| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2819527 | 52 | F | FL | 01/06/2025 |
PNC20 |
PFIZER\WYETH |
lj5281 |
Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Other Vaccines: Vaccin...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: ; LotNumber: 235132; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 12/26/2024, VaccineTypeBrand: heplisav; Manufacturer: ; LotNumber: 945657; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 12/26/2024
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| 2819528 | 50 | F | NY | 01/06/2025 |
FLUC4 |
SEQIRUS, INC. |
391416 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Mild
Site: Pain at Injection Site-Mild
|
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| 2819529 | 64 | F | NV | 01/06/2025 |
FLUC4 |
SEQIRUS, INC. |
308499 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2819530 | 64 | M | NC | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Pain in extremity
Pain in extremity
|
Patient is having no signs/symptoms other than a sore arm.
Patient is having no signs/symptoms other than a sore arm.
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| 2819531 | 47 | F | 01/06/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Injection site erythema, Injection site pain, Pyrexia
Injection site erythema, Injection site pain, Pyrexia
|
injection site erythema and pain developing the same day as injection - treated with supportive care...
injection site erythema and pain developing the same day as injection - treated with supportive care with compresses; fever reported by patient which self-resolved 2 days after vaccine
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| 2819532 | 71 | F | VA | 01/06/2025 |
PNC20 |
PFIZER\WYETH |
5579 |
Arthralgia, Injection site cellulitis, Injection site rash, Injection site warmt...
Arthralgia, Injection site cellulitis, Injection site rash, Injection site warmth, Neck pain
More
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Patient reported cellulitis at the injection site including a hot rash, soreness of neck shoulders a...
Patient reported cellulitis at the injection site including a hot rash, soreness of neck shoulders and down her arm with a low grade 99 degree temperature. Symptoms started the next day from vaccination. She was treated with prednisone and cephalexin.
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| 2819533 | 10 | F | NY | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Pruritus, Urticaria
Pruritus, Urticaria
|
Hives, itchy lower down on same arm as injection. No systemic symptoms. Used some lotion and feeling...
Hives, itchy lower down on same arm as injection. No systemic symptoms. Used some lotion and feeling better but still has welts.
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| 2819534 | 67 | M | IA | 01/06/2025 |
COVID19 |
MODERNA |
3043159 |
Death
Death
|
Death
Death
|
โ | |||||
| 2819535 | 75 | M | TN | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received Arexvy vaccine on 1/3/25 from our pharmacy. Patient had already received this vacci...
Patient received Arexvy vaccine on 1/3/25 from our pharmacy. Patient had already received this vaccine last year on 12/1/23. Currently, patient has experienced no adverse events from receiving the 2nd vaccine and requested that the patient follow up with us if he does.
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| 2819536 | 9 | F | NJ | 01/06/2025 |
PPV |
MERCK & CO. INC. |
X023559 |
Expired product administered
Expired product administered
|
Patient was given expired dose of vaccine Pneumovax 23 on 12/20/2024 vaccine expired 11/24/2024, the...
Patient was given expired dose of vaccine Pneumovax 23 on 12/20/2024 vaccine expired 11/24/2024, the reason a hard stop did not happen is because employee put in wrong lot number of vaccine. I spoke with provider, Dr., she stated that titers would be done 2-3 months after vaccine was given and if no antibodies then patient would receive another dose of Pneumovax 23. Patients parent was called, and she understood, several follow up appointments have been made.
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| 2819537 | 75 | F | SC | 01/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received Arexvy on 12/27/23. Patient received another dose on 1/5/25. Patient reports no sid...
Patient received Arexvy on 12/27/23. Patient received another dose on 1/5/25. Patient reports no side effects.
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| 2819538 | 1 | M | SD | 01/06/2025 |
MMR |
MERCK & CO. INC. |
Y003499 |
Rash
Rash
|
Has rash on his trunk, neck and back. Rash started on 1/5. Dr. diagnosed by photo of rash sent thro...
Has rash on his trunk, neck and back. Rash started on 1/5. Dr. diagnosed by photo of rash sent through app to the clinic.
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| 2819539 | 66 | M | FL | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
This was the patient's second dose and it was given in error as that has not been approved yet....
