| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2641325 | 62 | F | IL | 06/02/2023 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 EW0168 |
Apraxia, Asthenia, Balance disorder, Computerised tomogram, Coordination abnorma...
Apraxia, Asthenia, Balance disorder, Computerised tomogram, Coordination abnormal; Deafness, Dizziness, Ear discomfort, Ear pain, Electrocardiogram; Electronystagmogram, Eye disorder, Gait inability, Headache, Hypoaesthesia; Illusion, Laboratory test, Labyrinthitis, Loss of personal independence in daily activities, Loss of proprioception; Magnetic resonance imaging, Muscle spasms, Neck pain, Nystagmus, Pain; Pain in extremity, Photopsia, Tremor, Vertigo, Vertigo positional; Vestibular disorder, Vitreous floaters, Vomiting, Walking aid user, Weight decreased; Allergy to vaccine, Blood pressure measurement, Conversion disorder, Diarrhoea, Dizziness; Eye disorder, Gait disturbance, Gene mutation, Glaucoma, Headache; Laboratory test, Labyrinthitis, Mast cell activation syndrome, Movement disorder, Ophthalmological examination; Photopsia, Post-acute COVID-19 syndrome, Vertigo, Vertigo positional, Visual field tests; Vitreous floaters, Vomiting
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Became dizzy within half hour. R eye Headache, threw up, R ear fullness, dizziness kept getting wors...
Became dizzy within half hour. R eye Headache, threw up, R ear fullness, dizziness kept getting worse - vertigo, vomiting not able to walk. Vertigo looking up, neck pain, R eye impairment floaters, flashes, leg cramps, numbness/pain 4 & 5 fingers, right foot. Got worse ended up in hospital. Oct 3/4-6th. Sent to office for Vestibular PT. NM ENT. Nystagmus. Labrynthtis L ear BPPV Right, hearing loss L/ high frequency both ears, R ear fullness & pain, NM eye specialist-change prescription again nystagmus, ordered a vision field exam. See another neurologist this week. Not able to use the computer without getting sick vertigo keeps returning. Need cane to walk. Ambulation deficits, balance deficits, coordination/proprioception deficits enduranc deficits, pain limiting function, strength deficits transfer deficits, transition deficits, Vestibular deficits visual perceptual deficits, occular flutter, inability to fixate gaze on target. High risk for falls. Lost weight. Tremors - hands, R leg.
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โ | โ | ||||
| 2826392 | 72 | F | 02/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, Injection site pain
Extra dose administered, Injection site pain
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Patient had previously received the vaccine on 12/17/2023, so this was an extra unnecessary dose. Pa...
Patient had previously received the vaccine on 12/17/2023, so this was an extra unnecessary dose. Patient has experience no other symptoms except for normal injection site reactions (soreness)
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| 2826393 | 31 | F | IA | 02/15/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Exposure during pregnancy, Immediate post-injection reaction, Limb d...
Arthralgia, Exposure during pregnancy, Immediate post-injection reaction, Limb discomfort, Loss of personal independence in daily activities; Musculoskeletal discomfort, Pain, Pain in extremity, Sleep disorder
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Patient received a TDAP vaccine last week as part of routine 28 week prenatal care, which caused sig...
Patient received a TDAP vaccine last week as part of routine 28 week prenatal care, which caused significant pain and discomfort in her right arm and shoulder. The pain was immediate and has persisted for eight days, making it difficult to sleep. It is described as throbbing and deep, not typical muscle soreness. Patient is concerned that the vaccine was administered too high, possibly affecting the rotator cuff. There are no visible signs of redness, warmth, or rash on the arm. No numbness or tingling in the fingers, but the pain is severe enough to interfere with daily activities. She is also concerned about the potential impact of the vaccine on her baby. Planning for RT shoulder ultrasound. treating with cyclobenzaprine and tylenol.
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| 2826394 | 73 | F | KY | 02/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n77j2 |
Injection site erythema, Pain, Pyrexia
Injection site erythema, Pain, Pyrexia
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pt reported pain, fever and redness in arm. pt stopped by pharmacy on 02/15/25 to have redness chec...
pt reported pain, fever and redness in arm. pt stopped by pharmacy on 02/15/25 to have redness checked. about a 2 inch diameter of redness was around injection side. no visible swelling observed. rph advised pt to place a cool pack on it to help with redness.
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| 2826395 | 68 | M | WA | 02/15/2025 |
HEPA HEPA HEPA HEPA HEPA HEPA HEPA HEPA HEPA HEPA HEPA HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
772YT- 772YT- 772YT- 772YT- 772YT- 772YT- 772YT- 772YT- 772YT- 772YT- 772YT- 772YT- |
Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransfe...
Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Atelectasis, Back pain; Benign prostatic hyperplasia, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood cholesterol increased; Blood creatinine increased, Blood magnesium normal, Blood triglycerides increased, Chest X-ray abnormal, Chills; Computerised tomogram, Computerised tomogram abdomen abnormal, Condition aggravated, Diarrhoea, Epistaxis; Gastric varices, Hepatic steatosis, Hepatitis A, Hepatitis A antibody positive, High density lipoprotein decreased; Hyperlipidaemia, Hypertriglyceridaemia, Hypervolaemia, Hypomagnesaemia, Hypophagia; Intensive care, Lipase increased, Low density lipoprotein increased, Magnetic resonance cholangiopancreatography, Malnutrition; Myalgia, Nausea, Pain, Pancreatic pseudocyst, Pancreatitis acute; Pancreatitis necrotising, Penile swelling, Peripancreatic fluid collection, Polyuria, Procalcitonin increased; Pulmonary hypertension, Respiratory failure, Respiratory tract infection, Retching, Scrotal swelling; Sepsis, Splenic vein thrombosis, Stool analysis normal, Tachycardia, Ultrasound abdomen normal; Vomiting, Weight decreased, White blood cell count increased
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Nov 2024, family vacationed in another country. Dec 2024, the patient's wife and son contracted...
Nov 2024, family vacationed in another country. Dec 2024, the patient's wife and son contracted hepatitis A, and recovering. Patient received a single dose PEP hep A vaccine (12/14/24), no IG 1/10-1/16/25: clinic visit; patient developed chills, myalgias, abd pain; diagnosed with a respiratory infection (antibiotics), sent home but not improved. 1/21/25: ER visit ICU admission: severe upper abdominal pain, radiating to the back, nausea, vomiting, and occasional dry heaves. No fever but chills. Oral intake became nil, and he reported a 30lbs weight loss per 3-4 weeks; temp 36.4 ๏ฟฝC, blood pressure 134/109, heart rate 78, respiratory rate 20. Lipase 730 (1/21/2025). AST938, ALT3845, AP443, bili6.1 MRCP: pancreatitis Following his respiratory illness, patient developed severe upper abdominal pain that radiated to the back, nausea, vomiting, and occasional dry heaves. No objective fever; he had chills. Oral intake became nil, and he reported a 30 pound weight loss in the weeks prior to admission. Upon arrival to ED (1/21/2025): temperature 36.4 ๏ฟฝC, blood pressure 134/109, heart rate 78, respiratory rate 20. Lipase 730 (1/21/2025). AST 938, ALT 3845, alkaline phosphatase 443, bilirubin 6.1. MRCP (1/21/2025): hepatic steatosis; peripancreatic edema localized to the pancreatic head consistent with pancreatitis; normal gallbladder without cholelithiasis. No pancreatic divisum. Patient was admitted for acute pancreatitis. Hospital course: Triglyceride 594 (1/21/2025). Insulin clamp 10 units/hour administered (1/21/2025 - 1/22/2025). 1/24/2025: CT abdomen/pelvis (1/24/2025): diffuse fatty infiltration of the liver; diffuse pancreatic edema with early pseudocyst formation in the tail of the pancreas; extensive fluid extending into the paracolic gutter and left side of the pelvis; nonocclusive splenic vein thrombosis. 1/26/2025: Overnight, he had a nosebleed with passage of clot; this resolved. Ultrasound abdomen (1/26/2025): no ascites. 1/28/2025: Patient tolerated a very low-fat diet. 1/29/2025: Scrotum and penis swollen. Albumin 1.8; albumin 50 g IVPB. Furosemide 20 mg IV; KCl 40 mEq p.o. 1/30/2025: Breathing improved. CT abdomen/pelvis (1/30/2025): small area of necrosis in the pancreatic tail similar; new/more conspicuous small area of necrosis in the uncinate process; moderate peripancreatic stranding; no organized fluid collection; no ascites. Albumin 2.3; albumin 50 g IVPB. Furosemide 20 mg IV; KCl 40 mEq p.o. 1/31/2025: Patient had a copious urine output, and his abdomen was less distended. Breathing improved. He has not used his PCA for several hours. 2/1/2025: Patient said that he feels like he is getting better and stronger for the first time. Patient developed patchy erythematous rash on his buttocks consistent with allergic reaction. Patient went most of the day without using his PCA pump 2/2/2025: Patient having copious diarrhea. Stool pathogen panel (2/2/2025) no pathogens detected. 