| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2833333 | 5 | M | CA | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
y019465 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per...
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
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| 2833335 | 10 | F | IA | 03/26/2025 |
VARCEL |
MERCK & CO. INC. |
X007373 |
Expired product administered
Expired product administered
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The Varicella that was given expired on 3/12/2024. I did contact the state and Was informed to fill ...
The Varicella that was given expired on 3/12/2024. I did contact the state and Was informed to fill out this form and to repeat the varicella in 4 weeks.
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| 2833336 | 4 | M | CA | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
y019465 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per...
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
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| 2833337 | 0.17 | M | CA | 03/26/2025 |
DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP HIBV HIBV HIBV HIBV HIBV PNC20 PNC20 PNC20 PNC20 PNC20 RV1 RV1 RV1 RV1 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9D25P 9D25P 9D25P 9D25P 9D25P Y006393 Y006393 Y006393 Y006393 Y006393 LK6655 LK6655 LK6655 LK6655 LK6655 7E9Y2 7E9Y2 7E9Y2 7E9Y2 7E9Y2 |
Blood culture negative, Blood sodium normal, C-reactive protein increased, CSF c...
Blood culture negative, Blood sodium normal, C-reactive protein increased, CSF culture negative, Conjunctivitis; Culture urine positive, Diarrhoea, Escherichia infection, Full blood count normal, Immunoglobulin therapy; Lethargy, Measles antibody negative, Platelet count increased, Procalcitonin increased, Pyrexia; Pyuria, Rash macular, Red blood cell sedimentation rate increased, Respiratory viral panel, Rotavirus test positive; Urine analysis abnormal, White blood cells urine positive; Blood culture negative, Blood sodium normal, C-reactive protein increased, CSF culture negative, Conjunctivitis; Culture urine positive, Diarrhoea, Escherichia infection, Full blood count normal, Immunoglobulin therapy; Lethargy, Measles antibody negative, Platelet count increased, Procalcitonin increased, Pyrexia; Pyuria, Rash macular, Red blood cell sedimentation rate increased, Respiratory viral panel, Rotavirus test positive; Urine analysis abnormal, White blood cells urine positive; Blood culture negative, Blood sodium normal, C-reactive protein increased, CSF culture negative, Conjunctivitis; Culture urine positive, Diarrhoea, Escherichia infection, Full blood count normal, Immunoglobulin therapy; Lethargy, Measles antibody negative, Platelet count increased, Procalcitonin increased, Pyrexia; Pyuria, Rash macular, Red blood cell sedimentation rate increased, Respiratory viral panel, Rotavirus test positive; Urine analysis abnormal, White blood cells urine positive; Blood culture negative, Blood sodium normal, C-reactive protein increased, CSF culture negative, Conjunctivitis; Culture urine positive, Diarrhoea, Escherichia infection, Full blood count normal, Immunoglobulin therapy; Lethargy, Measles antibody negative, Platelet count increased, Procalcitonin increased, Pyrexia; Pyuria, Rash macular, Red blood cell sedimentation rate increased, Respiratory viral panel, Rotavirus test positive; Urine analysis abnormal, White blood cells urine positive
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Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, c...
Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, conjunctivitis, lethargy, and diffuse macular rash on 3/4/25. He was admitted to the hospital, and after CBC showed elevated platelets and UA showed pyuria, he was diagnosed with Kawasaki Disease. He was treated with IVIG and Remicade and started on daily aspirin and his fever resolved within 24 hours. Echocardiogram showed no evidence of coronary vessel dilatation.
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| 2833338 | 1 | M | CA | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
y019465 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per...
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
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| 2833339 | 1 | F | TX | 03/26/2025 |
HIBV HIBV HIBV PNC13 PNC13 PNC13 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
UJ669AA UJ669AA UJ669AA FL4125 FL4125 FL4125 |
Blood glucose normal, Breath holding, Crying, Echocardiogram normal, Electrocard...
Blood glucose normal, Breath holding, Crying, Echocardiogram normal, Electrocardiogram normal; Erythema, Feeling hot, Full blood count normal, Hyporesponsive to stimuli, Lethargy; Metabolic function test normal, Pallor, Ultrasound abdomen normal, Vomiting; Blood glucose normal, Breath holding, Crying, Echocardiogram normal, Electrocardiogram normal; Erythema, Feeling hot, Full blood count normal, Hyporesponsive to stimuli, Lethargy; Metabolic function test normal, Pallor, Ultrasound abdomen normal, Vomiting
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7 am patient woke up as normal ate breakfast, by 7:22 she was crying, her nose turned red, she was p...
7 am patient woke up as normal ate breakfast, by 7:22 she was crying, her nose turned red, she was pale and warm, threw up mucous, no fever, but not acting right. I changed her diaper, she was lethargic on the changing table. 7:39 i put her on the living room floor and she was mostly unrepsonsive and still breathing. I called 911. I rolled her to her side, she threw up. Firefighters arrived 7 mins, didnt crawl away or make a peep when they got her vitals. EMS arrived 5 mins later, still lethargic, not pulling away. Finally she started to open her eyes. Put her in the EMS van sitting in her carseat, but eyes closed and very fatigued. When they pricked her heel for blood she finally withdrew her limb. Glucose 115 Got to the ED by 8:33. Workup included an abdominal US which was negative for intussusception. She did tolerating crackers and breastfeed without issue. CBC and BMP negative. Neuro consult, not a seizure. She was back to herself and we were discharged. We had follow ups with cardiology. Her echo and EKG were both normal. We were told there is nothing wrong with her heart and that possible it was a crying spell or a breath holding spell, but she never turned blue. We also followed up with neurology who agreed that it was NOT a seizure.
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| 2833340 | 64 | F | IL | 03/26/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Injection site cellulitis
Injection site cellulitis
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Patient developed cellulitis at the site of injection following administration. Evaluated at the cli...
Patient developed cellulitis at the site of injection following administration. Evaluated at the clinic and received antibiotics.
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| 2833341 | 4 | F | CA | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
y019465 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per...
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
More
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| 2833342 | 76 | M | TX | 03/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7349l |
Anxiety, Blood pressure increased, Hot flush, Injection site erythema, Injection...
Anxiety, Blood pressure increased, Hot flush, Injection site erythema, Injection site pain
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Patient reported he experienced hot flashes the evening he received his first dose of Shingrix. He ...
Patient reported he experienced hot flashes the evening he received his first dose of Shingrix. He felt anxious about the sudden hot flashes that lasted about 24 hours; as a result, his blood pressure increased (he currently takes nifedipine and olmesartan for BP). Patient also reported mild redness and muscle soreness at the site of administration. When he came to report this to the pharmacy, 4 days have elapsed, and he is feeling much better.
