| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2822371 | 80 | F | TX | 01/23/2025 |
COVID19 |
MODERNA |
|
Death, Pain
Death, Pain
|
she passed a few months ago; hurting all over; This spontaneous case was reported by a patient famil...
she passed a few months ago; hurting all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (she passed a few months ago) and PAIN (hurting all over) in a 9-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (she passed a few months ago) (seriousness criteria death and medically significant) and PAIN (hurting all over) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. The patient was in 80s and received the Moderna COVID shot when came out and was "hurting all over" and stated that the shots were messed whole body up and passed a few months ago. No other details were reported. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-110011 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-110011:Reporter's case; Reported Cause(s) of Death: She passed a few months ago
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β | |||||
| 2822384 | 54 | F | NC | 01/23/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LC757 LC757 LC757 LC757 LC757 LC757 UNK UNK UNK UNK UNK UNK |
Antiphospholipid antibodies positive, Atelectasis, Computerised tomogram thorax ...
Antiphospholipid antibodies positive, Atelectasis, Computerised tomogram thorax abnormal, Fibrin D dimer increased, Hepatic steatosis; Injection site erythema, Injection site pruritus, Injection site reaction, Mean platelet volume increased, Muscle swelling; Pain in extremity, Peripheral swelling, Pulmonary embolism, Scan with contrast abnormal, Superficial vein thrombosis; Tenderness, Ultrasound Doppler abnormal, Weight bearing difficulty; Antiphospholipid antibodies positive, Computerised tomogram thorax abnormal, Injection site reaction, Muscle swelling, Pulmonary embolism; Rash, Rash erythematous, Rash pruritic, Respiration abnormal, Ultrasound scan abnormal; Antiphospholipid antibodies positive, Atelectasis, Computerised tomogram thorax abnormal, Fibrin D dimer increased, Hepatic steatosis; Injection site erythema, Injection site pruritus, Injection site reaction, Mean platelet volume increased, Muscle swelling; Pain in extremity, Peripheral swelling, Pulmonary embolism, Scan with contrast abnormal, Superficial vein thrombosis; Tenderness, Ultrasound Doppler abnormal, Weight bearing difficulty; Antiphospholipid antibodies positive, Computerised tomogram thorax abnormal, Injection site reaction, Muscle swelling, Pulmonary embolism; Rash, Rash erythematous, Rash pruritic, Respiration abnormal, Ultrasound scan abnormal
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Rt saphenous vein thrombosis with pulmonary embolism. My Entire Left Deltoid muscle was swollen...
Rt saphenous vein thrombosis with pulmonary embolism. My Entire Left Deltoid muscle was swollen on 10/12/2023 with rectangular patch at injection site approx 1x3 inches red and itchy. On Oct 15, 2023 a 2 inch diameter round sore swollen area popped up about 2 inches above my right ankle medially, where the saphenous vein is located. Over the next 2 weeks the area of swelling spread up my leg. No redness was noted. By 10/30/2023 I had severe Rt leg pain, and couldn't bear weight on that leg, so I went to the ER. I was diagnosed with pulmonary embolisms and atelectasis in my right lung, and a blood clot in the right distal saphenous vein.
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β | β | ||||
| 2822390 | 4 | M | MA | 01/23/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8209CN Y014937 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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LEFT UPPER ARM -> RED and very swollen. Entire upper arm from shoulder to elbow. Red + swollen x...
LEFT UPPER ARM -> RED and very swollen. Entire upper arm from shoulder to elbow. Red + swollen x 3 days.
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| 2822391 | 1.5 | F | MD | 01/23/2025 |
DTAP HIBV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
9KB9G UK092AB |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
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Swelling of upper left arm on deltoid region 2 days after the vaccination. Swelling is stable. Warm ...
Swelling of upper left arm on deltoid region 2 days after the vaccination. Swelling is stable. Warm to the touch, fever to 100.3F, painful to the touch, redness.
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| 2822392 | 61 | M | MN | 01/23/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Guillain-Barre syndrome
Guillain-Barre syndrome
|
Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN B...
Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN BARRE
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| 2822393 | 81 | M | AZ | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
fj5683 |
Breakthrough COVID-19, SARS-CoV-2 test positive
Breakthrough COVID-19, SARS-CoV-2 test positive
|
Reported Sysmptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTOIN; 10084268:COVID...
Reported Sysmptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTOIN; 10084268:COVID-19; NARRATIVE: Patient was admitted July 21 for COVID 19+ infection. He was discharged to home on July 23. Other Relevant HX: PMH: CAD, HTN, COPD, OSA, and GERD Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
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|
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| 2822394 | 78 | M | AZ | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
EK4176 |
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
|
Reported Symptoms: 10054112:HOSPITALISATION; 10067923;VACCINE BREATHROUGH INFECTION; 10084268:COVID-...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923;VACCINE BREATHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt was admitted on 7/21 for COVID and discharged to home on 7/25. Other Relevant HX: PMH: HTN, hx of CVA, cognitive disorder, BPH, HLD Other: hospitalization due to COVID-19 infection after having received COVID-19 vaccine
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| 2822395 | 59 | M | AZ | 01/23/2025 |
COVID19 |
JANSSEN |
201A21A |
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive, Treatment noncompl...
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive, Treatment noncompliance
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was admitted for COVID-19 infection 7/19 and left AMA on 7/26 Other Relevant HX: PMH: HTN, COPD, bipolar disorder, substance abuse, OSA Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2822396 | 76 | F | AZ | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
EM9810 |
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
|
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: admitted on 7/19 and discharged to home on 7/21. Other Relevant HX: PMH: myasthenia gravis, Parkinson's, dementia, HTN, HLD, tobacco use Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
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| 2822397 | 71 | M | AZ | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
EL3247 |
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
|
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: admitted 7/22 and discharged from hospital to home on 7/25 Other Relevant HX: PMH: Atrial fibrillation, HTN, T2DM, BPH, and OSA Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2822398 | 75 | M | AZ | 01/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ew0158 ew0158 |
Breakthrough COVID-19, COVID-19 pneumonia, Mental status changes, Pneumonia, Pne...
Breakthrough COVID-19, COVID-19 pneumonia, Mental status changes, Pneumonia, Pneumonia bacterial; SARS-CoV-2 test positive
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|
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was hospitalized for community acquired pneumonia and COVID-19 PNA (deemed asymptomatic). Patient received Augmentin and azithromycin for treatment of bacterial pneumonia. He did not receive treatment for COVID, but was found to be positive on admission. He initially presented with altered mental status. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
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| 2822399 | 85 | M | AZ | 01/23/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Blood pressure diastolic decreased, Bradycardia, Breakthrough COVID-19, Computer...
Blood pressure diastolic decreased, Bradycardia, Breakthrough COVID-19, Computerised tomogram thorax normal, Dizziness; Hypoxia, Inflammatory marker test, SARS-CoV-2 test positive, Scan with contrast normal
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTION; 10084268: COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREATHROUGH INFECTION; 10084268: COVID-19; Narrative: HOSPITAL COURSE: Patient was admitted to the hospital for further work-up of bradycardia, dizziness, and hypoxia. He was placed on supplemental O2 2L/min initially. Of note, patient was found to have COVID 19 for which he had just finished a Paxlovid course (started 6/25/24). From the COVID perspective patient was doing well and is inflammatory markers were unremarkable. Patient was saturating greater than 92% on room air. Patient also had orthostatics done for which he was positive where he dropped 10 mmHg and diastolic. Because of this IV fluids were given to the patient and responded appropriately. Of note, patient was also found to have bouts of bradycardia for which patient was asymptomatic at the time. on 7/4, patient was hemodynamically stable and symptomatic bradycardia. Other Relevant HX: Patient was prescribed Paxlovid in outpatient setting prior to hospitalization. Patient presented to the hospital for asymptomatic bradycardia and hypoxemia that may have been related to the COVID-19 infection since patient was still testing positive in the hospital. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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β | |||||
| 2822400 | 64 | M | AZ | 01/23/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FE3594 FE3594 FE3594 |
Atherectomy, Breakthrough COVID-19, Catheterisation cardiac abnormal, Chest X-ra...
