| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2851480 | 16 | F | KS | 07/28/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
XX33P U8370AA |
Syncope; Syncope
Syncope; Syncope
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syncope after giving vaccine. Monitored pulse, bp and o2 during episode. vitals - pulse 54, bp 92/44...
syncope after giving vaccine. Monitored pulse, bp and o2 during episode. vitals - pulse 54, bp 92/44 and o2 98%RA at 10:30. Rechecked 5 times during visit. Final measures were 11:02 pulse 51, o2 98% RA and BP of 95/54.
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| 2851481 | 12 | F | AZ | 07/28/2025 |
HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y013565 Y013565 Y013565 Y013565 |
Headache, Injection site swelling, Magnetic resonance imaging, Pain in extremity...
Headache, Injection site swelling, Magnetic resonance imaging, Pain in extremity, Rash erythematous; Rash pruritic, Skin warm, White blood cell count decreased; Blood test normal, Condition aggravated, Eczema, Headache, Injection site swelling; Magnetic resonance imaging, White blood cell count decreased; Headache, Injection site swelling, Magnetic resonance imaging, Pain in extremity, Rash erythematous; Rash pruritic, Skin warm, White blood cell count decreased; Blood test normal, Condition aggravated, Eczema, Headache, Injection site swelling; Magnetic resonance imaging, White blood cell count decreased; Headache, Injection site swelling, Magnetic resonance imaging, Pain in extremity, Rash erythematous; Rash pruritic, Skin warm, White blood cell count decreased; Blood test normal, Condition aggravated, Eczema, Headache, Injection site swelling; Magnetic resonance imaging, White blood cell count decreased
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Patient received shot and an hour later her arm started to swell at injection site. Arm was painful,...
Patient received shot and an hour later her arm started to swell at injection site. Arm was painful, warm to the touch. Later she received small red bumps on the inside of her arms that were very itchy. She does have some allergies so thought it was just a reaction to the shot. The next day she had a headache that hurts across her forehead. This has been 24hours a day since July 2. It is now July 28. We had a follow up with our primary doctor July 14. To discuss the side effects. We were recommended magnesium and b-2 to help the headache. After a week we saw no improvement and were sent to a neurologist. Blood work was taken and MRI done.
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| 2851482 | 11 | F | TX | 07/28/2025 |
MNQ |
SANOFI PASTEUR |
u8438aa |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Nausea
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2.5 X 2 inch of redness and swelling (was like a hard knotted ball on saturday). Patient was seen i...
2.5 X 2 inch of redness and swelling (was like a hard knotted ball on saturday). Patient was seen in office today, she became nauseated on friday and saturday and feeling a little better today. Area is still red and swollen but not so hard to the touch anymore. Pain and tenderness to the site.
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| 2851483 | 12 | M | TN | 07/28/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
343dd h4279 |
Injection site bruising, Injection site erythema, Injection site swelling, Injec...
Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth; Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
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GRAPEFRUIT AREA OF REDNESS, WARMTH AND MILD SWELLING OF INJECTION SITE. BRUISING CENTRALLY LOCATED ...
GRAPEFRUIT AREA OF REDNESS, WARMTH AND MILD SWELLING OF INJECTION SITE. BRUISING CENTRALLY LOCATED WITHIN AREA OF REDNESS THAT HAS FADED TO A LIGHT TAN COLOR.
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| 2851484 | 9 | F | MO | 07/28/2025 |
PPV PPV PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y016291 Y016291 Y016291 Y016291 |
C-reactive protein increased, Cellulitis, Decreased appetite, Fatigue, Full bloo...
C-reactive protein increased, Cellulitis, Decreased appetite, Fatigue, Full blood count; Injection site erythema, Injection site oedema, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging abnormal; Muscle oedema, Myositis, Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased; Shift to the left, X-ray limb abnormal
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Several hours after administration, patient developed pain to the left arm out of proportion to what...
Several hours after administration, patient developed pain to the left arm out of proportion to what was expected. She then developed fever to 102.5, fatigue, anorexia. Over the following 72 hours she had recurrent fevers and worsening edema, erythema, pain to the left arm distal to the injection site to extending to the elbow. She had decreased range of motion to the left elbow and presented for care. Imaging showed triceps and deltoid myositis, fluid collection, and cellulitis of the left arm. She was admitted for IV antibiotics.
