| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2419975 | 56 | F | MN | 08/25/2022 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FM7553 FM7553 FM7553 FM7553 FM7553 FM7553 FM7553 |
Alopecia, Computerised tomogram thorax abnormal, Pulmonary thrombosis, Sepsis, S...
Alopecia, Computerised tomogram thorax abnormal, Pulmonary thrombosis, Sepsis, Skin infection; Systemic inflammatory response syndrome; Aneurysm, Antibody test, Antibody test abnormal, Chromosomal mutation, Chronic active Epstein-Barr virus infection; Condition aggravated, Crying, Encephalitis, Fungal infection, Gene mutation; Granuloma, Impaired quality of life, Infection parasitic, Injected limb mobility decreased, Laboratory test; Noninfective encephalitis, Osteoporosis, Pain, Rib fracture, Shoulder injury related to vaccine administration; Skin ulcer, Thrombosis, Vaccination site injury
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After my first booster on 11.23.21, two weeks after that, my hair started falling out in big clumps....
After my first booster on 11.23.21, two weeks after that, my hair started falling out in big clumps. Then it turned into a skin infection, and then it turned in to sirs and then it was after the last booster on 06.09.22 that it developed into sepsis and also bloodspots in both lungs. Er visit and Hospital stay both at Hospital.
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โ | |||||
| 1537124 | 34 | M | MA | 08/09/2021 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FC3180 FC3180 FC3180 FC3180 FC3180 FC3180 FC3180 EW981 EW981 EW981 EW981 EW981 EW981 KC3180 KC3180 KC3180 KC3180 KC3180 KC3180 |
Paraesthesia; Anti-cyclic citrullinated peptide antibody negative, Antinuclear a...
Paraesthesia; Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood magnesium normal, Blood phosphorus normal; Blood thyroid stimulating hormone normal, C-reactive protein normal, Chlamydia test negative, Computerised tomogram head normal, Double stranded DNA antibody; Full blood count normal, Glycosylated haemoglobin, HIV test negative, Hepatitis B test negative, Laboratory test normal; Lipase normal, Liver function test normal, Metabolic function test normal, Pain, Paraesthesia; Protein urine absent, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sexually transmitted disease test, Treponema test negative; Urine analysis normal, Vitamin B12 normal, Vitamin B6 normal, Vitamin D; Paraesthesia; Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood magnesium normal, Blood phosphorus normal; Blood thyroid stimulating hormone normal, C-reactive protein normal, Chlamydia test negative, Computerised tomogram head normal, Double stranded DNA antibody; Full blood count normal, Glycosylated haemoglobin, HIV test negative, Hepatitis B test negative, Laboratory test normal; Lipase normal, Liver function test normal, Metabolic function test normal, Pain, Paraesthesia; Protein urine absent, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sexually transmitted disease test, Treponema test negative; Urine analysis normal, Vitamin B12 normal, Vitamin B6 normal, Vitamin D; Anxiety, Arthralgia, Burning sensation, Depression, Fatigue; Insomnia, Muscle spasms, Muscle twitching, Nervous system disorder, Pain; Paraesthesia, Tremor; Antibody test normal, Anxiety, Biopsy skin, Blood magnesium normal, Blood phosphorus normal; Blood thyroid stimulating hormone normal, C-reactive protein normal, Computerised tomogram head normal, Depression, Differential white blood cell count normal; Electric shock sensation, Electromyogram normal, Fear, Full blood count normal, Impaired work ability; Insomnia, Laboratory test normal, Lipase normal, Magnetic resonance imaging spinal normal, Metabolic function test normal; Muscle twitching, Muscular weakness, Neuralgia, Pain, Paraesthesia; Poor quality sleep, Red blood cell sedimentation rate normal, Sensory disturbance, Small fibre neuropathy; Antibody test normal, Anxiety, Biopsy skin, Blood magnesium normal, Blood phosphorus normal; Blood thyroid stimulating hormone normal, C-reactive protein normal, Computerised tomogram head normal, Depression, Differential white blood cell count normal; Electric shock sensation, Electromyogram normal, Fear, Full blood count normal, Impaired work ability; Insomnia, Laboratory test normal, Lipase normal, Magnetic resonance imaging spinal normal, Metabolic function test normal; Muscle twitching, Muscular weakness, Neuralgia, Pain, Paraesthesia; Poor quality sleep, Red blood cell sedimentation rate normal, Sensory disturbance, Small fibre neuropathy
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Patient started having tingling feelings in hands and legs a couple hours after vaccination and stil...
Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
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| 2820439 | 70 | M | 01/11/2025 |
PNC20 |
PFIZER\WYETH |
LC5482 |
Extra dose administered
Extra dose administered
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Patient received duplicate vaccine. Original vaccine administered 11/17/23. Re-administered 1/10/25.
Patient received duplicate vaccine. Original vaccine administered 11/17/23. Re-administered 1/10/25.
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| 2820440 | 27 | F | GA | 01/11/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Arthralgia, Asthenia, Back pain, Brain fog, Chills; Decreased appetite, Fatigue,...
Arthralgia, Asthenia, Back pain, Brain fog, Chills; Decreased appetite, Fatigue, Headache, Impaired work ability, Myalgia; Pain, Pyrexia, Somnolence
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Within 12 hours after receiving the vaccine, Ive experienced chills, body aches, muscle aches, back ...
Within 12 hours after receiving the vaccine, Ive experienced chills, body aches, muscle aches, back pain, joint pain, headache, fever, brain fog, weakness, fatigue, and loss of appetite. My fever has been between 100.0๏ฟฝ and 100.4๏ฟฝ even with 400 mg of ibuprofen at a time so I had to add 325mg of Tylenol to bring my fever below 100.0๏ฟฝ. I ve also tried using a heating pad for my back and sleeping a lot during the day, but my symptoms haven t resolved or improved, even after almost 48 hours. This is the same response I had when I got the second COVID shot, which was also Moderna. Both this instance and the time I received the second COVID shot I was forced to miss work. I still haven?t returned to work after my most recent vaccine 2 days ago. Ive never had any adverse reaction to any vaccine in the past.
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| 2820441 | 9 | M | OH | 01/11/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8080797 u8465ba |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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The patient was given Moderna vaccine for ages 12 and up in error. I discovered error on way home f...
The patient was given Moderna vaccine for ages 12 and up in error. I discovered error on way home from clinic and immediately reported to my supervisor at pharmacy. She called Moderna and received that no harm is anticipated in the dose other than increased redness at injection site. Moderna stated the CDC considers this a full dose and the child does not need a second dose. Moderna considers this dose as " acceptable". I contacted mother within 30 minutes of the vaccination and explained the error. She was very understanding and said her child was fine. I dis follow up calls to mother . The pediatrician never returned my calls .
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| 2820442 | 7 | F | OH | 01/11/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8080797 u8465ba |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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The patient was given Moderna Vaccine for 12 and up in error. I discovered the error on way home fro...
The patient was given Moderna Vaccine for 12 and up in error. I discovered the error on way home from clinic and immediately reported to my supervisor at pharmacy. She called Moderna and received information from them that no harm is anticipated in the dose given other than increased redness at injection site. moderna states the CDC considers this a full dose and the child does not need a second dose. Moderna considers this as "acceptable". I contacted the mother within 30 minutes of the vaccination and explained the error. She was very understanding and said her child was fine. I did follow up calls. The pediatrician never returned my calls.
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| 2820443 | 30 | F | VA | 01/11/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Biopsy lymph gland, Blood test, Bone scan, Breast cancer female, Chemotherapy; C...
Biopsy lymph gland, Blood test, Bone scan, Breast cancer female, Chemotherapy; Computerised tomogram head, Computerised tomogram pelvis, Computerised tomogram thorax, Lymphadenectomy, Lymphadenopathy; Magnetic resonance imaging breast, Mammogram, Radiotherapy
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Received vaccine in September, was diagnosed with breast cancer in December, a swollen lymph node in...
Received vaccine in September, was diagnosed with breast cancer in December, a swollen lymph node in my right armpit confirmed by biopsy.
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โ | |||||
| 2820444 | 41 | M | WI | 01/11/2025 |
HEPAB IPV MMRV TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4DS4N X1C891M Y014436 3RE73 Y008361 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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I called the patient to report the incident and at the time of the call, the patient reported that h...
I called the patient to report the incident and at the time of the call, the patient reported that he was feeling well.
