| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2832360 | 4 | F | VA | 03/20/2025 |
YF |
SANOFI PASTEUR |
Y018163 |
Inflammation, Pruritus
Inflammation, Pruritus
|
Inflammation and itchyness
Inflammation and itchyness
|
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| 2832361 | 33 | F | FL | 03/20/2025 |
UNK |
UNKNOWN MANUFACTURER |
2CA56C1 |
Fatigue, Injection site erythema, Injection site pain
Fatigue, Injection site erythema, Injection site pain
|
pain and erythema at injection site. 100.3 F oral temperature 3/20/2025 fatigue.
pain and erythema at injection site. 100.3 F oral temperature 3/20/2025 fatigue.
|
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| 2832362 | 4 | F | GA | 03/20/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Erythema, Peripheral swelling, Skin warm, Tenderness
Erythema, Peripheral swelling, Skin warm, Tenderness
|
Swollen arm red and tender to the touch, heat in arm
Swollen arm red and tender to the touch, heat in arm
|
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| 2832363 | 4 | F | GA | 03/20/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Skin warm, Swelling, Tenderness
Skin warm, Swelling, Tenderness
|
Swollen and hot to touch, Tender
Swollen and hot to touch, Tender
|
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| 2832364 | 83 | M | 03/20/2025 |
COVID19 TDAP |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3043837 L5229 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
More
|
Patient did not report any adverse reaction. Spikevax requires a beyond use date of 2 months when mo...
Patient did not report any adverse reaction. Spikevax requires a beyond use date of 2 months when moving from freezer to refrigerator. Expiration date was 06/16/2025 and beyond use date was 03/10/25. Patient received vaccination on 03/14/2025.
More
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| 2832365 | 10 | F | 03/20/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
X4T99 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Menveo vaccine ordered by provider in error on a 10 year old child, the MA did not question the orde...
Menveo vaccine ordered by provider in error on a 10 year old child, the MA did not question the order and administered the vaccine. No medical reason for the child to receive the dose early.
More
|
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| 2832366 | 77 | F | 03/20/2025 |
COVID19 RSV TDAP |
MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3043837 BL473 L5229 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event
More
|
Patient did not report any adverse reaction. Spikevax requires a beyond use date of 2 months when mo...
Patient did not report any adverse reaction. Spikevax requires a beyond use date of 2 months when moving from freezer to refrigerator. Expiration date was 06/16/2025 and beyond use date was 03/10/25. Patient received vaccination on 03/14/2025.
More
|
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| 2832367 | 63 | M | MA | 03/20/2025 |
CHIK |
VALNEVA USA, INC. |
24BO11 |
Decreased appetite, Fatigue, Pyrexia
Decreased appetite, Fatigue, Pyrexia
|
Fever, Loss of Appetite, Fatigue
Fever, Loss of Appetite, Fatigue
|
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| 2832368 | 3 | F | NY | 03/20/2025 |
DTPPVHBHPB PNC20 UNK |
MSP VACCINE COMPANY PFIZER\WYETH UNKNOWN MANUFACTURER |
|
Condition aggravated, Febrile convulsion; Condition aggravated, Febrile convulsi...
Condition aggravated, Febrile convulsion; Condition aggravated, Febrile convulsion; Condition aggravated, Febrile convulsion
More
|
Possible febrile seizures x2 in less than 24 hours
Possible febrile seizures x2 in less than 24 hours
|
โ | |||||
| 2832369 | 27 | M | 03/20/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300214A |
Asthenia, Decreased appetite, Diarrhoea, Dizziness, Pain
Asthenia, Decreased appetite, Diarrhoea, Dizziness, Pain
|
Pt received vaccine and ~ 1 hr post, pt started to develop lightheadedness, aches, weakness, loss of...
Pt received vaccine and ~ 1 hr post, pt started to develop lightheadedness, aches, weakness, loss of appetite and dizziness. Over course of next 3 days to current time of this report, pt still has those symptoms now w/ developed diarrhea. Pt is non-ill appearing and in no distress at time of visit. Treated w/ Tylenol and Zofran w/ diet modification w/ f/u planned in 1 day.
