| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2808169 | 81 | F | PA | 11/14/2024 |
HEPAB TDAP HEPAB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
D4774 9935H D4774 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
Patient received a dose of Twinrix after already completing a Hepatitis B series in 2020.
Patient received a dose of Twinrix after already completing a Hepatitis B series in 2020.
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| 2825583 | 41 | F | NM | 02/10/2025 |
MMR |
MERCK & CO. INC. |
Y000225 |
Lymphadenopathy, Oedema peripheral, Tenderness
Lymphadenopathy, Oedema peripheral, Tenderness
|
Client returned to the public health office on 02/10/2025 after receiving vaccines on 02/04/2025. Cl...
Client returned to the public health office on 02/10/2025 after receiving vaccines on 02/04/2025. Client states she may have had a reaction to vaccines due to swelling to right axilla; noticed swelling on 02/09/2025. RN examined right axilla and noted lymphadenopathy with mild pain upon palpation. Consulted with a physician, Dr. Client was instructed to keep monitoring swelling, use OTC medication as needed, and go to nearest ER if swelling or pain worsened.
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| 2825625 | 34 | F | CA | 02/10/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
235D2 |
Joint range of motion decreased, Pain in extremity, Shoulder injury related to v...
Joint range of motion decreased, Pain in extremity, Shoulder injury related to vaccine administration
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1) Left arm pain x 3 weeks, 2) Limited range of motion at left shoulder x 3 weeks, 3) Left shoulder ...
1) Left arm pain x 3 weeks, 2) Limited range of motion at left shoulder x 3 weeks, 3) Left shoulder injury related to vaccine administration (SIRVA) - Treatment: Ibuprofen as needed, heat, massage and referred to physical therapy (first appt scheduled on 2/12/25) 1-2 visits for 3-6 weeks. Outcome - improving as of 2/10/25 but not yet resolved.
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| 2825626 | 75 | M | WA | 02/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5A4H7 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Extra dose Shingrix administered 2/10/25. Received dose 1 12/9/22 and dose 2 12/9/24. No known harm ...
Extra dose Shingrix administered 2/10/25. Received dose 1 12/9/22 and dose 2 12/9/24. No known harm at this time.
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| 2825631 | F | 02/10/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FF8841 FF8841 FF8841 FF2593 FF2593 FF2593 |
Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Loss of ...
Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Loss of consciousness, Pyrexia; Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Inappropriate schedule of product administration, Loss of consciousness; Pyrexia; Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Loss of consciousness, Pyrexia; Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Inappropriate schedule of product administration, Loss of consciousness; Pyrexia
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Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; ...
Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2, on 08Oct2021 as dose 1, single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Grand-Mal Seizures/Clonic tonic seizures"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic to it"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "not conscious for much of it". The patient underwent the following laboratory tests and procedures: Body temperature: (2021) pyrexia high. Clinical details: The patient was trying to find out the full name of the Pfizer Covid 19 vaccine she got based on the lot number. She didn't know which was the one she got. She got two of them, one on 08Oct2021 and 21Oct2021. The two lots numbers were FF8841 and FF2593. Lot: FF8841, with this one she had Grand-Mal Seizures, but later clarified as Clonic Tonic Seizures. After getting it, she had grand mal seizures and a high fever. She was not conscious for much of it but said she had to get the second one. She's allergic to it. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500027976 same patient, different doses/events;
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| 2825633 | U | NJ | 02/10/2025 |
RSV |
PFIZER\WYETH |
LL8391 |
Product container issue
Product container issue
|
It cracked when drawing it from the vial, the diluent tip cracked; This is a spontaneous report rece...
It cracked when drawing it from the vial, the diluent tip cracked; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "It cracked when drawing it from the vial, the diluent tip cracked". Causality for "it cracked when drawing it from the vial, the diluent tip cracked" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: While drawing it up the tip cracked instantly. Normally this does not happen. It cracked when drawing it from the vial, the diluent tip cracked. NDC: 0069-0344-01. Abrysvo Vial Adapter: Lot number: J591, expiration date: 29Nov2028. Abrysvo Diluent Syringe: Lot number: HT4720, expiration date: Dec2026. NDC: 0069-0250-01. A sample of the product is available to be returned.
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| 2825634 | 62 | M | NY | 02/10/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8732 |
Insomnia, Pruritus
Insomnia, Pruritus
|
Sometimes I get to sleep, you know, two or three hours at a time; daily intense pruritus head to toe...