2/3/2025: PCA discontinued. Heparin drip transition to apixaban 10 mg twice daily. Discharge diagnoses: 1. Acute, necrotizing pancreatitis. Protonix 40 mg IV twice daily. Fentanyl PCA (1/21/2025). A. CT abdomen/pelvis (1/24/2025): diffuse fatty infiltration of the liver; diffuse pancreatic edema with early pseudocyst formation in the tail of the pancreas; extensive fluid extending into the paracolic gutter and left side of the pelvis; nonocclusive splenic vein thrombosis. B. CT abdomen/pelvis (1/30/2025): similar, small area of necrosis in the pancreatic tail; new/more conspicuous small area of necrosis in the uncinate process; moderate peripancreatic stranding; no organized fluid collection; no ascites; proximal splenic vein occlusion with upper abdominal gastric varices. C. IgG1 1690; IgG4 20.5 (1/27/2025). IgG4 is not elevated. 2. Sepsis due to infected pancreatic necrosis. ersistently tachycardic. WBC progressively rose to 20.88 with 10% bands (1/23/25). Procalcitonin 11.2 (1/24/25). Meropenem 2 g every 8 hours x 30 doses (1/23/2025๏ฟฝ2/1/2025). 3. Splenic vein thrombosis due to pancreatitis. Initially, systemic anticoagulation deferred; high risk of bleeds. As of 1/30/2025, has gastric varices A. Weight-based heparin protocol (1/31/2025๏ฟฝ2/3/2025). B. Apixaban 10 mg twice daily for 5 days (2/3/2025 - 2/7/2025). C. Apixaban 5 mg twice daily for 3 months. 4. Acute hepatitis A. Hepatitis A IgM reactive (1/21/2025) and transaminase values are consistent with acute infection. Not thought as HAV vaccine consequence 5. Acute hypoxemic respiratory failure (1/24/2025). A. Chest x-ray (1/24/2025) bibasilar atelectasis; no evidence of heart failure. Incentive spirometry. B. Subsequent volume overload (1/29/2025). I. Furosemide 20 mg IV (1/29/2025); KCl 40 mEq p.o. (1/29/2025); albumin 50 g IV (1/29/2025). II. Furosemide 20 mg IV (1/30/2025); KCl 40 mEq p.o. (1/30/2025); albumin 50 g IVPB. 6. Primary hypertension. Lisinopril 20 mg twice daily. Amlodipine 5 mg daily added (1/30/2025); dose increased to 10 mg daily (2/3/2025). 7. Type 2 diabetes mellitus. Recommend against future use of GLP-1 agonist. Glargine insulin decreased to 10 units daily with breakfast (2/2/2025); low-dose lispro 8. Hyperlipidemia; hypertriglyceridemia. Cholesterol 204, HDL 13, LDL 155, triglycerides 594 (1/21/2025), while patient prescribed atorvastatin 40 mg every evening. Insulin clamp 10 units/hour (1/21/2025 - 1/22/2025). Continue fenofibrate 160 mg daily (1/22/2025). Atorvastatin 40 mg daily evening held for 1 week after d/c 9. Prostatic hyperplasia. Tamsulosin 0.4 mg daily. 10. Hypomagnesemia. Magnesium 1.7 (1/22/2025); magnesium sulfate 4 g (1/22/2025). Ongoing replacement. 11. Moderate protein calorie malnutrition. Parenteral nutrition (1/25/2025๏ฟฝ2/1/2025). No lipids. Patient advanced his diet. 12. Diarrhea (2/2/2025). Repeat stool pathogen panel (2/2/2025) no pathogens found. 13. Rash (hives) on buttocks. Suspect reaction to fentanyl. Fentanyl PCA discontinued (2/3/2025).
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โ | โ | ||||
| 2826396 | 73 | M | MD | 02/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Blood pressure increased, Dizziness, Head discomfort, Headache
Blood pressure increased, Dizziness, Head discomfort, Headache
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3 days after vaccination I experienced severe Lightheadedness, rise of blood pressure, bad headache ...
3 days after vaccination I experienced severe Lightheadedness, rise of blood pressure, bad headache and pressure inside my head. Those symptoms were coming back about 10 days after vaccination.
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| 2826397 | 73 | F | MI | 02/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
x72d2 |
Pruritus, Rash
Pruritus, Rash
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Mentioned getting rash and itchiness on area got vaccine. Said been getting better since getting vac...
Mentioned getting rash and itchiness on area got vaccine. Said been getting better since getting vaccine a week ago, but reporting for precaution
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| 2826398 | 37 | F | TN | 02/15/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
|
Sapovirus test positive, Urinary tract infection; Sapovirus test positive, Urina...
Sapovirus test positive, Urinary tract infection; Sapovirus test positive, Urinary tract infection
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Tested positive for sapovirus and a UTI
Tested positive for sapovirus and a UTI
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| 2826399 | 86 | F | FL | 02/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered
Extra dose administered
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Patient received a Arexvy vaccination on 1/23/24. She did not require a revaccination. Another dose...
Patient received a Arexvy vaccination on 1/23/24. She did not require a revaccination. Another dose was administered on 2/13/25.
