| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2854918 | 54 | F | 08/20/2025 |
COVID19 |
MODERNA |
|
Depressed mood, Feeling abnormal, Pyrexia, Tremor
Depressed mood, Feeling abnormal, Pyrexia, Tremor
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shaking; felt awful and didn't get out of bed; pretty down; feeling feverish; This spontaneous ...
shaking; felt awful and didn't get out of bed; pretty down; feeling feverish; This spontaneous case was reported by a pharmacist and describes the occurrence of TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Pulmonary disorder. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish). In 2024, TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish) had resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient not had other vaccines within the past 4 weeks. The patient was felt feverish, shaky and pretty down for 17 hours. She felt awful and didn't get out of bed but then was back normal. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
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| 2854919 | 64 | F | TX | 08/20/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0162 EW0162 EW0162 |
Abdominal neoplasm, Biopsy, Biopsy lung, Borrelia test, Colonoscopy; HIV test, L...
Abdominal neoplasm, Biopsy, Biopsy lung, Borrelia test, Colonoscopy; HIV test, Limb mass, Lymphadenopathy, Lymphoma, Neoplasm; Polyp, Positron emission tomogram, Pulmonary mass, Skin discolouration
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have a dark color/On the back side of left thigh it has been dark since the front one was surgically...
have a dark color/On the back side of left thigh it has been dark since the front one was surgically removed; two polyps; same lump in the left side left lung; several very large lumps +6 inches diameter/lump on left thigh, on backside and frontside; few large lumps like 6 inch in diameter/third one is on right side, lower rib cage; few large lumps like 6 inch in diameter/Fourth one is in middle of spine, on her back; few large lumps like 6 inch in diameter that were now into lymph node areas; lymphoma; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID. A 64-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EW0162) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "allergies/Allergy" (unspecified if ongoing); "bones" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral taken for blood cholesterol abnormal, stop date: 2023; LEVOTHYROXIN oral taken for thyroid disorder, stop date: 2023; MONTELUKAST oral taken for drug hypersensitivity, stop date: 2023; CETIRIZINE oral taken for drug hypersensitivity (ongoing); IBANDRONATE SODIUM oral taken for bone disorder, stop date: 2023. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6204, left arm), administration date: 18Mar2021, when the patient was 64-year-old, for Covid-19 immunization. At the end of Apr2021, the patient experienced lumps that were not painful at first and now they were painful. She have several very large lumps +6 inches diameter following receiving the Pfizer covid vaccine. She had few large lumps like 6 inch in diameter that were now into lymph node areas. They have a dark color and now have burning pain. They are also located on backside of left thigh, hamstring. The next one is on left side of the left thigh. Third one is on right side, lower rib cage. Fourth one is in middle of spine, on her back. She also had, two previous ones on left leg front side of thigh lump and these were biopsied and surgically removed. One had two punch biopsied and one surgically removed. On the back side of left thigh, it has been dark since the front one was surgically removed. The patient also have same lump in the left side left lung. She can no longer sleep on her right side. These were burning pain in large lump. As per patient's husband, this seems this is a very serious issue. She has never had lumps before. This was all after the covid shot. She saw the doctor about the lumps in May2022 or Jun2022. She was then sent to her the surgeon in Jun2022 who did original bunch biopsy on one of the lumps. It was inconclusive. She was then sent to a dermatologist who did the second punch biopsy on the same lump. Those results were inconclusive. She was then sent to oncology and oncology ordered the Pet Scan. As a result of the Pet Scan, she was sent to a surgeon who surgically removed the entire second lump on 25Jan2023. The lump was sent and came back like it was lymphoma, or looks like lymphoma. This was during the holiday period of 2022 into 2023. She went through hell for a month and a half waiting for results. Then she got results back like it was not lymphoma, but they do not know what it is. She was sent back to her physician. The patient underwent the following laboratory tests and procedures: Biopsy: (2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; (Jun2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; Biopsy lung: (unspecified date) Unknown results; Borrelia test: (09May2023) negative; Colonoscopy: (21Dec2022) Unknown results; HIV test: (unspecified date) Unknown results; Positron emission tomogram: (08Dec2022) was lit up. On 21Dec2022, patient had removed two polyps. Patient mentioned has a lot of paperwork regarding testing that has occurred. Her doctor was going to send her to a place where test for communicable diseases. They've been to six different physicians and nothing. They have been referring the patient to different physicians and neither one knew what it was. They have run her through so many different test, biopsies, and they scared the mess out of her thinking she had lymphoma. They do not know what it was. After all the test done, they still did not know what it was, what to test for, or what to do. She was told certainly she was not the only one that has these lumps. The patient would like to know what to do or any information about these lumps. Recently, she has been having pain. The lumps were not painful at first. It was just an ugly eye sore. However, now within the last two weeks lumps are painful. The lump on right now, the lump on right rib cage, it is big now. She can no longer tolerate pressure on it. When sleeping, she cannot turn on that side to sleep. It is very painful. After 2.5 years will go ahead and made appointment with doctor will be seeing her doctor on 27Aug2025 at 15:30. Outcome of the darkened skin and polyp was unknown while of the remaining events was not recovered.