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| 2833343 | 4 | F | CA | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
y019465 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per...
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
More
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| 2833344 | 4 | M | CA | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
y019465 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per...
Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
More
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| 2833345 | 8 | M | TN | 03/26/2025 |
MMR |
MERCK & CO. INC. |
Y004114 |
Fall, Head injury, Nausea
Fall, Head injury, Nausea
|
AT APPROX 1500, HEARD MOTHER SCREAMING PT'S NAME IN HALLWAY, RN X2 IMMEDIATELY ASSESSED. CHILD...
AT APPROX 1500, HEARD MOTHER SCREAMING PT'S NAME IN HALLWAY, RN X2 IMMEDIATELY ASSESSED. CHILD FOUND IN FLOOR OUTSIDE WIC LAB. UNWITNESSED FALL. CHILD AWAKE, ALERT, AND ORIENTED. STATED HE HIT HIS HEAD. SMALL RED AREA NOTED TO L FOREHEAD. CHILD ASSISTED TO WIC LAB CHAIR. VITALS TAKEN AND STABLE. FACE, HEAD, NECK, AND SPINE PALPATED WITH NO C/O PAIN. CHILD C/O NAUSEA BUT NO EMESIS NOTED. CHILD MONITORED FOR 5-10 MIN. MENTATION APPROPRIATE, NEURO INTACT. ADVISED MOTHER TO TAKE CHILD TO ER TO RULE OUT ANY INJURY S/P FALL. CHILD AMBULATORY OUT TO VEHICLE WITHOUT DIFFICULTY.
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| 2833346 | 11 | M | NC | 03/26/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No adverse events - this report is being submitted because the Pfizer-BioNTech vaccine (2024 - 2025 ...
No adverse events - this report is being submitted because the Pfizer-BioNTech vaccine (2024 - 2025 formula, NDC: 59267-4438-02) was inadvertently administered past the product's 10 week Beyond Use Date (BUD). The products BUD as marked on the box by facility was 12/24/2024.
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| 2833347 | 9 | M | NC | 03/26/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No adverse events - this report is being submitted because the Pfizer-BioNTech vaccine (2024 - 2025 ...
No adverse events - this report is being submitted because the Pfizer-BioNTech vaccine (2024 - 2025 formula, NDC: 59267-4438-02) was inadvertently administered past the product's 10 week Beyond Use Date (BUD). The products BUD as marked on the box by facility was 12/24/2024.
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| 2833348 | 65 | M | MT | 03/26/2025 |
MMRV |
MERCK & CO. INC. |
Y009589 |
No adverse event, Underdose
No adverse event, Underdose
|
MMRV given instead of MMR to an adult. No adverse reactions noted.
MMRV given instead of MMR to an adult. No adverse reactions noted.
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| 2833349 | 61 | F | IL | 03/26/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3ZH27 |
Asthenia, Mobility decreased, Pain, Sleep disorder
Asthenia, Mobility decreased, Pain, Sleep disorder
|
Office Visit Note 3/18/25 - Pain began after vaccine administration. Pain is throbbing and affects ...
Office Visit Note 3/18/25 - Pain began after vaccine administration. Pain is throbbing and affects sleep. She has been sleeping in recliner to try and reduce pain. She has used heat and ice. Patiently, she has significantly reduced range of motion of the left shoulder. She has continued to work, but does not have full use of left arm. Significantly reduced range of motion of the left shoulder. Only able to actively abduct to approximately 30 degrees. Passive range of motion is slightly better, although patient has significant pain with this. Can use NSAIDs, but must stop 2 weeks prior to upcoming breast surgery. Can try Flexeril at night. Also recommend that she begin physical therapy as soon as possible. Physical Therapy Note 03/24/2025 - ASSESSMENT Patient presents to physical therapy evaluation with primary c/o L shoulder pain. The results of the objective tests and measures show decreased L shoulder ROM, decreased L shoulder strength, positive rotator cuff testing. Functional deficits include but are not limited to Reaching overhead, reaching across body, lifting. Signs and symptoms are consistent with diagnosis of Acute pain of left shoulder (M25.512). Pt and PT discussed evaluation findings, pathology, POC and HEP. Pt voiced understanding and performs HEP correctly without reported pain. Skilled Physical Therapy is medically necessary to address the above impairments and reach functional goals.
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| 2833356 | 8 | M | NC | 03/26/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No adverse events - This report is being submitted due to the Pfizer-BioNTech COVID-19 vaccine (2024...
No adverse events - This report is being submitted due to the Pfizer-BioNTech COVID-19 vaccine (2024 - 2025 formula, NDC 59267-4438-02) being inadvertently administered past its 10 week Beyond Use Date (BUD). It's BUD as marked by facility was 12/24/2024.
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| 2833367 | 61 | F | 03/26/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Unevaluable event
Unevaluable event
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Patient reports 2 weeks hospitalization after receiving Pfizer COVID-19 vaccine. No other informatio...
Patient reports 2 weeks hospitalization after receiving Pfizer COVID-19 vaccine. No other information provided.
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โ | ||||||
| 2833368 | 9 | F | WA | 03/26/2025 |
FLU3 PNC13 PPV |
SEQIRUS, INC. PFIZER\WYETH MERCK & CO. INC. |
2H2S9 Y016291 |
Body temperature increased, Chills, Gait disturbance; Body temperature increased...
Body temperature increased, Chills, Gait disturbance; Body temperature increased, Chills, Gait disturbance; Body temperature increased, Chills, Gait disturbance
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STUDENT BROUGHT TO NURSE AT 2;28PM 03/24/25BY TEACHER STATING SHE COULD NOT WALK ON HER LEG AND CHIL...
STUDENT BROUGHT TO NURSE AT 2;28PM 03/24/25BY TEACHER STATING SHE COULD NOT WALK ON HER LEG AND CHILLING THROUGHOUT THE DAY AFTER ARRIVING TO SCHOOL FROM HE DOCOTOR'S APPOINTMENT. INITIALLY TEMPERATURE WAS WNL AT 98.6 TAKEN BY INFRA-RED FOREHEAD THERMOMETER. PARENT CALLED TO PICK UP STUDENT. ICE PALCED ON INJECTION SITE OF 3 VACCINES IN SAME AREA. WHILE WAITING FOR PARENT TEMPERATURE SOARED TO 103.3. MONM ARRIVED AND HAD CALLED HER PEDIATRICIAN WHO RECOMMENDED TO NEDICATE WITH 400 MG IBUPROFEN. STUDENT MEDICATED BY MOM AND THE TRANSPORTED HOME.