This was the patient's second dose and it was given in error as that has not been approved yet. First dose was in September 2023
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| 2819540 | 77 | F | GA | 01/06/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Erythema, Peripheral swelling, Skin warm, Tenderness
Erythema, Peripheral swelling, Skin warm, Tenderness
|
left arm turned dark pink over large area of arm, tender, swollen, warm to touch.
left arm turned dark pink over large area of arm, tender, swollen, warm to touch.
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| 2819541 | F | NY | 01/06/2025 |
MMRV MMRV MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Autoantibody positive, Bone lesion, Chemokine increased, Clostridium test positi...
Autoantibody positive, Bone lesion, Chemokine increased, Clostridium test positive, Computerised tomogram head; Flow cytometry, Gene sequencing, Immunoglobulins normal, Interleukin level increased, Interleukin-2 receptor increased; Lymphopenia, Measles antibody negative, Mumps antibody test negative, Natural killer cell count, Orbital space occupying lesion; Rubella antibody positive, Swelling face
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absent specific antibody response to all vaccines tested; This literature marketed report has been r...
absent specific antibody response to all vaccines tested; This literature marketed report has been received from the authors of a published literature article, titled as stated below, referring to a 10-year-old female patient. The patient's concurrent conditions included cherubism and chronic sinusitis with constant nasal congestion. Medical history included severe diarrhea and anal fissures from ages 6 months to 1 year, which resolved spontaneously, recurrent otitis media (as a young child), requiring bilateral myringotomy and tympanostomy tube insertion, speech delay, several episodes of pneumonia, a recurring blistering rash, granuloma annulare diagnosed at age 7, and intermittent hives on the arms and face accompanied by flushing, which appeared to be triggered by temperature changes. Her concomitant vaccines included tetanus vaccine (unspecified) and pneumococcal 13 valent vaccine. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiry date were not reported), administered for prophylaxis. On an unknown date, the patient sought care for worsening cheek swelling. Physical examination was notable for bilateral maxillary and mandibular fullness and right proptosis. Computed tomographic imaging of the paranasal sinuses showed expansile soft tissue and lucent lesions in the bilateral maxillary bone and bilateral angles of the mandible suggestive of cherubism. One of the lesions was also noted to extend into the floor of the right orbit. Serum immunoglobulin levels were normal. Lymphocyte phenotyping showed normal T-cell numbers and mild B-cell lymphopenia. Antibody levels for Streptococcus pneumoniae showed protection against 3 of 13 serotypes 7 years after receipt of conjugated pneumococcal vaccine. The patient was revaccinated, and after revaccination, the patient developed immunity to 9 of 13 serotypes. Tetanus immunoglobulin G (IgG) was 0.2 IU/mL (reference range: less than 0.1 not protective), measles IgG was less than 13.50 AU/mL, mumps IgG was less than 9 AU/mL, rubella IgG was 26.50 (index), and varicella zoster vaccine response showed more than 4000.00 (index). Natural killer (NK) cells were 0.9 lytic units (minimally reduced). Serum inflammatory cytokine/chemokine levels were measured, showing the following results: soluble interleukin-2 (IL-2) receptor level was 1366.9 pg/mL (mildly elevated), IL-6 was 4.1 pg/mL (mildly elevated), IL-10 was 17.1 pg/mL (mildly elevated), chemokine (C-X-C motif) ligand 9 (CXCL9) was 965 pg/mL (mildly elevated), and IL-18 was 592 pg/mL (mildly elevated). Targeted single gene sequencing for SH3BP2 showed no variants of significance. Trio exome sequencing showed a de novo variant of unknown significance in the phospholipase C gamma 2 (PLCG2) gene. Flow cytometric measurement of lymphocyte calcium flux after surface receptor activation showed markedly enhanced B-cell calcium flux with relatively normal T-cell calcium flux. The outcome of the event of vaccine induced antibody absent was not reported. The authors considered the event of vaccine induced antibody absent as related to suspect vaccine. A copy of the published article is attached as further documentation of the patient's experience. This is one of two reports referring to the same literature article. Literature Report: Lot # is being requested and will be submitted if received.; Sender's Comments: US-009507513-2412USA005170:
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| 2819542 | 15 | M | MI | 01/06/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
8080803 8080803 8080803 |
C-reactive protein, Chest pain, Echocardiogram normal, Electrocardiogram normal,...