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| 2851485 | 50 | F | 07/28/2025 |
COVID19 FLU3 HEP MMR PNC21 |
MODERNA SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
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Arthralgia, Loss of personal independence in daily activities, Product administe...
Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain
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This has completely affected every area of my life; Arthralgia; Pharmacist gave me two shots on each...
This has completely affected every area of my life; Arthralgia; Pharmacist gave me two shots on each shoulder, one in my left forearm, on my right shoulder he did one too high, I still have pain in that shoulder, he did two in my left shoulder, pain is unbearable.; The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This has completely affected every area of my life), ARTHRALGIA (Arthralgia), VACCINATION SITE PAIN (Pharmacist gave me two shots on each shoulder, one in my left forearm, on my right shoulder he did one too high, I still have pain in that shoulder, he did two in my left shoulder, pain is unbearable.) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high) in a 50-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Hepatitis b vaccine rHBsAg (yeast) (Engerix b) for an unknown indication, Influenza vaccine inact split 3v (Afluria) for an unknown indication, Mmr ii for an unknown indication and Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Previously administered products included for Drug use for unknown indication: Clindamycin. Past adverse reactions to the above products included Allergy to antibiotic with Clindamycin. Concurrent medical conditions included Diabetes, Rheumatoid arthritis and Allergy to antibiotic. Concomitant products included Insulin porcine (Insulin), Methylphenidate hydrochloride (Ritalin), Metformin hydrochloride (Metformin), Meloxicam, Ibuprofen (Motrin), Prenatal vitamins, Magnesium, Tocopherol (Vitamin e), Ascorbic acid (Vitamin C), Ergocalciferol (Vitamin d) and Calcium for an unknown indication. On 03-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Other) 1 dosage form, dose of Hepatitis b vaccine rHBsAg (yeast) (Engerix b) (unknown route) 1 dosage form, dose of Influenza vaccine inact split 3v (Afluria) (Other) 1 dosage form, dose of Mmr ii (Other) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (unknown route) 1 dosage form. On 03-Dec-2024, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high). On 05-Dec-2024, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This has completely affected every area of my life), ARTHRALGIA (Arthralgia) and VACCINATION SITE PAIN (Pharmacist gave me two shots on each shoulder, one in my left forearm, on my right shoulder he did one too high, I still have pain in that shoulder, he did two in my left shoulder, pain is unbearable.). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This has completely affected every area of my life), ARTHRALGIA (Arthralgia) and VACCINATION SITE PAIN (Pharmacist gave me two shots on each shoulder, one in my left forearm, on my right shoulder he did one too high, I still have pain in that shoulder, he did two in my left shoulder, pain is unbearable.) had not resolved and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Other) was unknown. It was reported that the site of administration was reported as OT for Moderna COVID-19 vaccine and Afluria. It was reported that the pharmacist gave patient two shots on each shoulder, and one in left forearm. On her right shoulder he did one too high and she still had pain in that shoulder and pharmacist did two in her left shoulder and the pain was unbearable. She had to go to the emergency room a couple days after because the pain was too much. She had been to the emergency room three times since unknown date in Dec-2024 and 05-Feb-2025. This had completely affected every area of her life. The pain had not gotten better, and she did not know where to go from there. She underwent laboratory test and X-ray, but no results were reported. Treatment information was not reported.
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| 2851486 | 0.17 | M | 07/28/2025 |
HIBV PNC13 |
MERCK & CO. INC. PFIZER\WYETH |
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Injection site granuloma; Injection site granuloma
Injection site granuloma; Injection site granuloma
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Developed vaccine granulomas in fatty tissue of right thigh after vaccines given
Developed vaccine granulomas in fatty tissue of right thigh after vaccines given
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| 2851487 | 4 | F | CA | 07/28/2025 |
TD |
MASS. PUB HLTH BIOL LAB |
U8385BA |
Wrong product administered
Wrong product administered
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Grabbed from the labeled area in the fridge and didnt double check label. Vaccine was in wrong spot ...
Grabbed from the labeled area in the fridge and didnt double check label. Vaccine was in wrong spot patient was due for DTAP/IPV and I grabbed Td and drew it up and gave it. I didnt realize the mistake until after it was given.
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| 2851488 | 13 | F | OK | 07/28/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y015599 XL223 M2G3Z |
Hyporesponsive to stimuli, Pallor, Syncope; Hyporesponsive to stimuli, Pallor, S...