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| 2833369 | 67 | F | FL | 03/26/2025 |
PNC20 |
PFIZER\WYETH |
LK6651 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Duplicate vaccine - Prevnar20 was previously administered 4/2024 - patient reports no adverse react...
Duplicate vaccine - Prevnar20 was previously administered 4/2024 - patient reports no adverse reactions.
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| 2833370 | 72 | M | WV | 03/26/2025 |
COVID19 FLU3 PNC21 |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. |
LM2221 U8532CA Y011819 |
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mo...
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
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Patient has had pain in left arm since day after receiving vaccine. After 2 weeks went to a physici...
Patient has had pain in left arm since day after receiving vaccine. After 2 weeks went to a physician that recommended treatment with ibuprofen. Patient is still having pain in arm after 42 days. Reseen by physician who is referring him to orthopedic doctor. Patient also having difficulty with range of motion of left shoulder.
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| 2833371 | 22 | F | TX | 03/26/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944942 |
Dizziness
Dizziness
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Patient became dizzy and felt faint 3 minutes after her vaccine. She remained seated and was given a...
Patient became dizzy and felt faint 3 minutes after her vaccine. She remained seated and was given an ice pack to put behind her neck. She then stated that her legs and arms felt stiff and numb. I asked if patient has eaten and she only had a protein bar all day. I gave her some water and candy to increase her blood sugar. Patient felt better after wards and sat there for another 20 min. Her father came to help her home once she felt better.
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| 2833372 | 70 | F | FL | 03/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4F45Z |
Extra dose administered
Extra dose administered
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Patient received an extra Arexvy dose outside of recommendation guidlines. Received first dose on J...
Patient received an extra Arexvy dose outside of recommendation guidlines. Received first dose on Jan 28, 2024 and received a second dose by error on May 24, 2024
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| 2833373 | 1.42 | F | IL | 03/26/2025 |
IPV IPV |
SANOFI PASTEUR SANOFI PASTEUR |
UT7407NA UT7407NA |
Lethargy, Lip swelling, Mobility decreased, Nephrotic syndrome, Oedema periphera...
Lethargy, Lip swelling, Mobility decreased, Nephrotic syndrome, Oedema peripheral; Swelling of eyelid, Visual impairment
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Patient had zero illnesses or known viruses prior to the flu shot. About two weeks after the flu sh...
Patient had zero illnesses or known viruses prior to the flu shot. About two weeks after the flu shot, she started showing signs of swelling in her eyelids, lids, and lips. They progressed over the next few weeks and she became increasingly swollen to the point that she couldn't see well out of her eyes. She could barely move, was lethargic, and had edema in her arms and legs at this point. I called the clinic and Dr. insisted that we keep her home and put her in a steam shower. By the end of December, it was so bad that I took her to the ER against Dr.'s advice and she was hospitalized for 10 days. She was then diagnosed with nephrotic syndrome. Her nephrologist said that pediatric nephrotic syndrome is caused by an overreaction to a virus. Patient had no viruses prior to the flu shot. She was healthy, breastfed, and was not at daycare or around other children. It was during COVID and she was primarily at home without exposure to other viruses. The flu shot seems to be the only thing she was exposed to.
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โ | โ | โ | |||
| 2833374 | 32 | M | AZ | 03/26/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Arthralgia, Asthenia, Biopsy skin normal, Blepharospasm, Brain fog; Burning sens...
Arthralgia, Asthenia, Biopsy skin normal, Blepharospasm, Brain fog; Burning sensation, Chest X-ray normal, Dizziness, Electric shock sensation, Electrocardiogram normal; Electromyogram normal, Fatigue, Gait disturbance, Insomnia, Magnetic resonance imaging head normal; Magnetic resonance imaging spinal normal, Muscle twitching, Muscular weakness, Nerve conduction studies normal, Pain; Paraesthesia, Peripheral coldness, Skin discolouration, Somnolence, Tongue coated; Vitreous floaters, X-ray limb normal, X-ray normal
More
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Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my ri...
Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
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โ | |||||
| 2832977 | 1.33 | F | WV | 03/25/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
X002058 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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No additional AEs/PQC reported.; Caller reported expired dose of MMR II was administered. No other ...
No additional AEs/PQC reported.; Caller reported expired dose of MMR II was administered. No other information provided. No additional AEs/PQC reported.; This spontaneous report was received from a Nurse and refers to a 16-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Feb-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X002058, expiration date: 19-Jan-2025) 0.5 mL, administered by Subcutaneous route (expired vaccine administered), as Prophylaxis. It was reported that the vaccine was administered by a healthcare professional according to the instruction leaflet. No adverse event reported. The reporter stated that they were looking to reach out the patient's family to have the patient went in 6 weeks for re-administration.
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| 2832978 | PA | 03/25/2025 |
MMR |
MERCK & CO. INC. |
X00178 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Medical Assistant calling to report inadvertently administering an expired dose of MMRII to a patien...
Medical Assistant calling to report inadvertently administering an expired dose of MMRII to a patient.; no adverse event; This spontaneous report was received from a medical assistant and regarding a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-Feb-2025, the patient was inadvertently vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection (lot #X00178 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live) that was expired (expiration date: 02-Jan-2025) as prophylaxis along with sterile diluent (MERCK STERILE DILUENT), solution for injection (indication, expiration date, and lot # were not reported). Caller stated product did not undergo a temperature excursion and was supported per Post-Expiry Memo. No additional adverse events.
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| 2832979 | NY | 03/25/2025 |
HPV9 |
MERCK & CO. INC. |
1965046 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse side effects were reported.; Inbound call from HCP reporting GARDASIL 9 that was out of r...
No adverse side effects were reported.; Inbound call from HCP reporting GARDASIL 9 that was out of range, unmonitored for an unknown amount of time at unknown temperatures. Lot number was provided, expiration date was unknown. Administered 2/6/2025. Consent to contact is yes. No adverse si; This spontaneous report was received from Other health professional and refers to a 24-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, frequency, route of administration, vaccination site, and vaccination scheme were not provided; lot # 1965046, which has been verified as a valid number, and expiration date reported and validated as 22-Jan-2026) as a prophylaxis. The vaccine was out of range, unmonitored for an unknown amount of time at unknown temperatures (improper storage of product in use). However, no adverse side effects were reported.
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| 2832980 | 12 | F | MD | 03/25/2025 |
HPV4 |
MERCK & CO. INC. |
K010215 |
Anaphylactic reaction
Anaphylactic reaction
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Anaphylaxis; This spontaneous report was received from a physician and refers to a female patient of...