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| 2854920 | M | 08/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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tested positive for the covid spike protein which is very high; tested positive for the covid spike ...
tested positive for the covid spike protein which is very high; tested positive for the covid spike protein which is very high; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for the covid spike protein which is very high". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2854921 | 67 | F | SC | 08/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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came down with COVID/had the flu or something/at home tests, and they both came back positive, and t...
came down with COVID/had the flu or something/at home tests, and they both came back positive, and then I had the razor blade sensation in my throat; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Aug2025 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary DOSE SERIES complete (had the Pfizer vaccine in the past and never had a problem)), for COVID-19 immunization, reaction(s): "No adverse reaction ". The following information was reported: COVID-19 (non-serious) with onset 12Aug2025, outcome "unknown", described as "came down with COVID/had the flu or something/at home tests, and they both came back positive, and then I had the razor blade sensation in my throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Clinical course: During an inbound call for additional information regarding eligibility, the patient stated, I was calling regarding a conversation that I had last Friday with a representative from Pfizer regarding the Paxlovid antiviral medication. Later, she stated she received the COVID booster on August 9, and on August 12, this past Tuesday, I came down with COVID. So I was kind of shocked to have that happen to me because I had the Pfizer vaccine in the past and never had a problem. This is the first time I've had COVID ever after confirming she had the booster and then came down with COVID, she stated, "Yeah. 3 days later, she came down with COVID, the Nimbus variant. I was kind of shocked. I thought maybe I had the flu or something, but then I did 2 at home tests, and they both came back positive, and then I had the razor blade sensation in my throat. The severe sore throat, and I looked up the information online, and they said there was a variation called the Nimbus variant. Have you ever heard of anybody getting COVID after they had the vaccine. Later, she stated, she have received like many Pfizer vaccines over the years, and she was totally in shock that 3 days later, after she got the current booster shot, she came down with COVID. So she was not expecting that at all. The information on the batch/lot number for BNT162b2 omicron (kp.2), BNT162b2 will be requested and submitted if and when received.
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| 2854922 | F | 08/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthma, Cerebral infarction, Cerebrovascular accident, Pain in extremity
Asthma, Cerebral infarction, Cerebrovascular accident, Pain in extremity
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multiple strokes; inoperable brain blockage; asthma; a bit of arm pain after vaccines; This is a spo...
multiple strokes; inoperable brain blockage; asthma; a bit of arm pain after vaccines; 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)), 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 (has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years. Unknown dose number, Unknown manufacturer.), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "not recovered", described as "multiple strokes"; CEREBRAL INFARCTION (medically significant), outcome "not recovered", described as "inoperable brain blockage"; ASTHMA (non-serious), outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "a bit of arm pain after vaccines". Therapeutic measures were taken as a result of cerebrovascular accident, cerebral infarction, asthma. Clinical information: On 18Aug2025, it was reported that caller stated patient had multiple strokes, had an inoperable brain blockage and asthma. Patient was taking multiple medications for her conditions and has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years, caller indicated a bit of arm pain after vaccines. Created AE due to existing conditions as well as interaction with other medications. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events Stroke and Brain infarction are considered unrelated to the suspect drug, as it is explained by an alternative mechanism unrelated to the pharmacological action of the drug. 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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| 2854932 | F | VA | 08/20/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Influenza like illness, Lymphadenopathy
Influenza like illness, Lymphadenopathy
|
Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Oth...
Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Other HCP. A female patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization, reaction(s): "Generic flu like symptoms", "lymph node enlargement". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Generic flu like symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node enlargement". Additional Information: Clarified today, 18Aug2025, is day caller made aware of adverse events. Clarified, there were 2 different side effects. Lymph node enlargement: When caller asked when this side effect started, caller states, there were 2 side effects, reporter was saying to caller, that would usually occur every time she got Covid vaccine, back in 2021, 2022, 2023. That is what reporter is guessing. This occurred when getting 2 dose primary series, occurring both with first and second doses. The lymph node enlargement required her to get a mammogram, and lasted about 6 months. Generic flu like symptoms: Clarified second side effect as, just generic flu like symptoms, lasted about 4 days. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2854933 | M | 08/20/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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he got Covid after getting the Covid-19 vaccine 2 weeks ago; he got Covid after getting the Covid-19...
he got Covid after getting the Covid-19 vaccine 2 weeks ago; he got Covid after getting the Covid-19 vaccine 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2025 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 Aug2025, outcome "unknown" and all described as "he got Covid after getting the Covid-19 vaccine 2 weeks ago". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2854934 | 11 | F | SD | 08/20/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
LN75D CX4HL |
Blindness, Dizziness, Hyperhidrosis, Hyperventilation, Syncope; Blindness, Dizzi...
