| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2853192 | 49 | M | FL | 08/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Blindness unilateral, Cerebrospinal fluid leakage, Intracranial pressure increas...
Blindness unilateral, Cerebrospinal fluid leakage, Intracranial pressure increased, Laboratory test, Lipoinjection; Lumbar puncture, Papilloedema, Reduction of increased intracranial pressure, Ventriculo-peritoneal shunt, Visual impairment
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pt states that a couple of months after 2nd dose of the covid vaccine he woke up and he had a black ...
pt states that a couple of months after 2nd dose of the covid vaccine he woke up and he had a black line in his eye. He looked in the mirror and didn't see anything. He called his insurance and was referred to an ophthalmologist. He was diagnosed with papilledema and referred to his doctor. He contacted insurance and was sent to a specialist. He lost his vision in his right eye and only has 20% vision in his left eye. Dr. gave him a shot in his lower lumbar to release the pressure. He was then sent to another doctor. He placed a catheter in his groin to go up to his brain to release the pressure. These procedures helped slow the vision loss down to where he still had 20% vision in left eye. Then a coil was placed to lower the pressure in and around the brain. These procedures were done in a facility. Dr. placed a shunt in his brain. He was having fluid coming from his nose. He had to have a procedure done where they took a piece of belly fat and placed inside his nose to be cauterized so it would keep the cerebrospinal fluid from draining out of his nose. His pressure is normal at this time and has to be checked every 6 months by Dr. and his PCP.
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โ | โ | โ | |||
| 2853193 | 21 | F | FL | 08/07/2025 |
HPV9 |
MERCK & CO. INC. |
Z005055 |
Blood glucose normal, Dyskinesia, Electrocardiogram ST segment depression, Loss ...
Blood glucose normal, Dyskinesia, Electrocardiogram ST segment depression, Loss of consciousness, Unresponsive to stimuli
More
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Pt was given vaccine by RN and after the pt stated that her arm hurt. RN counseled her on how to red...
Pt was given vaccine by RN and after the pt stated that her arm hurt. RN counseled her on how to reduce pain and soreness and then left the room so that provider can speak to pt. After about 10 seconds a loud crash was heard. Doctor and RN went into room and found pt unresponsive face down on the floor with arms extended and small jerking movements. Moments after the pt was responsive and able to get on exam table on her own. A&Ox4. She seemed to have hit her head and bit her lip when she fell. After event she was joking about how she sat forward directly after the vaccine to take a picture for social media and that is when she passed out. EMS called and pt transferred to ER for further evaluation.
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| 2853194 | 16 | F | ND | 08/07/2025 |
MENB MENB |
PFIZER\WYETH PFIZER\WYETH |
HD2730 HD2730 |
Dermatitis acneiform, Erythema, Fatigue, Pain in extremity, Peripheral swelling;...
Dermatitis acneiform, Erythema, Fatigue, Pain in extremity, Peripheral swelling; Rash pruritic, Skin warm
More
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a few hours after administration mom called and sent pictures. patient's arm in which vaccine w...
a few hours after administration mom called and sent pictures. patient's arm in which vaccine was administered is red, swollen, painful and hot to touch. Face broke out in a pimple-like rash that is extremely itchy and experiencing fatigue. No difficulty breathing or shortness of breath.
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| 2853195 | 64 | F | FL | 08/07/2025 |
PNC21 |
MERCK & CO. INC. |
3273H |
Discomfort, Erythema, Paraesthesia, Peripheral swelling, Skin warm
Discomfort, Erythema, Paraesthesia, Peripheral swelling, Skin warm
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Patient received vaccine on 08/01, had swelling of arm when she woke up the next morning. Reports th...
Patient received vaccine on 08/01, had swelling of arm when she woke up the next morning. Reports that it has continued to spread since then (even as of this morning). The upper arm is red/pink in color, raised (appears swollen). Patient states it is warm to the touch and feels like it has pressure and tingling due to swelling, but does not report any pain or fever at this time.
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| 2853196 | 37 | M | CA | 08/07/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96868 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Injected patient IM instead of SQ as directed. Patient didn't report any adverse reactions.