Anaphylaxis; This spontaneous report was received from a physician and refers to a female patient of 21-years old by reporting time. The patient's medical history, concurrent conditions were not reported. The pt vaccination history included unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 07-JUL-2014, 26-JUL-2007, 23-NOV-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified immunoglobulin antihepatitis b (HEPATITIS B VACCINE) (reported as Hep B, adolescent or pediatric) (on 30-MAY-2003, 30-JUN-2003 and 05-MAR-2004) (captured in case 2262117); unspecified immunoglobulin antihepatitis a (HEPATITIS A VACCINE) (reported as Hep A, ped/adol, 2 dose) (on 02-MAY-2006 and 29-JUN-2005), unspecified hib vaccine (reported as HIB) (on 30-AUG-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 07-JUL-2014); unspecified polio vaccine (reported as IPV) (on 26-JUL-2007, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003); unspecified varicella zoster vaccine (reported as varicella) (on 26-JUL-2007 and 11-JUN-2004); unspecified measles vaccine, mumps vaccine, rubella vaccine (MMR) (on 26-JUL-2007 and 11-JUN-2004): unspecified pneumococcal vaccine (reported as pneumococcal conjugate PCV 7) (on 29-JUN-2005, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003), unspecified influenza vaccine (reported as Influenza, seasonal, injectable, presentative free) (on 22-OCT-2013), unspecified tuberculin PPD (reported as TST-PPD intradermal) (on 11-JUN-2013) and quadrivalent human papillomavirus (GARDASIL) (on 18-AUG-2015 On 18-AUG-2015, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) intramuscular injection (valid lot number K010215, expiration date: 05-MAY-2017 obtained per internal validation) (1 (units not provided) for prophylaxis. On an unknown date, the patient experienced anaphylaxis. The patient also was vaccinated with unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 02-MAR-2020), unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 02-MAR-2020). On 26-MAR-2021, the pt was vaccinated with the first dose of human papillomavirus, recombinant (GARDASIL 9) (captured in case 2221838) and with pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE) (reported as Tdap). At the reporting time, the outcome of Anaphylaxis was not provided. The causal relationship between the event of anaphylaxis and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was not reported. Upon internal review, the event of anaphylaxis was determined to be medically significant.
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| 2832981 | 51 | F | FL | 03/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Condition aggravated, Daydreaming, Delusion of parasitosis, Feeling abnormal, In...
Condition aggravated, Daydreaming, Delusion of parasitosis, Feeling abnormal, Investigation; Pruritus
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Morgellons delusional disorder; is flared up; Makes her lose normal functioning, makes her lose her ...
Morgellons delusional disorder; is flared up; Makes her lose normal functioning, makes her lose her mind; itching/Has been having lot of itchiness/experiencing itching all over whole body, hair, like in her head, everywhere, is so bad; gooeyness under the nail/ It feels like if you scratch your head there is like gooey on your nail and you can't get it off; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 54-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: has been crazy high lately, stuff is freaking her out; "Bad back has good pain management" (unspecified if ongoing), notes: Bad back Has good pain management, for that, has had for years; "Feels like they flare up or something" (unspecified if ongoing), notes: in 50 years. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, lot number unknown, Location of injection/shot: maybe arm, unknown which are), administration date: 20May2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Jun2024, outcome "not recovered", described as "gooeyness under the nail/ It feels like if you scratch your head there is like gooey on your nail and you can't get it off"; PRURITUS (non-serious) with onset Jun2024, outcome "not recovered", described as "itching/Has been having lot of itchiness/experiencing itching all over whole body, hair, like in her head, everywhere, is so bad"; DELUSION OF PARASITOSIS (medically significant), outcome "unknown", described as "Morgellons delusional disorder"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "is flared up"; DAYDREAMING (non-serious), outcome "unknown", described as "Makes her lose normal functioning, makes her lose her mind". The events "morgellons delusional disorder", "itching/has been having lot of itchiness/experiencing itching all over whole body, hair, like in her head, everywhere, is so bad", "gooeyness under the nail/ it feels like if you scratch your head there is like gooey on your nail and you can't get it off", "is flared up" and "makes her lose normal functioning, makes her lose her mind" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: drug tests: Unknown results, notes: Hospital did drug tests. Therapeutic measures were taken as a result of pruritus. Clinical course: The patient never had no reaction to any previous vaccination, medications, food or other products. The the patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient did not take any other medications within 2 weeks prior to the event onset, has been on same medications for 15 years, never had anything like this before. Seriousness reported as No. Concomitant Products: Has been on same medications for 15 years, never had anything like this before. Takes medications, has been taking for years, never had problems, has had the same ones. Test results: Does not think so. Just called because, she was starting to think something. Nothing has been making sense. Went to dermatologist, they did not even look at her, just thought that it may have been this, Morgellons delusional disorder. Hospital did drug tests, thinks she is on meds, is ridiculous. Caller is wanting to know if anybody else had symptoms similar such as itching and gooeyness under the nail. Wanting to know if anyone else had those symptoms and what she can do to get rid of that. Caller stated "I don't even realize. It seems like you have itching. It feels like if you scratch your head there is like gooey on your nail and you can't get it off. It does not go away. I tried everything. Every time I take a shower or a bath it gets worst. When I wash my hands it never goes off." "It's never ending. I don't really know what these things are I never seen nothing like that my whole life." Caller stated "Is itchiness when you was your hands. There is like a little clear but then sometimes you can see them you go sideways there is a black speck when you wash your hands and when you dry your hands it makes the paper towel tissue hard and like a black speck inside or outside." Caller stated "I tried everything. I tried Ivermectin, mint, everything for itching. Tried baking soda. I don't know what to do I need help. I need you guys to tell me what can I get this rid with. It itching all over her body, stays under her fingernails. Outcome of Itching: It will get bad then, does not know, can't get rid of it. Has been to doctor, hospital, nobody knows what is going on. They think she is nuts or on drugs. It is a nightmare, could kill herself, shit. Treatment: They gave her Ivermectin, told her to take Nix, nothing is helping Clarified, they told her to take Nix for lice, nothing was helping. Thought she had bed bugs, thought she had sand fleas, has been a nightmare. When clarifying previous statement that, she went to hospital, clarified, she was not admitted to hospital. When clarifying previous statement, that it is staying under her finger nails, clarified, she was referring to goo. Does not remember when she first noticed it, if it was in Jun2024, is not sure. Does not want to say something that is not exactly right. Knows this has all been going on since Jun2024. know that over last, probably 6 months, tried to tell people, they think she is nuts. This is scary, does not know what to do. Feels like something crawling on her, all the time. If she could scratch, it gets under finger nail, can't get it out. Clarified, goo appears, whenever she itches, the spot that she is itching, will scratch with fingernails, fells like something gooey. Washes hand's all the time. When clarifying color or consistency of goo, caller stats, is crazy, like clear but, a black speck. When she gets shower or bath, feels like she can see things better. Washes hands all the time however, hands are dry, like hard. The black specks are bad. Treatment: No, does not want to go back to doctor, all they do is, accuse her of being on drugs and being crazy. Does not know what to do. That is why she is calling, to find out what to do. Is not crazy, not on drugs, had doctor for 10 years. Right now, is flared up, like there is a haze on her head, does not know. Fells like a cap over her head, like there is another layer or something, does not know why. Totally drives her nuts, so over this shit, this is serious shit. Makes her lose normal functioning, makes her lose her mind. Is so bad, these 2 things, does not even know what those things are. When she tells people, they don't believe her, drives her nuts. Feels like she has cap on head, or something, can see out of corner of her eyes. It comes clean, does not come off. Wants it to come off. It must not be contagious, nobody else in her house has it. Has had this, about a year. Clarified, she had had the itchiness and goo, almost a year, that she knows of. Could have been before but, just can't figure it out. Thought someone must have given to her but, has not had sex. Thought it was bed bugs, thought it was sand fleas. Trying to make sense of it. Could not even tell it was a vaccine problem, did not know until just now. Thinks they have been growing so long, on her, does not really know for sure. These things are really weird. When caller asked to further explain these things, if there is shape or color, or if able to describe it, she states, it kind of blends in with her skin, feels it on like, her head. Feels like it has never gone away. Feels like they flare up or something, in 50 years, knows how hair feels like. Has bunch of knots, rats, well not knots but, tangles, she can't get out of her hair. Can't pull it out, does not know what to do anymore. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2832991 | 65 | F | CA | 03/25/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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6 cm circular area of redness and itching at vaccine site commencing 4 days after vaccine administra...