Blindness, Dizziness, Hyperhidrosis, Hyperventilation, Syncope; Blindness, Dizziness, Hyperhidrosis, Hyperventilation, Syncope
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Within one minute after receiving the shot child complained she could not see, became diaphoretic, h...
Within one minute after receiving the shot child complained she could not see, became diaphoretic, hyperventilating and fainted. She revived within 15 seconds when nurse pulled her up in the chair but continued to report she could not see. She was placed on the ground with her legs elevated, vitals were started and she reported she could see again. I clarified the visual disturbance appeared that when she became light headed, her vision went gray then she fainted. This child's sibling who is 2 years older has fainting syndrome. Vitals stabilized, she was moved to a siting position then placed back in the chair. She became dizzy with each position change but stabilized before the next position change. After 20 minutes of stability she was allowed to leave with her parent. This family has no Primary Care Provider, No report was sent for that reason. I contacted the parent that night, mom reported child was doing well. I contacted mom again on 8/1/25 mom again responded child is doing well, I confirmed they had no PCP, I encouraged her to go to urgent care or the ER if she had concerns regarding the child from this incident. This was possibly a fainting syndrome reaction.
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| 2854935 | 60 | M | PA | 08/20/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
3F7A5 |
Electrocardiogram normal, Fatigue, Musculoskeletal chest pain, Pain
Electrocardiogram normal, Fatigue, Musculoskeletal chest pain, Pain
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PATIENT RECEIVED VACCINE FRIDAY AFTERNOON. AT TIME OF VACCINE AND PRIOR PHONE CALL HE SEEMED NERVOUS...
PATIENT RECEIVED VACCINE FRIDAY AFTERNOON. AT TIME OF VACCINE AND PRIOR PHONE CALL HE SEEMED NERVOUS ABOUT POTENTIAL SIDE EFFECTS BECAUSE HE HAD EXTREMELY SORE ARM AFTER RSV. WE HAD THE OPINION THAT HE MAY HAVE BEEN MENTALLY COMPROMISED DUE TO SPEECH AND BEHAVIOR. HE SAID HE FELT FINE FRIDAY BUT WOKE UP SATURDAY FEELING LOUSY(TIRED, ACHEY AND HAD CHEST PAIN) IN SPEAKING WITH ER THEY NOTED FLU VACCINE ADMINISTERED BUT DID NOT LINK CHESTWALL PAIN SPECIFICALLY TO FLU VACCINE. PATIENT HAS RECEIVED ANNUAL FLU SHOTS FOR MULTIPLE YEARS
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| 2854936 | 0.67 | M | CA | 08/20/2025 |
DTPPVHBHPB MMR PNC20 VARCEL |
MSP VACCINE COMPANY MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
U7829AA Y011709 MF0425 Z004245 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
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No adverse events, Reporting wrong vaccines administered.
No adverse events, Reporting wrong vaccines administered.
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| 2854937 | 77 | F | MO | 08/20/2025 |
RSV TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
934fz 37r35 55kbp |
Vaccination site bruising; Vaccination site bruising; Vaccination site bruising
Vaccination site bruising; Vaccination site bruising; Vaccination site bruising
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Patient self reports bruising of vaccination site on left deltoid 08/20/25.
Patient self reports bruising of vaccination site on left deltoid 08/20/25.
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| 2854938 | 78 | M | GA | 08/20/2025 |
FLU3 UNK |
SANOFI PASTEUR UNKNOWN MANUFACTURER |
u8800aa y019158 |
Erythema; Erythema
Erythema; Erythema
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patient came into pharmacy and showed us that his lower arm was red. it wasnt itchy, swollen, or hot...
patient came into pharmacy and showed us that his lower arm was red. it wasnt itchy, swollen, or hot to the touch though. he wondered if the redness couldve been caused by the vaccines. the pharmacist said to take a bendaryl or use benadryl cream if it became itchy or swollen and to contact his doctor.
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| 2854939 | 11 | M | AR | 08/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
Rash maculo-papular
Rash maculo-papular
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Diffuse maculopapular rash on entire body; no medical management as what not particularly bothersome...
Diffuse maculopapular rash on entire body; no medical management as what not particularly bothersome to patient. Rash began 24 hours after injection and has persisted from 4-5 days following. Rash does seem to be improving.