Sometimes I get to sleep, you know, two or three hours at a time; daily intense pruritus head to toe; Intense head to toe pruritus; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8732, Expiration Date: Jul2021) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Multivitamin, notes: only took a multivitamin. Vaccination history included: Flu shot (annual/every fall). The following information was reported: INSOMNIA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Sometimes I get to sleep, you know, two or three hours at a time"; PRURITUS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "daily intense pruritus head to toe; Intense head to toe pruritus". The event "daily intense pruritus head to toe; intense head to toe pruritus" required physician office visit. Therapeutic measures were taken as a result of pruritus. Additional information: The patient had multiple visits to the Physician's office in 2021 and early 2022. GP MDs and RNs prescribed various type of steroids, antihistamines and antibiotics but none resolved the AE. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient was not taking any other medication within 2 weeks prior to the event onset and did not receive any other vaccine within 4 weeks prior to first administration of the suspect product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381378 Pfizer Inc.;US-PFIZER INC-202200845402 same patient/drug, different dose;
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| 2825673 | 4 | F | AK | 02/10/2025 |
MMR |
MERCK & CO. INC. |
x004346 |
Expired product administered
Expired product administered
|
Expired 02/08/2025, administered on 02/10/2025
Expired 02/08/2025, administered on 02/10/2025
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| 2825674 | 66 | M | GA | 02/10/2025 |
FLU3 |
SEQIRUS, INC. |
|
Neuralgia, Paraesthesia
Neuralgia, Paraesthesia
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Patient reports nerve pain/ tingle in left arm shortly after getting vaccine
Patient reports nerve pain/ tingle in left arm shortly after getting vaccine
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| 2825675 | 10 | F | UT | 02/10/2025 |
HPV9 |
MERCK & CO. INC. |
7010656 |
Dizziness, Injection site rash
Dizziness, Injection site rash
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felt dizzy and had skin rash at the site of her vaccine. Monitored in office, stable vitals signs, ...
felt dizzy and had skin rash at the site of her vaccine. Monitored in office, stable vitals signs, provided with Gatorade, rash resolved, no longer dizzy.
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| 2825676 | 79 | F | UT | 02/10/2025 |
COVID19 FLU3 |
NOVAVAX SANOFI PASTEUR |
6024mf020 ut8454ea |
Eye swelling; Eye swelling
Eye swelling; Eye swelling
|
Eye swelling
Eye swelling
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| 2825677 | 82 | F | FL | 02/10/2025 |
COVID19 TDAP |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
w72dcd3hxmbx 5hcph9eywr |
Chills, Feeling cold; Chills, Feeling cold
Chills, Feeling cold; Chills, Feeling cold
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Patient wants pharmacist to report she has a bad chill-cold with her teeth was shaking for 1 days.
Patient wants pharmacist to report she has a bad chill-cold with her teeth was shaking for 1 days.
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| 2825678 | 74 | F | FL | 02/10/2025 |
FLU3 |
SEQIRUS, INC. |
388477 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given a flu shot and it was missed they had already received a flu shot in August 2024. ...
Patient was given a flu shot and it was missed they had already received a flu shot in August 2024. No adverse events occurred with patient.
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| 2825679 | 50 | F | 02/10/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Chills, Feeling of body temperature change, Injection site reaction, Pain in ext...
Chills, Feeling of body temperature change, Injection site reaction, Pain in extremity, Peripheral swelling
More
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Chills, hot and cold at injection site, swelling & pain under left arm all for 5 days
Chills, hot and cold at injection site, swelling & pain under left arm all for 5 days
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| 2825680 | 13 | F | UT | 02/10/2025 |
HPV9 |
MERCK & CO. INC. |
Y010656 |
Dizziness
Dizziness
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She felt dizzy and lightheaded after vaccines. She was watched and monitored for about 20 minutes af...
She felt dizzy and lightheaded after vaccines. She was watched and monitored for about 20 minutes after. We did give her some Gatorade and crackers while waiting and she eventually felt better.
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| 2825682 | 76 | F | FL | 02/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
She requested to receive the RSV vaccine. After administration of this vaccine, we checked her vacci...
She requested to receive the RSV vaccine. After administration of this vaccine, we checked her vaccination history and realized she had gotten vaccinated in 2023 and had forgotten to state it prior to her request. Essentially, she received 2 doses in a period of approximately 2 years span.
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| 2825683 | 76 | M | FL | 02/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
Patient requested to get vaccinated but did not remember he had received this vaccine in 2023 along ...