6 cm circular area of redness and itching at vaccine site commencing 4 days after vaccine administration and persisting until date of report.
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| 2832992 | 33 | M | PR | 03/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood test, Chest X-ray, Chest pain, Costochondritis, Inflammation; Swelling
Blood test, Chest X-ray, Chest pain, Costochondritis, Inflammation; Swelling
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Adverse Events and Symptoms: After receiving the COVID-19 vaccine, I began experiencing significant ...
Adverse Events and Symptoms: After receiving the COVID-19 vaccine, I began experiencing significant inflammation and muscle pain throughout my body. These symptoms persisted and worsened over time. On March 13, I was admitted to the hospital due to severe chest pain. After ruling out heart attack it is believed to be costochondritis. Since that time, I have continued to suffer from persistent inflammation and swelling in various areas of my body. These symptoms have affected my daily life and overall well-being. Medical Interventions: Hospital admission on March 13 for chest pain. Ongoing medical consultations and treatments and monitoring Current Condition: As of now, I am still experiencing ongoing swelling and persistent symptoms related to costochondritis. These symptoms have not fully resolved, and I continue to seek medical care.
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| 2832993 | 27 | F | KY | 03/25/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Brain fog, Chills, Dyspnoea, Heart rate increased, Pruritus; Rash
Brain fog, Chills, Dyspnoea, Heart rate increased, Pruritus; Rash
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Rash, itching, fast heart rate, shortness of breath, chills, brain fog, used epi pen and took Benadr...
Rash, itching, fast heart rate, shortness of breath, chills, brain fog, used epi pen and took Benadryl, symptoms starting to go away
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| 2833002 | 03/25/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Chills, Erythema, Feeling hot, Malaise, Nodule; Pain, Pyrexia
Chills, Erythema, Feeling hot, Malaise, Nodule; Pain, Pyrexia
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The second made me so sick; Chills; Fever; Arm was red; big knot on arm; hot; sore almost to my neck...
The second made me so sick; Chills; Fever; Arm was red; big knot on arm; hot; sore almost to my neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (patient had them starting in his/ her twenties and had them multiple times). Previously administered products included shingles vaccine (1st dose on unknown date). In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, less than a week after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The second made me so sick), chills (Verbatim: Chills), fever (Verbatim: Fever), erythema of extremities (Verbatim: Arm was red), local swelling (Verbatim: big knot on arm), feeling hot (Verbatim: hot) and pain (Verbatim: sore almost to my neck). The outcome of the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain were not reported. It was unknown if the reporter considered the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain to be related to Shingles vaccine. It was unknown if the company considered the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 14-MAR-2025 This case was reported by a patient via interactive digital media. Patient had them starting in his/her twenties and had them multiple times. Sometimes not so bad. Other times a nightmare. Patient just took second shot last week. Patient stated that first one was fine. The second made patient so sick, chills , fever, arm was red with big knot, hot and sore almost to neck. Patient thanked goodness that he/she was done.
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| 2833003 | 03/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspeceted vaccination failure; got shingles 3 times; This serious case was reported by a consumer v...
Suspeceted vaccination failure; got shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 3 times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shot and got shingles 3 times and he/she mentioned that the vaccine did not work for him/her. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2833004 | F | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for herself. The reporter stated that patient could get the shots and still had gotten a bad case of shingles. She was in so much pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
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| 2833005 | 03/25/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Atrial fibrillation, Deep vein thrombosis, Pulmonary embolism; Atrial fibrillati...
Atrial fibrillation, Deep vein thrombosis, Pulmonary embolism; Atrial fibrillation, Deep vein thrombosis, Pulmonary embolism
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pulmonary embolism; my heart also then went into Afib; (I developed what turned out to be a DVT bloo...
pulmonary embolism; my heart also then went into Afib; (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf; This serious case was reported by a consumer via other manufacturer and described the occurrence of pulmonary embolism in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis. Co-suspect products included Elasomeran (Spikevax) for prophylaxis. Previously administered products included Covid 19 vaccine with an associated reaction of no adverse event (Pfizer vaccine). Concomitant products included other lipid modifying agents. On 15-NOV-2024, the patient received the 1st dose of Fluarix 2024-2025 season and Spikevax (intramuscular). In NOV-2024, 1 week after receiving Fluarix 2024-2025 season, the patient experienced dvt of calf (Verbatim: (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). In JAN-2025, the patient experienced atrial fibrillation (Verbatim: my heart also then went into Afib) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). On 17-JAN-2025, the patient experienced pulmonary embolism (Verbatim: pulmonary embolism) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). The outcome of the pulmonary embolism, dvt of calf and atrial fibrillation were not resolved. It was unknown if the reporter considered the pulmonary embolism, dvt of calf and atrial fibrillation to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the pulmonary embolism, dvt of calf and atrial fibrillation to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-MAR-2025 Approximately one-week later post vaccination of Fluarix and Spikevax 2024-2025, patient was developed a deep vein thrombosis (DVT) in the left calf. In January, the blood clot was moved to the lungs for patient, which caused a pulmonary embolism and atrial fibrillation for patient. Patient was developed a pulmonary embolism on 17-Jan-2025 in AM. Patient was hospitalized for five days from 22-Jan-2025 to 27-Jan-2025 and went through a catheter-based clot removal, and since then patient was on unspecified blood thinners and beta blocker as a treatment medication. Due to symptom patient wear compression socks. The reporter was stated that blood clot and Covid booster felt like the only possibility as a cause. A hematology consultation was scheduled for further evaluation for patient. Patient was not allergic to any medications, food or other products. Patient treatment medication included M.E.E.S 50 plus once a day for product used for unknown indication. Patient was first time received Moderna Covid-19 vaccination as booster dose.; Sender's Comments: Pulmonary embolism, Deep vein trombosis and Atrial fibrillation are unlisted events which are considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.