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| 2820445 | 13 | F | FL | 01/11/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
LM2211 LM2211 UT8475NA UT8475NA |
Deafness, Dizziness, Pallor, Syncope, Throat tightness; Visual impairment; Deafn...
Deafness, Dizziness, Pallor, Syncope, Throat tightness; Visual impairment; Deafness, Dizziness, Pallor, Syncope, Throat tightness; Visual impairment
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patient fainted, was pale, dizzy, couldn't see or hear, she said the throat was tight... we di...
patient fainted, was pale, dizzy, couldn't see or hear, she said the throat was tight... we did administered an EpiPen and called EMS. Patient left with the paramedics to a local ER.
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| 2820446 | 77 | F | WI | 01/11/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM7786 U8489AA |
Dizziness, Gait disturbance, Impaired driving ability, Nausea; Dizziness, Gait d...
Dizziness, Gait disturbance, Impaired driving ability, Nausea; Dizziness, Gait disturbance, Impaired driving ability, Nausea
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The patient received a flu and covid vaccine on 01/09/2025. She phoned today and said she started f...
The patient received a flu and covid vaccine on 01/09/2025. She phoned today and said she started feeling nausea on 1/10/25. she stated she was shopping at the store yesterday and started feeling very dizzy and couldn't walk with out support. She said several people helped her there and told her she shouldn't drive home. She told me today she was still having dizziness and wanted to know if it could be from the vaccine. I told her it was possible but that I wanted her to get checked out by a doctor in case it might be something more serious. She phoned the nurse line and they advised her to go to the er for examination to make sure she is not having a stroke. When I phoned her back a few minutes later to follow up she was waiting for her brother to come pick her up.
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| 2820447 | 81 | F | FL | 01/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Second dose of Arexvy given in error. No protocol for more than one dose. Previous dose not reported...
Second dose of Arexvy given in error. No protocol for more than one dose. Previous dose not reported on Website. First dose given 383 days prior. Patient experienced NO ADVERSE EVENTS.
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| 2820448 | 69 | F | AL | 01/11/2025 |
PNC20 |
PFIZER\WYETH |
LC5482 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received prevnar 20 on 1/10/2024 and was given an additional dose on 1/7/2025. She has no ad...
Patient received prevnar 20 on 1/10/2024 and was given an additional dose on 1/7/2025. She has no adverse effects to date.
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| 2820449 | 63 | F | AL | 01/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient requested RSV vaccine; told pharmacist she had not had one yet. Pharmacist failed to see pre...
Patient requested RSV vaccine; told pharmacist she had not had one yet. Pharmacist failed to see previous RSV vaccine given 01/07/2024. When the pharmacist informed the patient of the error, the patient stated that she did not realize it was a one time dose and miss understood the pharmacist's question regarding having the vaccine before. The patient was adamant that her provider told her she needed to get a booster despite not being the CDC recommendation for Arexvy. Patient states that she thought she qualified for a second dose due to having COPD.
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| 2820450 | 68 | F | WA | 01/11/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
lm2219 389307 |
Injection site rash, Rash, Rash pruritic; Injection site rash, Rash, Rash prurit...
Injection site rash, Rash, Rash pruritic; Injection site rash, Rash, Rash pruritic
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Rash around injection site, chest, and lower back. No hives, only slightly itchy. Feeling better a...
Rash around injection site, chest, and lower back. No hives, only slightly itchy. Feeling better as time goes on
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| 2820451 | 54 | M | 01/11/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3043837 TFAA2423 |
Dizziness, Hypoaesthesia; Dizziness, Hypoaesthesia
Dizziness, Hypoaesthesia; Dizziness, Hypoaesthesia
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Patient reports numbness in entire left arm and hand, especially last 3 finger (middle, ring, pinkie...
Patient reports numbness in entire left arm and hand, especially last 3 finger (middle, ring, pinkie) and 3 days of dizziness
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| 2820452 | 89 | M | FL | 01/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Second dose of Arexvy given in error. No protocol for more than one dose. Previous dose not reported...
Second dose of Arexvy given in error. No protocol for more than one dose. Previous dose not reported on Website. First dose given 383 days prior. Patient experienced NO ADVERSE EVENTS.
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| 2820453 | 1 | M | WI | 01/11/2025 |
HEPA |
MERCK & CO. INC. |
|
Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Py...
Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
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Fatigue - unable to keep his eyes open, fever over 103 that would not come down with medication, red...
Fatigue - unable to keep his eyes open, fever over 103 that would not come down with medication, red hot tender spot on back of left thigh.
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| 2820454 | 67 | F | NV | 01/11/2025 |
PNC20 |
PFIZER\WYETH |
LJ5280 |
Dizziness, Nausea, Rash, Rash erythematous
Dizziness, Nausea, Rash, Rash erythematous
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Patient has developed red rash all over the upper arm, & she says she feels very nauseous and ...
Patient has developed red rash all over the upper arm, & she says she feels very nauseous and dizzy .
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| 2820455 | 32 | F | CA | 01/11/2025 |
HPV9 |
MERCK & CO. INC. |
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Burning sensation, Muscular weakness, Pain, Pain in extremity, Sleep disorder
Burning sensation, Muscular weakness, Pain, Pain in extremity, Sleep disorder
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Received vaccine into L deltoid. I experienced burning sensation while the liquid was being administ...
Received vaccine into L deltoid. I experienced burning sensation while the liquid was being administered. I had arm soreness and pain with arm movement above my head later that day. I could not sleep on my left arm as it caused pain. The next day I had muscle weakness of the left arm and could not carry my grocery bag on my left forearm. I did not work out for several days. I continue to have left arm weakness and can not carry a duffel bag on my left arm.
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| 2820456 | 72 | M | NV | 01/11/2025 |
RSV |
PFIZER\WYETH |
ln5460 |
Laboratory test normal, Pain in extremity, Sleep disorder, Surgery
Laboratory test normal, Pain in extremity, Sleep disorder, Surgery
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It felt pain within 2 hours of the vaccine, could not sleep on that side, pain enough to wake him up...
It felt pain within 2 hours of the vaccine, could not sleep on that side, pain enough to wake him up at night. Tried hold/cold compresses, Voltaren and nothing worked. Went to doctor in December and was given antibiotics - not sure of name but thought it was cephalexin. Then had surgery late December and tornaket was put on same arm and since then has been better. Arm still hurts but not as bad.
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| 2820457 | 79 | M | AZ | 01/11/2025 |
COVID19 |
PFIZER\BIONTECH |
EJ1685 |
Myocardial infarction
Myocardial infarction
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Myocardial infarction
Myocardial infarction
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โ | |||||
| 2820458 | 81 | F | ID | 01/11/2025 |
COVID19 |
MODERNA |
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Injection site erythema, Injection site pain, Injection site pruritus
Injection site erythema, Injection site pain, Injection site pruritus
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On the day I received the Covid shot, I developed a very large area on my upper left arm that was s...
On the day I received the Covid shot, I developed a very large area on my upper left arm that was sore, ,red and very itchy. I am on day 5 now and it is still red but the soreness and itchiness is subsiding. I took Benadryl and Tylenol at bedtime to alleviate the soreness and itchiness.
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| 2820213 | 7 | M | TX | 01/10/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y59D4 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administered Boostrix to a 7 year old patient on December 13th 2024; This non-serious case was repor...
administered Boostrix to a 7 year old patient on December 13th 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Y59D4, expiry date 16-JUN-2026) for prophylaxis. On 13-DEC-2024, the patient received Boostrix. On 13-DEC-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Boostrix to a 7 year old patient on December 13th 2024). The outcome of the inappropriate age at vaccine administration was unknown. 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: 13-DEC-2024 The Healthcare Professional stated that they administered Boostrix to a 7 year old patient , which led to inappropriate age at vaccine administration.
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| 2820227 | 44 | M | CA | 01/10/2025 |
COVID19 |
MODERNA |
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Abscess, Anal fistula
Abscess, Anal fistula
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Personal abscess developed into anal fistula over the course of 2 months.
Personal abscess developed into anal fistula over the course of 2 months.
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| 2820230 | M | LA | 01/10/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
4KF75 |
Abdominal pain, Flank pain
Abdominal pain, Flank pain
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Abdomen right side pain; Flank area pain; This non-serious case was reported by a physician via call...