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| 2826400 | 70 | F | PA | 02/15/2025 |
FLU3 |
SEQIRUS, INC. |
388476 |
Chills, Pain, Pyrexia
Chills, Pain, Pyrexia
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On 2-15-25-PATIENT REPORTED A SEVERE REACTION TO FLUAD INJECTION, IN BED FOR 2.5 DAYS (FEVER, CHILLS...
On 2-15-25-PATIENT REPORTED A SEVERE REACTION TO FLUAD INJECTION, IN BED FOR 2.5 DAYS (FEVER, CHILLS, ACHES). SHE STATED SHE ALSO HAD A SEVERE REACTION TO SHINGRIX IN PAST. I RECOMMENDED REPORTING TO HER FAMILY DOCTOR (NOT ABLE TO TOLERATE ADJUVANTS) SHE STATED SHE DID NOT HAVE ISSUES IN THE PAST WITH FLU SHOTS.
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| 2826401 | 65 | M | TN | 02/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, Pain in extremity
Extra dose administered, Pain in extremity
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Patient received a prior RSV (Arexvy) on 10/29/2023 and was revaccinated on 2/15/2025. Pharmacist sp...
Patient received a prior RSV (Arexvy) on 10/29/2023 and was revaccinated on 2/15/2025. Pharmacist spoke to patient and he had a sore arm for a few hours which has since resolved. Patient feels well.
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| 2826402 | 5 | M | ME | 02/15/2025 |
MMR |
MERCK & CO. INC. |
N024694 |
Pruritus, Pyrexia, Rash morbilliform, Swelling
Pruritus, Pyrexia, Rash morbilliform, Swelling
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Fever, measles like rash all over body, itching and swelling
Fever, measles like rash all over body, itching and swelling
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| 2826403 | 65 | F | TX | 02/15/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
391428 391428 |
Acoustic stimulation tests abnormal, Ear inflammation, Ear injury, Hypoacusis, S...
Acoustic stimulation tests abnormal, Ear inflammation, Ear injury, Hypoacusis, Sinus congestion; Sleep disorder, Tinnitus
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After receiving seasonal flu vaccine, approximately 13 hours later, awoke in the night with ringing ...
After receiving seasonal flu vaccine, approximately 13 hours later, awoke in the night with ringing in left ear and sinus congestion. Treated with OTC decongestant medication, allertec nose spray. No change to ringing in ear, after weeks of otc treatment. Sought medical advice/treatment .
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| 2826404 | 64 | F | NY | 02/15/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7427s 7427s |
Blood blister, Injection site bruising, Injection site pain, Injection site reac...
Blood blister, Injection site bruising, Injection site pain, Injection site reaction, Injection site scab; Injection site warmth
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patient experienced a bruise/ blood blister at injection site that eventually scabbed over and is ab...
patient experienced a bruise/ blood blister at injection site that eventually scabbed over and is about the size of a quarter about 10 days after vaccination. patient went to physician 2/15/25 because area is now warm, painful and scab is not healing.
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| 2826405 | 79 | F | AL | 02/15/2025 |
PNC20 |
PFIZER\WYETH |
79336830 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received inappropriate dose of Prevnar 20. Patient had already received Prevnar 20 in 2023 b...
Patient received inappropriate dose of Prevnar 20. Patient had already received Prevnar 20 in 2023 but was not recorded on state system. Patient reports no adverse effects from having additional dose.
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| 2826406 | 45 | M | VA | 02/15/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
004cz1a 037b22a 560421a |
Dizziness, Ventricular extrasystoles; Dizziness, Ventricular extrasystoles; Dizz...
Dizziness, Ventricular extrasystoles; Dizziness, Ventricular extrasystoles; Dizziness, Ventricular extrasystoles
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Lightheaded than developed pvcs
Lightheaded than developed pvcs
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โ | |||||
| 2826407 | 33 | F | UT | 02/15/2025 |
RSV |
MODERNA |
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Blood pressure increased, Delivery, Exposure during pregnancy, Induced labour, P...
Blood pressure increased, Delivery, Exposure during pregnancy, Induced labour, Pre-eclampsia
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I was given the vaccine at 34 weeks pregnant. Prior to that my blood pressure had been very good (11...
I was given the vaccine at 34 weeks pregnant. Prior to that my blood pressure had been very good (113/80). Two weeks later my blood pressure was in the 140's. The following week (37 weeks pregnant; December 23rd) my blood pressure was 164/109. I was sent to labor and delivery. There my blood pressure was 173. I was diagnosed with pre-eclampsia and induced. Baby was born 10:36 am December XX, 2024, weighing 7lbs 10oz.
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| 2826408 | 26 | F | MO | 02/15/2025 |
COVID19 COVID19 UNK |
MODERNA MODERNA UNKNOWN MANUFACTURER |
EP 7534 |
Amniocentesis abnormal, Exposure during pregnancy, Foetal growth abnormality, St...