Injected patient IM instead of SQ as directed. Patient didn't report any adverse reactions.
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| 2853197 | 17 | M | NC | 08/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
772YT |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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17 year old patient received adult dose of Harvix instead of the pediatric dose. Patient tolerated i...
17 year old patient received adult dose of Harvix instead of the pediatric dose. Patient tolerated immunization well with no adverse effects.
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| 2853198 | 62 | F | 08/07/2025 |
COVID19 |
MODERNA |
8080803 |
Unevaluable event
Unevaluable event
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none
none
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| 2853199 | 31 | F | AZ | 08/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9K34M |
Pruritus, Rash
Pruritus, Rash
|
Patient reported rash on left palm (the vaccination was at the right arm) one hour after the vaccina...
Patient reported rash on left palm (the vaccination was at the right arm) one hour after the vaccination, then developed rash on her face 3-4 hours after (around 2:30 pm) and became generalized to her trunk and arms on the 5th hour (around 4:30 pm; denied SOB or swelling on her face, throat, or tongue; took Benadryl twice that night (8/6 last night) and this morning. She called facility at 10 am, reported rash and itching are improving; denied SOB or swelling on her face, throat, or tongue. Advised to monitor for worsening of symptoms and call facility, present to ED if she has SOB or other new or worsening symptoms; advised continue OTC Benadryl Q 6 hours as directed, and I'll call her back on 8/11/25.
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| 2853200 | 39 | M | NY | 08/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN6203 ER8730 |
Alopecia, Alopecia areata, Autoimmune disorder; Alopecia, Alopecia areata, Autoi...
Alopecia, Alopecia areata, Autoimmune disorder; Alopecia, Alopecia areata, Autoimmune disorder
More
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Developed an autoimmune disorder, Alopecia Areata. Noticed patches of hair falling out of my beard ...
Developed an autoimmune disorder, Alopecia Areata. Noticed patches of hair falling out of my beard and eyebrows in the months following the injections.
More
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| 2853201 | 16 | M | AZ | 08/07/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
99G34 U8494AA |
Fall, Head injury, Syncope; Fall, Head injury, Syncope
Fall, Head injury, Syncope; Fall, Head injury, Syncope
|
PATIENT FAINTED AFTER ADMINISTERING VACCINES. PT FEEL OFF CHAIR AND HIT HIS HEAD. HE WAS EVALUATED B...
PATIENT FAINTED AFTER ADMINISTERING VACCINES. PT FEEL OFF CHAIR AND HIT HIS HEAD. HE WAS EVALUATED BY PROVIDER CLEAR TO RETURN TO CLASS.
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| 2853202 | 68 | F | KY | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
35a77 |
Blister, Pruritus, Rash
Blister, Pruritus, Rash
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Breaking out on arms but it looks like hives according to pt. Pt also is breaking out on abdomen tha...
Breaking out on arms but it looks like hives according to pt. Pt also is breaking out on abdomen that also looks like Hives. She does have pus filled blisters on her legs and toes. Pt says these spots itch really badly. She has gone to doctor and they have wrote prescription for prednisone to alleviate the reaction.
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| 2853203 | 51 | F | TX | 08/07/2025 |
TDAP TDAP TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8015AA U8015AA |
Pain in extremity, Peripheral swelling, Skin warm; Limb ultrasound, Pain in extr...
Pain in extremity, Peripheral swelling, Skin warm; Limb ultrasound, Pain in extremity, X-ray limb normal; Pain in extremity, Peripheral swelling, Skin warm; Limb ultrasound, Pain in extremity, X-ray limb normal
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Left arm pain with swelling and warmth.
Left arm pain with swelling and warmth.
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| 2853204 | 16 | M | TN | 08/07/2025 |
IPV MMR TDAP |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
X1D141M PG3RP |
Syncope; Syncope; Syncope
Syncope; Syncope; Syncope
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After receiving the third vaccination, the patient began to faint while sitting on the exam table. T...