Abdomen right side pain; Flank area pain; This non-serious case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 49-year-old male patient who received HBV (Engerix B) (batch number 4KF75) for prophylaxis. On 02-JUL-2024, the patient received the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced abdominal pain (Verbatim: Abdomen right side pain) and flank pain (Verbatim: Flank area pain). The outcome of the abdominal pain and flank pain were resolved. It was unknown if the reporter considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient:US2024AMR166104 Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that patient had received Engerix B in an urgent care facility. The patient had right side pain in his abdomen and also in his flank area since the first dose of Engerix B. For tolerance of 2nd dose of Engerix B , refer case US2024AMR166104.; Sender's Comments: US-GSK-US2024AMR166104:Case for 2nd dose US-GSK-US2024AMR166104:1 st dose
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| 2820231 | U | MI | 01/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Dizziness
Dizziness
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Dizziness; This non-serious case was reported by a pharmacist via call center representative and des...
Dizziness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to Shingrix. It was unknown if the company considered the dizziness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-DEC-2024 The pharmacist asked that how long would dizziness from Shingrix last. The reporter confirmed that a patient was experiencing this reaction and when reporter was asked about the patient and product details, reporter said did not have it, a doctor was asking to the pharmacist how long the dizziness would last. The pharmacist did not even see the patient.
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| 2820232 | U | NJ | 01/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Innapropiate Schedule for vaccine (more than 6 months after first dose); This non-serious case was r...
Innapropiate Schedule for vaccine (more than 6 months after first dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Innapropiate Schedule for vaccine (more than 6 months after first dose)). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 11-DEC-2024 Patient received first dose on twenty-twenty two (unspecified) (more than six months after 1st dose). Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. Pharmacist wants to know if they have to restart the series of which guidance can GlaxoSmithKline provide.
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| 2820233 | 1.25 | F | IL | 01/10/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Given to 15 month old; Kinrix on 09Dec2024 as dose 4 in the DTaP series; This non-serious case was r...
Given to 15 month old; Kinrix on 09Dec2024 as dose 4 in the DTaP series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. On 09-DEC-2024, the patient received the 4th dose of Kinrix. On 09-DEC-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Given to 15 month old) and inappropriate schedule of vaccine administered (Verbatim: Kinrix on 09Dec2024 as dose 4 in the DTaP series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. 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: 13-DEC-2024 The Healthcare Professional stated that a 15 month old female patient was inadvertently given Kinrix on 9th December 2024 as dose 4 in the DTaP series, with dose 3 being administered 9 months prior, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Reporter did not have lot number or any further details available at time of call.
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| 2820234 | 72 | M | NJ | 01/10/2025 |
FLU3 FLU3 COVID19 COVID19 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
UT8473DA UT8473DA LN0588 LN0588 UT8473DA UT8473DA |
Ageusia, Dysgeusia; Ageusia; Ageusia, Dysgeusia; Ageusia; Ageusia, Dysgeusia; Ag...
Ageusia, Dysgeusia; Ageusia; Ageusia, Dysgeusia; Ageusia; Ageusia, Dysgeusia; Ageusia
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odd sensation in the mouth; bad taste; eventually loss of taste sensation; Initial information recei...
odd sensation in the mouth; bad taste; eventually loss of taste sensation; Initial information received on 08-Jan-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 72 years old male patient who experienced odd sensation in the mouth, bad taste and eventually loss of taste sensation after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 vaccine for Immunisation. On 27-Oct-2024, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8473DA, expiry: 30-Jun-2025, with unknown strength) via intramuscular route in unknown administration site as Immunization. On an unknown date in NOV-2024, Approximately 1 or 2 weeks after vaccination the patient started with odd sensation in the mouth (paraesthesia oral) and more on taste and stuff, bad taste (dysgeusia) and eventually loss of taste sensation (ageusia). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events.
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| 2820236 | 4 | F | CT | 01/10/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5G323D V016873 |
Erythema, Induration, Injection site pain, Injection site pruritus, Oedema perip...
Erythema, Induration, Injection site pain, Injection site pruritus, Oedema peripheral; Erythema, Induration, Injection site pain, Injection site pruritus, Oedema peripheral
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9.5 cm localized reaction including redness, edema and induration of the right arm. Patient complain...