More
|
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| 2832370 | 1.08 | F | OH | 03/20/2025 |
DTAP HEPA HIBV MMRV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
TX77L-VFC Y008285-VFC 53472-VFC Y009108-VFC HR3649-VFC |
Rash; Rash; Rash; Rash; Rash
Rash; Rash; Rash; Rash; Rash
|
Presented to ER for evaluation on 3/20/2025 at 7:18 AM with report of "rash." Child was ev...
Presented to ER for evaluation on 3/20/2025 at 7:18 AM with report of "rash." Child was evaluated by the ER physician and received oral cetirizine and acetaminophen. Child was discharged in stable condition. Family presented to the office with child to report potential reaction to vaccinations. Reported the child had facial swelling upon awakening that morning, greater than 12 hours following vaccination administration.
More
|
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| 2832371 | 4 | F | MD | 03/20/2025 |
DTAPIPV |
SANOFI PASTEUR |
U7908AB |
Injection site cellulitis
Injection site cellulitis
|
Cellulitis developed within 48hrs of administration. 5-6 inch diameter on RT.
Cellulitis developed within 48hrs of administration. 5-6 inch diameter on RT.
|
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| 2832372 | 11 | M | CT | 03/20/2025 |
MMR TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
X027446 X449Y |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
|
MMR was given instead of required Meningococcal vaccine. MMR was a third dose. Medical Director was...
MMR was given instead of required Meningococcal vaccine. MMR was a third dose. Medical Director was notified. No adverse reaction noted and no follow-up required.
More
|
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| 2832373 | 2 | M | WI | 03/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Patient was given wrong vaccine, parent called to verify what was given, child has no adverse reacti...
Patient was given wrong vaccine, parent called to verify what was given, child has no adverse reaction from vaccine given
More
|
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| 2832374 | 4 | F | KS | 03/20/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8009AB Y014439 |
Injection site erythema, Injection site induration, Injection site warmth; Injec...
Injection site erythema, Injection site induration, Injection site warmth; Injection site erythema, Injection site induration, Injection site warmth
More
|
Pts mother describes red, hot to touch and hard area at site of vaccine injection.
Pts mother describes red, hot to touch and hard area at site of vaccine injection.
|
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| 2832375 | 11 | M | WA | 03/20/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
x024560 U8375AA U8232AA |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
More
|
injection site raised area of redness to left thigh noticed on 3/19/2025.
injection site raised area of redness to left thigh noticed on 3/19/2025.
|
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| 2832376 | 62 | F | MI | 03/20/2025 |
FLU3 FLU3 FLU3 PPV PPV PPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
B37N3 B37N3 B37N3 Y009239 Y009239 Y009239 |
Asthenia, Body temperature increased, Decreased appetite, Dizziness, Fatigue; Fe...
Asthenia, Body temperature increased, Decreased appetite, Dizziness, Fatigue; Feeling abnormal, Full blood count, Injection site erythema, Injection site induration, Injection site pain; Metabolic function test, Muscle spasms, Pain in extremity, Respiratory pathogen panel, SARS-CoV-2 test; Asthenia, Body temperature increased, Decreased appetite, Dizziness, Fatigue; Feeling abnormal, Full blood count, Injection site erythema, Injection site induration, Injection site pain; Metabolic function test, Muscle spasms, Pain in extremity, Respiratory pathogen panel, SARS-CoV-2 test
More
|
Has continued to feel weak and poor through the course of the week. No nausea vomiting urinary symp...
Has continued to feel weak and poor through the course of the week. No nausea vomiting urinary symptoms cough. It sounds like a week ago had a T-max of a 101๏ฟฝ but nothing over the last several days. She has right posterior arm pain at the injection site. Baseball size area of erythema posterior right proximal upper arm with tenderness and central firm area. Appears consistent with mild cellulitis. Patient continues to be extremely tired, dizzy and doesn?t have an appetite. In addition, since last Thursday (03/13), she has had very painful spasms in her fingers on both hands. She describes it as having a Charlie horse in her fingers. At first it was at night, alternating hands. She has applied heat and uses a stress ball to try to stretch her fingers . Now it is happening during the day too. I have given her water w electrolytes and regular water. The spasms seem to last about a half hour- sometimes longer and lingers in the thumb for even longer.