After receiving the third vaccination, the patient began to faint while sitting on the exam table. The father and mother assisted me with getting the patient in supine position, the father immediately elevated the patient's lower extremities. As I was assessing the patient's level of consciousness, additional clinic staff returned to assist with the patient's recovery. Blood pressure was within normal range, a bottle of water was provided, and sweet candy was given to the patient to eat. Advised the parents that a vasovagal syncope is common for children getting vaccinations at this age. Patient reported feeling nauseated and displayed diaphoresis above the upper lip area. Patient laid supine for five plus minutes then stayed in a seated position on the exam table. During this time the parents made the decision to not proceed with the remaining three vaccinations. Education was provided about waiting 28 days before receiving the varicella live vaccine. Prior to leaving the clinic the patient stated that he was "ok". Advised to continue with drinking water and can take Tylenol if discomfort is felt.
More
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| 2853205 | 69 | F | CA | 08/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Erythema, Pruritus
Erythema, Pruritus
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diffused redness/itchiness . no pain, afebrile. advised if worsened present to ER.
diffused redness/itchiness . no pain, afebrile. advised if worsened present to ER.
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| 2853206 | 12 | F | GA | 08/07/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
|
Syncope; Syncope
Syncope; Syncope
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syncopal episode about 5 min- assessed patient vital signs . patient was fine afterwards
syncopal episode about 5 min- assessed patient vital signs . patient was fine afterwards
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| 2853207 | 5 | F | TN | 08/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
42dm9 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Second dose of hepatitis a was administered too soon.
Second dose of hepatitis a was administered too soon.
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| 2853208 | 18 | F | MA | 08/07/2025 |
COVID19 TDAP |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
ME6072 37R35 |
Dizziness, Fall, Staring, Tremor; Dizziness, Fall, Staring, Tremor
Dizziness, Fall, Staring, Tremor; Dizziness, Fall, Staring, Tremor
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Pt got up a couple min after vaccination. She went to drop off to get proof printed for school. She ...
Pt got up a couple min after vaccination. She went to drop off to get proof printed for school. She had a blank stare then fell, her sister caught her prior to falling but she did hit her head on the side of a pharmacy area. She was out for a couple seconds. Once she came back she slowly sat up. She was given water and popcorn. The ambulance came and took her to the hospital because she was still shaking and dizzy.
More
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| 2853209 | 18 | F | GA | 08/07/2025 |
UNK UNK MENB MENB |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
0072H 0072H |
Contusion, Pruritus, Swelling, Urticaria; Rash, Rash pruritic, Urticaria; Contus...
Contusion, Pruritus, Swelling, Urticaria; Rash, Rash pruritic, Urticaria; Contusion, Pruritus, Swelling, Urticaria; Rash, Rash pruritic, Urticaria
More
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Extreme hives, itching, swelling, bruising all over the body. Time course: morning after vaccine and...
Extreme hives, itching, swelling, bruising all over the body. Time course: morning after vaccine and has been severe for one week
More
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| 2853210 | 23 | M | CA | 08/07/2025 |
COVID19 |
JANSSEN |
204A21A |
Cardiac stress test normal, Electrocardiogram ambulatory normal, Palpitations, S...
Cardiac stress test normal, Electrocardiogram ambulatory normal, Palpitations, Supraventricular extrasystoles
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I received the J&J Covid vaccine in May of 2021, and later that summer, I began experiencing hea...
I received the J&J Covid vaccine in May of 2021, and later that summer, I began experiencing heart palpitations for the first time in my life. These sensations were unfamiliar and concerning enough that I discussed them with my physician. I was prescribed a 48-hour Holter monitor test to evaluate my heart rhythm. During that monitoring period, the results showed multiple (fewer than 100) Premature Ventricular Contractions (PVCs) as well as one or possibly more Premature Atrial Contractions (PACs). At the time, I was advised that these irregularities were benign, however my physician followed up with a cardic stress test, which I passed. However, over time, the symptoms have not improved ? they have worsened. I continue to experience these palpitations, and they can be quite distressing. This has had a negative impact on my overall well-being and quality of life. I am submitting this report now, rather than earlier, because I?ve recently learned how to better advocate for myself in medical and institutional settings. I also believe it's important to document ongoing and unresolved symptoms, even if the initial reaction occurred years ago, to contribute to the broader understanding of potential adverse effects.
