| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2844762 | 65 | M | NY | 06/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Chills, Drug ineffective, Nasopharyngitis
COVID-19, Chills, Drug ineffective, Nasopharyngitis
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the COVID that he had was causing this; the COVID that he had was causing this; Pretty bad chills/ha...
the COVID that he had was causing this; the COVID that he had was causing this; Pretty bad chills/had a heating pad on him and he was still cold; Pretty bad chills/had a heating pad on him and he was still cold; This is a spontaneous report received from a Consumer or other non HCP, Program ID: A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "SLL, non-Hodgkin lymphoma", start date: 2022 (ongoing), notes: diagnosed in the spring of 2022, during a routine physical; "COVID" (unspecified if ongoing), notes: once in 2020, in late Feb2020; "B12 level was low" (unspecified if ongoing), notes: had four consecutive B12 injections a week apart and he took B12, 1000 micrograms everyday at night. The patient's family history included: "COVID" (unspecified if ongoing), notes: The patient's family member passed from COVID. Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation as dose 2, single; INFLUENZA VACCINE taken for immunisation as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown, single; VENETOCLAX taken for b-cell small lymphocytic lymphoma; ZANUBRUTINIB taken for b-cell small lymphocytic lymphoma. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6198), administration date: 18Feb2021, when the patient was 61-year-old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Comirnaty (2023-2024 formula) (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Shingles shot (Dose 1, manufacturer unknown), for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "the COVID that he had was causing this"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious), outcome "not recovered" and all described as "Pretty bad chills/had a heating pad on him and he was still cold". Therapeutic measures were taken as a result of drug ineffective, covid-19, chills, nasopharyngitis. Clinical course: The patient had had six Pfizer COVID vaccines, the last one in Sep of last year (Sep2024). The patient also took the second shingles shot, flu shot and pneumonia shot, all four of them (included covid shot), two weeks apart over the course of a month. The patient took care of himself and did not know how he got this. When he thought though which do not know was that he was immunocompromised because of his cancer diagnosis and chemo drugs that he was on, so his platelet count was low and that might had exacerbated what was going on, the cancer was diagnosed in 2022, the doctor saw a swelling in his neck, it looked like a goiter and he went for all kind of tests and this was what it was. He was taking two chemo drugs or the non-chemo drugs, called as co-targeted therapy, that was for the cancer. He was not allowed to take the drugs while he was on this protocol though, once he took this medication for 5 days, he would not be allowed to take his chemo drugs, he was going to be off it for five days. The patient had lab work in the hospital this morning (10Jun2025). He want to ask that if the COVID that he had was causing this or could it be something else. He had been suffering from chills, from pretty bad chills. He was lying in bed right now. He had a heating pad on me and he was still cold. He felt it was like somebody put an ice cube on top of him. H e did not get it. He wondered if chills were part of COVID protocol. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500119149 same patient/drug, different dose/event;
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| 2844763 | 06/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Injury, Post-acute COVID-19 syndrome
Injury, Post-acute COVID-19 syndrome
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Vaccine injuries; Long Covid; This is a spontaneous report received from a Consumer or other non HCP...
Vaccine injuries; Long Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "Vaccine injuries"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid". Additional Information: Reporter states, her primary care doctor was retiring this month. Patient need a primary care physician who knows something about long covid and vaccine injuries. Symptoms are constantly changing. She was going to all sorts of doctors, heart, skin, gastroenterologist, physical therapy, & ENT. Patients need medical doctor to oversee my issues. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2844764 | 61 | M | NY | 06/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Laboratory test, Neoplasm malignant, Platelet count, Platelet count decreased, S...