More
|
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| 2832377 | 1.25 | M | MI | 03/20/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered
More
|
Wrong vaccine given. Not age appropriate. No adverse reactions.
Wrong vaccine given. Not age appropriate. No adverse reactions.
|
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| 2832378 | 38 | F | DC | 03/20/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
|
Antiphospholipid antibodies positive, Arthritis, Arthritis reactive, COVID-19, D...
Antiphospholipid antibodies positive, Arthritis, Arthritis reactive, COVID-19, Dry eye; Eye pruritus, Food allergy, Gastrointestinal disorder, Hypersensitivity, Photosensitivity reaction; Skin disorder, Sneezing, Urinary tract infection
More
|
Following the J&J COVID vaccine, I developed arthritis in my hands and wrists. I saw several rhe...
Following the J&J COVID vaccine, I developed arthritis in my hands and wrists. I saw several rheumatologists. It subsided after 7-8 months, but came back after a COVID infection in 2022, and again in 2023, and again in 2024. I have now had it since September 2024. I again saw rheumatologists in 2022, who confirmed that I have reactive arthritis. I also have strange new allergies including to the sun and raw fruits/vegetables/nuts, regular UTIs (7 in 2024), gastrointestinal issues, and other problems. I saw a dermatologist in February 2025 about two strange marks on my back, and after a few more questions, she tested me for Lupus, which I received a borderline positive result on. The Lupus symptoms started a few weeks after the J&J vaccine, and have continued.
More
|
โ | |||||
| 2832379 | 68 | F | FL | 03/20/2025 |
PNC20 |
PFIZER\WYETH |
LJ5283 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Our system showed the patient due for pneumonia shot so the pharmacist gave the shot Prevnar 20. The...
Our system showed the patient due for pneumonia shot so the pharmacist gave the shot Prevnar 20. Then we got an email from our corporate to review file for duplicate claim that's when we realized Patient already got Prevnar 20 last year in a span of less than a year. Patient experienced no side effects so far.
More
|
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| 2832380 | 85 | M | IA | 03/20/2025 |
COVID19 |
MODERNA |
3044202 |
Death
Death
|
Hospice care, passed away
Hospice care, passed away
|
โ | |||||
| 2832381 | 10 | M | VA | 03/20/2025 |
HEPA |
MERCK & CO. INC. |
X026485 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Patient received adult dose instead of peds dose of Vaqta Hep A vaccine. No reaction noted from inco...
Patient received adult dose instead of peds dose of Vaqta Hep A vaccine. No reaction noted from incorrect dose.
More
|
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| 2832382 | 70 | M | KY | 03/20/2025 |
HEPAB PNC20 RSV |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH |
4DS4N LG5577 LN5487 |
Asthenia, Fatigue, Impaired work ability, Mobility decreased, Somnolence; Asthen...
Asthenia, Fatigue, Impaired work ability, Mobility decreased, Somnolence; Asthenia, Fatigue, Impaired work ability, Mobility decreased, Somnolence; Asthenia, Fatigue, Impaired work ability, Mobility decreased, Somnolence
More
|
patient described severe fatique and weakness, not able to climb stairs or work in the yard for more...
patient described severe fatique and weakness, not able to climb stairs or work in the yard for more than an hour and has to take frequent naps during the day.
More
|
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| 2832383 | 74 | M | PA | 03/20/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Feeling of body temperature change
Feeling of body temperature change
|
One or two AM I was freezing, an hour later on my body got very hot. I took 2 tylenol which helped
One or two AM I was freezing, an hour later on my body got very hot. I took 2 tylenol which helped
|
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| 2832384 | 2 | F | PA | 03/20/2025 |
HEPA |
MERCK & CO. INC. |
|
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Medical Assistant gave Adult Hepatitis A Vaccine (Vaqta) to patient instead of pediatric dose.