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| 2833006 | F | MI | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash
Rash
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a little rash on the neck and upper back; This non-serious case was reported by a physician via call...
a little rash on the neck and upper back; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: a little rash on the neck and upper back). The outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date : 20-MAR-2025 Medical doctor called to informed that patient got the first dose of Shingrix in a pharmacy (unknown date and location) and after the administration developed a little rash on the neck and upper back. Reporter questioned that could the patient received the 2nd dose still.
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| 2833045 | 11 | M | MD | 03/25/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
9M2R7 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Redness and swelling of skin at the injection site.
Redness and swelling of skin at the injection site.
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| 2833047 | 87 | F | 03/25/2025 |
DTAP DTAP DTAP DTAP DTAP DTAP DTAP DTAP DTAP DTAP DTAP DTAP DTAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa u8264aa |
Acute kidney injury, Anaemia, Anion gap, Aortic stenosis, Atelectasis; Atrial fi...
Acute kidney injury, Anaemia, Anion gap, Aortic stenosis, Atelectasis; Atrial fibrillation, Bacterial test negative, Bilirubin urine, Blood calcium decreased, Blood chloride normal; Blood creatinine increased, Blood glucose normal, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal; Blood sodium decreased, Blood thyroid stimulating hormone increased, Blood urea increased, Carbon dioxide normal, Chest X-ray abnormal; Chronic kidney disease-mineral and bone disorder, Coma scale normal, Condition aggravated, Creatinine renal clearance decreased, Dry skin; Dyslipidaemia, Electrocardiogram QT prolonged, Fall, Fatigue, Glomerular filtration rate decreased; Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, Haemoglobin urine absent, Hiatus hernia; Hypokalaemia, Hypothyroidism, Lung consolidation, Lung infiltration, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Nausea, Nitrite urine absent; Platelet count increased, Protein urine present, Pruritus, Red blood cell count decreased, Red cell distribution width increased; Skin abrasion, Specific gravity urine normal, Thyroxine normal, Troponin increased, Urinary squamous epithelial cells increased; Urine analysis, Urine ketone body absent, Urobilinogen urine increased, White blood cell count normal, White blood cells urine; White blood cells urine negative, pH urine normal
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Document Type: Internal Medicine IP Progress Note Document Subject: Progress Note Comprehensive ...
Document Type: Internal Medicine IP Progress Note Document Subject: Progress Note Comprehensive Encounter Info: Observation, 03/20/25 - 03/24/25 * Final Report * Subjective Patient is an 87-year-old female past medical history of A-fib, CKD, GERD, hypothyroidism, hypertension, Raynaud's disease, rheumatoid arthritis, TIA, GERD who presented to the ER with complaints of nausea. Patient was seen and evaluated by her bedside today. She feels very tired. She is attributing her tiredness to metoprolol as she endorsed that metoprolol always makes her feel that way. At home, she is on bisoprolol due to intolerance to metoprolol. Heart rate is still very difficult to control with metoprolol and diltiazem. ???????Cardiology has been consulted to assist with heart rate control Hypertensive on vitals Review of Systems All 13 point review of systems were reviewed with the patient and are negative except as specified in the HPI??????? Objective Vitals and Measurements Vitals & Measurements most recent past 24 hours T: 37.2 ๏ฟฝC (Oral) TMIN: 36.3 ๏ฟฝC (Route Not Specified) TMAX: 37.2 ๏ฟฝC (Oral) BP: 145/107 HR: 109 (Monitored) RR: 16 SpO2: 93% Oxygen Therapy: Room air Oxygen Flow Rate: 2 (L/min) WT: 59.1 kg Hemodynamics Neurologic Glasgow Coma Score: 15 Patient Weight Current Daily Weight: 59.1 kg 03/24/25 Previous Daily Weight: 58.1 kg 03/23/25 Difference from Previous: 1.000 kg Weight for Nutrition: 240 kg 03/22/25 BMI: 23.4 03/21/25 Normal Weight (BMI 18.5-24.9) Patient Height Current Height: 152.4 cm 03/24/25 Nutritional Orders: Ensure Enlive., 03/21/25 17:22:00 EDT, With Meals ---------------------- 2000 mg Sodium, 20 gm Saturated Fat Diet, Start on: 03/21/25 1:16:00 EDT, "No Fluid Restrictions" mL Nursing ---------------------- Intake/Output I/O TOTALS ONLY - Last 24 hrs (0600-0559) from 03/23 - 03/24 Total Intake 480.00 mL Total Output 0.00 mL Balance 480.00 mL Physical Exam General: Alert and oriented, No acute distress. Eye: Normal conjunctiva. Cardiovascular: No murmur. Respiratory: Lungs are clear to auscultation, Respirations are non-labored. Gastrointestinal: Soft, Non-tender, Non-distended, Normal bowel sounds, ??????? Neurologic: Alert, Oriented, non focal Psychiatric: Cooperative, Appropriate mood & affect. Musculoskeletal: No swelling, ??????? Lines, Tubes, and Drains IV cannula Forearm Right 22 gauge PIV Assessment/Plan Acute-on-chronic kidney injury N17.9 1. Acute-on-chronic kidney injury N17.9 Improved today and almost back to baseline. Nephrology following. - will need to establish with nephro as o/p Continue to hold nephrotoxics 2. Chronic kidney disease-mineral and bone disorder N18.9 3. Hypokalemia E87.6 Resolved with replacement 4. Elevated troponin R79.89 Downtrended. 