More
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| 2853211 | 4 | M | TX | 08/07/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
58D72 Z007581 |
Crying, Eye swelling, Nausea, Pruritus, Urticaria; Crying, Eye swelling, Nausea,...
Crying, Eye swelling, Nausea, Pruritus, Urticaria; Crying, Eye swelling, Nausea, Pruritus, Urticaria
More
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AFTER PT LEFT HE WAS IN THE CAR IN BACKSEAT MOM DRIVING AND HE STARTED TO CRY, SHE LOOKED BACK AND H...
AFTER PT LEFT HE WAS IN THE CAR IN BACKSEAT MOM DRIVING AND HE STARTED TO CRY, SHE LOOKED BACK AND HIS EYE WAS SWOLLEN, SHE CAME BACK TO THE CLINIC. BY THS TIME BOTH EYES WERE EDEMATOUS , AND PT WAS STARTING TO HAVE HIVES AND ITCHING ALL OVER, NAUSEA . EMS WAS CALLED. 12.5 MG BENADRYL AND 5 MG PREDNISOLONE WAS GIVEN. EMS GAVE EPINEPHRINE AND ALBUTEROL AND TRANSFERRED HIM TO HOSPITAL WITH PATENT AIRWAY.
More
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| 2853212 | 42 | F | TX | 08/07/2025 |
FLU3 HEP HPV9 TDAP |
SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. SANOFI PASTEUR |
U8790AA 946064 Z005055 U8353AA |
Mobility decreased, Pain in extremity, Peripheral swelling; Mobility decreased, ...
Mobility decreased, Pain in extremity, Peripheral swelling; Mobility decreased, Pain in extremity, Peripheral swelling; Mobility decreased, Pain in extremity, Peripheral swelling; Mobility decreased, Pain in extremity, Peripheral swelling
More
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Patient presented to the pharmacy with a sore arm after receiving immunizations the day before. Site...
Patient presented to the pharmacy with a sore arm after receiving immunizations the day before. Site was not red, but patient states that it feels swollen and that her range of motion is limited. Advised her to follow up with us tomorrow is symptoms persist. Patient applied ice to injection site
More
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| 2853213 | 19 | F | MA | 08/07/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
N/A |
Crying, Pain in extremity, Pyrexia
Crying, Pain in extremity, Pyrexia
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I went to my doctors to get a regular physical she stated to me that I needed to get 2 vaccines, hep...
I went to my doctors to get a regular physical she stated to me that I needed to get 2 vaccines, hepatitis A and B. 3 later I go to my appointment to get my vaccine. They give me no explanation on what the vaccine is or any side effects. Later that night my arm is so sore to the point that i can?t move it and I cry of pain. I developed a slight fever and an even worse pain the morning following.
More
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| 2853214 | 0.58 | F | MI | 08/07/2025 |
RV5 |
MERCK & CO. INC. |
Y015021 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse event. Was told to report since patient received her 1st dose at age of 7 months & 20...
No adverse event. Was told to report since patient received her 1st dose at age of 7 months & 20 days.
More
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| 2853215 | 74 | F | MO | 08/07/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Injection site discomfort, Injection site erythema, Injection site warmth
Injection site discomfort, Injection site erythema, Injection site warmth
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Patient presented to the pharmacy today with redness and some swelling surrounding the injection sit...
Patient presented to the pharmacy today with redness and some swelling surrounding the injection site approximating 3 inches in diameter, she stated it was warm to the touch, not especially painful but it felt like there was pressure bulging out underneath, and had almost doubled in size since the previous day. She was referred to her primary are provider for evaluation.
More
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| 2853216 | 33 | M | MD | 08/07/2025 |
FLU3 TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
TFAA2501 U8670BA |
Dizziness, Hyperhidrosis; Dizziness, Hyperhidrosis
Dizziness, Hyperhidrosis; Dizziness, Hyperhidrosis
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Patient stood up after receiving flu and tetanus shot and stated he was feeling dizzy and sweaty. I...