Patient requested to get vaccinated but did not remember he had received this vaccine in 2023 along with his wife. He stated his Dr. recommends they get it. As a result, he received 2 total doses of the RSV vaccine in a span of 2 years.
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| 2825684 | 41 | M | TX | 02/10/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ek5730 el3248 |
Eczema, Rash; Eczema, Rash
Eczema, Rash; Eczema, Rash
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eczema and skin rashes on back and legs
eczema and skin rashes on back and legs
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| 2825685 | 71 | F | CA | 02/10/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX |
6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 6024MF020 |
Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness; Lip disorde...
Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness; Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness, Osteoarthritis; X-ray abnormal; Arthralgia, Arthritis, Asthenia, Chondropathy, Condition aggravated; Fatigue, Joint stiffness, Lip disorder, Lip pain, Magnetic resonance imaging; Meniscus injury, Mobility decreased, Muscle tightness, Muscular weakness, Musculoskeletal stiffness; Myalgia, Osteoarthritis, X-ray, X-ray abnormal; Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness; Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness, Osteoarthritis; X-ray abnormal; Arthralgia, Arthritis, Asthenia, Chondropathy, Condition aggravated; Fatigue, Joint stiffness, Lip disorder, Lip pain, Magnetic resonance imaging; Meniscus injury, Mobility decreased, Muscle tightness, Muscular weakness, Musculoskeletal stiffness; Myalgia, Osteoarthritis, X-ray, X-ray abnormal
More
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Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thi...
Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
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| 2825387 | 45 | F | FL | 02/09/2025 |
HPV9 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
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Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity; ...
Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity; Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
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Pain during injection and entire arm sore after vaccine. Hard to move arm and hurts to move it.
Pain during injection and entire arm sore after vaccine. Hard to move arm and hurts to move it.
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| 2825388 | 5 | M | KY | 02/09/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site rash, Injection site warmth
Injection site erythema, Injection site rash, Injection site warmth
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. Grandmother reported child was seen yesterday 020725 at Clinic and received a TDaP and Polio Vacci...
. Grandmother reported child was seen yesterday 020725 at Clinic and received a TDaP and Polio Vaccine in his RLE/thigh. Grandmother reported that pt has developed red, warm localized rash to his Right anterior thigh that was noted this morning 020825 but has increased in size. Pt denies pain or itching. Denies F/C, N/V, mucous membrane involvement, palms/soles involvement. . Denies Swelling of face, eyes, intraoral, trouble swallowing or breathing, wheezing, cough,coryza/ intranasal mucosal membrane inflammation. . Denies potential allergens, recent travel, risk for MRSA, family/friends/close contacts with similar SXs, sharing of clothing items. . Denies known liver disease, recent jaundice appearance or alcoholism. . Denies being easily Bruised or bleeding, anemia, clots, recent transfusions.. Denies Joint pain/swelling/redness, back pain.
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| 2825389 | 40 | F | PA | 02/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Migraine, Palpitations
Migraine, Palpitations
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My heart began racing just under 24 hours after shot. I was laying down at the time yet my heart rat...
My heart began racing just under 24 hours after shot. I was laying down at the time yet my heart rate increased to 114, I tried to use some breathing techniques to bring it down and I could get it to 104. Pulsox was fine. This lasted for about an hour, other than a migraine I felt fine otherwise.
More
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| 2825390 | 76 | M | FL | 02/09/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient incorrectly received a second dose of Arexvy 1.5 years after first dose even though not clin...
Patient incorrectly received a second dose of Arexvy 1.5 years after first dose even though not clinically indicated. Patient did not report any adverse effects of the second dose.
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| 2825391 | 17 | F | MD | 02/09/2025 |
COVID19 FLU3 HEPA |
MODERNA SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
B0004 388520 5JA57 |
Eyelid rash, Pyrexia, Rash, Rash pruritic, Swelling of eyelid; Eyelid rash, Pyre...
Eyelid rash, Pyrexia, Rash, Rash pruritic, Swelling of eyelid; Eyelid rash, Pyrexia, Rash, Rash pruritic, Swelling of eyelid; Eyelid rash, Pyrexia, Rash, Rash pruritic, Swelling of eyelid
More
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Pt states that that night she started with a slight rash on her hairline as well as a fever. The fev...