Hyporesponsive to stimuli, Pallor, Syncope; Hyporesponsive to stimuli, Pallor, Syncope; Hyporesponsive to stimuli, Pallor, Syncope
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Pt received routine immunizations. Pt went into the hallway before full 15 minute assessment could ...
Pt received routine immunizations. Pt went into the hallway before full 15 minute assessment could be completed. Pt then became pail in color and then her legs started to collapse. RN assisted pt to the floor. Code RRT called. Pt remained in the floor as RRT team arrived. Pt was assessed. BP 100/61, P-79, R-16, FSBS-96.Pt started becoming more reponsive and talking. They sat pt up which she tolerated well. Able to ambulate with ER providers at her side. Then left the area.
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| 2851489 | 67 | F | AR | 07/28/2025 |
PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
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Blood pressure increased, Cardiac stress test, Computerised tomogram normal, Con...
Blood pressure increased, Cardiac stress test, Computerised tomogram normal, Condition aggravated, Electrocardiogram; Headache, Heart valve incompetence, Joint swelling, Peripheral swelling, Swelling; Tension
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After i got the shot my arm started to bother me and it was swelling. I have issues all in my neck a...
After i got the shot my arm started to bother me and it was swelling. I have issues all in my neck and it was swelling. I had headaches really bad and pain in my head. My blood pressure was going up and then it was going up and down. It was so high that i went back to the Clinic and nurse took my blood pressure there and it was still up and down and she let me know the doctor would be with me. The Dr came in and took it again and the same thing was happening and the pains were there as well i could hardly old my head up. She ordered a CT Scan and wanted me to go to the hospital. And since then i have been steady in and out the ER trying to get some help and also at the Clinic. It was so high that i was scared i was gonna have a stroke or a heart attack. When i was in the hospital as long as i was awake it would be 190/200. Before I had the shot I had high blood pressure but it was regulated and every since I got the shot it has been over 200 and not able to control it. I got on more medications and not one day has gone by that it does not go over 200, everyday since i got the shot its been like that. All the times i went to the hospital they never kept me over night and they would just treat me and send me home. They gave me medication to bring me down but the rebound of the medication would cause it to go back up. The hospital would just send me home every time and sometimes i would leave and my blood pressure would still be high. Since then i have been diagnosed with a leaky heart valve due to the blood pressure being up so high at all times. My cardiologist states i have bad tension in my legs and ankles they stay swollen.
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| 2851490 | 66 | F | FL | 07/28/2025 |
RAB |
SANOFI PASTEUR |
Y1A86P1 |
Injection site erythema, Injection site oedema, Pyrexia
Injection site erythema, Injection site oedema, Pyrexia
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She got her last Rabies Vaccine after cat bite on 07/22/2025. On the next day Wednesday Pm she had ...
She got her last Rabies Vaccine after cat bite on 07/22/2025. On the next day Wednesday Pm she had fever redness and edema only at vaccine site. She took Benadryl Cream and took 50 mg. PO
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| 2851491 | 61 | F | NC | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5A4XG |
Rash
Rash
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RASH ON PALMS AND TOP OF THE FOREARM
RASH ON PALMS AND TOP OF THE FOREARM
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| 2851492 | 71 | M | WI | 07/28/2025 |
PNC20 |
PFIZER\WYETH |
LP4946 |
Injection site discolouration, Injection site pain, Injection site pruritus
Injection site discolouration, Injection site pain, Injection site pruritus
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Five days after injection patient noted large area of "yellowish" skin surrounding the inj...
Five days after injection patient noted large area of "yellowish" skin surrounding the injection site. The yellowish discolored area was sounded by a thin red line. This was noted on the lateral right shoulder and measured approximately 6" x 4 ". The area was slightly itchy and tender but not warm to the touch.
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| 2851493 | 63 | M | AL | 07/28/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Diarrhoea, Fatigue, Gastrointestinal sounds abnormal, Headache, Immunisation rea...
Diarrhoea, Fatigue, Gastrointestinal sounds abnormal, Headache, Immunisation reaction; Injection site pain, Lethargy, Nausea, Pyrexia
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after being vaccinated he developed a sore arm at the injection site then 24 hours later he develope...
after being vaccinated he developed a sore arm at the injection site then 24 hours later he developed a headache at the base of his skull. He became nauseated with fever and chills. Then he developed sever diarrhea with a rumbling gut. He feels lethargic and very tired and continues to have these symptoms.
