of local redness, swellin...
Vaccines administered 1/29/25, patient called the pharmacy 2/1/25 with c/c of local redness, swelling and warmth and headache. The headache resolved after 24 hours but the patient continues to have local injection site reactions. RPh advised patient to continue acetaminophen as directed and to apply ice. Pt verbalized understanding.
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| 2824085 | 65 | M | SC | 02/01/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2210 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
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pt says on 1/31/25 injection site began slight swelling, redness and itching. he tried putting some ...
pt says on 1/31/25 injection site began slight swelling, redness and itching. he tried putting some alcohol on it. But no other symptoms or reactions.
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| 2824148 | 67 | F | OH | 02/01/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1780 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Pt. received dose of Pfizer Comirnaty (2024-25) vaccine in right deltoid. Pt had soreness, redness a...
Pt. received dose of Pfizer Comirnaty (2024-25) vaccine in right deltoid. Pt had soreness, redness at injection site. Minor swelling at injection site.
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โ | |||||
| 2823830 | 11 | F | IN | 01/31/2025 |
MMRV |
MERCK & CO. INC. |
X026597 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No additional AE; HCP called to report a 11-year-old patient was administered PROQUAD, when she was ...
No additional AE; HCP called to report a 11-year-old patient was administered PROQUAD, when she was only due for Varicella vaccine. Inquiring about the validity of the Varicella and potential side effects of additional MMR II. See request cases, 02741163 and 0271190.; This spontaneous report was received from Other Health Professional (Medical Assistant) and refers to an 11-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 22-JAN-2025, the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot #X026597, expiration date: 11-MAY-2025, administered for prophylaxis (strength, dose, route of administration, and anatomical site of injection were not provided). The patient was only due for the varicella vaccine, but the combination vaccine (PROQUAD) was administered instead (wrong product administered). Additionally, the patient was vaccinated with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose description, lot #, expiry date, route of administration, and indication were not provided). No additional adverse events were reported (no adverse event). No additional information was available.
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| 2823831 | 61 | U | AZ | 01/31/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
More
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The patient has not report and medical concerns or symptoms regarding this report; Pharmacist stated...
The patient has not report and medical concerns or symptoms regarding this report; Pharmacist stated that a 61 year old patient was concomitantly administered VARIVAX and MMR II during the same vaccination appointment today; This spontaneous report was received from a pharmacist and refers to a 61-year-old of unknown gender.The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 28-JAN-2025, during the same vaccination appointment, the patient was concomitantly vaccinated with a both varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/two dose series and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter /two dose series, administered for prophylaxis (strengths, lot numbers, expiry dates, and routes of administration were not provided) (product administered to patient of inappropriate age ). It was confirmed the patient has not report and medical concerns or symptoms regarding this report (no adverse event). No additional information provided. Additional information is not expected.
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| 2823832 | U | IL | 01/31/2025 |
MMRV |
MERCK & CO. INC. |
Y010050 |
Product storage error
Product storage error
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Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025.; This ...
Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025.; This spontaneous report was received from an Other Health Professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On 23-JAN-2025, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #Y010050, expiration date: 25-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).
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| 2823833 | F | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache, Pain
Headache, Pain
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Body aches as worsened; headache was reported as worsened; This non-serious case was reported by a o...
Body aches as worsened; headache was reported as worsened; This non-serious case was reported by a other health professional via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13-JAN-2025, the patient received Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Body aches as worsened) and headache (Verbatim: headache was reported as worsened). The outcome of the general body pain and headache were not resolved. The reporter considered the general body pain and headache to be related to Shingrix. The company considered the general body pain and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 14-JAN-2025 The patient received Shingrix and had body aches and headache. Body aches and headache was reported as worsened. The patient had subsequent dose of Shingrix.
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| 2823834 | 72 | M | ID | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
G97Y2 |
Product preparation issue
Product preparation issue
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Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine ...
Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis. On 04-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that who received Shingrix adjuvant alone without the powder as a Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025001095, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025001095:Same reporter/Different aptient
More
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| 2823835 | 11 | M | PA | 01/31/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
9R5LC |
Expired product administered
Expired product administered
|
expired Havrix vaccine was administered; This non-serious case was reported by a other health profes...
expired Havrix vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis. On 14-JAN-2025, the patient received Havrix. On 14-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix vaccine was administered). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 14-JAN-2025 The office manager reported that an expired Havrix vaccine was administered to a patient which led to, expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2025004473, reported by the same reporter.; Sender's Comments: US-GSK-US2025004473:Same reporter/Different patient
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| 2823836 | F | WV | 01/31/2025 |
MEN |
UNKNOWN MANUFACTURER |
|
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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received menquadfi 26 months apart, she didn't receive the 2nd menquadfi after the age of sixte...
received menquadfi 26 months apart, she didn't receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, the child female patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 26 months apart, she didn't receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination 26 months apart, she didn't receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event (product administered to patient of inappropriate age) (unknown latency). Reportedly, The problem is she didn't receive the 2nd Menquadfi after the age of sixteen. Both were done before the patient turned 16 but were 26 months apart. They want to know if the patient is still immunized or do they need the booster after age of sixteen even though the patient had the 2 Menquadfi. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823837 | F | NJ | 01/31/2025 |
YF |
SANOFI PASTEUR |
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Product preparation issue
Product preparation issue
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administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of...
administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of the diluent supplied with the yf-vax with no reported ae; administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of the diluent supplied with the yf-vax with no reported ae; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age female patient who received yellow fever vaccine - US [YF-VAX] reconstituted using a sterile diluent for an MMR vaccine instead of the diluent supplied with the YF-VAX with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect yellow fever vaccine - US Solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization, reconstituted using a sterile diluent for an MMR vaccine instead of the diluent supplied with the YF-VAX with no reported adverse event (product preparation error) (poor quality product administered) (Latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, the patient was a singer on a cruise ship. She was mandated to take a yellow fever vaccine, and since the dose was invalid, she needs to be re-vaccinated as soon as possible. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823838 | 1.33 | M | 01/31/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK114AA |
Product storage error
Product storage error
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PENTACEL being inadvertently administered to a patient after being exposed to a shipping temperature...
PENTACEL being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine Conj 20V (CRM197) (Prevnar 20) for Immunisation. On 27-Jan-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK114AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the left vastus lateralis for Immunization and pentacel being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event (poor quality product administered) (latency : same day). Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administration of PENTACEL after a shipping excursion." This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823839 | U | LA | 01/31/2025 |
HIBV |
SANOFI PASTEUR |
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Product preparation issue
Product preparation issue
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inappropriate use due to only the diluent of ACT-HIB was given to a patient with no reported adverse...
inappropriate use due to only the diluent of ACT-HIB was given to a patient with no reported adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, the inappropriate use due to only the diluent of HIB (PRP/T) Vaccine [ACT-HIB] was given to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the inappropriate use due to only the diluent of HIB (PRP/T) Vaccine Powder and solvent for solution for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination was given to a patient with no reported adverse event (single component of a two-component product administered) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Supervisor did not have the patient's information at the time of the call. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823840 | 11 | F | NY | 01/31/2025 |
HIBV |
SANOFI PASTEUR |
UK092AB |
Extra dose administered, Product administered to patient of inappropriate age
Extra dose administered, Product administered to patient of inappropriate age
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ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and ...
ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and this was considered an extra dose with no adverse event; ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and this was considered an extra dose with no adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves HIB (PRP/T) VACCINE [ACT-HIB] was administered to a 11 year old female patient and child was not intended to receive ACT-HIB and this was considered an extra dose with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine and HPV vaccine VLP rL1 2v (baculovirus) (Human papillomavirus (types 16, 18) vaccine, adsorbed) for Immunisation. On 27-Jan-2025, the 11 year old patient received 0.5 ml (dose 3) of HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK092AB; Expiration Date: 31-May-2025) via intramuscular route in the left deltoid for Immunization and child was not intended to receive ACT-HIB and this was considered an extra dose with no adverse event (product administered to patient of inappropriate age) (extra dose administered) (latency: same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823851 | F | MI | 01/31/2025 |
PPV |
MERCK & CO. INC. |
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Therapy non-responder
Therapy non-responder
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A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two ser...
A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two serotypes tested (types 3 and 18C). However, her last pneumococcal vaccine was 12 years prior.; Literature Report. This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, she was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. It was reported that her last pneumococcal vaccination was 12 years ago. On an unknown date, reported as 12 years later, A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two serotypes tested (types 3 and 18C). The outcome of the event was not provided. The authors of the article considered low levels of antibodies as related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. Lot # is being requested and will be submitted if received.
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| 2823852 | 23 | M | 01/31/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
95DB2 |
Expired product administered
Expired product administered
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Expired dose given; This non-serious case was reported by a nurse via call center representative and...
Expired dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 06-JAN-2025, the patient received the 1st dose of Havrix. On 06-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-JAN-2025 The patient received his first dose of Havrix that was expired on 13th December 2024 which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
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| 2823853 | 54 | F | TX | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
354M3 |
Extra dose administered
Extra dose administered
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received two doses of Shingrix on the same day back on January 8th 2025 by accident; This non-seriou...
received two doses of Shingrix on the same day back on January 8th 2025 by accident; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 08-JAN-2025, the patient received the 3rd dose of Shingrix. On 08-JAN-2025, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced accidental overdose (Verbatim: received two doses of Shingrix on the same day back on January 8th 2025 by accident). The outcome of the accidental overdose was unknown. Additional Information: GSK receipt date: 09-JAN-2025 The pharmacist reported that the patient received two doses of Shingrix on the same day which led to, accidental overdose.
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| 2823906 | 1.25 | F | OH | 01/31/2025 |
HIBV PNC20 |
MERCK & CO. INC. PFIZER\WYETH |
UK170AB LG5574 |
Erythema, Induration, Local reaction, Tenderness; Erythema, Induration, Local re...
Erythema, Induration, Local reaction, Tenderness; Erythema, Induration, Local reaction, Tenderness
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local reaction--10cm redness, induration, tenderness. no systemic symptoms
local reaction--10cm redness, induration, tenderness. no systemic symptoms
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| 2823907 | 77 | F | NH | 01/31/2025 |
RSV |
MODERNA |
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Feeling abnormal, Influenza like illness, Nausea, Vertigo, Vomiting
Feeling abnormal, Influenza like illness, Nausea, Vertigo, Vomiting
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pt says when she stood up she had virtigo. The room started spinning and she vomited. She stayed nau...
pt says when she stood up she had virtigo. The room started spinning and she vomited. She stayed nauseated and her head was spinning all day. She vomited about 30 times. She called her doctors office and recommended her to go to the ER. She went to Medical Center. After sitting in the ER for about 2 hours her symptoms seemed to get better so she left before being treated. She went home and had some broth and sodas, however she was not able to keep them down. She no longer had the virtigo. By this morning she was able to eat some toast and have some juice and keep it down. She still feels bad like she has the flu but she does feel some better and thinks she will be okay. She will contact her PCP to follow up.
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| 2823908 | 6 | F | MN | 01/31/2025 |
FLU3 |
SANOFI PASTEUR |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient received Flublock vaccine, which is intended for patients 18 and older, not for a 6 year old...
Patient received Flublock vaccine, which is intended for patients 18 and older, not for a 6 year old patient. No significant side effects noted following this. Family reported some low grade fever, congestion following the vaccine but also acknowledged that she could have minor viral illness.