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| 2854940 | 51 | F | CA | 08/20/2025 |
HEP HEP TDAP TDAP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR SANOFI PASTEUR |
946907 946907 U8503AA U8503AA |
Arthralgia, Injection site bruising, Injection site discolouration, Injection si...
Arthralgia, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pruritus; Injection site swelling, Injection site warmth, Rash, Soft tissue infection; Arthralgia, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pruritus; Injection site swelling, Injection site warmth, Rash, Soft tissue infection
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Edema Patient stated, her right deltoid has been swollen, red and itchy. These symptoms developed ...
Edema Patient stated, her right deltoid has been swollen, red and itchy. These symptoms developed 8/16/2025 after she received the Tdap and Hep B. Tdap given in the right deltoid. patient noting shoulder pain since getting two vaccines, noting heat, skin color changes with redness and bruising, admits some itching of injection site. Patient states there is a circular rash encompassing the entire shoulder. She denies fever, denies pain with movement, admits pain when sleeping on the arm. Patient experiencing soft tissue infection after vaccine administration. Prescription of sulfamethoxazole-trimethoprim 800-160 mg sent to patient pharmacy . Patient has f/u scheduled 8/26/25
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| 2854942 | 27 | M | AZ | 08/20/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2ng23 |
Syncope
Syncope
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I gave the tetanus shot in the left arm and then proceeded to administer the flu shot in the Right a...
I gave the tetanus shot in the left arm and then proceeded to administer the flu shot in the Right arm. After injecting the flu shot, the patient said" I think you hit a nerve" He fainted. In 2 minutes, he woke up. I gave him orange juice, and water and an ice pack for his neck because he warm to the touch.
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| 2854943 | 68 | F | FL | 08/20/2025 |
PNC20 |
PFIZER\WYETH |
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Extra dose administered
Extra dose administered
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Vaccine was given after patient had already had vaccination on 10/07/2023
Vaccine was given after patient had already had vaccination on 10/07/2023
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| 2854944 | 59 | M | TX | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
p5f7t |
Extra dose administered
Extra dose administered
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patient unknowingly received third dose for shingles vaccine
patient unknowingly received third dose for shingles vaccine
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| 2854945 | 12 | F | NC | 08/20/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y013818 U8573AA U8252AA |
Asthenia, Dizziness, Headache, Loss of consciousness, Pallor; Asthenia, Dizzines...
Asthenia, Dizziness, Headache, Loss of consciousness, Pallor; Asthenia, Dizziness, Headache, Loss of consciousness, Pallor; Asthenia, Dizziness, Headache, Loss of consciousness, Pallor
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After giving vaccines around 3 pm, the patient sat for about 5-10 minutes, but when got up to leave ...
After giving vaccines around 3 pm, the patient sat for about 5-10 minutes, but when got up to leave when she started to pass out when mom and sister caught her and lowered her to the floor. On assessment, the patient had passed out but then regained consciousness and was pale, weak, and reported dizziness/headache. Mom reports the patient did not eat since breakfast and that she didn't eat much for breakfast. See the following for notes on the patient's care: -3:10 pm: BP- 86/58, HR 53, RR 16, O2 98% on RA, A&Ox3 but unaware of where she is. -3:15 pm: blood sugar in clinic 174 -3:25 pm: 24 gauge IV started on left AC. 500 mL's of fluids started when ended at 4:00 pm. Patient a&o x 4, weak and pale -3:30 pm: BP 99/66, HR 64, 100% on RA, RR 18 -3:45 pm: BP 107/71, HR 65, 100% on RA, RR 18 -4:00 pm: BP 114/77, HR 80, 100% on RA, RR 18, patient sitting up, feeling better, a&o x 4. Fluids finished. -4:10 pm: BP 106/72, HR 78, 100% on RA, RR 18, patient sitting up, chatting with cousin, A&O x 4. NAD noted. Safe for discharge at this time. This provider walked the patient to the car, the patient tolerated well w/o dizziness. Instructed patient to eat when she gets home and to rest. Return to clinic if new symptoms develop or if symptoms worsen tonight, go to ER.
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| 2854946 | 37 | M | NY | 08/20/2025 |
TYP |
SANOFI PASTEUR |
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Arthralgia, Arthritis reactive, Joint swelling
Arthralgia, Arthritis reactive, Joint swelling
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Reactive arthritis (pain and swelling in right knee)
Reactive arthritis (pain and swelling in right knee)
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| 2854947 | 82 | M | NV | 08/20/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
K73J3 |
Extra dose administered
Extra dose administered
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GAVE PATIENT RSV SHOT AND IT WAS DISCOVERED PATIENT GOT RSV IN 9/2023
GAVE PATIENT RSV SHOT AND IT WAS DISCOVERED PATIENT GOT RSV IN 9/2023
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| 2854646 | 0.75 | F | NC | 08/19/2025 |
IPV |
SANOFI PASTEUR |
X1C891M |
Exposure via breast milk
Exposure via breast milk
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administered 0.1ml of ipol intradermally rather than intramuscularly to a nursing mother with no rep...