C-reactive protein, Chest pain, Echocardiogram normal, Electrocardiogram normal, Full blood count; Intensive care, Liver function test, Metabolic function test, Myocarditis, Respiratory pathogen panel; Troponin increased
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Myocarditis. Patient is a 15 y.o. male who presented to Hospital on 1/5/2025 for chest pain with ele...
Myocarditis. Patient is a 15 y.o. male who presented to Hospital on 1/5/2025 for chest pain with elevated troponins ongoing since COVID vaccine on 12/31/24. Patient was admitted to the PICU for continuous monitoring (telemetry and serial troponins) and further workup. Work up included ECHO and EKG which returned with no abnormal findings. Troponins decreased overnight and cardiology agreed with home management and outpatient follow up.
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โ | |||||
| 2819543 | 66 | M | WI | 01/06/2025 |
FLU3 RSV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UT8463BA 3254C |
Anxiety, Arthralgia, Heart rate increased, Pain in extremity; Anxiety, Arthralgi...
Anxiety, Arthralgia, Heart rate increased, Pain in extremity; Anxiety, Arthralgia, Heart rate increased, Pain in extremity
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The first 3 nights, patient felt moderately anxious with heart rate a little higher than normal. On ...
The first 3 nights, patient felt moderately anxious with heart rate a little higher than normal. On the second day, patient reported his joint pain increased by a fair amount. On Friday, 1/3/25 patient reports the joint pain has finally returned to a level prior to vaccines. Patient reports left arm soreness yet today (1/6/25).
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| 2819544 | 16 | F | TX | 01/06/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Anxiety, Loss of consciousness; Anxiety, Loss of consciousness; Anxiety, Loss of...
Anxiety, Loss of consciousness; Anxiety, Loss of consciousness; Anxiety, Loss of consciousness; Anxiety, Loss of consciousness
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passed out, ice pack applied and effective. Mother explained after the fact that child has anxiety.
passed out, ice pack applied and effective. Mother explained after the fact that child has anxiety.
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| 2819545 | 23 | F | OK | 01/06/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
300214a X2A231M aw1612a |
Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal; E...
Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal; Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal; Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal
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first trimester fetal demise. P1 G0 LMP 28 Sep. Vaccinated 16 Oct. BhCG positive 16 Oct (16.37), 29 ...
first trimester fetal demise. P1 G0 LMP 28 Sep. Vaccinated 16 Oct. BhCG positive 16 Oct (16.37), 29 Oct hCG 6637.5. Symptoms: MAT CARE,PR FT GRW,1TRI,N/A/UN(O365910).
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| 2819546 | 58 | M | OR | 01/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
031L20A 031L20A |
Asthenia, Exercise tolerance decreased, Fatigue, Gait disturbance, Illness; Inso...
Asthenia, Exercise tolerance decreased, Fatigue, Gait disturbance, Illness; Insomnia, Muscle disorder, Myalgia, Nasopharyngitis, Physical deconditioning
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Initially any health impairment (cold, less sleep, extra exertion...) resulted in extreme weakness, ...
Initially any health impairment (cold, less sleep, extra exertion...) resulted in extreme weakness, e.g. difficulty climbing stairs, tottering while walking, feeling of exhaustion. Over several months deconditioning increased, ability to exercise decreased, debility with any illness increased. Recently (2.75 years post vaccine) exercise attempts (pull ups/pushups) are sometimes painful w/sense of tearing fibers in muscles. Weakness is chronic.
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โ | |||||
| 2819547 | 73 | M | FL | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
Patient came in asking for RSV vaccine without realizing patient received same vaccine on 9/11/2023....
Patient came in asking for RSV vaccine without realizing patient received same vaccine on 9/11/2023. Patient received 2 doses
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| 2819548 | 33 | M | TX | 01/06/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9YB4G |
Immediate post-injection reaction, Peripheral swelling
Immediate post-injection reaction, Peripheral swelling
|
Patient was given Tdap boostrix vaccine IM in left deltoid, arm immediately swelled up. Patient was ...