Pt states that that night she started with a slight rash on her hairline as well as a fever. The fever lasted 3 days and the rash continued to spread so it is now all over her face. On day 4 her eyelids were a bit puffy - esp the L one. Applied 1% hydrocortisone cream. On day 4, rash spread to her cheeks and forehead and eyelids this AM. Rash is slightly itchy. Denies any tongue swelling/SOB. On Day 4 had congestion today and felt slightly dizzy. Took Tylenol for fever. No new foods or anything new to her face - just the 2 creams that she's been using for a while now - benzoyl peroxide and differin cream. No history of any vaccine reactions or food allergies. No rash on other parts of body. Suggested adding loratadine and continue using hydrocortisone. By day 7 rash and itching improved and loratadine and hydrocortisone was discontinued. On day 10, rash had returned but without swelling. By day 14 symptoms resolved. Past Medical History: Unremarkable
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| 2825392 | 31 | M | WA | 02/09/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL8982 EL8982 EL9262 EL9262 |
Blood pressure increased, Chills, Electrocardiogram ambulatory abnormal, Headach...
Blood pressure increased, Chills, Electrocardiogram ambulatory abnormal, Headache, Injection site pain; Myalgia, Tachycardia; Blood pressure increased, Chills, Electrocardiogram ambulatory abnormal, Headache, Injection site pain; Myalgia, Tachycardia
More
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I had severe chills, muscle soreness of injection site, muscle aches and headache 10 hours after inj...
I had severe chills, muscle soreness of injection site, muscle aches and headache 10 hours after injection. The next morning I had the same symptoms but with post vaccination tachycardia (114-123 BPM). My normal resting heart rate is 68 BPM. My smart Watch kept alerting me of an increased heart rate at rest. After receiving the alerts I checked it manually and was getting the same while checking my radial pulse. I was a firefighter/EMT and currently work in the medical field. My blood pressure was also elevated 145/97
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| 2825393 | 33 | M | TX | 02/09/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
038C21A 038C21A |
Cardiac monitoring, Costochondritis, Electrocardiogram abnormal, Heart rate irre...
Cardiac monitoring, Costochondritis, Electrocardiogram abnormal, Heart rate irregular, Hypoaesthesia; Left atrial dilatation, Skin discolouration, Tricuspid valve incompetence
More
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03 September 2021 I was in the emergency room. I was hooked up to an EKG, I had an irregular heartbe...
03 September 2021 I was in the emergency room. I was hooked up to an EKG, I had an irregular heartbeat and I had lost sense of touch in my hands (they were purple). I had costochondritis, and I was on a 6-month profile. I also was awarded a 30% disability They described it as: severely dilated left atrial cavity with trace tricuspid regurgitation of unknown etiology. I am now wearing a device for two weeks to see if I still have an irregular heartbeat from the vaccine.
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| 2825394 | 62 | M | FL | 02/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N77J2 |
Fatigue, Myalgia, Pyrexia, Urticaria
Fatigue, Myalgia, Pyrexia, Urticaria
|
Patient developed hives on face only, a fever of 100, muscle pain and exhaustion this morning after ...
Patient developed hives on face only, a fever of 100, muscle pain and exhaustion this morning after vaccination yesterday. No anaphylaxis suspected. Benadryl given as treatment of hives.
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| 2825395 | 52 | F | GA | 02/09/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Erythema, Exfoliative rash, Fatigue, Neuralgia, Pain; Rash, Swelling
Erythema, Exfoliative rash, Fatigue, Neuralgia, Pain; Rash, Swelling
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starting Friday morning felt achy and tired, starting friday night shooting nerve pain, starting sat...
starting Friday morning felt achy and tired, starting friday night shooting nerve pain, starting saturday morning, scaly rash on face with swelling and redness -- all symptoms continuing today 2/9/25
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| 2825396 | 1 | M | MA | 02/09/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash, Skin warm, Urticaria
Rash, Skin warm, Urticaria
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Patient woke up from his nap with a rash/hives on his face and neck which was at noon and noticed th...
Patient woke up from his nap with a rash/hives on his face and neck which was at noon and noticed the rash go away over time. Then when he woke up from his second nap around 4:30pm it came back again. We noticed the trend that wherever his skin was getting warm the rash would appear. Then at night patient had his bath and the hives appeared for a third time on his legs. This solidified our assumption that heat was causing the rash/hives which has never happened to patient before. After 48 hours after receiving the Hep A we didn t continue to see the adverse events return.