Medical Assistant gave Adult Hepatitis A Vaccine (Vaqta) to patient instead of pediatric dose.
|
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| 2832386 | 2 | F | OH | 03/20/2025 |
FLU3 HEP HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9K74F C24B9 |
Injection site mass; Injection site mass; Injection site mass
Injection site mass; Injection site mass; Injection site mass
|
Patient's mother called to report a knot on her daughter's thigh after receiving vaccines....
Patient's mother called to report a knot on her daughter's thigh after receiving vaccines. Mother noted it the morning of 3/20/25. She reported it to be the size of a quarter. Area did not seem tender based on her report. This provider counseled her over the phone about reasons to come into clinic.
More
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| 2832387 | 2 | F | TX | 03/20/2025 |
HEPA MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
yo14585 yo13132 yoo6524 |
Cyanosis, Immediate post-injection reaction, Unresponsive to stimuli; Cyanosis, ...
Cyanosis, Immediate post-injection reaction, Unresponsive to stimuli; Cyanosis, Immediate post-injection reaction, Unresponsive to stimuli; Cyanosis, Immediate post-injection reaction, Unresponsive to stimuli
More
|
Patient turn blue and unresponsive immediately after given the vaccines, vitals were taken and patie...
Patient turn blue and unresponsive immediately after given the vaccines, vitals were taken and patient O2sats was 100% so no oxygen was administered. ,patient was observed here in the office for about 45 mins and checked multiple times by the Doctor.
More
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| 2832388 | 0.75 | F | AZ | 03/20/2025 |
RV5 RV5 RV5 RV5 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
2073367 2073367 2073367 2073367 |
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; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
More
|
Patient was given Rotavirus oral vaccine after the recommended age. At this time no symptoms.
Patient was given Rotavirus oral vaccine after the recommended age. At this time no symptoms.
|
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| 2832389 | 73 | F | MO | 03/20/2025 |
RSV |
PFIZER\WYETH |
LN5487 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
no adverse event didn't realized she had already had arevxy 9/2023 so this was outside CDC reco...
no adverse event didn't realized she had already had arevxy 9/2023 so this was outside CDC recommendation
More
|
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| 2832390 | 8 | F | WA | 03/20/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Patient given the contents of the Pfizer Covid vaccine for ages 6 mos through < 5 years.
Patient given the contents of the Pfizer Covid vaccine for ages 6 mos through < 5 years.
|
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| 2832391 | 48 | F | WI | 03/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
NZ552 |
Erythema, Pruritus, Skin warm
Erythema, Pruritus, Skin warm
|
skin reaction - erythema, warmth, itching
skin reaction - erythema, warmth, itching
|
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| 2832392 | 7 | M | MD | 03/20/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
57Y17 |
Lip swelling, Periorbital swelling
Lip swelling, Periorbital swelling
|
Patient with periorbital swelling, upper lip swelling within 1 hour of taking Influenza Vaccine and ...
Patient with periorbital swelling, upper lip swelling within 1 hour of taking Influenza Vaccine and Zofran
More
|
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| 2832393 | 25 | F | 03/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9YB4G |
Arthralgia, Neck pain
Arthralgia, Neck pain
|
3-4 hours after administration bruising appeared at the site of administration that worsened over th...
3-4 hours after administration bruising appeared at the site of administration that worsened over the next 72 hours. Patient experienced shoulder pain that spread into the neck and caused extreme discomfort. Patient did not seek evaluation as she thought the symptoms were normal following vaccine administration.
More
|
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| 2832394 | 11 | F | VA | 03/20/2025 |
MNQ MNQ TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8375AA U8375AA DY3K7 DY3K7 |
Feeling jittery, Headache, Loss of consciousness; Feeling jittery, Headache, Los...
Feeling jittery, Headache, Loss of consciousness; Feeling jittery, Headache, Loss of consciousness; Feeling jittery, Headache, Loss of consciousness; Feeling jittery, Headache, Loss of consciousness
More
|
Patient experienced unconscicousness after TDAP and MCV4 immunization vaccination. Around 10-15 seco...