Patient was given Tdap boostrix vaccine IM in left deltoid, arm immediately swelled up. Patient was seen by physician and was advised to take Benadryl PRN, Aleve, and to apply cold compress to arm.
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| 2819549 | 41 | F | OR | 01/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0171 EW0171 |
Abdominal discomfort, Fatigue, Headache, Immediate post-injection reaction, Inje...
Abdominal discomfort, Fatigue, Headache, Immediate post-injection reaction, Injection site swelling; Malaise, Pain, Pyrexia, Respiratory symptom
More
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The injection site immediately swelled after the vaccine. For the next few days, I had a mild fever,...
The injection site immediately swelled after the vaccine. For the next few days, I had a mild fever, mild respiratory symptoms, and body aches. Since then, that injection site has swelled numerous times . Generally, I notice fatigue, malaise, headaches, and moderate stomach upset each time my arm has been swollen. I have not been able to correlate if there is something that happens that makes it swell and makes me sick though.
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| 2819550 | 40 | M | WI | 01/06/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3RE73 / public |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Mistaken administration, given too soon.
Mistaken administration, given too soon.
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| 2819551 | 24 | M | DC | 01/06/2025 |
COVID19 |
MODERNA |
3053835 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient injected with expired vaccine due to improper storage. Patient has not reported any adverse ...
Patient injected with expired vaccine due to improper storage. Patient has not reported any adverse effects.
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| 2819552 | 48 | M | MI | 01/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Z27PB |
Wrong product administered
Wrong product administered
|
Pt requested third dose of HEP B and received HEP A vaccine instead,
Pt requested third dose of HEP B and received HEP A vaccine instead,
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| 2819553 | 33 | F | GA | 01/06/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
LN5467 LN5467 |
Arthralgia, Diarrhoea, Exposure during pregnancy, Fatigue, Myalgia; Pain
Arthralgia, Diarrhoea, Exposure during pregnancy, Fatigue, Myalgia; Pain
|
I received the RSV vaccine at my OB appointment while I was 35 weeks and 5 days pregnant. The follow...
I received the RSV vaccine at my OB appointment while I was 35 weeks and 5 days pregnant. The following day, approx 30 hours after, I experienced diarrhea, body and joint aches. These symptoms lasted all of Friday night and Saturday all day/night. Sunday and today (Monday) is just fatigue and muscle aches. Baby is moving fine and I?m trying to rehydrate from the weekend but I definitely believe I experienced the hypersensitive immune response.
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| 2819554 | 71 | M | FL | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
Patient given same vaccine twice - on 9/18/23 and 01/04/25
Patient given same vaccine twice - on 9/18/23 and 01/04/25
|
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| 2819555 | 91 | F | OK | 01/06/2025 |
COVID19 |
MODERNA |
8057456 |
No adverse event
No adverse event
|
No adverse event noted at time of administration.
No adverse event noted at time of administration.
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| 2819556 | 60 | M | FL | 01/06/2025 |
TYP |
BERNA BIOTECH, LTD. |
|
Lymph node pain, Lymphadenopathy, Rash, Sleep disorder
Lymph node pain, Lymphadenopathy, Rash, Sleep disorder
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8 days after my 4th dose, I broke out in what first presented as a rash in both underarms, my chest ...
8 days after my 4th dose, I broke out in what first presented as a rash in both underarms, my chest and pubic mound. Less than a day later the rash turned in to severe swollen lymph nodes. They were so painful that after a week I sought medical advice because I was not sleeping soundly anymore due to the pain, and the Doctor basically told me I had to deal with it by taking antihistamines and NSAIDS. The treatment did little and now its 17 days later and the lymph nodes are still extremely swollen and painful. I just want to note that my girlfriend, who is going to be travelling with me had the same symptoms, though less severe than mine, a mere 2 days after finishing her last dose. She may report this separately though it sounds like she doesn't want to, but I feel its important that you know this.
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| 2819557 | 0.25 | M | TX | 01/06/2025 |
HEP |
MERCK & CO. INC. |
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Urticaria
Urticaria
|
PT developed a few hives on legs and some on face; This spontaneous report was received from nurse a...