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| 2825397 | 68 | F | TN | 02/09/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was recommended by her nurse practitioner to get a dose of the RSV vaccine. She presented to...
Patient was recommended by her nurse practitioner to get a dose of the RSV vaccine. She presented to the pharmacy asking for the vaccination and it was provided; however she had already received the same vaccine a year earlier on 1/30/24. This is a second dose given outside of guidelines. No adverse side effects reported.
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| 2825398 | 57 | F | KS | 02/09/2025 |
FLU3 TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
33G3M M77CC 4H79Y |
Abdominal distension, Erythema, Injection site pain, Injection site warmth, Skin...
Abdominal distension, Erythema, Injection site pain, Injection site warmth, Skin lesion; Abdominal distension, Erythema, Injection site pain, Injection site warmth, Skin lesion; Abdominal distension, Erythema, Injection site pain, Injection site warmth, Skin lesion
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on 2/9/25 patient came to walk in care at clinic reporting swelling and pain in left arm where she g...
on 2/9/25 patient came to walk in care at clinic reporting swelling and pain in left arm where she got her shingrix and flu vaccinations. Provider examined the patient and documented 9x8cm erythematous lesion on left deltoid, musculoskeletal pain, warm to the touch. For treatment, patient was given 30mg/ml of Ketorolac Tromethamine solution, 1 mL, given one time, prescribed famotidine tablet 20mg tablets, take 1 tablet at bedtime as needed and fexofenadine HCl 180mg tablets, swallow whole with water orally once a day. Patient left the clinic.
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| 2825399 | 91 | F | GA | 02/09/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Injection site cellulitis
Injection site cellulitis
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Cellulitis around the injection site and down the arm
Cellulitis around the injection site and down the arm
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| 2825400 | 11 | F | 02/09/2025 |
HPV9 |
MERCK & CO. INC. |
|
Autoimmune disorder, Fatigue, Postural orthostatic tachycardia syndrome, Syncope
Autoimmune disorder, Fatigue, Postural orthostatic tachycardia syndrome, Syncope
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Fainted, started having long term auto immune disorders. Suffered from chronic fatigue and POTS. Was...
Fainted, started having long term auto immune disorders. Suffered from chronic fatigue and POTS. Was treated for several years as if auto immune. Changes to diet. Was prescribed medication to help with fainting.
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โ | ||||||
| 2825401 | 77 | F | AZ | 02/09/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Injected limb mobility decreased, Pain in extremity; Injected limb mobility decr...
Injected limb mobility decreased, Pain in extremity; Injected limb mobility decreased, Pain in extremity
More
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The pt complained about pain in both arms, she mentioned can barley lift her arms,. The pain started...
The pt complained about pain in both arms, she mentioned can barley lift her arms,. The pain started couple hours after the vaccine was administered and got worse. Pt did not take any ibuprofen or tylenol to relieve the pain. She also denied any redness or swelling
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| 2825402 | 67 | F | FL | 02/09/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
PATIENT RECIEVED ONE BOOSTRIX IN 2024 AND ANOTHER IN 2025 NOT IN ACCORDANCE WITH ACIP GUIDELINES
PATIENT RECIEVED ONE BOOSTRIX IN 2024 AND ANOTHER IN 2025 NOT IN ACCORDANCE WITH ACIP GUIDELINES
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| 2825403 | 85 | M | 02/09/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
xn575 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
PATIENT RECEIVED 1 BOOSTRIX IN 2024 AND ANOTHER IN 2025 NOT IN ACCORDANCE WITH ACIP GUIDELINES
PATIENT RECEIVED 1 BOOSTRIX IN 2024 AND ANOTHER IN 2025 NOT IN ACCORDANCE WITH ACIP GUIDELINES
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| 2825404 | 66 | M | FL | 02/09/2025 |
PNC20 |
PFIZER\WYETH |
LJ5281 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given a second dose of Prevnar 20 when only one dose is recommended. Patient not current...
Patient was given a second dose of Prevnar 20 when only one dose is recommended. Patient not currently experiencing any side effects
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| 2825405 | 60 | F | FL | 02/09/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
020F21A 020F21A 020F21A 020F21A 020F21A 020F21A 020F21A 020F21A 020F21A 020F21A 020F21A 020F21A |
Abnormal behaviour, Alanine aminotransferase increased, Ammonia decreased, Amnes...