5. Prolonged QT interval R94.31 replace electrolytes, avoid qtc prolonging meds Repeat EKG 6. Anemia D64.9 no overt bleeding, stable on recheck 7. Atrial fibrillation I48.20 Still In RVR. dced Metoprolol due to previous intolerance replaced with carvedilol Bisoprolol is unavailable in IUH - continue home apixaban renally dose, Cardiology consulted 8. Hypertension I10 Continue antihypertensives 9. Recurrent falls R29.6 PT/OT consulted 10. Severe Aortic Stenosis I35.0 noted Outpt f/u Dyslipidemia E78.5 GERD (gastroesophageal reflux disease) K21.9 not on medication tx Hypothyroidism E03.9 Just recently started on levothyroxine for tsh uptrending 18, symptomatic hypothyroid T4 is normal Rheumatoid arthritis M06.9 continues home leflunomide and prednisone. Rheumatoid arthritis (disorder) M06.9 Skin pruritus L29.9 resolving Eucerin cream, appears this may be precipitated by dry skin resulting in excoriated areas ppx - on Eliquis. Fluids Lines: PIV Diet: Heart Healthy Code Status/Goals of Care Discussion: Full Code VTE ppx: On therapeutic anticoagulation Dispo: Inpatient Anticipated Length of stay on admission: Less than 2 midnights Discharge Disposition: _Expect the patient to be medically ready for discharge in tomorrow, pending patient vital signs (HR/BP/RR/T) are within stable discharge parameters Location: Plan for discharge to be determined after therapy evaluations Discharge Needs: None Case Management Engaged Anemia D64.9 Atrial fibrillation I48.20 Chronic kidney disease-mineral and bone disorder N18.9 Dyslipidemia E78.5 Elevated troponin R79.89 GERD (gastroesophageal reflux disease) K21.9 Hypertension I10 Hypokalemia E87.6 Hypothyroidism E03.9 Prolonged QT interval R94.31 Recurrent falls R29.6 Rheumatoid arthritis M06.9 Rheumatoid arthritis (disorder) M06.9 Severe Aortic Stenosis I35.0 Skin pruritus L29.9 Orders: carvedilol, 25 mg, Orally, Tablet, BID, 03/24/25 21:00:00 EDT Electrocardiogram Code Status Resuscitation Status - Ordered -- 03/21/25 1:16:00 EDT, DNR/DNI/Comprehensive Care Medications Active Scheduled Inpatient Medications apixaban, Tablet, 2.5 mg, Orally, BID, Start: 03/21/25 09:00:00 carvedilol, Tablet, 25 mg, Orally, BID, Start: 03/24/25 21:00:00 cetirizine, Tablet, 10 mg, Orally, Daily, Start: 03/21/25 12:03:00 diltiaZEM (diltiaZEM (Eqv-Cardizem CD) 120 mg/24 hours oral capsule, extended release), Cap, Extended Rel, 120 mg, Orally, Daily, Start: 03/23/25 22:00:00 folic acid, Tablet, 1 mg, Orally, Daily, Start: 03/21/25 12:04:00 leflunomide, Tablet, 10 mg, Orally, Daily, Start: 03/22/25 09:00:00 levothyroxine, Tablet, 25 mCg, Orally, Daily, Start: 03/22/25 06:00:00 predniSONE, Tablet, 2.5 mg, Orally, Daily, Start: 03/21/25 12:04:00 One-Time Medications Given 03/23/25 00:00:00 TO 03/24/25 12:13:42 metoPROLOL (metoPROLOL tartrate), Tablet, 25 mg, Orally, ONCE, (1 DOSE 03/23/25 11:44:00) metoPROLOL (metoPROLOL tartrate), Injection, 5 mg, IV Push, ONCE, (1 DOSE 03/23/25 14:18:00) metoPROLOL (metoPROLOL tartrate), Injection, 5 mg, IV Push, ONCE, (1 DOSE 03/23/25 17:09:00) PRN Medications (0600 - 0559) from 03/23 - 03/24 OXYcodone, 2.5 mg, Orally, Q4H, 0 Dose(s) acetaminophen, 1,000 mg, Orally, Q8H, 0 Dose(s) fentaNYL, 12.5 mCg, IV Push, Q4H, 0 Dose(s) hydrOXYzine, 25 mg, Orally, Q8, 0 Dose(s) magnesium sulfate, 2 GM, IVPB, Q12H, 0 Dose(s) magnesium sulfate, 4 GM, IVPB, Q12H, 0 Dose(s) morphine, 1 mg, IV Push, Q10min, 0 Dose(s) potassium chloride, 20 mEq, Orally, Unscheduled, 0 Dose(s) potassium chloride, 30 mEq, Orally, Unscheduled, 0 Dose(s) potassium chloride, 40 mEq, Orally, Unscheduled, 0 Dose(s) potassium phosphate-sodium phosphate, 250 mg, Orally, Unscheduled, 0 Dose(s) trimethobenzamide, 200 mg, IM, Q8H, 0 Dose(s) Lab Results All Labs Last 24 hours (No Micro or Pathology) Hematology: WBC: 9.1 k/cumm (03/24/25 02:15:00) RBC: 3.6 million/cumm Low (03/24/25 02:15:00) Hgb: 10.1 GM/dL Low (03/24/25 02:15:00) Hct: 30.4 % Low (03/24/25 02:15:00) MCV: 85 fL (03/24/25 02:15:00) MCH: 28 pg (03/24/25 02:15:00) MCHC: 33.1 GM/dL (03/24/25 02:15:00) RDW: 19.4 % High (03/24/25 02:15:00) Platelet: 477 k/cumm High (03/24/25 02:15:00) MPV: 7.9 fL (03/24/25 02:15:00) Chemistry: Sodium SerPl QN: 135 mmol/L (03/24/25 02:15:00) Potassium SerPl QN: 4.3 mmol/L (03/24/25 02:15:00) Chloride SerPl QN: 100 mmol/L (03/24/25 02:15:00) Carbon Dioxide SerPl QN: 25 mmol/L (03/24/25 02:15:00) Anion Gap: 10 mmol/L (03/24/25 02:15:00) BUN SerPl QN: 34 mg/dL High (03/24/25 02:15:00) Creatinine SerPl QN: 1.28 mg/dL High (03/24/25 02:15:00) Estimated GFR (CKD-EPI, no race): 41 mL/min/1.73m2 Low (03/24/25 02:15:00) Estimated CRCL (CG): 24 mL/min Low (03/24/25 02:15:00) Glucose SerPl QN: 94 mg/dL (03/24/25 02:15:00) Calcium Total SerPl QN: 8.7 mg/dL (03/24/25 02:15:00) Phosphorus SerPl QN: 3.5 mg/dL (03/24/25 02:15:00) Magnesium SerPl QN: 2.1 mg/dL (03/24/25 02:15:00) Urine Studies: Color: Light-Yellow (03/23/25 18:24:00) Clarity: Clear (03/23/25 18:24:00) Specific Gravity: 1.017 (03/23/25 18:24:00) pH: 6.5 (03/23/25 18:24:00) Protein: 100 Abnormal (03/23/25 18:24:00) Glucose: Normal (03/23/25 18:24:00) Ketones: NEGATIVE (03/23/25 18:24:00) Bilirubin: NEGATIVE (03/23/25 18:24:00) Hgb Ur: NEGATIVE (03/23/25 18:24:00) Nitrite: NEGATIVE (03/23/25 18:24:00) Urobilinogen: 2.0 2 Abnormal (03/23/25 18:24:00) Leukocyte Esterase Ur: NEGATIVE (03/23/25 18:24:00) WBC: 0-5 (03/23/25 18:24:00) RBC: None Seen (03/23/25 18:24:00) Bacteria: NONE (03/23/25 18:24:00) Squamous Epithelial: Few (03/23/25 18:24:00) Diagnostics Radiology Results - Last 24 hours Across Visits 03/24/2025 07:11 - XR Chest PA or AP Portable IMPRESSION:1. Large hiatal hernia.2. Increasing bilateral infiltrates with increasing atelectasis andconsolidation in the left lower lobe and a small-moderate leftpleural effusion.