Laboratory test, Neoplasm malignant, Platelet count, Platelet count decreased, Swelling; Vitamin B12, Vitamin B12 deficiency, Weight
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a swelling in my neck; my platelet count is low; my B12 level was low; got cancer after getting Pfiz...
a swelling in my neck; my platelet count is low; my B12 level was low; got cancer after getting Pfizer COVID-19 Vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old male patient received BNT162b2 (BNT162B2 NOS), on 18Feb2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Feb2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, LOT: EN6198, Expiration date: 18Feb2021), administration date: 18Feb2021, when the patient was 61-year-old, for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset 2022, outcome "unknown", described as "got cancer after getting Pfizer COVID-19 Vaccine"; SWELLING (non-serious), outcome "unknown", described as "a swelling in my neck"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "my platelet count is low"; VITAMIN B12 DEFICIENCY (non-serious), outcome "unknown", described as "my B12 level was low". The patient underwent the following laboratory tests and procedures: lab work: (10Jun2025) Unknown results, notes: I had lab work this morning; Platelet count: (unspecified date) Low; Vitamin B12: (unspecified date) Low; Weight: (unspecified date) 107; (unspecified date) 107.9. Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: The consumer, who has received six doses of the Pfizer COVID-19 vaccine (the last administered in September 2024), reported experiencing severe chills despite using a heating pad. They are currently undergoing treatment for cancer, which was diagnosed in the spring of 2022 following the discovery of a neck swelling resembling a goiter during a routine physical. The consumer believes their immunocompromised state-due to both the cancer and the co-targeted chemotherapy drugs they are taking-may have contributed to their current condition. They mentioned a low platelet count and a history of COVID-19 infection once in February 2020, with no reinfections until now. The consumer is currently experiencing symptoms consistent with COVID-19, including intense chills, and is questioning whether these symptoms are related to the virus or another underlying issue. They also noted receiving B12 injections due to a deficiency, with four weekly injections followed by a daily oral supplement of 1000 mcg. During the current treatment protocol, they were advised to pause their cancer medications for five days. The consumer expressed frustration about being redirected when seeking answers regarding potential side effects and whether their current symptoms could be linked to COVID-19 or their immunocompromised status. They emphasized their desire to understand the cause of their symptoms and whether chills are a recognized part of the COVID-19 symptom profile.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500119014 same patient/drug, different dose/event;
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| 2844765 | M | NY | 06/12/2025 |
COVID19 PNC20 RSV |
PFIZER\BIONTECH PFIZER\WYETH PFIZER\WYETH |
|
Febrile convulsion; Febrile convulsion; Febrile convulsion
Febrile convulsion; Febrile convulsion; Febrile convulsion
|
The patient had a febrile seizure after getting 3 vaccines at one time.; This is a spontaneous repor...
The patient had a febrile seizure after getting 3 vaccines at one time.; This is a spontaneous report received from a Physician from a sales representative. An elderly male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stroke" (unspecified if ongoing), notes: Previous history of stroke. The patient's concomitant medications were not reported. The following information was reported: FEBRILE CONVULSION (hospitalization), outcome "recovered", described as "The patient had a febrile seizure after getting 3 vaccines at one time.". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), rsv vaccine prot.subunit pref 2v, BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 and ABRYSVO in triggering the onset of febrile seizure cannot be fully excluded, considering the plausible temporal relationship. Previous history of stroke and elderly age are major confounders. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 2844766 | 06/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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They made vaccines for Covid that I don't think worked that well; They made vaccines for Covid ...
They made vaccines for Covid that I don't think worked that well; They made vaccines for Covid that I don't think worked that well; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete: unknown manufacture), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "They made vaccines for Covid that I don't think worked that well". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2844767 | 06/12/2025 |
PNC20 |
PFIZER\WYETH |
|
Injection site pain
Injection site pain
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Severe pain in arm that received injection; This is a spontaneous report received from a Consumer or...
Severe pain in arm that received injection; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Severe pain in arm that received injection". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2844768 | F | 06/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A...