administered 0.1ml of ipol intradermally rather than intramuscularly to a nursing mother with no reported ae; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9-month-old female patient and is reported administered 0.1ml of IPV (VERO) [IPOL] intradermally rather than intramuscularly to a nursing mother with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the nursing patient received a 0.1 ml dose of suspect IPV (VERO) Suspension for injection of lot X1C891M and expiry date: 31-Oct-2026 via intradermally rather than intramuscularly in unknown administration site for Immunization with no reported ae (exposure via breast milk) (latency: on same day). Reportedly, HCP mentioned that she is unsure if the mother is nursed after getting the IPOL. She is inquiring about the side effects, reactions, and adverse events that they should watch out for and the effects to the child of a nursing mother administered with IPOL. Action taken was not applicable.
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| 2854647 | NY | 08/19/2025 |
IPV |
UNKNOWN MANUFACTURER |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient was given 2 doses of ipv with no reported ae; Initial information received on 15-Aug-2025 re...
patient was given 2 doses of ipv with no reported ae; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who was given 2 doses of Poliomyelitis Vaccine (Inactivated) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj, Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediacel) for Immunisation. On an unknown date, the patient received 2DF (dosage form) of suspect Poliomyelitis Vaccine (Inactivated), produced by unknown manufacturer, (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site, with no reported adverse event (extra dose administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, Nurse calling for a patient that received extra doses of IPV. Patient was first given Pediacel then was given 2 doses of IPV. 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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| 2854658 | 27 | F | CA | 08/19/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Bone pain, Butterfly rash, Lymphadenopathy, Systemic lupus erythemat...
Arthralgia, Bone pain, Butterfly rash, Lymphadenopathy, Systemic lupus erythematosus
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At time of second vaccination in January 2021, I had extreme bone pain in forearms, thigh bones, and...
At time of second vaccination in January 2021, I had extreme bone pain in forearms, thigh bones, and hips. My lymph nodes later enlarged and stayed swollen for months. About 1 year later I developed severe joint pain in multiple joints with a red butterfly rash. 5 years later and I have been diagnosed with SLE.
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| 2854663 | 44 | M | 08/19/2025 |
TDAP |
UNKNOWN MANUFACTURER |
H4279 |
Pain in extremity, Swelling
Pain in extremity, Swelling
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Sore arm; Swelling; This non-serious case was reported by a other health professional and described ...
Sore arm; Swelling; This non-serious case was reported by a other health professional and described the occurrence of pain in arm in a 44-year-old male patient who received DTPa (Reduced antigen) (dTpa vaccine) (batch number H4279) for prophylaxis. On 21-JUL-2025, the patient received dTpa vaccine (intramuscular) .5 ml. On 21-JUL-2025, less than a day after receiving dTpa vaccine, the patient experienced pain in arm (Verbatim: Sore arm) and swelling (Verbatim: Swelling). The outcome of the pain in arm and swelling were not resolved. It was unknown if the reporter considered the pain in arm and swelling to be related to dTpa vaccine. It was unknown if the company considered the pain in arm and swelling to be related to dTpa vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 The patient experienced sore arm and swelling. The adverse events were treated. On 08-AUG-2025 the adverse events were ongoing.
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| 2854664 | 3 | M | 08/19/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5H773 |
Expired product administered
Expired product administered
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Expired dose administered; This non-serious case was reported by a other health professional via ca...
Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On 31-JUL-2025, the patient received Infanrix. On 31-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-AUG-2025 A patient received a dose of Infanrix that had expired back in 13-Jul-2025 which led to expired vaccine used. The dose was given to patient on 31-Jul-2025 No further details provided.
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| 2854665 | 30 | F | 08/19/2025 |
TDAP |
SANOFI PASTEUR |
48620AA |
No adverse event, Product storage error
No adverse event, Product storage error
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patient received ADACEL which was exposed to temperature excursion because fridge temperature was ou...
patient received ADACEL which was exposed to temperature excursion because fridge temperature was out of range with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 30 years old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was exposed to temperature excursion because fridge temperature was out of range 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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength, dose unknown) lot 48620AA expiry date-31-Aug-2027 via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) which was exposed to temperature excursion because fridge temperature was out of range with no reported adverse event (poor quality product administered) (same day latency). Action taken-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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| 2854666 | 44 | MO | 08/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Exposure to communicable disease, No adverse event, Off label use
Exposure to communicable disease, No adverse event, Off label use
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Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis for Contact wi...
Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis for Contact with and suspected exposure to unspecified communicable disease, with no reported adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 44 years old and unknown gender patient who was prescribed Ipv (Vero) [Imovax] with off label diagnosis for contact with and suspected exposure to unspecified communicable disease, with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed 1DF (dosage form) of suspect IPV (Vero), Powder for solution for injection, (Frequency 4 times) (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for Contact with and (suspected) exposure to unspecified communicable (Exposure to communicable disease), with no reported adverse event (off label use). Action taken was not applicable.
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| 2854667 | 29 | F | IN | 08/19/2025 |
TDAP |
SANOFI PASTEUR |
48620AA |
Product storage error
Product storage error
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patient received ADACEL which was exposed to temperature excursion because fridge temperature was ou...
patient received ADACEL which was exposed to temperature excursion because fridge temperature was out of range with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional, this case become valid on 06-AUG-2025. This case was linked to US-SA-2025SA238019 (cluster case) This case involves a 29 years old female patient (157 cm and 105.23 kg) who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was exposed to temperature excursion because fridge temperature was out of range 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 dose of Suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 48620AA and expiry date 31-Aug-2027 via unknown route in unknown administration site for prophylactic vaccination (immunisation), which was exposed to temperature excursion because fridge temperature was out of range with no reported adverse event (poor quality product administered). 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. Additional information was received on 06-Aug-2025 from Other Health Professional: Case was upgraded from non-valid to valid and patient information was added, batch lot and expiry date added, event verbatim updated, narrative amended accordingly.; Sender's Comments: US-SA-2025SA238019:
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| 2854668 | 56 | F | NC | 08/19/2025 |
YF |
SANOFI PASTEUR |
UK117AA |
Rash erythematous, Rash papular
Rash erythematous, Rash papular
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mild, raised, red area about 5 cm x 3.5 cm in size; mild, raised, red area about 5 cm x 3.5 cm in si...
mild, raised, red area about 5 cm x 3.5 cm in size; mild, raised, red area about 5 cm x 3.5 cm in size; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 56 years old female patient who had mild, raised, red area about 5 cm x 3.5 cm in size after receiving Yellow Fever Vaccine - [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Aug-2025, the patient received 0.5 ml dose of suspect Yellow Fever Vaccine - Solution for injection, lot UK117AA, expiry date:30-Sep-2025, strength: standard, frequency: once, via subcutaneous route in the right upper arm for immunisation. On 06-Aug-2025 the patient had mild, raised, red area about 5 cm x 3.5 cm in size (vaccination site swelling) (vaccination site erythema) (latency: same day). Reportedly, The area was not tender. The patient does not feel badly. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events.
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| 2854669 | 11 | F | TN | 08/19/2025 |
DTAP |
SANOFI PASTEUR |
2CA77C1 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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DAPTACEL was administered to an 11 years 11 months patient by accident with no reported adverse even...
DAPTACEL was administered to an 11 years 11 months patient by accident with no reported adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years and 11 months old female patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] by accident with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 07-Jan-2025, the patient received 0.5mL dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength Standard, lot 2CA77C1 and expiry date 30-Apr-2025 via intramuscular route in Arm NOS (not otherwise specified) for immunization, by accident with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). Reportedly, Daptacel was administered to an 11 year old patient by accident on January and they wanted to know if the patient was still supposed to get a TDap booster or if there is a wait booster between the vaccines. HCP (Health care professional) mentioned that they were to use Adacel for the booster. 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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| 2854670 | 0.33 | AZ | 08/19/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK196AAN |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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only administered the DTAP/POLIO portion and not the HIB component with no reported adverse event; I...
only administered the DTAP/POLIO portion and not the HIB component with no reported adverse event; Initial information received on 14-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old patient with unknown gender who was only administered to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] with the dtap/polio portion and not the hib component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) and rotavirus vaccine for Immunisation. On 14-Aug-2025, the patient received 0.5mL (frequency once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK196AAN, expiry date 31-MAR-2026, strength not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and was administered the dtap/polio portion and not the hib component with no reported adverse event (product preparation issue). Reportedly, they wanted to know if they can use a sterile diluent to mix with HIB to give the remainder of that combination vaccine. Concomitnat- rotavax. 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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| 2854671 | 29 | M | NJ | 08/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Aspiration, Cardiac assistance device user, Endotracheal intubation, Fatigue, Im...
Aspiration, Cardiac assistance device user, Endotracheal intubation, Fatigue, Impaired driving ability; Impaired work ability, Resuscitation, Sudden cardiac death
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Listed in first page of this form, I suffered a life changing cardiac episode.
Listed in first page of this form, I suffered a life changing cardiac episode.