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| 2851494 | 56 | F | PA | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
MD2414 |
Vertigo
Vertigo
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2 days post vaccine patient suddenly began to experience severe vertigo. It has lasted so far until ...
2 days post vaccine patient suddenly began to experience severe vertigo. It has lasted so far until today's date. She sought medical treatment and was put on meclizine with no relief and then prescriber added diazepam
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| 2851495 | 60 | F | CA | 07/28/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
Dyspnoea, Injection site pain, Injection site urticaria, Pain
Dyspnoea, Injection site pain, Injection site urticaria, Pain
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patient recieved the vaccination on 7/23/25 and was experiencing the normal bodyaches and local inje...
patient recieved the vaccination on 7/23/25 and was experiencing the normal bodyaches and local injection site pain. Starting on the morning of 7/27/25, patient started to have hives near the injection site and started to experience difficulty breathing.
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| 2851496 | 1.42 | F | GA | 07/28/2025 |
VARCEL |
MERCK & CO. INC. |
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Blister, Rash, Rash pruritic
Blister, Rash, Rash pruritic
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Blisters and rash on back, torso, and down legs. Very itchy and painful. 4 weeks long.
Blisters and rash on back, torso, and down legs. Very itchy and painful. 4 weeks long.
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| 2851497 | 51 | F | OH | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Injected limb mobility decreased, Pain, Pain in extremity
Injected limb mobility decreased, Pain, Pain in extremity
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Left arm pain that developed a few hours after vaccine. Severe pain limiting ROM. Pain has lasted mo...
Left arm pain that developed a few hours after vaccine. Severe pain limiting ROM. Pain has lasted more than a week. Has pain with active and passive ROM. Concern for rotator cuff injury.
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| 2851498 | 38 | F | MA | 07/28/2025 |
VARCEL |
MERCK & CO. INC. |
Z004245 |
Inappropriate schedule of product administration, No adverse event, Wrong produc...
Inappropriate schedule of product administration, No adverse event, Wrong product administered
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Patient was to receive the MMR vaccine as a result of non-immune titers. Varicella vaccine was admin...
Patient was to receive the MMR vaccine as a result of non-immune titers. Varicella vaccine was administered instead. MMR vaccine had been placed in the Varicella bin in the freezer. Patient did not and has not experienced any side effects. MMR dose was administered two days later.
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| 2851499 | 75 | M | TX | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Carpal tunnel decompression, Pain in extremity, Rheumatoid factor positive
Carpal tunnel decompression, Pain in extremity, Rheumatoid factor positive
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I started to have intense pain in my hands. Had carpal tunnel surgery on each hand and the pain did...
I started to have intense pain in my hands. Had carpal tunnel surgery on each hand and the pain did not subside. I was then tested for rheumatoid arthritis and I tested positive.
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| 2851500 | 52 | M | DE | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Carcinoid tumour of the small bowel, Death
Carcinoid tumour of the small bowel, Death
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He died of carsonoid tumor in his small intestines
He died of carsonoid tumor in his small intestines
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โ | โ | ||||
| 2851501 | F | 07/28/2025 |
COVID19 |
MODERNA |
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Mast cell activation syndrome, Weight
Mast cell activation syndrome, Weight
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Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the ...
Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) (seriousness criterion medically significant). At the time of the report, MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: she used to be 196 lbs and is currently down to 140 lbs.. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. In 2020 or 2021, when the first vaccine came out, patient took it. Patient took another one a year later. She had since been sick all the time. She got flare-ups in the forms of hives and rashes. She felt pain in her body and limbs, and they always felt weak. Her joints hurt. She went to a dermatologist, but he was not able to diagnose her. She also had ongoing vomiting and diarrhea accompanied by abdominal pain. When she went to the ER, they were not able to tell her what the problem was. She used to be 196 lbs and was currently down to 140 lbs. She was finally diagnosed to have Mast Cell Syndrome. It was also reported that she had mast cells in her stomach. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to MOD-2025-788256 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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| 2851502 | 0.33 | F | MA | 07/28/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U8265AA |
Injection site haematoma
Injection site haematoma
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Small hematoma on left thigh at injection site
Small hematoma on left thigh at injection site
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| 2851503 | 65 | M | CO | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0588 |
Ageusia
Ageusia
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I have not been able to taste anything that I eat. Most thing taste like a sandy taste.
I have not been able to taste anything that I eat. Most thing taste like a sandy taste.