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "Covid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2844769 | FL | 06/12/2025 |
TDAP |
SANOFI PASTEUR |
|
Expired product administered, No adverse event
Expired product administered, No adverse event
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inappropriate use due to administration of adacel post expiry with no reported adverse event; Initia...
inappropriate use due to administration of adacel post expiry with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from nurse. This case involves an unknown age and unknown gender patient who had received an expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown expired dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection with :expiration date of 05/01 (lot number, and strength not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency:same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2844770 | 8 | M | IN | 06/12/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK015AA |
No adverse event
No adverse event
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administering PENTACEL to a patient 8 years of age with no reported adverse event; Initial informati...
administering PENTACEL to a patient 8 years of age with no reported adverse event; Initial information received on 10-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 years old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-May-2025, the patient received a dose of 0.5 ml (dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UK015AA, expiry date 30-May-2025, strength: standard and frequency: once) via intramuscular route in the left deltoid for immunisation with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2844771 | 18 | M | 06/12/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse reaction. Gave 19+ vaccine. Should have given - 18 yo vaccine
No adverse reaction. Gave 19+ vaccine. Should have given - 18 yo vaccine
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| 2844772 | 67 | F | MI | 06/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Swelling
Swelling
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Local swelling measuring 7 inches long by 2 inches wide per patient 6 days post vaccination no adve...
Local swelling measuring 7 inches long by 2 inches wide per patient 6 days post vaccination no adverse effects until 06/11/2025 noted.
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| 2844773 | 63 | F | NJ | 06/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93n4j |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No physical adverse event. Patient received an extra dose of the Shingrix vaccination in error
No physical adverse event. Patient received an extra dose of the Shingrix vaccination in error
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| 2844774 | 79 | F | OK | 06/12/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LX4483 E754F |
Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling, Swelling; H...
Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling, Swelling; Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling, Swelling
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Pt had swelling after the injection on her whole arm and part of her chest. She was given the inject...
Pt had swelling after the injection on her whole arm and part of her chest. She was given the injection over a month ago and she states that it is still swollen. She says the arm still aches and that she is having tingling and numbness in her hand when she drives. The patient will follow up with her PCP today.
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| 2844775 | 61 | M | NY | 06/12/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
|
Arthralgia, Decreased appetite, Fatigue, Headache, Insomnia; Myalgia
Arthralgia, Decreased appetite, Fatigue, Headache, Insomnia; Myalgia
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Loss of appetite, headache, tiredness, muscle and joint pain, irritability and inability to sleep we...
Loss of appetite, headache, tiredness, muscle and joint pain, irritability and inability to sleep well.
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| 2844776 | 44 | F | KY | 06/12/2025 |
HEP IPV MMR VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
945658 Y1A201M Z003766 Z003766 |
Pruritus, Throat irritation, Urticaria; Pruritus, Throat irritation, Urticaria; ...
Pruritus, Throat irritation, Urticaria; Pruritus, Throat irritation, Urticaria; Pruritus, Throat irritation, Urticaria; Pruritus, Throat irritation, Urticaria
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pt. arrived today 6/12/25 at the clinic stating that she began experiencing generalized hives and it...
pt. arrived today 6/12/25 at the clinic stating that she began experiencing generalized hives and itchiness all over her body at around 6pm yesterday 6/11/25 after having received the Varicella, MMR, HepB, and IPV vaccine at around 12p that same day. Pt. stated that she took cleratin and it helped with the itching but it came back this morning and she stated that she also had slight itching in her throat. RN recommended pt. seek immediate medical care at the local urgent care or ER as the signs and symptoms she is exhibiting are similar to those of an allergic reaction. Pt. stated that she would go straight to the urgent care/ER for f/u and treatment.
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| 2844777 | 65 | F | FL | 06/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
EK225 EK225 |
Acute sinusitis, Injection site discolouration, Injection site nodule, Injection...
Acute sinusitis, Injection site discolouration, Injection site nodule, Injection site pain, Injection site pruritus; Pain
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Itching started the day following vaccination (5/29). Around that time the patient was prescribed a...