Patient stood up after receiving flu and tetanus shot and stated he was feeling dizzy and sweaty. I had him sit back down and put a ice pack on the back of his neck and had him lean over. his wife got him a gatorade and he drank it. I ask him and his wife if they wanted me to call 911, they said no. He sat for a few more minutes and he felt and looked much better. I gave his wife her flu shot and he said he felt much better and could leave. I asked him to call if he had any problems and asked his his wife if she would drive them home, she said she would. I counseled them on any signs or symptoms to look for if he were to have any later allergic reaction.
More
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| 2853217 | 11 | F | MD | 08/07/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
49M9N |
Wrong product administered
Wrong product administered
|
Pt given incorrect vaccine
Pt given incorrect vaccine
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| 2853218 | 22 | F | NY | 08/07/2025 |
VARCEL |
MERCK & CO. INC. |
Y014511 |
Erythema, Pruritus, Swelling
Erythema, Pruritus, Swelling
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small local reaction started evening of the day of vaccination. Mild swelling, erythema with sharp d...
small local reaction started evening of the day of vaccination. Mild swelling, erythema with sharp demarcated borders, and itchiness. Then progress to large local reaction two days following 60x60mm in circumference targetoid.
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| 2853219 | 3 | M | AR | 08/07/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Wrong product administered
Wrong product administered
|
Patient was given a kenrix at age 3 years but patient should have gotten a dtap and polio separately...
Patient was given a kenrix at age 3 years but patient should have gotten a dtap and polio separately.
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| 2853220 | 64 | M | 08/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
Shingrex not on |
Asthma, Post-acute COVID-19 syndrome
Asthma, Post-acute COVID-19 syndrome
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Persisting symptoms similar to asthma. These persistent symptoms are what I experienced after Covid...
Persisting symptoms similar to asthma. These persistent symptoms are what I experienced after Covid - "Long Covid. "
More
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| 2853221 | 53 | F | SC | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523j |
Diarrhoea
Diarrhoea
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patient reports having severe diarrhea since the vaccine, till today (8/7/25) and ongoing. has tried...
patient reports having severe diarrhea since the vaccine, till today (8/7/25) and ongoing. has tried over the counter antidiarrheals, probiotics, fiber, with no resolve.
More
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| 2853222 | 30 | M | CA | 08/07/2025 |
TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3bh5h 3bh5h 3bh5h |
Antinuclear antibody, Blood creatine phosphokinase, Blood folate, Blood thyroid ...
Antinuclear antibody, Blood creatine phosphokinase, Blood folate, Blood thyroid stimulating hormone, Full blood count; Glycosylated haemoglobin, Lymphocyte count, Metabolic function test, Muscular weakness, Myoglobin blood; Paraesthesia, Urine analysis, Vitamin B12, Vitamin D
More
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Reports mild tingling in left upper arm and in left hand to localized area x1 day. Denies weakness i...
Reports mild tingling in left upper arm and in left hand to localized area x1 day. Denies weakness in LUE, or pain in LUE or decrease in rom. Neurologic and musculoskeletal exam findings were normal on exam. Advised to please complete labs and schedule a follow up appointment on symptoms within the week.
More
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| 2853223 | 12 | F | TX | 08/07/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
X024650 LD48369AA 48274AA |
Cold sweat, Hypotension, Nausea; Cold sweat, Hypotension, Nausea; Cold sweat, Hy...
Cold sweat, Hypotension, Nausea; Cold sweat, Hypotension, Nausea; Cold sweat, Hypotension, Nausea
More
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After vaccinating with last immunization HPV in right deltoid. A few minutes later patient began to ...
After vaccinating with last immunization HPV in right deltoid. A few minutes later patient began to say she felt nauseated and her skin was clammy. Transferred patient to reclining chair and took vitals. Blood presure was low and elevated her legs in chair. Provider at clini notified, Patient began to feel beter as she sipped on some water. Patient later stated that she did not eat Vitals retaken sevral times with last BP @ 99/69. Patient monitored and discharged home with provider per provider assessing vital signs.
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| 2853233 | TX | 08/07/2025 |
HEPA HEPA HEPA |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z005852 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
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No additional AE/No PQC.; HCP calling to report a 3rd dose of VAQTA administered today (08/06/2025) ...