Atherectomy, Breakthrough COVID-19, Catheterisation cardiac abnormal, Chest X-ray normal, Chest discomfort; Chest pain, Coronary arterial stent insertion, Coronary artery occlusion, Echocardiogram abnormal, Ejection fraction abnormal; SARS-CoV-2 test positive, Troponin increased
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt presents with 4 days of atypical chest pain found to have elevated troponin in the ED. Pt was admitted to medicine for further ACS workup. Cardiology was consulted and heparin drip was initiated on admission along with aspirin and high intensity statin. Initially discussed possibility of type II MI vs COVID myocarditis. Serial troponins continued to rise. Pt underwent LHC with pRCA stenting. No medications were started for treatment for COVID-19. Chest pain resolved during hospitalization & patient was discharged home after 1 day. Other Relevant HX: Patient with PMH of HTN, T2DM complicated by peripheral neuropathy, HLD who presents with 4 days of central chest pain/pressure. Hx of smoking. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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β | |||||
| 2822401 | 65 | M | AZ | 01/23/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Abdominal pain, Ageusia, Asthenia, Breakthrough COVID-19, Cholecystitis; Cough, ...
Abdominal pain, Ageusia, Asthenia, Breakthrough COVID-19, Cholecystitis; Cough, Duodenitis, Gastritis, Oropharyngeal pain, Respiratory tract congestion; Rhinorrhoea, SARS-CoV-2 test positive
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt was admitted to the hospital due to severe abdominal pain. Was found to have gastritis/duodenitis/cholecystitis as primary diagnosis. Several days into the hospitalization, pt reported cough, congestion, sore throat, runny nose, generalized weakness, and loss of taste. Tested positive for COVID 19 infection - no hypoxemia. Discussed option for tx w/ remdesivir given age >65. Discussed risks/benefits and patient opted for treatment. Experienced symptom improvement and was discharged home. Other Relevant HX: PMH of diverticulitis, hyperlipidemia, DM, and hypertension, presented with diffuse abdominal pain. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2822402 | 67 | M | AZ | 01/23/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8729 ER8729 ER8729 |
Aphasia, Blood lactic acid increased, Breakthrough COVID-19, Chest X-ray normal,...
Aphasia, Blood lactic acid increased, Breakthrough COVID-19, Chest X-ray normal, Chronic obstructive pulmonary disease; Condition aggravated, Dyspnoea, Full blood count, Gram stain positive, Productive cough; SARS-CoV-2 test positive, Troponin normal, White blood cell count increased
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Reported Symptoms: 10054112:HOSPITALSATION; 100676923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALSATION; 100676923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient reports that few days ago he had worsening shortness of breath and was prescribed 3 day course of prednisone which he completed yesterday evening. He still had increased shortness of breath with a clear productive cough this morning and presented to the ED with shortness of breath and inability to speak due to shortness of breath. In the ED they did back-to-back treatments of duo nebs, IV solumedrol, IV magnesium and 2L fluids along with IV ceftriaxone. Was admitted for COPD exacerbation secondary to COVID-19. Dexamethasone and remdesivir were started upon admission. Patient experienced symptomatic improvement and was discharged home. Other Relevant HX: PMHx of COPD GOLD D not on home O2, HTN, HLD, PAD, gout, melanoma s/p resection and colonic pseudo-obstruction presenting to the ED for shortness of breath. Admitted for COPD exacerbation secondary to COVID-19 infection. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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β | |||||
| 2822403 | 88 | M | NJ | 01/23/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Death, Renal failure; Death, Renal failure
Death, Renal failure; Death, Renal failure
|
Online report of death by renal failure approximately 4 months after 2nd inoculation of EUA medical ...
Online report of death by renal failure approximately 4 months after 2nd inoculation of EUA medical countermeasure deemed "COVID-19 vaccine". Manufacturer, dose dates and lot numbers are unknown. Regardless of manufacturer, either Moderna or Pfizer-Biotech, this adverse event does not appear to have been enumerated into VAERS. As a result, the fatal post inoculation adverse event of this patient will receive the required enumeration as per the EUA.