Amniocentesis abnormal, Exposure during pregnancy, Foetal growth abnormality, Stillbirth, Trisomy 18; Amniocentesis abnormal, Exposure during pregnancy, Foetal growth abnormality, Stillbirth, Trisomy 18; Amniocentesis abnormal, Exposure during pregnancy, Foetal growth abnormality, Stillbirth, Trisomy 18
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First child, diagnosed with trisomy 18. Fetal growth issue. Still born at 32 months pregnant
First child, diagnosed with trisomy 18. Fetal growth issue. Still born at 32 months pregnant
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โ | |||||
| 2826409 | 67 | F | GA | 02/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
ET475 |
Injection site erythema, Injection site mass, Injection site warmth, Pain in ext...
Injection site erythema, Injection site mass, Injection site warmth, Pain in extremity
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Large very red area at injection site. Sore arm. Large lump in left arm at injection site. This co...
Large very red area at injection site. Sore arm. Large lump in left arm at injection site. This continued to be red and hot to the touch. The lump. erythema and pain were still evident 2 weeks post injection which warranted my phone call to my PCP and visit to him the next day. On 4/28/24 I still had a lump in my left arm from the injection.
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| 2826193 | M | 02/14/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer and described ...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 31-JAN-2025 The patient self-reported this case for himself. No other products given to the patient. The patient received Shingles vaccine (2 doses) and had shingles for which intervention required. The patient had shingles four times a year. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2826194 | U | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise, Peripheral swelling, Pyrexia
Malaise, Peripheral swelling, Pyrexia
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fever; The first Shingrix vax made me really sick; my arm swelled like a football; ache in my should...
fever; The first Shingrix vax made me really sick; my arm swelled like a football; ache in my shoulder; This non-serious case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included autoimmune disorder. 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 fever (Verbatim: fever), sickness (Verbatim: The first Shingrix vax made me really sick), swelling arm (Verbatim: my arm swelled like a football) and shoulder pain (Verbatim: ache in my shoulder). The outcome of the fever, sickness, swelling arm and shoulder pain were resolved (duration 10 days). It was unknown if the reporter considered the fever, sickness, swelling arm and shoulder pain to be related to Shingrix. It was unknown if the company considered the fever, sickness, swelling arm and shoulder pain to be related to Shingrix. Additional Information: GSK receipt date: 14-JAN-2025 The patient indicated that he/she do not get regular flu vaccinations because they tend to harm more than help. The patient had the Shingrix vaccine because patient was concerned about getting shingles in optical nerve. The first Shingrix vaccine made him/her really sick and had ran a fever, his/her arm swelled like a football, and had full virus like symptoms for 10 days. The patient had a lesser reaction for the booster, but it lasted 7 days. The patient was required to be vaccinated for job. The patient had an ache in shoulder a few days later, had totally forgotten that he/she had the vax. The patient have had a couple of boosters. No reaction were reported. The patient stated that his/her body hates everything and if a medication of any kind can be taken by 99 percent of the world, he/she was the 1 percent and the patient could not even take baby aspirin.
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| 2826195 | M | CT | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received his first Shingrix dose in his doctor's office over 2 years ago; This non-serious case...
received his first Shingrix dose in his doctor's office over 2 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose over 2 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received his first Shingrix dose in his doctor's office over 2 years ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The pharmacist reported that a patient had received his first Shingrix dose in his doctor office might had been before covid and wants to know that the patient still get the second dose or he start over. Till the time of reporting, the patient did not receive second dose of Shingrix which led to incomplete course of vaccination. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020239730:same reporter US-GSK-US2020209374:same reporter US-GSK-US2020209373:same reporter
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| 2826196 | M | CA | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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first dose of Shingrix over year ago and has not received second dose; This non-serious case was rep...
first dose of Shingrix over year ago and has not received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose over a year ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix over year ago and has not received second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The pharmacist stated that a patient had not received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2025015910 reported by the same reporter.; Sender's Comments: US-GSK-US2025015910:Same reporter
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| 2826197 | F | 02/14/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
Unknown Unknown |
Anaemia, Cardiomegaly, Hepatic cirrhosis, Hepatic failure, Internal haemorrhage;...
Anaemia, Cardiomegaly, Hepatic cirrhosis, Hepatic failure, Internal haemorrhage; Oxygen saturation, Oxygen saturation decreased, Rib fracture, Teeth brittle, Tooth fracture
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Internal Bleeding; Liver failure; NASH cirrhosis; oxygen saturation decreased; Anemia; Enlarged Hear...