Itching started the day following vaccination (5/29). Around that time the patient was prescribed a medrol dosepak for an unrelated condition (acute sinusitis) which she started on 6/3. We think this may have helped the symptoms of the localized vaccine reaction subside. After completing the steroid, patient noticed the itching again at the vaccination site around 6/11, then a large hard nodule formed at the injection site which became discolored and was accompanied by pain and tingling (described as a burning, stinging, throbbing feeling). Patient will be advised to seek further evaluation from her primary care physician.
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| 2844778 | 12 | F | NC | 06/12/2025 |
HPV9 |
MERCK & CO. INC. |
Y018398 |
Injection site pain
Injection site pain
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Prolonged pain in arm after injection
Prolonged pain in arm after injection
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| 2844780 | 78 | F | IA | 06/12/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
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passed away
passed away
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✓ | |||||
| 2844781 | 81 | F | SC | 06/12/2025 |
RSV |
PFIZER\WYETH |
lg9827 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Pharmacy unknowingly administered unneeded rsv shot. Pt was previously immunized with arexvy on 10/4...
Pharmacy unknowingly administered unneeded rsv shot. Pt was previously immunized with arexvy on 10/4/23. Spoke to pt on 6/12/25. She is well, feeling great, noted no side effects from the vaccination.
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| 2844782 | 4 | F | MI | 06/12/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U7838AA Z002986 |
Injection site erythema, Injection site pain, Injection site swelling; Injection...
Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling
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Left thigh became red, swollen, and painful to touch. Patient was seen in the ER due to these sympto...
Left thigh became red, swollen, and painful to touch. Patient was seen in the ER due to these symptoms. Patient is doing better now
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| 2844783 | 54 | F | GA | 06/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
75D3A 75D3A |
Hypersomnia, Inflammation, Neck pain, Pain, Rash erythematous; Skin irritation
Hypersomnia, Inflammation, Neck pain, Pain, Rash erythematous; Skin irritation
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GSK is the manufacturer for (Shingrix). I went into the pharmacy 2 days ago to do a pickup and the ...
GSK is the manufacturer for (Shingrix). I went into the pharmacy 2 days ago to do a pickup and the Pharmacist gave me a slip that recommended several vaccines for people over 50. Now, 54, I opt to get the Shingles Vaccine. The person that administered the injection explained that I should "ONLY" experience soreness . Day 1 - Soreness (as expected and I slept ALLLLL day). Day 2 - still sore, but expected. By 11pm that night, I started scratching my upper back on the left side, below the shoulder blade. When I woke up this morning, I noticed the same area was irritated. Upon showering, I noticed a red rash there. I rubbed some alcohol on it and continued on with my day. An hour later, (I'd say 9:30am), I noticed it turning really "red" and "irritating." I took another look so I applied desonide ointment to help with the inflammation/pain. I continued on with my day. By 10:45am, I noticed the same pain on the left side of my neck. WTH?? I thought I was bitten by something but I haven't left the home in 2 days so what is happening. I feels like a thousand mosquitoes are biting me and sensitive to the touch. WHAT THE HELL? I've never ever experienced this before. I called the Pharmacy to speak with pharmacist but she wasn't in today, another Pharmacist suggested I take Ibprophen, Tylenol and/or Benadryl. Ughhh. HAd I known taking the vaccine would "CAUSE" this sort of reaction I'd have just taken my chances without it. SMH Now what? How long will this last?
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| 2844784 | 74 | M | IN | 06/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Pharmacy's system recommended a "second dose" of shingrix when the patient had alread...
Pharmacy's system recommended a "second dose" of shingrix when the patient had already had two doses previously. Patient received a third dose.
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| 2844785 | 12 | F | LA | 06/12/2025 |
HEP TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
X027728 U8252AA |
Asthenia, Blood glucose, Fatigue, Feeling hot; Asthenia, Blood glucose, Fatigue,...