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β | β | ||||
| 2822404 | 44 | M | CA | 01/23/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Sudden death; Sudden death
Sudden death; Sudden death
|
Online report of sudden unexpected at death of EUA medical countermeasure recipient. Online report i...
Online report of sudden unexpected at death of EUA medical countermeasure recipient. Online report indicates he passed away peacefully on 01/02/2025. Unable to ascertain DOB. DOB is just an estimate. A review of his social media post indicate his second injection was on 05/04/21 and prior post has a picture with his son holding a pharmacy sign. Therefore, its likely he was injected at a pharmacy location. Information on manufacturer, LOT #, DOSE#1 date unavailable. Victim made a post about the presence of black mold on the walls of his apartment within a year of death.
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β | |||||
| 2822405 | 17 | M | TX | 01/23/2025 |
COVID19 FLU3 HEP HEPA HPV9 IPV MENB MMR MNQ TDAP VARCEL |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
LN0591 H39Z4 T5727 Y010466 X1C891M ZH7SN X4T99 9YB4G Y013073 |
Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oed...
Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash; Eye oedema, Face oedema, Oedema peripheral, Pruritus, Rash
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Approximately 30-45 minutes post vaccine administration child began to complain of itching/rash to n...
Approximately 30-45 minutes post vaccine administration child began to complain of itching/rash to neck assessed by Medical Coordinator. rash/wells noted bilat arms neck front and back torso Benadryl 50mg administered p.o., dispensed hydrocortizone cream for child to apply. given ice pack for comfort Edema to face hands eyes noted within 10 minutes post initial assessment PCP made aware. administer epi-pen. child taken to hospital ED. child treated in ER with Benadryl IV. IVFluids, prednisone. 1/23/25 @ 7:15am. child denies itching. rash/edema resolving Child will be assessed by PCP this afternoon
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| 2822406 | 1 | M | WA | 01/23/2025 |
MENHIB MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Erythema, Lip discolouration, Staring, Unresponsive to stimuli; Erythema, Lip di...
Erythema, Lip discolouration, Staring, Unresponsive to stimuli; Erythema, Lip discolouration, Staring, Unresponsive to stimuli
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Unresponsive to stimuli; Erythema; Staring; Cyanosis; Information was obtained on a request by The C...
Unresponsive to stimuli; Erythema; Staring; Cyanosis; Information was obtained on a request by The Company from the Agency (agency # AU-TGA-0000827465) via a Public Case Detail, received by a physician concerning a 1-year-old male patient. The patient's medical history included fever and coryzal symptoms. His concurrent conditions and concomitant therapies were not reported. Previous vaccine reaction reported as not applicable. On 07-JUN-2015, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, lot #, expiry date, route of administration, and indication were not provided); and hib vaccine conj (tet tox), meningococcal vaccine c conj (tet tox) (MENITORIX) (strength, formulation, dose, lot #, expiry date, route of administration, and indication were not provided). On 14-JUN-2015, the patient experienced cyanosis. On the same day at 17:30, the patient experienced erythema, staring, unresponsive to stimuli (reported as 3-minute episode blank stare, nil response, red face, purple lips). No seizing of limbs/torso. In addition, per ''ED'' review no neurological signs of upper respiratory tract infection (URTI). On 14-JUN-2015, the patient recovered from the event of cyanosis. On the same day at 17:33, the patient recovered from the events of erythema, staring, and unresponsive to stimuli. General pediatric review follow up. The reporter considered all the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and hib vaccine conj (tet tox), meningococcal vaccine c conj (tet tox) (MENITORIX). Upon internal review the event of unresponsive to stimuli was considered as medically significant.
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| 2822407 | F | WA | 01/23/2025 |
6VAX-F PNC RV5 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
|
Seizure; Seizure; Seizure
Seizure; Seizure; Seizure
|
Seizure; Information has been received from health authority (#AU-TGA-0000827457). This spontanous r...
Seizure; Information has been received from health authority (#AU-TGA-0000827457). This spontanous report was received from physician and refers to female patient in the age less than 1 year. The patient's medical history was not reported. The patient's concurrent conditions included prophylaxis. Concomitant therapies were not reported. On 15-MAR-2011, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVENAR), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). On 15-MAR-2011, the patient experienced seizure. On an unknown date, the patient was admitted to the hospital due to seizure. On 16-MAR-2011, the patient recovered from the event of seizure. The reporter considered seizure to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The reporter considered seizure to be medically significant.