No additional AE/No PQC.; HCP calling to report a 3rd dose of VAQTA administered today (08/06/2025) to a patient who has already received their two doses in the past. The two doses were administered on 08/04/2022 and 02/03/2023, respectively. Confirmed patient is not symptoma; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-AUG-2022, the patient was vaccinated with first dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location, lot number and expiration date were not reported). On 03-FEB-2023, the patient was vaccinated with second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location, lot number and expiration date were not reported) and on 06-AUG-2025, the patient received a third dose of Hepatitis A Vaccine, Inactivated (valid lot number Z005852, expiration date: 15-OCT-2026) for prophylaxis (extra dose administered). Confirmed patient was not symptomatic. No other information available at that time. No additional adverse event (AE).
More
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| 2853234 | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Eye pruritus
Eye pruritus
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Itchy eyes at night; This is a spontaneous report received from a Consumer or other non HCP. A pati...
Itchy eyes at night; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE PRURITUS (non-serious), outcome "unknown", described as "Itchy eyes at night". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
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| 2853235 | 50 | F | CA | 08/07/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4930 LN4930 |
Chills, Erythema, Inflammation, Pain in extremity, Pruritus; Pyrexia, Skin tight...
Chills, Erythema, Inflammation, Pain in extremity, Pruritus; Pyrexia, Skin tightness, Skin warm
More
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Swelling; Inflammation to the upper arm spreading through the lower arm; extreme redness to upper ar...
Swelling; Inflammation to the upper arm spreading through the lower arm; extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight; extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight/Hot to touch; arm pain; extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight/Redness; extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight/Itchiness; fever of 101 (tympanic); chills; This is a spontaneous report received from a Nurse. A 50-year-old female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Jul2025 as dose 1, single (Lot number: LN4930, Expiration Date: 31Jul2026) at the age of 50 years, in left arm for immunisation, Device Lot Number: LN4930, Device Expiration Date: 31Jul2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Jul2025, outcome "recovering", described as "arm pain"; CHILLS (non-serious) with onset 26Jul2025, outcome "recovering"; SKIN TIGHTNESS (non-serious) with onset 26Jul2025, outcome "recovering", described as "extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight"; FEELING HOT (non-serious) with onset 26Jul2025, outcome "recovering", described as "extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight/Hot to touch"; PRURITUS (non-serious) with onset 26Jul2025, outcome "recovering", described as "extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight/Itchiness"; ERYTHEMA (non-serious) with onset 26Jul2025, outcome "recovering", described as "extreme redness to upper arm spreading to lower arm - feels warm to touch, itchy and tight/Redness"; PYREXIA (non-serious) with onset 26Jul2025, outcome "recovering", described as "fever of 101 (tympanic)"; INFLAMMATION (non-serious), outcome "unknown", described as "Inflammation to the upper arm spreading through the lower arm"; SWELLING (non-serious), outcome "unknown". Therapeutic measures were taken as a result of feeling hot, skin tightness, pain in extremity, erythema, pruritus, pyrexia, chills. Additional information: The patient receive any other vaccines on the same date as the vaccine(s) reported as no. The patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) reported as no. The patient taking any other medications within 2 weeks of the event starting reported as unknown. The treatment received for the adverse event; Orders placed to shut down inflammation process - Doxycycline, Prednisone, Triamcinolone, Zyrtec. This is the first case out of Two split cases. Concern: Reporter stated, " just reporting some adverse reaction to the Prevnar 20 Vaccine for two, two of our patients." When paraphrased the above concern: Reporter stated, "Yes. There's two of the patients received the Prevnar 20 and it's within the same LOT number." When probed to clarify if reporter need any medical enquiry: Reporter stated, "Not medical enquiry, just like we are already treating, the primary care is already treating the patient. So, I just want to know what we are supposed to do.