Internal Bleeding; Liver failure; NASH cirrhosis; oxygen saturation decreased; Anemia; Enlarged Heart; Fluid build-up shattered a rib on left side; brittle teeth; 2 front teeth had broken; This spontaneous report received from a patient concerned a female patient of unspecified age. via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. During the Covid debacle, the patient was forced to take the J & J vaccine. As soon as patient was jabbed, health plummeted. NASH Cirrhosis, Anemia, Internal Bleeding, Enlarged Heart, Ascites (which at times, fluid build-up from nonfunctioning liver overtook the heart, lungs, pancreas, and spleen). Before patient realized these health issues, the fluid build-up shattered a rib on the left side. It would never heal correctly due to the amount of breaks; it was considered a "floater." To this day, patient could not bend over and pick up anything. Not even a feather without extreme pain. Pain so bad that it made patient want to puke. Patient could no longer move around, walk around, or lift anything, not even grocery shop without falling out with major pain. Patient had worn braces, but that was only a small fix. Legs, ankles, and feet swelled up to the point they no longer looked like legs, ankles, and feet. Internal bleeding well, patient didn't realize this would happen. Last April, then May, patient was at work started fainting in the office. One morning, patient felt so weak, patient drove self to the liver specialist for help. When the blood work was done, patient had lost so much blood patient was one point from dying. Patient had to have a blood transfusion. Then, patient had the 68-inch needle stuck into the side to drain more fluid. Then, one of the nights in the hospital, patient's blood oxygen dropped to 40. Barely able to walk. Patient had been sent to Hospital to get in line for a liver transplant. Then, the general physician told patient during a regular visit that patient would be dead in 6 months due to the J & J vaccine and liver failure. Patient also had terrible tremors. Teeth also took a terrible hit with this vaccine. Next week, patient had to go to Dental because 2 front teeth had broken. Teeth had become very brittle. They insisted patient had to have all teeth pulled and get dentures. Patient had enough low esteem. Patient's life had all but ended. The patient had to resign the position due to health. Other friends had witnessed their health fail due to this vaccine. Patient wanted someone at J & J to explain to patient why all this had happened and what J & J was going to do about it. If patient went bankrupt, so would J & J. Patient wouldn't stop this until patient got help from J & J. On an unspecified date, the patient experienced internal bleeding, liver failure, nash cirrhosis, oxygen saturation decreased, anemia, enlarged heart, fluid build-up shattered a rib on left side, brittle teeth, and 2 front teeth had broken. (dose series 1) On an unspecified date, laboratory data included: blood oxygen (NR: not provided) reduced to 40. The action taken with janssen covid-19 vaccine was not applicable. The outcome of internal bleeding, liver failure, nash cirrhosis, oxygen saturation decreased, anemia, enlarged heart, fluid build-up shattered a rib on left side, brittle teeth and 2 front teeth had broken was not reported. This report was serious (other medically important condition).; Sender's Comments: V0-Internal haemorrhage,Cirrhosis of Liver, Liver failure, , Anemia, Decreased oxygen saturation. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
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| 2826209 | 33 | M | CA | 02/14/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0588 |
Blood test, Chest pain, Electrocardiogram, X-ray
Blood test, Chest pain, Electrocardiogram, X-ray
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Chest pain in the lower right breast. Persistent soreness with occasional shotting pain
Chest pain in the lower right breast. Persistent soreness with occasional shotting pain
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| 2826217 | U | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
COVID-19
COVID-19
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that they received the shingles vaccine in 2020 and thought they were coming down with COVID-19 unti...
that they received the shingles vaccine in 2020 and thought they were coming down with COVID-19 until they read the side effects from Shingrix and realized they ticked all the boxes.; This non-serious case was reported by a consumer and described the occurrence of covid-19 in a 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 covid-19 (Verbatim: that they received the shingles vaccine in 2020 and thought they were coming down with COVID-19 until they read the side effects from Shingrix and realized they ticked all the boxes.). The outcome of the covid-19 was resolved. It was unknown if the reporter considered the covid-19 to be related to Shingrix. It was unknown if the company considered the covid-19 to be related to Shingrix. Additional Information: GSK Receipt Date:16-JAN-2025 The patient got the shingles shot in 2020. The reporter thought for sure I was coming down with Covid, and then he/she read all of the side effects from the Shingrix , ticked all the boxes.
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| 2826218 | U | 02/14/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Potential late second dose; This non-serious case was reported by a other health professional via ca...
Potential late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Potential late second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter contacted via web chat anonymous started conversation mentioning was it acceptable to administer 2 dose of shingles greater than 6 months after 1st. The healthcare provider abandoned the chat right after agent asked for consent to store contact details into the database, without any additional data about the case. It was not clarified if a patient was involved or if it was just a hypothetical question, and if the vaccine was Shingrix. The agent did not have a chance to ask for consent to follow up with safety team. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine which led to incomplete course of vaccination.
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| 2826220 | M | IA | 02/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to dat...