Abnormal behaviour, Alanine aminotransferase increased, Ammonia decreased, Amnesia, Angiogram normal; Aspartate aminotransferase increased, Bilirubin urine, Blood alcohol normal, Blood culture negative, Blood glucose normal; Blood magnesium normal, Blood potassium decreased, Blood thyroid stimulating hormone decreased, Blood urea decreased, Blood urea increased; Blood urea nitrogen/creatinine ratio increased, Blood urine absent, Brain oedema, C-reactive protein increased, CSF culture negative; CSF glucose normal, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF test normal; CSF white blood cell count negative, Chest X-ray normal, Computerised tomogram head normal, Diplopia, Drug screen positive; Electroencephalogram abnormal, Epstein-Barr virus test negative, Full blood count, Fungal test negative, Glucose urine absent; Gram stain, JC polyomavirus test negative, Magnetic resonance imaging head abnormal, Mean cell volume decreased, Mental status changes; Metabolic function test, Mycobacterium test negative, Nitrite urine absent, Posterior reversible encephalopathy syndrome, Procalcitonin normal; Protein urine absent, Prothrombin time prolonged, Red blood cell count normal, Red blood cell sedimentation rate decreased, SARS-CoV-2 test negative; Specific gravity urine normal, Treponema test negative, Troponin I normal, Urine ketone body absent, Urobilinogen urine; Vision blurred, West Nile virus test negative, White blood cells urine negative, X-ray dental normal, pH urine normal
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Behavioral changes began 08/26/201, Altered mentation began 08/28/2021, Cerebral edema, blurry/ dou...
Behavioral changes began 08/26/201, Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
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| 2825432 | 38 | F | MN | 02/09/2025 |
COVID19 |
MODERNA |
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Allergy test, Food allergy, Immunisation reaction, Injection site rash
Allergy test, Food allergy, Immunisation reaction, Injection site rash
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I became infected with the Alpha Gal Syndrome (Meat Allergy). I became allergic to Beef, Pork, bovin...
I became infected with the Alpha Gal Syndrome (Meat Allergy). I became allergic to Beef, Pork, bovine, and porcine gelatin.
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| 2825433 | 35 | F | MD | 02/09/2025 |
COVID19 |
PFIZER\BIONTECH |
EN018? |
Allergy test, Blood test, Pruritus
Allergy test, Blood test, Pruritus
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Itchy palms and soles of feet for 4 years
Itchy palms and soles of feet for 4 years
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| 2825434 | 33 | F | CA | 02/09/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0161 EW0161 EW0161 EW0182 EW0182 EW0182 |
Autonomic nervous system imbalance, Brain fog, Fatigue, Gastrointestinal microor...
Autonomic nervous system imbalance, Brain fog, Fatigue, Gastrointestinal microorganism overgrowth, Impaired work ability; Influenza like illness, Insomnia, Mast cell activation syndrome, Nausea, Pain; Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome; Autonomic nervous system imbalance, Brain fog, Fatigue, Gastrointestinal microorganism overgrowth, Impaired work ability; Influenza like illness, Insomnia, Mast cell activation syndrome, Nausea, Pain; Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome
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Within a day or so of getting the vaccine I became chronically fatigued, had severe brain fog, all o...
Within a day or so of getting the vaccine I became chronically fatigued, had severe brain fog, all over body pain like a fever from the flu, had insomnia, nausea and struggled to eat foods without pain. The symptoms worsened after vaccine #2. I went to part time work in April of 2021 and had to quick working due to the illness in June of 2021. I was later diagnosed with SIBO and Mast Cell Activation Syndrome. I was later diagnosed with dysautnomia and POTS after years of disabling symptoms. Although it took years to reach these diagnosis they all began after the vaccine. After obtaining the COVID virus in August of 2024, I had a flare of symptoms again and Long COVID was confirmed by clinic.
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| 2825351 | F | 02/08/2025 |
COVID19 COVID19 COVID19 |
NOVAVAX NOVAVAX NOVAVAX |
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Biopsy peripheral nerve, Blood test, Computerised tomogram, Dysphagia, Facial pa...
Biopsy peripheral nerve, Blood test, Computerised tomogram, Dysphagia, Facial paralysis; Gait inability, Hypoaesthesia, Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging; Pain in extremity, Paraesthesia, Speech disorder
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Tingling in her fingers; Pain in the back of her legs; Lost all feelings in her hands and legs; Unab...