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โ | โ | โ | |||
| 2854708 | 40 | F | CT | 08/19/2025 |
DTAP |
SANOFI PASTEUR |
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Rash
Rash
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Approximately one week after receiving vaccine rash started to cover body, starting with feet and pr...
Approximately one week after receiving vaccine rash started to cover body, starting with feet and progressing to trunk, legs, arms, hands, and torso. The rash grew together until the separate bumps connected and looked like an itchy, giant sunburn. Took prednisone roughly 48-72 hours after going to walk in. Resolved in a few days. Had similar reaction apprx 10 years ago a week after receiving TDAP booster. Took no medication to reduce it. Rash lasted 2 weeks before resolving.
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| 2854709 | 76 | F | PA | 08/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Chills, Vomiting
Chills, Vomiting
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Had chills and then vomiting.
Had chills and then vomiting.
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| 2854710 | 11 | M | PA | 08/19/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8562AA 9JT4S |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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Mother report that patient had passed out after his vaccines when he stood up. Provider examined pat...
Mother report that patient had passed out after his vaccines when he stood up. Provider examined patient after incident and released him.
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| 2854711 | 1 | M | TX | 08/19/2025 |
DTPPVHBHPB HEPA MMR PNC20 VARCEL |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
U8335AA L4EA4 Y013130 LN4928 Y020586 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered
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Medical assistant administered Vaxelis instead of Varivax.
Medical assistant administered Vaxelis instead of Varivax.
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| 2854712 | 76 | F | AL | 08/19/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
JB27A JB27A |
Pain, Pain in extremity, Peripheral swelling, Rash, Rash erythematous; Skin warm
Pain, Pain in extremity, Peripheral swelling, Rash, Rash erythematous; Skin warm
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Patient reported having adverse side effects the same night and more the next morning of having a ho...
Patient reported having adverse side effects the same night and more the next morning of having a hot red rash, swelling, and sharp radiating pain down her arm that felt like a bee sting. Patient came to the pharmacy several days later reporting same symptoms and still had hot red rash that was swollen with pain. Told patient to immediately call doctor and let them assess her arm. She did not recall how low the vaccine was given and she had a preexisting "bad shoulder" on the arm that she had received it.
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| 2854713 | 56 | M | VT | 08/19/2025 |
PNC20 |
PFIZER\WYETH |
LN4932 |
Erythema, Injection site warmth, Skin warm, Tenderness
Erythema, Injection site warmth, Skin warm, Tenderness
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Vaccine administered 8/5/25. Confirmed he has redness, warmth and tenderness for 8 days,. No fever, ...
Vaccine administered 8/5/25. Confirmed he has redness, warmth and tenderness for 8 days,. No fever, no weak/ness. Injection site describes as hard to touch for first 4-6. Spoke to pt days. Pt did not take any NSAIDS or tyl. Contacted pcp office 8/11. Call returned 8/14, left message. Spoke to pt to confirm sxs 8/19
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| 2854714 | 41 | M | ME | 08/19/2025 |
MENB |
PFIZER\WYETH |
GP8622 |
No adverse event
No adverse event
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Patient reports no adverse reactions.
Patient reports no adverse reactions.
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| 2854715 | 66 | F | VA | 08/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site pain, Injection site pruritus, Injection site reaction, Injection...
Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
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Red rash distal to injection site, warm and tender. Worst on Monday, still warm and tender on Tuesda...
Red rash distal to injection site, warm and tender. Worst on Monday, still warm and tender on Tuesday. Now starting to itch intermittently.
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| 2854716 | 1 | M | ID | 08/19/2025 |
HEPA MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
y011731 y008284 x026325 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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I collected (what I thought was MMR) vaccine from the blue MMR box in the fridge. I verified the exp...
I collected (what I thought was MMR) vaccine from the blue MMR box in the fridge. I verified the expiration date and noted the Measles, Mumps, Rubella on the label. I did not notice the Varicella until I was documenting. I rechecked the fridge and the box was still there with 1 additional dose of ProQuad. Vaccine was removed from fridge and taken to CA. Immunization Dept, Supervisor and PCP notified. Mother was notified via phone call.
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| 2854717 | 74 | F | AL | 08/19/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
U8764BB LP4947 |
Extra dose administered, Injection site bruising, Injection site discomfort; Ext...
Extra dose administered, Injection site bruising, Injection site discomfort; Extra dose administered, Injection site bruising, Injection site discomfort
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Administration error regarding Prevnar 20. Patient received Prevnar 20 on 11/28/23. An additional do...
Administration error regarding Prevnar 20. Patient received Prevnar 20 on 11/28/23. An additional dose of Prevnar 20 was administered on 08/15/2025. Patient stated she experienced some discomfort and bruising at the injection site that has since improved. No further issues post administration.