Patient experienced unconscicousness after TDAP and MCV4 immunization vaccination. Around 10-15 seconds. Patient awaken and able to walk to nurses office to recover. C/O headache and feeling jittery. Pupils PERRLA. No injury to patient noted from losing consciousness.
More
|
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| 2832395 | 55 | M | NY | 03/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
235D2 |
Burning sensation, Neck pain, Pain, Pain in extremity, Paraesthesia
Burning sensation, Neck pain, Pain, Pain in extremity, Paraesthesia
|
Left Arm Pain that developed following day, aching pain with tingling and burning that radiated into...
Left Arm Pain that developed following day, aching pain with tingling and burning that radiated into the neck. Patient still having aching pain as of 3/20/25 when he presented to my medical office for evaluation.
More
|
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| 2832396 | 15 | M | CO | 03/20/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
A274J 7GF79 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
|
No Adverse event described. Given too Soon. Vaccine Error.
No Adverse event described. Given too Soon. Vaccine Error.
|
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| 2832397 | 28 | M | TN | 03/20/2025 |
MNQ |
SANOFI PASTEUR |
U7594AC |
Expired product administered
Expired product administered
|
I gave an expired vaccine. exp 03/04/25 todays date 03/20/25
I gave an expired vaccine. exp 03/04/25 todays date 03/20/25
|
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| 2832398 | 1 | M | AL | 03/20/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y007615 Y013347 |
Erythema, Rash; Erythema, Rash
Erythema, Rash; Erythema, Rash
|
erythema, intermittent localized rash for 8 weeks
erythema, intermittent localized rash for 8 weeks
|
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| 2832399 | 36 | F | FL | 03/20/2025 |
HPV9 |
MERCK & CO. INC. |
X020725 |
Arthralgia, Injected limb mobility decreased, Pain in extremity
Arthralgia, Injected limb mobility decreased, Pain in extremity
|
severe right shoulder and arm pain. Due to the severity of the pain and shoulder movement limitatio...
severe right shoulder and arm pain. Due to the severity of the pain and shoulder movement limitations patient was sent to the emergency room for further evaluation and treatment
More
|
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| 2832401 | 1 | F | NM | 03/20/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
x4t99 |
Wrong product administered
Wrong product administered
|
Provider had ordered for patient to receive the MMR vaccine and was given the meningococcal vaccine
Provider had ordered for patient to receive the MMR vaccine and was given the meningococcal vaccine
|
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| 2832402 | 86 | F | MO | 03/20/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3042646 UT8409BA |
Joint contracture, Loss of personal independence in daily activities, Mobility d...
Joint contracture, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal disorder, Pain in extremity; Joint contracture, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal disorder, Pain in extremity
More
|
pain in right arm and hand started end of Oct 2024. Was seen by doctor in December 2024 after tryin...
pain in right arm and hand started end of Oct 2024. Was seen by doctor in December 2024 after trying to self treat with warm packs, cold, etc. Hand curls up at night and difficult to open up the next morning. Lost use of right hand, can't even open soda pop cans anymore like she use to. Doctor told her likely caused by covid vaccine. Had doctor visit March 18 and has another appt in April.
More
|
โ | |||||
| 2832403 | 13 | M | ID | 03/20/2025 |
PNC20 |
PFIZER\WYETH |
LC5483 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
No adverse events/side events reported. This was given off schedule and was already given full serie...
No adverse events/side events reported. This was given off schedule and was already given full series of PCV13.
More
|
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| 2832404 | 73 | M | KY | 03/20/2025 |
FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
Aw3227A Aw3227A Aw3227A |
Arthritis, Condition aggravated, Haematoma, Joint effusion, Limb injury; Magneti...
Arthritis, Condition aggravated, Haematoma, Joint effusion, Limb injury; Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Pain in extremity, Peripheral swelling, Rotator cuff syndrome; Tendon rupture, Tendonitis
More
|
Patient was seen in office on 10/21/2024. He received an influenza vaccine in right deltoid. Patient...