Tingling in her fingers; Pain in the back of her legs; Lost all feelings in her hands and legs; Unable to stand, walk, hold any objects or write; Unable to stand, walk, hold any objects or write; Lose the ability to speak; Lose the ability to...swallow; Facial muscles became paralyzed; This serious initial spontaneous safety report was received by Novavax on 03-Feb-2025 from a consumer or other non health professional via Regulatory Authority (ref. no. US-1000000476-NVAX). A 73 year-old female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 22-Nov-2024. No medical history was reported. No concomitant medications were reported. On an unspecified date in Nov-2024 (reported as "within a week of the vaccine") after vaccination the patient experienced Pain in the back of her legs(Pain in extremity)(Serious: Caused/Prolonged Hospitalization) and Tingling in her fingers(Paraesthesia)(Serious: Caused/Prolonged Hospitalization). On an unspecified date in 2024 (reported as "within two weeks") after vaccination the patient experienced Lost all feelings in her hands and legs (Hypoaesthesia)(Serious: Caused/Prolonged Hospitalization), Unable to stand, walk, hold any objects or write(Loss of personal independence in daily activities)(Serious: Caused/Prolonged Hospitalization) and Unable to stand, walk, hold any objects or write(Gait inability)(Serious: Caused/Prolonged Hospitalization). On an unspecified date in 2024 after vaccination the patient experienced Facial muscles became paralyzed (Facial paralysis)(Serious: Caused/Prolonged Hospitalization, Other Medically Important Condition), Lose the ability to speak(Speech disorder)(Serious: Caused/Prolonged Hospitalization) and Lose the ability to...swallow(Dysphagia)(Serious: Caused/Prolonged Hospitalization). The patient visited a hospital on 16-Dec-2024 and Neurologist on 20-Dec-2024. Neurologist advised the patient to go immediately to another hospital. The patient visited ER and then was admitted to the medical unit and then transferred to ICU. Duration of the hospitalization was reported to be 5 weeks (35 days). Treatment included Five days of IVIG treatment. A week later when not improving, she received steroid treatment for seven days. Relevant lab tests included: Multiple MRIs (Result: Not provided, Test Date: Unknown), CAT scans (Result: Not provided, Test Date: Unknown), Spinal puncture (Result: Not provided, Test Date: Unknown), Spinal puncture (Result: Not provided, Test Date: Unknown), Nerve biopsy (Result: Not provided, Test Date: Unknown) and Blood work for all types for all types of potential viruses and bacterial infections and autoimmune disorders (Result: Not provided, Test Date: Unknown). At the time of reporting, the outcome of the events Facial paralysis, Paraesthesia, Pain in extremity, Hypoaesthesia, Loss of personal independence in daily activities, Gait inability, Speech disorder and Dysphagia was Not Recovered/Not Resolved/Ongoing.; Sender's Comments: This 73 year-old female experienced Facial paralysis, Paraesthesia, Pain in extremity, Hypoaesthesia, Loss of personal independence in daily activities, Gait inability, Speech disorder and Dysphagia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Facial paralysis was reported as serious. The event Paraesthesia was reported as serious. The event Pain in extremity was reported as serious. The event Hypoaesthesia was reported as serious. The event Loss of personal independence in daily activities was reported as serious. The event Gait inability was reported as serious. The event Speech disorder was reported as serious. The event Dysphagia was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Facial paralysis, Paraesthesia, Pain in extremity, Hypoaesthesia, Loss of personal independence in daily activities, Gait inability, Speech disorder and Dysphagia is considered Possible.
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| 2825362 | 70 | F | FL | 02/08/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
KB2YT KB2YT |
Biopsy skin abnormal, Rash, Rash pruritic, Urticaria; Rash, Urticaria; Biopsy sk...
Biopsy skin abnormal, Rash, Rash pruritic, Urticaria; Rash, Urticaria; Biopsy skin abnormal, Rash, Rash pruritic, Urticaria; Rash, Urticaria
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Two weeks later develop a widespread severe rash/hives on my legs and moved up to my lower back, hip...
Two weeks later develop a widespread severe rash/hives on my legs and moved up to my lower back, hips,neck and continuing through out my body I was put on prednisone 3 times. It was extremely itchy. The rash/hives would not stop. The rash/hives lasted 45 days.
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| 2825363 | 78 | M | FL | 02/08/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
52Z52 3032086 |
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 2 doses of Arexvy vaccination. Reported no adverse side effects.
Patient received 2 doses of Arexvy vaccination. Reported no adverse side effects.
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| 2825364 | 43 | F | TN | 02/08/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
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Burning sensation, Hypoaesthesia, Lymphadenopathy, Mammogram normal, Metabolic f...