PT developed a few hives on legs and some on face; This spontaneous report was received from nurse and refers to a 3-month-old male. The patient's medical history was not reported. The patient's concurrent conditions included milk allergy, and hydrocele. Concomitant therapies were not reported. His brother medical history included anaphylactic reactions post vaccines when he was younger On 27-NOV-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On an unknown date in 2024, the patient experienced experienced a few hives on legs and some on face (mild). On an unknown date in 2024, the patient was treated with 3 ml of children's bonodryl once and within 20 minutes hives almost resolved. The patient was assessed another 30 minutes later and all resolved and the patient was going well On an unknown date in 2024, the patient recovered from the event. The mother of the patient was informed that the reaction could have been due to the alcohol wipes, the gloves, or event the bandaid. The patient's mother was given samples of all 3. When rash had completely resolved the mother can retry them individually to see if he reads to any of them. If so then less likely due to the vaccine/ If not will plan on referring to allergist for evaluation or guidance on future vaccines. The patient's mother was informed that the patient can continue to do vaccines one at a time if desired. The patient's mother was given the script for prednisolone in case needed over the holiday weekend. The action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding the event was not applicable. The causal relationship between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
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| 2819558 | 26 | F | NY | 01/06/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Inflammation, Mobility decreased, Pain in extremity, X-ray normal
Arthralgia, Inflammation, Mobility decreased, Pain in extremity, X-ray normal
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I received the tetanus TDAP vaccine on 12/20/2024 for a routine physical prior to start of college (...
I received the tetanus TDAP vaccine on 12/20/2024 for a routine physical prior to start of college (spring semester)- I anticipated arm soreness but after a couple of days pain continued to intensify and localize in my left shoulder joint. A week later I woke up and my arm was so painful I could not move it. I returned to the same office and was seen by a different doctor, and requested steroids to help with the inflammation. I completed a 5 day taper of prednisone, which helped temporarily during the day but pain would resume at night. It has now been 18 days and I am still having unresolved joint pain which has not subsided. I have used Tylenol, pain meds at night, heat, massage, and rest with no success.
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| 2819559 | 62 | F | NJ | 01/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM7786 TFAA2421 |
Dizziness, Fall, Skin warm; Dizziness, Fall, Skin warm
Dizziness, Fall, Skin warm; Dizziness, Fall, Skin warm
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Patient got warm after the vaccination and stepped outside immunization room and fell on the floor b...
Patient got warm after the vaccination and stepped outside immunization room and fell on the floor because of light headness.
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โ | |||||
| 2819560 | 11 | F | CA | 01/06/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Syringe issue, Underdose
Syringe issue, Underdose
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Unknown amount of vaccine dose leaked from the needle hub during administration, rendering an incomp...
Unknown amount of vaccine dose leaked from the needle hub during administration, rendering an incomplete dose administered
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| 2819561 | 0.25 | F | NC | 01/06/2025 |
HIBV HIBV PNC20 PNC20 |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
Y003145 Y003145 LG5578 LG5578 |
Crying, Cyanosis, Erythema, Hypertonia, Infant irritability; Infantile spitting ...
Crying, Cyanosis, Erythema, Hypertonia, Infant irritability; Infantile spitting up, Musculoskeletal stiffness, Respiration abnormal; Crying, Cyanosis, Erythema, Hypertonia, Infant irritability; Infantile spitting up, Musculoskeletal stiffness, Respiration abnormal
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Patient is a 3 m.o. female born at term via NSVD, twin gestation, to a GBS negative mother who had n...
Patient is a 3 m.o. female born at term via NSVD, twin gestation, to a GBS negative mother who had no pregnancy or delivery complication presenting for admission after a episode of cyanosis and hypertonia at home. She was at her baseline health without concerns for illness. Earlier in the day she went to get her vaccinations with her twin sister. S/p vaccination, patient had was increasingly fussy. Mom fed her and her sister with minimal amount of spit up. Mom set patient down to change her diaper which baseline cries and gets upset with. She started crying and turned red, she then turned blue and started getting stiff and breathing only out. Spit then started coming out of her mouth as she was breathing outwards with her eyes open. Mom called EMS and took patient outside hoping cold air would make her gasp and take a breath in. Mom states this kept going on for 3 minute and when EMS arrived O2 was 88%. Episode did not resolve until she was given O2 by EMS.