Patient was seen in office on 10/21/2024. He received an influenza vaccine in right deltoid. Patient's pharmacy also administered Shingrix and RSV vaccine the same day. Patient followed up in office on 12/17/2024 with complaints of right upper extremity pain and swelling. Diagnosed with hematoma. Patient suffered with pain of right upper extremity due to hematoma X many months resulting in multiple Drs office trips, and ED visit, and MRI of right shoulder. MRI of right shoulder revealed advanced arthritic changes of the AC joint and glenohumeral joint with large joint effusion. There is complete tear of the supraspinatus and infraspinatus tendon compatible with superior rotator cuff tear. Tendonitis of the subscapularis and coracohumeral narrowing. Patient seen ortho on 3/4/25. Patient states that he was told that the hematoma caused from the vaccine has aggravated an old injury in his right shoulder and now he may suffer with chronic LROM and pain in right shoulder.
More
|
โ | |||||
| 2832406 | 60 | F | PA | 03/20/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00553 |
Incorrect route of product administration
Incorrect route of product administration
|
The vaccine was inadvertently given subcutaneously instead of intramuscularly, as labeled by the man...
The vaccine was inadvertently given subcutaneously instead of intramuscularly, as labeled by the manufacturer, by a pharmacy intern. The patient was quickly notified (within 5 minutes of vaccination) and administration site looked over by myself, as the pharmacist on staff. I confirmed the vaccine was not given in the deltoid and went over potential adverse effects with the patient (injection site reaction, pain at injection site), how to manage effects, and when to follow up with a physician. I contacted the manufacturer to clarify if a repeat dose needs to be administered and am awaiting reply.
More
|
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| 2832407 | 64 | F | SC | 03/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47N3Y |
Hypotension
Hypotension
|
The day after pt received her vaccination she had an appointment with her Primary Care Provider and ...
The day after pt received her vaccination she had an appointment with her Primary Care Provider and at her appointment her blood pressure was very low for her.
More
|
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| 2832408 | 0.33 | M | IL | 03/20/2025 |
RV5 |
MERCK & CO. INC. |
Y005907 |
Haematochezia, Mucous stools
Haematochezia, Mucous stools
|
Patient had mucousy, bloody stool later that day
Patient had mucousy, bloody stool later that day
|
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| 2832409 | M | FL | 03/20/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
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Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received fr...
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 83-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2024, outcome "unknown" and all described as "Tested positive for COVID-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2024) Positive; (Jul2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. This case is for the child's (reporter) father. The patient's child tested positive for COVID-19 and was staying at the parents' and all three of them have tested positive. They did two tests each. So, the patient's child tested the patient that morning (14Jul2024), and his child and his wife all three of them have it. Now the patient and his wife, they're 82 and 85 and the child doesn't want to have to take them to get re-tested, but all three of them were positive. The child guessed the reason why they haven't gotten it like extremely bad (they were pretty sick), but the service was like a week ago, and guessed it's probably been hanging on to it. But just recently, the patient started feeling really out of sorts on 11Jul2024 and luckily, they all have been taking Pfizer vaccine even up until the last available one. And they've all taken them and so the child was wondering. The patient and his wife have doctors, and the child will call them and asked if they could call in a prescription for the patient and his wife. Both the patient and his wife take quite a few medications. With the patient's age, the child was concerned too and guessed that it's best that they got it now because they've been vaccinated. They've been taking the Pfizer Vaccination from day one, and then they were all up to date. The child thinks the last time they got vaccinated was maybe 3 or 4 months ago (2024), they got the final most recent one. They were all vaccinated up, child guessed on the third or the fourth kind, the new when Pfizer kept coming out with the next one for the next strain, they would go and get it so that's obviously what's helped them to be functioning. The child was told that an aunt and her husband went into nirmatrelvir/ritonavir (PAXLOVID) and so the child trying to figure out what to do for him/herself, the patient, and patient's husband to get them on it as quickly as possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500058182 Same Vaccine/AE, Diff Pt;US-PFIZER INC-PV202500031906 Same Vaccine/AE, Diff Pt;
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| 2832411 | 16 | F | PA | 03/20/2025 |
MEN MENB |
UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS |
U8369AA |
Injection site cellulitis, Injection site pain, Injection site rash, Injection s...