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| 2851504 | 71 | F | CA | 07/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5A4X6 5A4X6 |
Injection site inflammation, Injection site pain, Injection site reaction, Injec...
Injection site inflammation, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous; Rash pruritic
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AFTER RECEIVING THE VACCINE, PATIENT HAD TENDERNESS IN THE AREA FOR 2 TO 3 DAYS AND THEN DEVELOPED A...
AFTER RECEIVING THE VACCINE, PATIENT HAD TENDERNESS IN THE AREA FOR 2 TO 3 DAYS AND THEN DEVELOPED A RED RASH ON THE MORNING OF THE 3RD DAY. PATIENT SAYS IT WAS ITCHY AND INFLAMED. THERE IS NO PAIN BUT IT WAS WARM TO THE TOUCH.
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| 2851505 | 11 | M | MN | 07/28/2025 |
HPV9 HPV9 MNQ MNQ TDAP TDAP HPV9 HPV9 MNQ MNQ TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y015599 Y015599 U8493AA U8493AA 9JT4S 9JT4S Y015599 Y015599 U8493AA U8493AA 9JT4S 9JT4S |
Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching; Cold swea...
Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching; Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching; Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching; Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching; Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching; Cold sweat, Pallor, Tinnitus; Dizziness, Dyspnoea, Flushing, Retching
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Patient received vaccines: HPV, Tdap, Meningococcal at 1:46 pm. At 2:15 PM, writer was paged to assi...
Patient received vaccines: HPV, Tdap, Meningococcal at 1:46 pm. At 2:15 PM, writer was paged to assist with patient. patient was clammy, pale, and reported ringing in his ears. Patient was monitored for ~15 mins, VS stable, and discharged home with mother.
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| 2851506 | 0.5 | M | MO | 07/28/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site rash, Rash
Injection site rash, Rash
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Rash developed 2 days after vaccination to injection site and chest. 2.5 mg Zyrtec given for rash wi...
Rash developed 2 days after vaccination to injection site and chest. 2.5 mg Zyrtec given for rash with some improvement.
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| 2851507 | 15 | M | NV | 07/28/2025 |
COVID19 MENB MNQ |
MODERNA NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
b0021 77ka5 z92L4 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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no adverse events. but the teen received the MCV4 and Men B in error.. these vaccines were not due...
no adverse events. but the teen received the MCV4 and Men B in error.. these vaccines were not due until age 16yrs- which is 6 months and 1 week in the future
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| 2851508 | 24 | F | IN | 07/28/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Apnoea, Paralysis, Seizure, Swollen tongue; Apnoea, Paralysis, Seizure, Swollen ...
Apnoea, Paralysis, Seizure, Swollen tongue; Apnoea, Paralysis, Seizure, Swollen tongue
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Upon waking the morning after injections the pt had a visibly swollen tongue, approx. 2x normal size...
Upon waking the morning after injections the pt had a visibly swollen tongue, approx. 2x normal size, with teeth indents present. This swelling persisted for approx. 1 week and gradually reduced from days 7-14 post vaccination. Pt also experienced numerous nocturnal seizures or paralytic episodes in which breathing ceased and full body paralysis occurred for an unknown length of time estimated to be between 10 and 60 seconds. These seizures initially occurred once nightly post vaccination and possibly involved elevated heart rate and blood pressure. The seizures became less frequent and less severe after 2 weeks post vaccination.
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| 2851509 | 16 | F | IN | 07/28/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
3443E 3443E |
Dizziness, Fall, Flushing, Hyperhidrosis, Hyperventilation; Loss of consciousnes...
Dizziness, Fall, Flushing, Hyperhidrosis, Hyperventilation; Loss of consciousness, Syncope, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Additional Details: Pt was sitting during vaccine, pt stood up afterwards and sat back down, a few moments later she slumped and fell out of her chair onto the ground and was unconscious for a few seconds. By the time a ran from the pharmacy counter back to her another couple seconds passed and she woke up and sat up. Pt was alert and oriented x 3, just dizzy and sweaty after fainting. EMS came to check her out and they carted her out to her moms car and went home with her mother.
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| 2851510 | 22 | F | VA | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946065 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: Boosttix; Manufacturer: G...
Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: Boosttix; Manufacturer: GSK; LotNumber: 37R35; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
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| 2851512 | 72 | F | CA | 07/28/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
m4834 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Other Vaccines: Vacci...