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| 2853236 | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Tinnitus
Tinnitus
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tinnitus; This is a spontaneous report received from a Consumer or other non HCP. A patient (age an...
tinnitus; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500157611 same patient/reporter, different vaccine dose/AE;US-PFIZER INC-202500158063 same patient/reporter, different vaccine dose/AE;
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| 2853237 | 83 | F | NV | 08/07/2025 |
RSV |
UNKNOWN MANUFACTURER |
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Influenza like illness, Malaise
Influenza like illness, Malaise
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like having the flu or something/I just got sick/knocked me down; This is a spontaneous report recei...
like having the flu or something/I just got sick/knocked me down; This is a spontaneous report received from an Other HCP. An 83-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Nov2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 83 years intramuscular for immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: COMIRNATY 2024-2025 FORMULA intramuscular taken for covid-19 immunisation, on 01Nov2024 as dose 1, single; INFLUENZA VACCINE intramuscular taken for influenza immunisation, on 01Nov2024 as dose number unknown, single; OMEPRAZOLE intramuscular taken for gastrooesophageal reflux disease. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2024, outcome "recovered", described as "like having the flu or something/I just got sick/knocked me down". Therapeutic measures were taken as a result of influenza like illness. Additional information: The patient took the COVID shot and Flu shot, then waited three or four weeks and went back and took the RSV shot. The patient in all four years, never ever had a reaction to the Pfizer shot or Flu shot, but then when she took the RSV shot, it knocked her down. She had a reaction to it. It was short, just two or three days, but she did have a reaction to it. She stated it was not that serious. She probably just took a Tylenol and went to bed for 2 days, 3 days. It was like having the flu or something. She just got sick, but it was only two or three days long. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
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| 2853238 | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Drug ineffective, Suspected COVID-19
Drug ineffective, Suspected COVID-19
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Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine; D...
Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine; Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2853239 | 46 | FL | 08/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Off label use
Off label use
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Imovax is prescribed with off label diagnosis Open bite of right wrist with no reported adverse even...
Imovax is prescribed with off label diagnosis Open bite of right wrist with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient of 46 years old with unknown gender who had IPV (Vero) [Imovax] was prescribed with off label diagnosis open bite of right wrist with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed with 1mL of suspect IPV (Vero), Suspension for injection (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site for Open bite of right wrist (bite) with no reported adverse event (off label use). Information on the batch number could not be requested corresponding to the one at time of event occurrence Action taken was not applicable. No follow up possible since reporter denied to respond to Sanofi PV Follow up.
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| 2853240 | 12 | M | CA | 08/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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After receiving the immunization he stood up to wait for his brother to receive an immunization. Aft...
After receiving the immunization he stood up to wait for his brother to receive an immunization. After about 1 to 2 minutes he suffered syncope. He did not injure himself in the fall. He was unresponsive for about 10 seconds. He woke up spontaneously and had slight confusion. His blood pressure and pulse were not elevated. His skin was not pale or clammy. He remained seated for about 10 minutes with his feet elevated before attempting to stand again. With assistance from his mother he was able to stand and walked on his own. Mother declined a call to EMS.
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| 2853241 | 73 | F | FL | 08/07/2025 |
COVID19 FLU3 RSV |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
MD3414 U8764BB 52Z52 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE. PATIENT WAS FEELING WELL AFTER VACCINE AND 5 DAYS AFT...
PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE. PATIENT WAS FEELING WELL AFTER VACCINE AND 5 DAYS AFTER EVENT, PATIENT WAS FEELING WELL
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| 2853242 | 1.33 | F | WI | 08/07/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
A32BB |
Wrong product administered
Wrong product administered
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Pt. was only due for a Dtap ( Infanrix ) only and was given a Combo Dtap, Hep B and IVP . Pt. was n...
Pt. was only due for a Dtap ( Infanrix ) only and was given a Combo Dtap, Hep B and IVP . Pt. was not due for Hep B or IVP at this time .Pending outcome monitor Pt. over night per provider
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| 2853243 | 63 | F | 08/07/2025 |
PNC21 RSV TDAP |
MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
Y019157 LN5486 H4K3S |
Injection site erythema, Injection site induration, Injection site pain, Pyrexia...
Injection site erythema, Injection site induration, Injection site pain, Pyrexia, Swelling; Injection site erythema, Injection site induration, Injection site pain, Pyrexia, Swelling; Injection site erythema, Injection site induration, Injection site pain, Pyrexia, Swelling
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Rph spoke with patient on phone about reaction. She states that the area is red, painful and hard. S...