Asthenia, Blood glucose, Fatigue, Feeling hot; Asthenia, Blood glucose, Fatigue, Feeling hot
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Approx. 10-15 minutes following vaccination patient reported feeling hot head to toe, tired and weak...
Approx. 10-15 minutes following vaccination patient reported feeling hot head to toe, tired and weak. VS monitored and blood sugar checked. MD present for evaluation of patient. Patient monitored for approx 45 minutes in the clinic. Discharged to home with mother. VS stable. patient reported feeling much better and symptoms resolved.
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| 2844786 | 33 | F | OH | 06/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PG3RP |
Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
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Pt. reports via telephone that two days after vaccine given she developed fever with right upper ar...
Pt. reports via telephone that two days after vaccine given she developed fever with right upper arm swelling, erythema and "lump". Lump persisted and she was recently seen by her PCP ae placed on an antibiotic.
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| 2844787 | 1 | M | MI | 06/12/2025 |
HIBV |
SANOFI PASTEUR |
uk198aa |
No adverse event
No adverse event
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no adverse effects noted, no harm
no adverse effects noted, no harm
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| 2844788 | 85 | F | OH | 06/12/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
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Patient came in to pharmacy on 6/12 at 12:00pm to ask about a reaction she says seems to be due to v...
Patient came in to pharmacy on 6/12 at 12:00pm to ask about a reaction she says seems to be due to vaccine. Her arm was red and warm to touch around where pt said injection site was. It was also itchy. Patient said for a few days it was just normal sore but then started getting red, warm and hurting then moving to itchy. suggested pt see doctor incase it is somehow infected cannot guarantee pt went at this point
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| 2844789 | 66 | M | FL | 06/12/2025 |
PNC21 |
MERCK & CO. INC. |
y019158 |
Pain in extremity, Peripheral swelling
Pain in extremity, Peripheral swelling
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patient described pain and swelling in left arm that took several days to subside. patient has since...
patient described pain and swelling in left arm that took several days to subside. patient has since fully recovered
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| 2844790 | 53 | F | GA | 06/12/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Dyspnoea, Pain in extremity, Pulmonary pain
Dyspnoea, Pain in extremity, Pulmonary pain
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I have a lot of soreness in my arm and i am having a hard time breathing it feels like shell breathi...
I have a lot of soreness in my arm and i am having a hard time breathing it feels like shell breathing, and in my back where my lungs are it hurts a lot and is very painful.
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| 2844791 | 62 | F | IL | 06/12/2025 |
HEPAB PNC21 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
p2443 y019157 |
Inflammation, Injection site reaction, Injection site swelling, Injection site w...
Inflammation, Injection site reaction, Injection site swelling, Injection site warmth; Inflammation, Injection site reaction, Injection site swelling, Injection site warmth
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patient presented 3 days post vaccine with an inflamed arm. the vaccine administration site was red,...
patient presented 3 days post vaccine with an inflamed arm. the vaccine administration site was red, warm to the touch, and swelling. the affected area was roughly the size of a softball. we recommended she treat with ice, advil, and benadryl. patient states symptoms are improving from when we saw her yesterday.
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| 2844792 | 49 | M | MN | 06/12/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
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Blood test, Computerised tomogram head abnormal, Dyspnoea, Fatigue, Haemoglobin ...
Blood test, Computerised tomogram head abnormal, Dyspnoea, Fatigue, Haemoglobin abnormal; Intracranial aneurysm, Magnetic resonance imaging head abnormal, Malaise, Pulmonary function test abnormal, Red blood cell count abnormal; Scan, Tachycardia
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Cerebral anerysm,, post exertional malaise, chronic fatigue, shortness of breath, tachycardia
Cerebral anerysm,, post exertional malaise, chronic fatigue, shortness of breath, tachycardia
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✓ | ✓ | ✓ | |||
| 2844793 | 60 | F | UT | 06/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
58160-0823-11 58160-0823-11 |
Asthenia, Back pain, Dizziness, Fatigue, Headache; Injection site pain, Myalgia,...