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β | ||||||
| 2822455 | 1 | M | PA | 01/23/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
X027908 Y011019 |
Morbillivirus test positive, Pyrexia, Rash; Morbillivirus test positive, Pyrexia...
Morbillivirus test positive, Pyrexia, Rash; Morbillivirus test positive, Pyrexia, Rash
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Mom brought patient into the office on 1/17/2025 for a rash that showed up on his abdomen, upper thi...
Mom brought patient into the office on 1/17/2025 for a rash that showed up on his abdomen, upper thighs, and diaper area. Per mom, patient had also had a fever x 2 days before rash appeared.
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| 2822456 | 72 | F | DE | 01/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Asthenia, Facial spasm, Magnetic resonance imaging head abnormal, Muscle spasms,...
Asthenia, Facial spasm, Magnetic resonance imaging head abnormal, Muscle spasms, Neurovascular conflict; Oropharyngeal pain, Pain in extremity, Paraesthesia, Urinary incontinence
More
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Three hours later began three days of severe muscle spasms in neck, head, body. Lost bladder control...
Three hours later began three days of severe muscle spasms in neck, head, body. Lost bladder control, had pains running down my legs. Voice began to hurt, when talking would vibrate in my head. Spasms did not stop for all three,days. months later pains in legs cleared and bladder control restored. I could not get to Drs had just moved here so no primary. Later was given gabapentin and carbamazapine. Saw neurologist who said he would not and could not help me until CDC report issued.
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β | |||||
| 2822457 | 11 | F | IL | 01/23/2025 |
MNQ |
SANOFI PASTEUR |
u8351aa |
Arthralgia
Arthralgia
|
patient's mother, called this nurse and reported that patient still has some left shoulder pain...
patient's mother, called this nurse and reported that patient still has some left shoulder pain, mainly located in the joint. this has continued since getting her vaccine on 12-31-24. She does play sports and thought maybe it was related to that but shes not sure. She has not been back to the pcp yet. has tried advil for the pain. I advised the vaccine could have been given a bit high on the deltoid, and it should be ok but recommended she contact her doctor for advice and that I would do this report. mom is agreeable to this.
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| 2822458 | 24 | F | 01/23/2025 |
FLU3 |
SANOFI PASTEUR |
u8518Ba |
Extra dose administered
Extra dose administered
|
Given flu shot twice in one season. Client received flu vaccine in 9/24 and received same vaccine 1/...
Given flu shot twice in one season. Client received flu vaccine in 9/24 and received same vaccine 1/21/25
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| 2822459 | 15 | F | NY | 01/23/2025 |
MMR MNQ TDAP VARCEL |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y003677 U8361AA 3RE73 YO11711 |
Fatigue, Headache, Syncope; Fatigue, Headache, Syncope; Fatigue, Headache, Synco...
Fatigue, Headache, Syncope; Fatigue, Headache, Syncope; Fatigue, Headache, Syncope; Fatigue, Headache, Syncope
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SYNCOPE EVENT OCCURED AFTER VACCINE ADMINISTRATION THAT LASTED APPROX 20 SECONDS,PT WAS PLACED IN TH...
SYNCOPE EVENT OCCURED AFTER VACCINE ADMINISTRATION THAT LASTED APPROX 20 SECONDS,PT WAS PLACED IN THE RECUMBANT POSITION AS SYNCOPE WAS OCCURRING. PT CO HEADACHE AND FEELING TIRED VITAL SIGNS MONITORED, PT DRANK H20,ASSISTED TO CHAIR,STATED SHE FELT BETTER AND ASKED TO GO HOME. PT REFUSED OFFER TO BE EVALUATED AT THE ER. SHE WAS ADVISED TO SEEK MEDICAL ATTENTION FOR ANY FURTHER CONCERNS,EPISODES. PT LEFT CLINIC AT9;50 AM, ACCOMPANIED BY HER MOTHER AND COUSIN
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| 2822460 | 25 | F | CO | 01/23/2025 |
CHIK |
VALNEVA USA, INC. |
24B011 |
Blood glucose decreased, Dizziness, Fall, Head injury, Loss of consciousness
Blood glucose decreased, Dizziness, Fall, Head injury, Loss of consciousness
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The patient came to the pharmacy after receiving four other vaccinations from the travel clinic. She...