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: twinrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2851513 | 22 | F | FL | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9jt4s |
Injection site erythema, Rash
Injection site erythema, Rash
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Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Nause...
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Nausea-Medium, Other Vaccines: VaccineTypeBrand: havrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: fluarix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2851514 | 69 | F | SC | 07/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
pj353 pj353 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site streaking, Injection site swelling; Injection site warmth
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: on day of vaccine administration patient reports injection site felt warm and sore, the next day the soreness continued and was still warm with additional red streaking that has been spreading some and itching and swelling and continued soreness. the patient reports the injection site is currently no longer sore but the other symptoms still remain
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| 2851515 | 20 | F | CA | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9jt4s |
Asthenia, Flushing, Hyperhidrosis, Hypotension
Asthenia, Flushing, Hyperhidrosis, Hypotension
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Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additi...
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: paramedics arrived and moved patient to ambulance for further testing until patient's mother arrives, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: GSK; LotNumber: 9jt4s; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
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| 2851516 | 16 | M | TX | 07/28/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
d2343 |
Dizziness
Dizziness
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Systemic: Dizziness / Lightheadness-Mild
Systemic: Dizziness / Lightheadness-Mild
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| 2851517 | 50 | F | NV | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5Y4TL |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2851518 | 69 | F | NC | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5Y4TL |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injec...
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
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| 2851520 | 65 | M | CA | 07/28/2025 |
PNC21 |
MERCK & CO. INC. |
z003579 |
Pain
Pain
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Systemic: Body Aches Generalized-Medium, Additional Details: pharmacist spoke to patient on 07/24/25...
Systemic: Body Aches Generalized-Medium, Additional Details: pharmacist spoke to patient on 07/24/25. per pt, side effects (body ache) went away after 1 days. pt fully recovered.
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| 2851521 | 55 | M | TX | 07/28/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
XA53Y XA53Y |
Injected limb mobility decreased, Injection site erythema, Injection site pain, ...
Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Lethargy; Muscular weakness
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Muscle weakness, unable to lift arm-Severe, Additional Details: Patient reported over the phone about adverse effect about 24 hours post vaccine admistration on right arm (Arexvy), patient also got Tdap and Heplisav on left arm with adverse event. Chief complaints including: pain at injection side, swelling, lethargy and muscle weakness, unable to lift arm. Patient has visitted primary care doctor on 7/23/25 and got prescribed narcotic pain med for pain management.
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| 2851522 | 5 | M | MI | 07/28/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5H773 |
Expired product administered
Expired product administered
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Given past expiration. Vaccine expires 7/13/2025. Administered on 7/28/2025.
Given past expiration. Vaccine expires 7/13/2025. Administered on 7/28/2025.
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| 2851523 | M | CA | 07/28/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Fatigue, Pain in extremity
Fatigue, Pain in extremity
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During phone call with patient he advised during vaccine administration for Covid he experienced the...
During phone call with patient he advised during vaccine administration for Covid he experienced the following Adverse Event tiredness and sore arm.
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| 2851524 | 74 | F | CA | 07/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
046B21A 046B21A |
Blood culture, Computerised tomogram, Laboratory test, Malaise, Positron emissio...
Blood culture, Computerised tomogram, Laboratory test, Malaise, Positron emission tomogram; Pyrexia
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Shortly after receiving the vaccine, I started feeling sick and running low grade fevers every day. ...
Shortly after receiving the vaccine, I started feeling sick and running low grade fevers every day. Four years later, I am still having fevers every day. Diagnosed as Fevers of Unknown Origin. Fevers are usually 99.3 to 101 almost every day.
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| 2851525 | 66 | F | MO | 07/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Condition aggravated, Electrocardiogram, Erythema, Lip swelling, Metabolic funct...
Condition aggravated, Electrocardiogram, Erythema, Lip swelling, Metabolic function test; Migraine, Tachycardia
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Shingrix was administered at pharmacy. Within 10 minutes tachycardia- 130, face red and lip swelling...
Shingrix was administered at pharmacy. Within 10 minutes tachycardia- 130, face red and lip swelling. No response by pharmacy staff despite telling them side effects. Side effects continued. Went to urgent care side effects continued until treated with IV and famotidine. Side effects? triggered a migraine that lasted for 3 days
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| 2851526 | 9 | F | OR | 07/28/2025 |
HPV9 |
MERCK & CO. INC. |
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Circumstance or information capable of leading to medication error, Underdose
Circumstance or information capable of leading to medication error, Underdose
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HPV vaccine was being administer when patient moved and said to stop vaccine, vaccine was not admini...