Asthenia, Back pain, Dizziness, Fatigue, Headache; Injection site pain, Myalgia, Nausea, Sleep disorder
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Approximately 9:30 I got a terrible headache, muscles aches, dizziness, nauseous, my left arm where ...
Approximately 9:30 I got a terrible headache, muscles aches, dizziness, nauseous, my left arm where I received the shot was painful, and I had low energy level. My back aches the most. I felt drained and extremely fatigued. I didn't sleep because the aches and headache pain was awful. I did take a migraine Excedrin in the morning but I was very nauseous.
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| 2844794 | 20 | M | 06/12/2025 |
HPV9 |
MERCK & CO. INC. |
Y018398 |
Pharyngeal swelling
Pharyngeal swelling
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5 minutes after vaccination, patient developed a sensation of throat swelling without signs of respi...
5 minutes after vaccination, patient developed a sensation of throat swelling without signs of respiratory compromise. No other symptoms, vitals stable. Patient was monitored for 45 minutes, with complete resolution of symptoms without any additional treatment.
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| 2844795 | 62 | M | TX | 06/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93ET2 |
Injection site paraesthesia, Paraesthesia
Injection site paraesthesia, Paraesthesia
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Patient describes a tingling sensation that starts at the injection site and goes down the arm towar...
Patient describes a tingling sensation that starts at the injection site and goes down the arm towards the elbow. This started the day after the vaccine and occurs every day. Patient also states that the tingling increases when they sleep on their back at night all the way down to the wrist.
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| 2844796 | 59 | F | FL | 06/12/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
U8366AA U8366AA U8366AA |
Cellulitis, Chills, Fatigue, Headache, Hyperhidrosis; Influenza virus test, Inje...
Cellulitis, Chills, Fatigue, Headache, Hyperhidrosis; Influenza virus test, Injection site erythema, Injection site pain, Injection site swelling, Pain; Pyrexia, SARS-CoV-2 test
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Patient received TDAP on 06/09/2025 due to right hand abrasion. She then started experiencing sympto...
Patient received TDAP on 06/09/2025 due to right hand abrasion. She then started experiencing symptoms the following day 06/10/2025. Symptoms included right arm ( at injection site) redness, swelling, and pain. Had associated fever, chills, sweating, body aches, headaches, and fatigue. Was diagnosed with cellulitis and treated with oral Keflex.
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| 2844797 | 58 | M | AL | 06/12/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
z004301 5a4xg |
Pyrexia, Rash; Pyrexia, Rash
Pyrexia, Rash; Pyrexia, Rash
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rash on arm on the side of the shingles vaccine , also a slight fever
rash on arm on the side of the shingles vaccine , also a slight fever
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| 2844798 | 11 | M | AZ | 06/12/2025 |
COVID19 HPV9 MNQ TDAP |
PFIZER\BIONTECH MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
MD3414 Y012865 DL4YY TD2FD |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Patient is currently 11 years old and patient was administered by another Medical Assistant a COVID1...
Patient is currently 11 years old and patient was administered by another Medical Assistant a COVID19 Pfizer Vaccine of 12 year +
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| 2844799 | 68 | F | VA | 06/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Pallor, Rash, Rash erythematous, Rash papular, Rash pruritic; Urticaria
Pallor, Rash, Rash erythematous, Rash papular, Rash pruritic; Urticaria
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On 06/10/2025 developed a red rash and welts, slightly raised, itchy. no oral/ facial swelling/ coug...
On 06/10/2025 developed a red rash and welts, slightly raised, itchy. no oral/ facial swelling/ cough/ wheeze/ gi upset. Came to clinic, was prescribed medrol pak and started on oral zyrtec once a day. Returned to clinic 06/12/2025 because symptoms worsening and severe, over whole body. Red blanchable rash on trunk, arms, legs, hands, and feet.