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โ | |||||
| 2819562 | 74 | F | CA | 01/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
333G3M |
Underdose, Wrong product administered
Underdose, Wrong product administered
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Nurse gave wrong vaccine dose, Flu vaccine regular dose administered to this 74 year old female rath...
Nurse gave wrong vaccine dose, Flu vaccine regular dose administered to this 74 year old female rather than the high-dose which is indicated for patients 65 years and older.
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| 2819563 | 74 | M | PA | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
FM9992 |
Fatigue, Laboratory test, Muscular weakness
Fatigue, Laboratory test, Muscular weakness
|
We have been working up patient over the last couple years for progressive LE weakness and generaliz...
We have been working up patient over the last couple years for progressive LE weakness and generalized fatigue. Patient has had extensive work-up without definitive diagnosis. Upon continued evaluation concern was this possible could be related to adverse reaction to a COVID vaccination.
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| 2819564 | 35 | F | 01/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
300214A |
Urticaria
Urticaria
|
HIVES
HIVES
|
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| 2819565 | 53 | F | WI | 01/06/2025 |
HEP |
MERCK & CO. INC. |
945659 |
Erythema, Skin warm
Erythema, Skin warm
|
Redness noticed to right arm 1-5-25 Expanding redness-2-3 inches. 1/6/25, redness and warmth expandi...
Redness noticed to right arm 1-5-25 Expanding redness-2-3 inches. 1/6/25, redness and warmth expanding to 3"x4". Assisted with appointment for evaluation
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| 2819566 | 55 | M | IA | 01/06/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic
|
Diffuse pruritic erythematous rash over arms, chest, abdomen, back and some involvement of lower ext...
Diffuse pruritic erythematous rash over arms, chest, abdomen, back and some involvement of lower extremities presented on 12/25/2024. Patient denies anything else new that may have contributed to onset of rash. Worse under arms but no reaction at injection site. Seen for symptoms on 1/3/2025 and treated with Prednisone, Zyrtec, Benadryl and topical triamcinolone cream.
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| 2819567 | 54 | M | CA | 01/06/2025 |
MMR |
MERCK & CO. INC. |
Xo26219 |
Contraindication to vaccination, No adverse event
Contraindication to vaccination, No adverse event
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54 y/o male presented to PCP requesting MMR vaccine for entry into school. Vaccine was administered ...
54 y/o male presented to PCP requesting MMR vaccine for entry into school. Vaccine was administered despite the contraindication for live vaccines while the patient is taking teriflunomide to treat his chronic MS. Patient was contacted and monitored via phone calls. No symptoms or adverse effect was noted.
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| 2819568 | 79 | F | LA | 01/06/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL3246 EL3246 EL3246 EL9265 EL9265 EL9265 FF8839 FF8839 FF8839 |
Arachnoiditis, Blood test, Diplegia, Embolism, Fall; Gait disturbance, General p...
Arachnoiditis, Blood test, Diplegia, Embolism, Fall; Gait disturbance, General physical health deterioration, Intervertebral disc annular tear, Magnetic resonance imaging, Spinal nerve stimulator implantation; Spinal operation, Walking aid user, X-ray; Arachnoiditis, Blood test, Diplegia, Embolism, Fall; Gait disturbance, General physical health deterioration, Intervertebral disc annular tear, Magnetic resonance imaging, Spinal nerve stimulator implantation; Spinal operation, Walking aid user, X-ray; Arachnoiditis, Blood test, Diplegia, Embolism, Fall; Gait disturbance, General physical health deterioration, Intervertebral disc annular tear, Magnetic resonance imaging, Spinal nerve stimulator implantation; Spinal operation, Walking aid user, X-ray
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Tripping, falling, legs paralyzed. Two embolisms, spinal surgery (fissures) in 2022. Spinal cord s...
Tripping, falling, legs paralyzed. Two embolisms, spinal surgery (fissures) in 2022. Spinal cord stimulator implanted in 2024. Use walker to ambulate. Symptoms/treatments occurred/occurring over the last three plus years. No further treatment known; will continue to deteriorate with arachnoiditis now.