The patient came to the pharmacy after receiving four other vaccinations from the travel clinic. She then received the Chikengunya vaccine and stated she felt fine. We walked from the vaccination room back to the pharmacy where she stood for a few minutes before proceeding to the counter to receive other travel medications. When she was checking out, she stated that she felt faint and the pharmacist came around the counter to help in case she passed out, which she did. She fell faster than the pharmacist could react and the patient hit her head on the counter with no obvious signs of trauma from the impact. We placed her on the floor until she regained consciousness. She sat in a chair for about 30 minutes and a rapid response was called. She was checked out by a couple of nurses, cleared, and left the pharmacy that day.
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| 2822461 | 28 | F | OH | 01/23/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Decreased appetite, Dizziness, Fatigue, Hot flush, Migraine; Nausea, Pain, Vomit...
Decreased appetite, Dizziness, Fatigue, Hot flush, Migraine; Nausea, Pain, Vomiting
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Extreme fatigue, extreme dizziness, horrible body aches, feeling lightheaded, migraine since last ni...
Extreme fatigue, extreme dizziness, horrible body aches, feeling lightheaded, migraine since last night it?s 11:18am. No appetite, nausea/ vomiting, hot flashes.
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| 2822462 | 84 | F | TX | 01/23/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
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Product administered at inappropriate site; Product administered at inappropriat...
Product administered at inappropriate site; Product administered at inappropriate site
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Routine getting two shots in same arm
Routine getting two shots in same arm
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β | |||||
| 2822463 | 68 | M | KS | 01/23/2025 |
TYP TYP |
BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. |
|
Chills, Diarrhoea, Headache, Hyperhidrosis, Myalgia; Nausea
Chills, Diarrhoea, Headache, Hyperhidrosis, Myalgia; Nausea
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Nausea, diarrhea, chills, sweating, muscle aches,, headache
Nausea, diarrhea, chills, sweating, muscle aches,, headache
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| 2822464 | 47 | M | 01/23/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
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Unevaluable event
Unevaluable event
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nothing
nothing
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| 2822465 | 12 | M | MT | 01/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
237ZH |
Hypoaesthesia, Injected limb mobility decreased
Hypoaesthesia, Injected limb mobility decreased
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Mom reported in January 2025 that patient's left arm cannot be raised above his head for more t...
Mom reported in January 2025 that patient's left arm cannot be raised above his head for more than 30 seconds without his arm/hand going number. It started on the day he got the vaccine and did not occur prior to vaccine. Does not occur in his other arm.
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| 2822466 | 53 | F | WV | 01/23/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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no adverse reaction occurred , RN administered two flu vaccines.
no adverse reaction occurred , RN administered two flu vaccines.
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| 2822467 | 73 | F | 01/23/2025 |
FLU3 |
SANOFI PASTEUR |
ut8425ca |
Injection site erythema
Injection site erythema
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Redness developed down the arm away from the injection site toward the elbow later that day after th...
Redness developed down the arm away from the injection site toward the elbow later that day after the injection. Upon questioning patient stated this had happened before in the past when she had received a pneumonia vaccine. At that time she did not receive treatment and the redness went away. I encouraged patient to reach out to primary caregiver to be evaluated.
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| 2822468 | 60 | F | OR | 01/23/2025 |
PNC20 |
PFIZER\WYETH |
HR3906 |
Injection site induration, Injection site pain, Injection site rash, Injection s...
Injection site induration, Injection site pain, Injection site rash, Injection site swelling
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Patient report on 1-19-2025 rash, pain and swelling at the injection site. Patient was ordered Benad...
Patient report on 1-19-2025 rash, pain and swelling at the injection site. Patient was ordered Benadryl and Zyrtec once on that day. The was reported to NP on 1/22/2025. The Vaccine nurse access the site on 1/23/2025 @ 0800. Patient had sight hardness at the injection site decrease swelling and slight scan of rash present. Patient report feeling better.