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| 2844800 | 69 | F | MI | 06/12/2025 |
PPV |
MERCK & CO. INC. |
X023561 |
Wrong product administered
Wrong product administered
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Patient cam into clinic and requested Pneumonia vaccine. PPSV23 given to patient. PCV 20 should have...
Patient cam into clinic and requested Pneumonia vaccine. PPSV23 given to patient. PCV 20 should have been offered instead.
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| 2844801 | 87 | F | FL | 06/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
F95YS |
Chills, Fatigue
Chills, Fatigue
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Shivering and feeling tired.
Shivering and feeling tired.
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| 2844802 | 24 | M | WI | 06/12/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
038C21A 038C21A 038C21A |
Amnesia, Aphasia, Confusional state, Dizziness, Dysarthria; Electric shock sensa...
Amnesia, Aphasia, Confusional state, Dizziness, Dysarthria; Electric shock sensation, Excessive eye blinking, Headache, Migraine, Motor dysfunction; Nausea, Posture abnormal
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A light headache will start to occur letting me know it's about to happen, followed by excessiv...
A light headache will start to occur letting me know it's about to happen, followed by excessive blinking whenever I focus on performing any act (driving, typing, texting, writing, etc.). Once It sets in after a day or two of this, I experience the following symptoms for weeks at a time: Headache, nausea, dizziness, excessive blinking, confusion, memory loss, slurred speech, unable to speak, loss of motor function. At it's worst Its felt as though lightning struck across my brain and I hunched over, nearly falling to the ground unable to speak. The only occasional relief I can get is applying pressure to the nape of my neck, which doesn't work for too long. There has been no treatments found to alleviate this, as most medical professionals that I've seen don't seem to take it seriously or tell me it's a migraine.
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| 2844803 | 60 | M | CA | 06/12/2025 |
PNC20 |
PFIZER\WYETH |
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Influenza like illness, Tendon rupture
Influenza like illness, Tendon rupture
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I believe I have a partial or full rupture of my proximal long head of right biceps tendon as well a...
I believe I have a partial or full rupture of my proximal long head of right biceps tendon as well as pain at injection site and flu-like symptoms that began the day following vaccination.
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| 2844804 | 58 | F | NC | 06/12/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y7XG3 Y7XG3 y7xg3 y7xg3 |
Wrong technique in product usage process; Headache, Injection site erythema, Inj...
Wrong technique in product usage process; Headache, Injection site erythema, Injection site pain; Wrong technique in product usage process; Headache, Injection site erythema, Injection site pain
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The technician that administered the vaccine, injected the vaccine below the deltoid and I believe t...
The technician that administered the vaccine, injected the vaccine below the deltoid and I believe that means it was erroneously injected subcutaneously and not intramuscularly. Also, it felt like the and I believe injection was not going in at a 90 degree angle.
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| 2844805 | 53 | F | OH | 06/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Erythema, Feeling hot, Swelling
Erythema, Feeling hot, Swelling
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Patient called in 6/12 stating that she developed a local reaction on 6/11 and it has gotten worse t...
Patient called in 6/12 stating that she developed a local reaction on 6/11 and it has gotten worse today (red, warm, swollen). Nurse came to home and advised pt to take Benadryl and steroids
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| 2844806 | 57 | F | TX | 06/12/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
73z9p |
Bloody discharge, Contusion, Erysipelas, Erythema, Swelling
Bloody discharge, Contusion, Erysipelas, Erythema, Swelling
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Erysipelas, red, swollen, bruised, serosanguinous drainage
Erysipelas, red, swollen, bruised, serosanguinous drainage
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| 2844807 | 0.5 | F | DE | 06/12/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK199AA |
No adverse event, Underdose
No adverse event, Underdose
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no adverse reaction just partial dosing
no adverse reaction just partial dosing
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| 2844808 | 1 | M | PA | 06/12/2025 |
MMR MMRV PNC20 |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
Y011484 y013572 LP946 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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proquad administered instead of varicella. Patient received additional dose of mmr and Proquad is no...
proquad administered instead of varicella. Patient received additional dose of mmr and Proquad is not indicated at this age. Error noted immediately after administration.