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| 2819569 | 22 | F | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Exposure during pregnancy, Product use issue
Exposure during pregnancy, Product use issue
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Pregnant patient (36 weeks) received Arexvy, should?ve gotten Abrysvo.
Pregnant patient (36 weeks) received Arexvy, should?ve gotten Abrysvo.
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| 2819570 | 11 | M | CA | 01/06/2025 |
COVID19 |
MODERNA |
8080797 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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11 y/o male brought to Clinic for well child visit was administered the COVID vaccine (Spikevax) whi...
11 y/o male brought to Clinic for well child visit was administered the COVID vaccine (Spikevax) which is indicated for patients 12 years of age and older.
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| 2819572 | 3 | F | VA | 01/06/2025 |
HEPA IPV PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
TF27T W1C751M HL3889 Y004553 |
Pyrexia, Rash macular, Urticaria; Pyrexia, Rash macular, Urticaria; Pyrexia, Ras...
Pyrexia, Rash macular, Urticaria; Pyrexia, Rash macular, Urticaria; Pyrexia, Rash macular, Urticaria; Pyrexia, Rash macular, Urticaria
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Hives or red splotchy areas on face, shoulder and back. Less so on legs, lasted 6 days. Had little...
Hives or red splotchy areas on face, shoulder and back. Less so on legs, lasted 6 days. Had little fever on day one, no vomiting or other complaints. Gave Benadryl on the next day, did not see another provider as advised.
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| 2819573 | 52 | F | VT | 01/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
LP1780 LP1780 |
Atrial fibrillation, Blood thyroid stimulating hormone decreased, C-reactive pro...
Atrial fibrillation, Blood thyroid stimulating hormone decreased, C-reactive protein, Cardioversion, Full blood count normal; Thyroxine normal, Tri-iodothyronine normal
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On 12/21/24 I experienced an episode of Rapid A-fib (rate 150-240 BPM) with RVR which required Emerg...
On 12/21/24 I experienced an episode of Rapid A-fib (rate 150-240 BPM) with RVR which required Emergency care. Adenosine was given x 2. Cardioversion with 200 joules was done and converted me back to a normal sinus rhythm. I have not previously experienced any arrhythmias. Needed to be started on Eliquis 5 mg PO BID
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| 2819574 | 18 | F | NH | 01/06/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient received infanrix when boostrix indicated. No adverse reaction had by patient
Patient received infanrix when boostrix indicated. No adverse reaction had by patient
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| 2819575 | 38 | U | CO | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
R3F729 |
Exposure during pregnancy, Product use issue
Exposure during pregnancy, Product use issue
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Ob patient got Arexvy instead of Abrysvo
Ob patient got Arexvy instead of Abrysvo
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| 2819576 | 42 | M | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
2B74N |
Off label use
Off label use
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RSV was administered per primary care provider's instruction due to Pt's active diagnoses&...
RSV was administered per primary care provider's instruction due to Pt's active diagnoses'. Pt tolerated administration well and left clinic without incident.
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| 2819577 | 12 | M | GA | 01/06/2025 |
FLU3 FLU3 HPV9 HPV9 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
idb57yt7-cp idb57yt7-cp msdx025115-cp msdx025115-cp |
Confusional state, Immediate post-injection reaction, Loss of consciousness, Pal...
Confusional state, Immediate post-injection reaction, Loss of consciousness, Pallor, Posture abnormal; Unresponsive to stimuli; Confusional state, Immediate post-injection reaction, Loss of consciousness, Pallor, Posture abnormal; Unresponsive to stimuli
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Child was given second vaccine. He immediately started turning pale, passed out, then slumped down i...
Child was given second vaccine. He immediately started turning pale, passed out, then slumped down in the chair. Patient was unresponsive for about 4 seconds then opened his eyes confused about what had occurred. Vitals signs as following: FSBS-113, Pulse 94, O2 saturation-99% on room air, and bp-108/64 in his right arm. Patient was given 4 ounces of apple juice and 4 ounces of water. After sitting in clinic for 20 minutes, patient ambulated out of facility accompanied by his mother and sister.
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