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| 2822469 | 4 | F | VA | 01/23/2025 |
MMRV |
MERCK & CO. INC. |
Y003143 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received an accidental third dose of Proquad: human error. No reactions noted at this time.
Patient received an accidental third dose of Proquad: human error. No reactions noted at this time.
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| 2822470 | 1.5 | M | MT | 01/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
C24B9 |
Vomiting
Vomiting
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Patient vomiting about 5 hours after the immunization that has continued into the morning of 1/23/25...
Patient vomiting about 5 hours after the immunization that has continued into the morning of 1/23/25. Seen in office for this with no other symptoms outside of vomiting.
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| 2822471 | 83 | F | SC | 01/23/2025 |
FLU3 |
SEQIRUS, INC. |
388477 |
Pruritus
Pruritus
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Patient reports itching (full body) beginning two days after immunization. Pharmacist looked at pati...
Patient reports itching (full body) beginning two days after immunization. Pharmacist looked at patient hx and she has received the same vaccine before (same manufacturer). Patient reported no other environmental or medication changes.
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| 2822472 | 7 | F | TX | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2221 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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On 11/05/2024 at 5:30pm one of the medical assistants gave patient the covid vaccine Pfizer-BioNTech...
On 11/05/2024 at 5:30pm one of the medical assistants gave patient the covid vaccine Pfizer-BioNTech COVID-19 Vaccine unfraternally was the wrong vaccines for patient's age. Patient's mother was notified, and patient follow up with provider on 11/12/2024. Per Visit note no reaction, patient was feeling well and was advised to follow up if any further concerns.
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| 2822473 | 19 | F | CA | 01/23/2025 |
MNQ |
SANOFI PASTEUR |
U8194AA |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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No immediate or later reported adverse events thus far although wrong vaccination was administered -...
No immediate or later reported adverse events thus far although wrong vaccination was administered - patient was supposed to receive second dose of Bexsero vaccine but instead received a third dose of Menquadfi vaccine.
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| 2822474 | 80 | M | WV | 01/23/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
8081564 8081564 |
Acoustic stimulation tests, Deafness, Deafness unilateral, Magnetic resonance im...
Acoustic stimulation tests, Deafness, Deafness unilateral, Magnetic resonance imaging ear, Magnetic resonance imaging normal; Sudden hearing loss
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COMPLETE HEARING LOSS IN ONE EAR ONE WEEK AFTER RECEIVING VACCINE. VISITED AUDIOLOGIST, FAMILY DOCTO...
COMPLETE HEARING LOSS IN ONE EAR ONE WEEK AFTER RECEIVING VACCINE. VISITED AUDIOLOGIST, FAMILY DOCTOR AND THEN ENT SPECIALIST TWICE. HE WAS STARTED ON 2 ROUNDS OF PREDISONE, HEARING WAS COMPLETELY GONE FOR 2 WEEKS AND WOULD COME AND GO FOR THE UPCOMING WEEKS. IT HAS IMPROVED IN THE LAST WEEK, ABOUT A MONTH AFTER THE VACCINE. NO OTHER SYMPTOMS OTHER THAN SUDDEN HEARING LOSS
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β | |||||
| 2822475 | 0.17 | M | NE | 01/23/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
737J5 |
Crying
Crying
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Inconsolability with spontaneous resolution, thought to have been an intusussception.
Inconsolability with spontaneous resolution, thought to have been an intusussception.
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| 2822476 | 77 | F | TX | 01/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
AE435 |
Blood pressure increased, Chills, Injection site swelling, Injection site warmth...
Blood pressure increased, Chills, Injection site swelling, Injection site warmth, Pyrexia
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Chills, Fever 101, elevated blood pressure (180/110 mmHg, normally 160/80 mmHg), pulse 115, swollen ...