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| 2844809 | 36 | F | GA | 06/12/2025 |
RAB |
SANOFI PASTEUR |
Y1B401M |
Hypersensitivity, Injection site erythema, Injection site pruritus, Injection si...
Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth, Paraesthesia
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The patient experienced tingling in right arm with no redness or numbness at 0828. At 0835 the tingl...
The patient experienced tingling in right arm with no redness or numbness at 0828. At 0835 the tingling improved, and the patient left in stable condition. At 0845, the patient returned to the ambulatory care unit with complaints of itching, redness, and warm to touch in right deltoid. At 0849 the rapid response team was called. The rapid response team gave the patient Benadryl in the left deltoid. At 0912, the patient complained of itching in the left deltoid and was sent to the emergency room. The patient was accessed at 0923 and reassessed at 1024 and the condition had improved. The diagnosis was an acute allergic reaction, and the patient was discharged with Pepcid 20 mg oral tablet and hydrOXYzine pamoate 25mg oral capsule.
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| 2844810 | 12 | M | KY | 06/12/2025 |
HEPA HEPA HEPA HEPA MNQ MNQ MNQ MNQ TDAP TDAP TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
y008483 y008483 y008483 y008483 u8256AB u8256AB u8256AB u8256AB 3ca10c1 3ca10c1 3ca10c1 3ca10c1 |
Back pain, Central nervous system lesion, Computerised tomogram abdomen, Compute...
Back pain, Central nervous system lesion, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax; Condition aggravated, Extensor plantar response, Fatigue, Hyperreflexia, Hypoaesthesia; Joint range of motion decreased, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging whole body; Muscular weakness; Back pain, Central nervous system lesion, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax; Condition aggravated, Extensor plantar response, Fatigue, Hyperreflexia, Hypoaesthesia; Joint range of motion decreased, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging whole body; Muscular weakness; Back pain, Central nervous system lesion, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax; Condition aggravated, Extensor plantar response, Fatigue, Hyperreflexia, Hypoaesthesia; Joint range of motion decreased, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging whole body; Muscular weakness
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numbness of right leg. started in toes, progressed upwards, stopped at his knee, resolved 18 hrs lat...
numbness of right leg. started in toes, progressed upwards, stopped at his knee, resolved 18 hrs later. right leg muscle weakness, limited ROM of feet toes. increased deep tendon reflexes. hyper reflexia, positive babinski in Left side. Back pain several days later. worsening persistent fatigue
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| 2844811 | 4 | F | ME | 06/12/2025 |
DTAPHEPBIP IPV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
D252F X1D14M |
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 received an extra dosage of IPV by the IPOL injection. Patient did not have any adverse rea...
Patient received an extra dosage of IPV by the IPOL injection. Patient did not have any adverse reaction, just had a double dosage of IPV on 05/13/25. Patient also received an extra dosage of Hepatitis B with the Pediarix vaccine. Again patient did not have any adverse reaction, just received an extra dosage of Hepatitis B on 05/13/25.
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| 2844812 | 15 | M | FL | 06/12/2025 |
HEPA HPV9 MNQ |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR |
H3N97 Y012865 U8438AA |
Urticaria; Urticaria; Urticaria
Urticaria; Urticaria; Urticaria
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The patient received the first dose for Hepatitis A, Menquadfi, and HPV on 6/9/2025. The patient wok...
The patient received the first dose for Hepatitis A, Menquadfi, and HPV on 6/9/2025. The patient woke up the next morning and saw that hives appeared on both arms. The patient denies taking any medications when he saw the hives. The patient's father reports that this is the first time his son has had a reaction after receiving vaccines.
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