Burning sensation, Hypoaesthesia, Lymphadenopathy, Mammogram normal, Metabolic function test; Neuropathy peripheral, Pain in extremity, Paraesthesia, Ultrasound lymph nodes
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Patient experienced soreness in arm within hours. The following morning upon waking up, left axillar...
Patient experienced soreness in arm within hours. The following morning upon waking up, left axillary lymph nodes were swollen and patient was experiencing neuropathy and paresthesia in left arm. The lymph nodes were swollen for a few days. Over the next few weeks, neuropathy in the left arm persisted, radiating down the entire arm. The arm would burn, tingle, and sometimes go completely numb. After 2 months, the neuropathy reduced slightly, localizing to upper inner arm and armpit area where it still occurs. In Jan 2025, patient made appointment and was seen by plastic surgeon who performed breast augmentation in 2014 to have implants checked to rule out issues were being caused by implants. Plastic surgeon cleared patient and felt issues were caused by flu shot. Patient had PCP examine area, do lab work, and underwent an axillary ultrasound and mammogram in attempt to diagnosis/identify cause in Jan 2025. Results of tests did not reveal any anatomical abnormalities or identifiable cause. As of Feb 2025, neuropathy and paresthesia persist.
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| 2825365 | 44 | F | MA | 02/08/2025 |
HEPA HEPA TYP TYP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
2345B 2345B Y2A021M Y2A021M |
Dehydration, Depressed level of consciousness, Dizziness, Loss of consciousness,...
Dehydration, Depressed level of consciousness, Dizziness, Loss of consciousness, Muscle tightness; Pallor, Syncope; Dehydration, Depressed level of consciousness, Dizziness, Loss of consciousness, Muscle tightness; Pallor, Syncope
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Patient with syncopal episode after second vaccine given around 9:25 am. Pt with no hx of fainting ...
Patient with syncopal episode after second vaccine given around 9:25 am. Pt with no hx of fainting with vaccines in the past. Pt immediatly pale and laid pt supine on exam table raising legs. Pt with LOC for approx. 10-15 seconds, with some muscle tension present. More difficult to arouse, pt with return of consciousness and pale but fully aware of surroundings. Vital signs stable and able to sit up. Given juice and chips with some relief. Pt needing to lay down again in fear of faint. Pt recovery seemed extended, possibly due to dehydration and recent cold which resolved. Though initially refused ambulance, pt agree seemed a bit worse for her, I called EMS and ambulance came within minutes and evaluated by Paramedics, taken to Hospital near by. AVS given to paramedics. Husband and son came to clinic as well to be with pt. Pt agreeable to being evaluated further at ED.
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| 2825366 | 40 | F | IL | 02/08/2025 |
COVID19 |
JANSSEN |
043A21A |
Chest pain, Fibrin D dimer increased, Platelet count decreased, Platelet disorde...
Chest pain, Fibrin D dimer increased, Platelet count decreased, Platelet disorder, Polymenorrhoea
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Chest pain, low platelets, large platelets, high d-dimer, double periods.
Chest pain, low platelets, large platelets, high d-dimer, double periods.
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| 2825367 | 65 | M | MI | 02/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Chills, Extra dose administered, Pain, Pyrexia
Chills, Extra dose administered, Pain, Pyrexia
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Patient accidentally received a 2nd dose of Arexvy on 2-7-25 when he already had one on 1-18-24. Pat...
Patient accidentally received a 2nd dose of Arexvy on 2-7-25 when he already had one on 1-18-24. Patient was called to be notified that 2nd vaccine was done by mistake, and patient report minor to moderate chills, aches, and fever.
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| 2825368 | 64 | F | NY | 02/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
X72D2 |
Herpes zoster
Herpes zoster
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Developed shingles on left side of the buttocks, vagina, and rectum.
Developed shingles on left side of the buttocks, vagina, and rectum.
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| 2825370 | 51 | F | CA | 02/08/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Arthralgia, Discomfort, Hypoaesthesia, Joint range of motion decreased, Pain
Arthralgia, Discomfort, Hypoaesthesia, Joint range of motion decreased, Pain
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per patient at approximately 3 weeks after vaccine administration, patient started to experience rad...
per patient at approximately 3 weeks after vaccine administration, patient started to experience radiating pain of R shoulder with numbness from shoulder to fingers. Patient also experiencing less range of motion due to discomfort.
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