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| 2823909 | 28 | F | NY | 01/31/2025 |
MMR |
MERCK & CO. INC. |
y008290 |
Contraindication to vaccination
Contraindication to vaccination
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MMR given to patient while patient on Humira
MMR given to patient while patient on Humira
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| 2823910 | 26 | F | MA | 01/31/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00595 |
Lymph node pain, Lymphadenopathy
Lymph node pain, Lymphadenopathy
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Pt. Had Post exposure rabies vaccines- this was #2. vaccine given in morning and that evening she no...
Pt. Had Post exposure rabies vaccines- this was #2. vaccine given in morning and that evening she noticed 2 swollen lymph Glands in clavicle area On exam, Pt. has 2 tender swollen glands, 1 cm each. 1 is infraclavicular on the left and the other is above this approximately 4cm . Normal range of arm . No other infectious source is noted. Pt advised to use ibuprofen and hot packs. Will touch base next day. Also has follow up appointment on 2/5/2025
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| 2823911 | 87 | F | KY | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2224 |
Death, Electrocardiogram ST segment elevation
Death, Electrocardiogram ST segment elevation
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Sent out for ST elevation; expired on 1/12/24
Sent out for ST elevation; expired on 1/12/24
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โ | โ | ||||
| 2823912 | 89 | F | KY | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2224 |
Death
Death
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none at time of administration
none at time of administration
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| 2823913 | 11 | M | GA | 01/31/2025 |
FLU3 MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UT8485KA U8370AA U7983AA |
Vaccination error; Vaccination error; Vaccination error
Vaccination error; Vaccination error; Vaccination error
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Flu vaccine was given in error. Flu vaccine was declined by parent.
Flu vaccine was given in error. Flu vaccine was declined by parent.
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| 2823914 | 46 | F | VT | 01/31/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
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Arthralgia, C-reactive protein increased, Chest X-ray abnormal, Chest pain, Dysp...
Arthralgia, C-reactive protein increased, Chest X-ray abnormal, Chest pain, Dyspnoea; Electrocardiogram normal, Fibrin D dimer normal, Leukocytosis, Myalgia, Peripheral swelling; Pulmonary mass, Pyrexia, Red blood cell sedimentation rate normal, Troponin normal, Twin reversed arterial perfusion sequence malformation; White blood cell count increased
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Already described earlier in the report- fever, acardia, chest pain, severe myalgia and arthralgias,...
Already described earlier in the report- fever, acardia, chest pain, severe myalgia and arthralgias, shortness of breath, localized swelling in the arm, elevated white count.
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| 2823915 | 56 | F | TX | 01/31/2025 |
PNC20 |
PFIZER\WYETH |
lj5280 |
Injection site pain, Injection site pruritus, Pruritus
Injection site pain, Injection site pruritus, Pruritus
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Patient did not have reaction right away and has itching throughout her body as well as the injectio...
Patient did not have reaction right away and has itching throughout her body as well as the injection site along with pain at the site
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| 2823916 | 92 | F | KY | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2224 |
Death
Death
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resident died
resident died
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โ | |||||
| 2823918 | 17 | M | NY | 01/31/2025 |
COVID19 |
MODERNA |
3044211 |
Underdose
Underdose
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On 1/10/2025 the patient received a Moderna covid vaccine for 6 months-11 years of age instead of fo...
On 1/10/2025 the patient received a Moderna covid vaccine for 6 months-11 years of age instead of for 12 years of age and above.
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| 2823919 | 37 | F | ND | 01/31/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
Gh9702 Gh9702 |
Angiogram, Autoimmune thyroiditis, Laboratory test, Magnetic resonance imaging, ...
Angiogram, Autoimmune thyroiditis, Laboratory test, Magnetic resonance imaging, Mast cell activation syndrome; Syncope, Tilt table test, X-ray
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Currently diagnosed hashimotos auto immune disease, mcas, vasovagal syncope
Currently diagnosed hashimotos auto immune disease, mcas, vasovagal syncope
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โ |