HPV vaccine was being administer when patient moved and said to stop vaccine, vaccine was not administered fully, father of patient is aware vaccine series will be restarted.
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| 2851527 | 11 | F | AL | 07/28/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
XL223 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
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Erythema to left mid to upper arm area w/ mld induration + warmth and tenderness measuring 9cm x 7....
Erythema to left mid to upper arm area w/ mld induration + warmth and tenderness measuring 9cm x 7.5 cm.
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| 2851538 | M | MI | 07/28/2025 |
HPV9 |
MERCK & CO. INC. |
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Peripheral swelling
Peripheral swelling
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his "arm swelled really bad after" receiving his first dose of GARDASIL 9 and that "...
his "arm swelled really bad after" receiving his first dose of GARDASIL 9 and that "they were concerned about nerve damage"; This spontaneous report was received from pharmacist tech referring to himself as male patient of unknown age. The patient's medical history, current conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (exact dose, strength, anatomical route of administration, lot # and expiration date were not reported) as vaccine (prophylaxis). The reporter stated that, his arm "swelled really bad" after receiving first dose of vaccine Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) and they were concerned about nerve damage. It was reported that, this occurred a couple of days after the shot and went away about a week later" and he is apprehensive about getting the second shot. No missed dose and it was unknown if any treatment was provided or when this occurred (Vaccination site swelling). The outcome of the event Vaccination site swelling was assessed as recovered on an unspecified date. The causal relationship between the event Vaccination site swelling and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided. Lot number is being requested and will be submitted if received.
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| 2851539 | M | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergic reaction to excipient, Vaccination site macule
Allergic reaction to excipient, Vaccination site macule
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A few years later found out that he had an allergy to polyethylene glycol.; Local reaction with larg...
A few years later found out that he had an allergy to polyethylene glycol.; Local reaction with large spot on leg that lasted 3-4 days; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]), in 2022 as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGIC REACTION TO EXCIPIENT (non-serious) with onset 2022, outcome "recovered" (2022), described as "A few years later found out that he had an allergy to polyethylene glycol."; VACCINATION SITE MACULE (non-serious) with onset 2022, outcome "recovered" (2022), described as "Local reaction with large spot on leg that lasted 3-4 days". Therapeutic measures were taken as a result of allergic reaction to excipient, vaccination site macule. Additional information: Person reported their son had a local reaction to the COVID vaccine when patient was a baby. Reporter thought date of vaccination was 2022. Local reaction with large spot on leg that lasted 3-4 days. Reporter was unsure which Covid vaccine patient was received. A few years later found out that patient had an allergy to polyethylene glycol. Patient received "Hydrocortisone cream" as a treatment for the adverse event. Patient received any other vaccines on the same date as the vaccine was mentioned as "Unknown". Patient received any other vaccines within 4 weeks prior to the vaccine was mentioned as "Unknown". Patient took any other medications within 2 weeks of the event started was mentioned as "Unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2851540 | F | 07/28/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Patient reported that when administered it felt like a bee sting that persisted for 2/3 days.; Area ...
Patient reported that when administered it felt like a bee sting that persisted for 2/3 days.; Area where it was administered was red and had some swelling; Area where it was administered was red and had some swelling; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jul2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 21Jul2025, outcome "recovering" and all described as "Area where it was administered was red and had some swelling"; VACCINATION SITE PAIN (non-serious) with onset 21Jul2025, outcome "recovering", described as "Patient reported that when administered it felt like a bee sting that persisted for 2/3 days.". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema. Additional information: The patient didn't receive any other vaccines on the same date as the vaccine(s) for which you are reporting. It was unknown if the patient received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2851541 | 28 | M | TN | 07/28/2025 |
TD |
SANOFI PASTEUR |
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Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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administered the TENIVAC vaccine via IV to a patient with no reported adverse event; Initial informa...
administered the TENIVAC vaccine via IV to a patient with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 28 years old male patient who received the diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] via IV (Intravenous) to a patient 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 23-Jul-2025, the patient received unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection (Unknown strength, lot and expiry date) via IV NOS (Intravenous Not otherwise specified) route in unknown administration site for Immunization with no reported adverse event (incorrect route of product administration) (Latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Nurse administered the vaccine. Action taken was not applicable. 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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