This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to date. I still got Covid on 05Oct; This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to date. I still got Covid on 05Oct; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 73-year-old male patient 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. Past drug history included: Paxlovid, start date: 07Oct2023, for COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Oct2024, outcome "unknown" and all described as "This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to date. I still got Covid on 05Oct". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient found it really strange, he always took the vaccines, the Pfizer vaccines, and thought he was up to date. He still got Covid on 05Oct. The doctor got him on our product (Paxlovid) and so in the 5 days he was fine. The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received.
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| 2826257 | 29 | M | TN | 02/14/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Allergy test, Food allergy, Hypertension, Vomiting; Allergy test, Food allergy, ...
Allergy test, Food allergy, Hypertension, Vomiting; Allergy test, Food allergy, Hypertension, Vomiting
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I now have high blood pressure and have developed a severe allergic reaction to eating eggs. I wasn&...
I now have high blood pressure and have developed a severe allergic reaction to eating eggs. I wasn't allergic to anything food related prior to covid vaccine. I grew up eating eggs. Now if I eat even one egg I throw up.
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| 2826258 | 80 | M | TX | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334y |
Vaccination error
Vaccination error
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patient did not request this vaccine
patient did not request this vaccine
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| 2826259 | 47 | M | MA | 02/14/2025 |
COVID19 |
MODERNA |
3042879 |
Pruritus, Rash
Pruritus, Rash
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PATIENT REPORTED THAT HE STARTED FEELING ITCHY IN THE EVENING ON THE VACCINE ON 02/11/2025 AND OVERN...
PATIENT REPORTED THAT HE STARTED FEELING ITCHY IN THE EVENING ON THE VACCINE ON 02/11/2025 AND OVERNIGHT HE DEVELOPED RASHES ALL OVER HIS BODY. HE DID NOT DEVELOP ANY OTHER SYMPTOMS
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| 2826260 | 80 | M | ME | 02/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8499CA |
Unevaluable event
Unevaluable event
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None
None
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| 2826261 | 59 | M | AZ | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Headache, Pyrexia
Chills, Headache, Pyrexia
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Intense shivering and fevers the evening of the vaccination. The next morning, headaches
Intense shivering and fevers the evening of the vaccination. The next morning, headaches
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| 2826262 | 4 | M | 02/14/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
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Chills, Decreased appetite, Headache, Pain, Pyrexia; Respiratory pathogen panel,...
Chills, Decreased appetite, Headache, Pain, Pyrexia; Respiratory pathogen panel, Vomiting
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Fever >103 x 4 days, still febrile on day 4, 103.8, headache, body aches, chills, vomiting, loss ...
Fever >103 x 4 days, still febrile on day 4, 103.8, headache, body aches, chills, vomiting, loss of appetite
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| 2826263 | 0.17 | F | TX | 02/14/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7392AA LJ5280 2091233 |
Aphasia, Decreased eye contact; Aphasia, Decreased eye contact; Aphasia, Decreas...
Aphasia, Decreased eye contact; Aphasia, Decreased eye contact; Aphasia, Decreased eye contact
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Decreased vocalization/babbling (slowly improving with time), Decreased eye contact (slowly improvin...
Decreased vocalization/babbling (slowly improving with time), Decreased eye contact (slowly improving with time)
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| 2826264 | 52 | F | TX | 02/14/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Biopsy lymph gland, Lymphadenopathy; Biopsy lymph gland, Lymphadenopathy; Biopsy...
Biopsy lymph gland, Lymphadenopathy; Biopsy lymph gland, Lymphadenopathy; Biopsy lymph gland, Lymphadenopathy
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Lymph nodes were enlarged for months. Ultra Sound done on 7/13/21
Lymph nodes were enlarged for months. Ultra Sound done on 7/13/21
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| 2826265 | 1.33 | F | UT | 02/14/2025 |
TYP |
SANOFI PASTEUR |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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SHE RECEIVED THEY TYPHOID VACCINE AFTER WE WERE TOLD SHE COULDN'T HAVE IT BECAUSE OF HER AGE
SHE RECEIVED THEY TYPHOID VACCINE AFTER WE WERE TOLD SHE COULDN'T HAVE IT BECAUSE OF HER AGE
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| 2826266 | 11 | F | MA | 02/14/2025 |
MNQ |
SANOFI PASTEUR |
U7938AA |
Pyrexia, Rash
Pyrexia, Rash
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Per the parents patient experienced fever and rash after administration of MCV4 vaccine. Rash on to...
Per the parents patient experienced fever and rash after administration of MCV4 vaccine. Rash on torso, face and extremities. No lethargy, wheeze, resp distress or sore throat. Resolved with OTC Benadryl.
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| 2826267 | 1.42 | M | SC | 02/14/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
Extra dose administered
Extra dose administered
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Patient was given an extra dose of IPV at 15 month visit. Patient should have only received DTaP and...
Patient was given an extra dose of IPV at 15 month visit. Patient should have only received DTaP and received DTaP-IPV
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| 2826268 | 59 | F | NJ | 02/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
72M55 |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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The Lot # is for the Diluent that came with the vaccine. The medical assistant did not mix the vacci...