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| 2854719 | 57 | M | 08/19/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
BM20A 036A21A |
Blindness unilateral, Central serous chorioretinopathy, Dermatitis, Eczema, Fluo...
Blindness unilateral, Central serous chorioretinopathy, Dermatitis, Eczema, Fluorescence angiogram; Blindness unilateral, Central serous chorioretinopathy, Dermatitis, Eczema, Fluorescence angiogram
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Loss of vision right eye. Central Serous Retinopathy. No treatment available. Severe Eczema, derm...
Loss of vision right eye. Central Serous Retinopathy. No treatment available. Severe Eczema, dermatitis. Taking Rinvoq daily indefinitely.
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| 2854720 | 62 | F | 08/19/2025 |
RSV |
PFIZER\WYETH |
LL8391 |
Contusion, Influenza like illness, Pain in extremity, Peripheral swelling, Pyrex...
Contusion, Influenza like illness, Pain in extremity, Peripheral swelling, Pyrexia
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Arm pain and swelling followed by bruising. Fever for 3 days and flu like symptoms
Arm pain and swelling followed by bruising. Fever for 3 days and flu like symptoms
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| 2854721 | 68 | F | OH | 08/19/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Headache, Myalgia, Pyrexia
Chills, Headache, Myalgia, Pyrexia
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Fever 103.4, headache, muscle aches, rigors,
Fever 103.4, headache, muscle aches, rigors,
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| 2854722 | 3 | M | CA | 08/19/2025 |
IPV MMR |
SANOFI PASTEUR MERCK & CO. INC. |
Y1A212M Y018703 |
Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria
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Per mother, patient received 2 vaccines on 8/7/25. When he woke up on 8/9/25, he was covered in &quo...
Per mother, patient received 2 vaccines on 8/7/25. When he woke up on 8/9/25, he was covered in "hives" on his whole body (mouth, chest, stomach, neck), the rash was not itchy and she denied fever at that time. She administered oral Claritin and applied Benadryl topical cream. She stated this would initially help and the "patches" would go away but then come back a few hours later; the rash lasted about 3 days.
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| 2854723 | 31 | F | AK | 08/19/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y015108 Y015108 |
Fatigue, Hyperhidrosis, Injection site erythema, Injection site swelling, Oropha...
Fatigue, Hyperhidrosis, Injection site erythema, Injection site swelling, Oropharyngeal pain; Rash, Rash erythematous, Rash papular, Rash pruritic, Yellow skin
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Report was received today 8/19/25. Starting on 8/16/25 the patient reports fatigue and a red raised...
Report was received today 8/19/25. Starting on 8/16/25 the patient reports fatigue and a red raised spot at vaccine injection site. On 8/18/25 the patient reports she developed red raised spots to back, umbilicus, neck, arm; states spots are itchy, raised, and red but not scabbed, yellowish underneath "like a pimple". She also reports sore throat and sweaty today but no measured fever. Instructed by Dr. that patient should monitor and call back with worsening. Monitoring is ongoing at this time.
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| 2854724 | 3 | M | CA | 08/19/2025 |
IPV MMR |
SANOFI PASTEUR MERCK & CO. INC. |
Y1A212M Y018703 |
Pyrexia, Rash, Urticaria; Pyrexia, Rash, Urticaria
Pyrexia, Rash, Urticaria; Pyrexia, Rash, Urticaria
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Per mother, patient received 2 vaccines on 8/7/2025. When he woke up on 8/10/25 and he developed &qu...
Per mother, patient received 2 vaccines on 8/7/2025. When he woke up on 8/10/25 and he developed "hives" on his body (neck, chest, face), the rash was not itchy and she denied fever at that time. She administered oral Claritin and applied Benadryl topical cream. She stated this would initially help and the "patches" would go away but then come back a few hours later; the rash lasted about 3 days. Mother also reported a fever of 103 on 8/15/25.
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| 2854725 | 26 | M | PA | 08/19/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Asthenia, Blood test normal, HIV test negative, Lumbar puncture normal, Magnetic...
Asthenia, Blood test normal, HIV test negative, Lumbar puncture normal, Magnetic resonance imaging normal; Muscular weakness, Paraesthesia, Sensory loss
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symptoms had tingling sensation in lower legs and he was weak. Left lower body had loss sensation up...
symptoms had tingling sensation in lower legs and he was weak. Left lower body had loss sensation up to the umbilical region. Above that was normal. All test were normal/negative. He got 3 doses of steroids for treatment. He reported improved but now is back in (withheld name) ER for lower extremity weakness. PCP will follow up with patient after discharges.
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| 2854726 | 58 | M | CA | 08/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
93KK4 |
Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Chills, Fatigue, Headache, Pain in extremity, Pyrexia
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shivering, fever, pain in arm, fatigue, headache
shivering, fever, pain in arm, fatigue, headache
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