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| 2833048 | 10 | F | 03/25/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
Malaise, Pallor, Visual impairment, Vomiting
Malaise, Pallor, Visual impairment, Vomiting
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pt receieved HPV , went to waiting room, about 5 minutes after, got pale, felt like she was going to...
pt receieved HPV , went to waiting room, about 5 minutes after, got pale, felt like she was going to be sick, vomited and reports vision going black. Got into exam room, given ice pack to neck and juice and sat for 5-10 mins and felt fine
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| 2833049 | 1.83 | M | NY | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 ( |
Urticaria
Urticaria
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Hives on chest- patient returned to clinic 20 minutes after vaccine admininstration in three ag...
Hives on chest- patient returned to clinic 20 minutes after vaccine admininstration in three agrea two on chest and one on face temperature checked pt reported no itching checked temperature elevated fever last reading 100.2 Follow up phone call with parents 3-25-25 in the am state that he is doing well had tylenol over night and has improved and hives are gone
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| 2833050 | 61 | F | MI | 03/25/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Chills, Diarrhoea, Erythema, Headache, Hyperhidrosis; Nausea, Pain, Peripheral s...
Chills, Diarrhoea, Erythema, Headache, Hyperhidrosis; Nausea, Pain, Peripheral swelling, Pruritus
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large localized reaction a few hours after vaccine administered, nausea, sweats, chills, body aches,...
large localized reaction a few hours after vaccine administered, nausea, sweats, chills, body aches, headache, diarrhea for 4 days, her left upper arm is erythematous, swollen and itchy. Prescription for oral prednisone given for 5 days
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| 2833051 | 75 | F | GA | 03/25/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
lc5482 lc5482 |
Chills, Injection site erythema, Injection site reaction, Injection site warmth,...
Chills, Injection site erythema, Injection site reaction, Injection site warmth, Malaise; Pain, Pyrexia
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Site reaction with redness and heat spreading down arm toward elbow from injection site covering mos...
Site reaction with redness and heat spreading down arm toward elbow from injection site covering most of outer upper arm. Patient complains of pain, chills, malaise, fever and states that it began a couple of days after the vaccine was administered. There is a language barrier and all information was obtained via a smartphone translation app.
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| 2833052 | 1.58 | F | VA | 03/25/2025 |
MMRV |
MERCK & CO. INC. |
Y019171 |
Wrong product administered
Wrong product administered
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Incorrect vaccine given. ProQuad administered, MMR was ordered.
Incorrect vaccine given. ProQuad administered, MMR was ordered.
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| 2833053 | 50 | F | TX | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
A5t73 |
Injection site swelling, Pyrexia
Injection site swelling, Pyrexia
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pt called on 3/25/2025 7 days later to report. she had a fever of 100 degrees for 3 days. The vacci...
pt called on 3/25/2025 7 days later to report. she had a fever of 100 degrees for 3 days. The vaccinated area grew bigger in size, spreading to her elbow. she says it was raised and after 7 days it is beginning to calm down. signs of improvements in the area after 7days. Pt says may not need to be seen by md as it is showing signs of improvement. Pt mentions will wait longer than 2 mos for the 2nd dose.
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| 2833054 | 1.92 | F | AZ | 03/25/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
X021283 X021283 |
Blister, Blister rupture, Pyrexia, Rash, Rash pruritic; Scab, Varicella
Blister, Blister rupture, Pyrexia, Rash, Rash pruritic; Scab, Varicella
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23 month 19 day old female presents with c/o Chickenpox Patient has had 2-3 days of low grade fever ...
23 month 19 day old female presents with c/o Chickenpox Patient has had 2-3 days of low grade fever and pruritic rash, recently had Varicella vaccine. Rash started on trunk and spread distally to extremities and head. The rash started as small red bumps that looked like pimples or insect bites. Then developed into thin-walled blisters filled with fluid. The blister walls broke, leaving open sores, which finally crust over to become dry, brown scabs. All three stages of the chickenpox rash (red bumps, blisters, and scabs) are on the body at the same time. Patient is otherwise doing well with good appetite, good UOP, and has been febrile..
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| 2833055 | 45 | M | FL | 03/25/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300215A |
Dyspnoea, Heart rate increased
Dyspnoea, Heart rate increased
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1030: PATIENT WAS ADMINISTERED ANTHRAX VACCINE VIA IM TO THE LEFT DELT. 1130: PATIENT RETURNED TO ME...
1030: PATIENT WAS ADMINISTERED ANTHRAX VACCINE VIA IM TO THE LEFT DELT. 1130: PATIENT RETURNED TO MEDICAL WITH CONCERNS OF ELEVATED HEART RATE, SHORTNESS OF BREATH. THE IDC HS2 PERFORMED A WORKUP INCLUDING VITALS PHYSICAL EXAM AND BRIEF HISTORY. UPON COMPLETING THE EXAM WITH THE ASSISTANCE OF APA-C, IT WAS DECIDED TO SEND PATIENT TO THE EMERGENCY ROOM FOR CARE AT EMERGENCY ROOM.
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| 2833056 | 72 | F | AR | 03/25/2025 |
COVID19 |
MODERNA |
045A12A |
COVID-19
COVID-19
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covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
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| 2833057 | 50 | F | MN | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
x5t42 |
Injection site swelling
Injection site swelling
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Parent (gaurdian) states patient had golf sized swelling on arm a few hours after vaccination that l...
Parent (gaurdian) states patient had golf sized swelling on arm a few hours after vaccination that lasted around 48 hours. States patient is also disabled and can not help rubbing injection site after injection. States this might be cause but unsure.
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