Chills, Fever 101, elevated blood pressure (180/110 mmHg, normally 160/80 mmHg), pulse 115, swollen arm at injection-site with warmth over injection site. Patient took Tylenol and clonidine to resolve. Symptoms lasted 24 hours
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| 2822477 | 79 | M | FL | 01/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Vertigo
Vertigo
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DEVELOPED VERTIGO ONE DAY AFTER INJECTION LASTED FOR 4 DAYS.
DEVELOPED VERTIGO ONE DAY AFTER INJECTION LASTED FOR 4 DAYS.
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| 2822478 | 4 | M | GA | 01/23/2025 |
DTAPIPV MMRV VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
Y49B7 Y009106 Y010374 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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NONE
NONE
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| 2822479 | 65 | F | NJ | 01/23/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Decreased appetite, Erythema, Influenza like illness, Skin swelling
Decreased appetite, Erythema, Influenza like illness, Skin swelling
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Flu-like symptoms, loss of appetite, skin red and swollen. No fever. Symptoms lasted for 4 to 5 days
Flu-like symptoms, loss of appetite, skin red and swollen. No fever. Symptoms lasted for 4 to 5 days
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| 2822480 | 24 | F | IL | 01/23/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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Abdominal pain upper, Back pain, Exposure during pregnancy, Headache, Immediate ...
Abdominal pain upper, Back pain, Exposure during pregnancy, Headache, Immediate post-injection reaction; Mobility decreased, Muscular weakness, Pain in extremity, Vertigo, Vomiting
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Pregnancy due date 06/27/25. Unsure of which flu test. Immediate pain in stomach. Vomiting 1 hr afte...
Pregnancy due date 06/27/25. Unsure of which flu test. Immediate pain in stomach. Vomiting 1 hr after receiving dose. Extreme muscle weakness and head pain 2 hrs after dose, feeling like head is spinning. Unable to move on own without the help of fiancοΏ½. Extreme pain in head, legs, and back roughly 4 hrs and still experiencing this 28 hrs later. Going to hospital
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| 2822481 | 39 | F | MN | 01/23/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
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Cardiac stress test, Catheterisation cardiac, Dyspnoea, Echocardiogram, Electroc...
Cardiac stress test, Catheterisation cardiac, Dyspnoea, Echocardiogram, Electrocardiogram; Pulmonary hypertension; Cardiac stress test, Catheterisation cardiac, Dyspnoea, Echocardiogram, Electrocardiogram; Pulmonary hypertension
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I was hospitalized at the ER with breathing problems I had never had before within weeks of my vacci...
I was hospitalized at the ER with breathing problems I had never had before within weeks of my vaccination and later diagnosed with pulmonary hypertension
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β | β | ||||
| 2822482 | 63 | U | FL | 01/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Pt received rsv shots a year apart. Pt does not have any symptoms. After speaking with the pt she is...
Pt received rsv shots a year apart. Pt does not have any symptoms. After speaking with the pt she is doing well and has no concerns
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| 2822483 | 9 | F | LA | 01/23/2025 |
COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 |
MODERNA MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
80777-0291-80 80777-0291-80 80777-0291-80 70461-0654-03 70461-0654-03 70461-0654-03 |
Blood creatine phosphokinase, C-reactive protein, Differential white blood cell ...
Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Full blood count, Liver function test; Metabolic function test, Myoglobin blood, Pain in extremity, Pyrexia, Red blood cell sedimentation rate; Rhabdomyolysis, Urine analysis; Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Full blood count, Liver function test; Metabolic function test, Myoglobin blood, Pain in extremity, Pyrexia, Red blood cell sedimentation rate; Rhabdomyolysis, Urine analysis
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Child developed rhabdomyolysis following vaccinations. She required hospitalization overnight. Her c...
Child developed rhabdomyolysis following vaccinations. She required hospitalization overnight. Her calves were the main area causing pain. She was also running a fever around 100-102 for 4 days. She recovered after administering aggressive hydration.
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β | |||||
| 2822484 | 27 | F | NJ | 01/23/2025 |
MMR |
MERCK & CO. INC. |
Y005802 |
Rash pruritic, Urticaria
Rash pruritic, Urticaria
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hives 1 day after vaccine administration that subsided but patient is still has a slight pruritic ra...
hives 1 day after vaccine administration that subsided but patient is still has a slight pruritic rash
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