Injection site cellulitis, Injection site pain, Injection site rash, Injection site warmth, Rash erythematous; Injection site cellulitis, Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
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rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; ras...
rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; diagnosed with cellulitis; Significant pain started in left arm <5 hours after shot; rash was red/on arm approximately 2cm below the injection site; Initial information received on 15-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional. This case involves a 16 years old female patient who was diagnosed with cellulitis after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The patient's past medical history included Pharyngitis streptococcal on 14-FEB-2025. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 13-Mar-2025, the patient received an unknown dose of Bexsero not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) via unknown route in the left arm and received a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date- unknown and lot U8369AA) via intramuscular route in the left arm for Routine vaccination (Immunization). On 13-Mar-2025 the patient developed a significant pain started in left arm <5 hours after shot (pain) (latency- approximately few hours) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On 14-Mar-2025 the patient was diagnosed with cellulitis (cellulitis) (latency- 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On 15-Mar-2025 the patient developed rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before (rash) (condition aggravated) (latency- 2 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On an unknown date in MAR-2025 the patient developed rash was red/on arm approximately 2cm below the injection site (rash erythematous) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. Reportedly, Pain continued on 16-MAR-2025. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site. Circle drawn around the rash. Oral cephalexin prescribed Action taken was not applicable. The patient was treated with IBUPROFEN (ADVIL 12 HOUR), NAPROXEN and PARACETAMOL (TYLENOL) for Symptomatic treatment. At time of reporting, the outcome was Not Recovered / Not Resolved for the events.
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| 2832412 | M | NC | 03/20/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
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flu; patient went to the emergency room last night around midnight with a 106F fever,; Patient recei...
flu; patient went to the emergency room last night around midnight with a 106F fever,; Patient received a Sanofi flu shot, and it did not work; Initial information received on 17-Mar-2025 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's mother). This case involves an unknown age male patient who received influenza vaccine flu shot, and it did not work and experienced flu. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date In September 2024, the patient received an unknown dose of suspect influenza vaccine, produced by unknown manufacturer, unknown formulation, Strength: standard, frequency: once, lot number not reported via unknown route in unknown administration site for Influenza (vaccination failure) (latency:same day). On 17-Mar-2025 the patient developed flu (influenza) and went to the emergency room last night around midnight with a 106f fever, (pyrexia) (latency: 6 months approximately) following the administration of influenza vaccine . Relevant laboratory test results included: Body temperature - On 17-March-2025: 106 F Influenza virus test - On 17-March-2025: [tested positive for flu] Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (influenza) (pyrexia) At time of reporting, the outcome was Unknown for the events (influenza) (pyrexia) Seriousness criteria: Medically significant for the event (vaccination failure); Sender's Comments: Sanofi company comment dated 19-Mar-2025:: This case involves an unknown age male patient who received influenza vaccine flu shot, and it did not work and experienced flu. Further information regarding allergic history, medical history, concomitant medication, any history of exposure to flu; are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2832413 | 1 | M | WA | 03/20/2025 |
HIBV |
SANOFI PASTEUR |
UK093AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
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ACT-HIB was administrated with a different diluent (sterile water), with no adverse event; Initial i...
ACT-HIB was administrated with a different diluent (sterile water), with no adverse event; Initial information received on 17-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to:- US-SA-2025SA079793. This case involves a 1 years old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] with a different diluent (sterile water), with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. On 14-Mar-2025, the patient received a 0.5ml dose 3 of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK093AB and expiry 30-Sep-2025) standard strength, frequency-once via intramuscular route in the left vastus lateralis for immunization with a different diluent (sterile water), with no adverse event (product preparation error) (latency-same day). Reportedly-Nurse called to get information about reconstituting ACTHIB with a different diluent (sterile water), which was administered to 2 patients. 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.; Sender's Comments: US-SA-2025SA079793:02451344
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