The Lot # is for the Diluent that came with the vaccine. The medical assistant did not mix the vaccine and the diluent and only gave the patient the diluent. No adverse reactions were reported . Vaccine count was done same day and we found the mistake. Dr contacted the patient and informed her of the mistake and told the patient to make an appointment to come back in to receive the actual vaccine.
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| 2826269 | 79 | F | 02/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
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patient had already had vaccine on Jan 4, 2024
patient had already had vaccine on Jan 4, 2024
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| 2826270 | 11 | M | GA | 02/14/2025 |
MNQ MNQ TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8256BA U8256BA U8015AA U8015AA |
Erythema, Fatigue, Pain, Pruritus, Rash macular; Skin warm, Swelling; Erythema, ...
Erythema, Fatigue, Pain, Pruritus, Rash macular; Skin warm, Swelling; Erythema, Fatigue, Pain, Pruritus, Rash macular; Skin warm, Swelling
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Splotchy after shot, became warm to touch, swollen, sore, itching, redness fatigue, body aches
Splotchy after shot, became warm to touch, swollen, sore, itching, redness fatigue, body aches
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| 2826271 | 5 | M | CO | 02/14/2025 |
IPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
W1C831M Y015991 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient was given a dose of Polio and MMR when he was not due for them. The series were previously ...
Patient was given a dose of Polio and MMR when he was not due for them. The series were previously completed 02/15/2024. Patient has not had any adverse reactions or outcomes reported.
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| 2826272 | 4 | M | IN | 02/14/2025 |
COVID19 DTAPIPV MMRV |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. |
LN8272 U8009AB Y014440 |
Injection site erythema, Injection site pruritus, Injection site rash, Injection...
Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
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Red raised warm area around injection sites to left upper thigh. Itchy. Started small and increased ...
Red raised warm area around injection sites to left upper thigh. Itchy. Started small and increased in size within 24 hours. Examined today X4 days after vaccines, X3 days post site reaction-site is visible, flat, hyperpigmented with irregular borders. Mom reports improvement overall.
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| 2826273 | 8 | M | TN | 02/14/2025 |
VARCEL |
MERCK & CO. INC. |
y011019 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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given less than 28 days since MMR dose given 11/21/2024
given less than 28 days since MMR dose given 11/21/2024
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| 2826274 | 9 | F | MI | 02/14/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Vaccine was given past Beyond Use Date of 02/04/2025. No adverse events or complications reported. ...
Vaccine was given past Beyond Use Date of 02/04/2025. No adverse events or complications reported. Parents were informed and advised to have patient re-vaccinated for adequate coverage against COVID-19 infection.
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| 2826275 | 9 | M | TN | 02/14/2025 |
VARCEL |
MERCK & CO. INC. |
y011019 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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vaccine given when MMR live virus given less than 28 days apart 11/21/24
vaccine given when MMR live virus given less than 28 days apart 11/21/24
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| 2826276 | 60 | F | WI | 02/14/2025 |
FLU3 |
SANOFI PASTEUR |
UT8496MA |
Pain in extremity
Pain in extremity
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Patient reported today she has had arm aching, pain even. Gets better throughout the day, but is bad...
Patient reported today she has had arm aching, pain even. Gets better throughout the day, but is bad in the morning. Reportedly started with her Fluzone shot and has continued
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| 2826277 | 37 | F | UT | 02/14/2025 |
COVID19 |
PFIZER\BIONTECH |
FJ4991 |
Seasonal allergy, Sneezing
Seasonal allergy, Sneezing
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Seasonal allergies which I never had before. I got the 3rd booster, and was out of the country. When...
Seasonal allergies which I never had before. I got the 3rd booster, and was out of the country. When I came back I instantly started sneezing, and first assumed I was catching a cold from my flight. Then I had the AC checked twice because I thought something was wrong. Eventually I realized my symptoms were of allergies, and I got tested. Now I have allergies each year at the end of the summer
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| 2826278 | 0.5 | M | NY | 02/14/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
B532G FJ342 LG5578 YOO9341 |
Injection site reaction, Papule, Rash, Rash erythematous, Rash macular; Injectio...
Injection site reaction, Papule, Rash, Rash erythematous, Rash macular; Injection site reaction, Papule, Rash, Rash erythematous, Rash macular; Injection site reaction, Papule, Rash, Rash erythematous, Rash macular; Injection site reaction, Papule, Rash, Rash erythematous, Rash macular
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Approximately 20 minutes after injections and oral immunization administration, the patient develope...
Approximately 20 minutes after injections and oral immunization administration, the patient developed a red rash all over the right cheek and a red macular rash on the forehead, top of head, and around mouth. There were some red papular lesions on the legs around the injections sites
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