Rph spoke with patient on phone about reaction. She states that the area is red, painful and hard. She states that reaction occurred on 8/2/2025 and continued to look the same until today 8/7/25. She is experiencing swelling and occasional fever.
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| 2853244 | 51 | F | IN | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2M7GR |
Erythema, Rash vesicular
Erythema, Rash vesicular
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Day 10 post 2nd in Shingles series of 2, raised red blister-like vesicles in cluster of 5 on back of...
Day 10 post 2nd in Shingles series of 2, raised red blister-like vesicles in cluster of 5 on back of left knee. No pain, no itching. Vesicles subsided over the course of 14 days with no change in other symptoms.
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| 2853249 | 79 | M | FL | 08/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
f4ac3 |
No adverse event
No adverse event
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No adverse reactions; the vaccine was administered twice
No adverse reactions; the vaccine was administered twice
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| 2853250 | 11 | F | MI | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
No adverse event
No adverse event
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There was no adverse event. The patient's mother was contacted and stated her daughter is feeli...
There was no adverse event. The patient's mother was contacted and stated her daughter is feeling good, and there were no problems after the administration of the vaccine
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| 2853251 | 18 | F | TX | 08/07/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
CD44A U8369AA |
Abdominal pain, Chest pain; Abdominal pain, Chest pain
Abdominal pain, Chest pain; Abdominal pain, Chest pain
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At 11:10 AM after 18 yrs old female patient was vaccinated with Meningococcal Conjugate Menquadfi Lo...
At 11:10 AM after 18 yrs old female patient was vaccinated with Meningococcal Conjugate Menquadfi Lot number U8369AA - Given IM / LEFT deltoid at 11:03 AM and Meningococcal B Bexsero Lot number CD44A - Given IM/ RIGHT deltoid at 11:02 am and during patient observation at 11:10 am, patient looked pale and laid back. Patient was alert and oriented x 3. Patient began to complain of chest pain but no shortness of breath, the following vital sign readings were taken at 11:10 am BP: 70/50 - HR: 56' SAT: 99%. Provider was notified. At 11:20 am : BP: 115/89 - HR: 94' - SAT: 98%. Patient was still complaining of chest pain. 911 was called and ambulance dispatched. At 11:25 am BP: 131/75 HR 63 SAT 97. Patient was complaining of increasing sharp abdominal pain. Ambulance arrived at scene where they said that patient was going to be transferred to Hospital.
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| 2853252 | 82 | F | FL | 08/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
f4ac3 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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no reaction; duplicate vaccine given
no reaction; duplicate vaccine given
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| 2853253 | 1 | M | TX | 08/07/2025 |
HEPA HEPA MMR MMR VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
MB599 MB599 Y015022 Y015022 Z005233 Z005233 |
Crying, Discoloured vomit, Enema administration, Intussusception, Metabolic func...
Crying, Discoloured vomit, Enema administration, Intussusception, Metabolic function test; Ultrasound abdomen abnormal; Crying, Discoloured vomit, Enema administration, Intussusception, Metabolic function test; Ultrasound abdomen abnormal; Crying, Discoloured vomit, Enema administration, Intussusception, Metabolic function test; Ultrasound abdomen abnormal
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vaccines administered at 10:55am. Father called office around 3:00pm stating infant was vomiting and...
vaccines administered at 10:55am. Father called office around 3:00pm stating infant was vomiting and crying. Child had several episodes of non-bloody emesis that was described as green and parents took him to ED. Ultrasound showed ileocolic intussusception. Pt transferred to hospital overnight and had air enema which reduced intussusception. Child monitored >24 hours and intussusception did not recur. Child discharged home on regular diet.
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| 2853254 | 90 | F | LA | 08/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
me6072 u8800aa |
Diarrhoea, Nausea; Diarrhoea, Nausea
Diarrhoea, Nausea; Diarrhoea, Nausea
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patient said she is experiencing diarrhea and nausea.
patient said she is experiencing diarrhea and nausea.
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