9.5 cm localized reaction including redness, edema and induration of the right arm. Patient complained of pain at site and itching. Parent administered Tylenol and Zyrtec at the direction of the MD without much relief. Patient was evaluated in a face to face encounter later in the day. Determined to be a significant local reaction. MD reaching out to allergy for recommendations since this was the second time this child had a similar reaction to two different vaccines/
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| 2820295 | 63 | F | NY | 01/10/2025 |
PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
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Chills, Diaphragmalgia, Dyspnoea, Fatigue, Liver function test increased; Muscul...
Chills, Diaphragmalgia, Dyspnoea, Fatigue, Liver function test increased; Musculoskeletal chest pain, Myalgia, Pain in extremity, Pruritus, Pyrexia; Renal function test abnormal, Urticaria
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Muscle pain, fever, chills, fatigue, hives on arm with pain and itching, pain in right rib and diaph...
Muscle pain, fever, chills, fatigue, hives on arm with pain and itching, pain in right rib and diaphragm area with difficulty taking deep breath. Lasted 3d.
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| 2820296 | 78 | F | FL | 01/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered
Extra dose administered
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Patient at the time of the vaccine administration on 1/8/2025 at Pharmacy 0424 already received the ...
Patient at the time of the vaccine administration on 1/8/2025 at Pharmacy 0424 already received the RSV vaccine at another pharmacy location in 2023. Per current guideline, RSV vaccine is one time dose vaccination. Thus, patient received an additional/inappropriate vaccine dose of the RSV vaccine.
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| 2820297 | 19 | F | RI | 01/10/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
3L339 3L339 |
Asthenia, Chills, Fatigue, Headache, Nausea; Vomiting
Asthenia, Chills, Fatigue, Headache, Nausea; Vomiting
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within an hour of vaccine, patient had sudden onset significant headache, nausea, vomiting, chills a...
within an hour of vaccine, patient had sudden onset significant headache, nausea, vomiting, chills and fatigue/weakness. This improved with zofran, aleve, tylenol and sleeping, and the fatigue slowly improved.
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| 2820298 | 11 | M | LA | 01/10/2025 |
FLU3 HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
AE2J7 Y008119 U8369BA Z25D2 |
Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness; Erythema, Skin...
Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness
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1 X 2 cm area of erythema, tenderness, and warmth
1 X 2 cm area of erythema, tenderness, and warmth
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| 2820299 | 59 | F | FL | 01/10/2025 |
COVID19 |
MODERNA |
3043823 |
Rash, Rash erythematous, Rash pruritic, Sensitive skin, Skin warm
Rash, Rash erythematous, Rash pruritic, Sensitive skin, Skin warm
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Arm rash approximately 3 inches by 3 inches. Area sore, hot, itchy, red, sensitive to touch. Four ...
Arm rash approximately 3 inches by 3 inches. Area sore, hot, itchy, red, sensitive to touch. Four days of symptoms, on fifth day symptoms present but reduced to mostly sore and hot. Treated with antihistamine for itchiness.
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| 2820300 | 18 | F | VA | 01/10/2025 |
HPV9 |
MERCK & CO. INC. |
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Dizziness, Hyperhidrosis
Dizziness, Hyperhidrosis
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Dizziness, sweating. Patient laid down with legs elevated. Resolved quickly.
Dizziness, sweating. Patient laid down with legs elevated. Resolved quickly.
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| 2820301 | 69 | M | NY | 01/10/2025 |
RSV |
PFIZER\WYETH |
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Neuromuscular pain
Neuromuscular pain
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General neuro-muscular pain starting in arms, extending to chest and back area, and involving hands
General neuro-muscular pain starting in arms, extending to chest and back area, and involving hands
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| 2820302 | 70 | F | NY | 01/10/2025 |
RSV |
PFIZER\WYETH |
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Musculoskeletal stiffness, Neuromuscular pain
Musculoskeletal stiffness, Neuromuscular pain
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Neuro-muscular pain in back and sides extending to hands and fingertips; stiffness of back muscles a...
Neuro-muscular pain in back and sides extending to hands and fingertips; stiffness of back muscles and legs
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| 2820303 | 4 | M | MI | 01/10/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK107AA |
Unevaluable event
Unevaluable event
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N/A
N/A
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| 2820304 | 36 | M | MA | 01/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FJ9A7 |
Product preparation issue
Product preparation issue
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I received an order for Shingrix #2 from Dr. I drew up diluent but did not combine with powder to fo...
I received an order for Shingrix #2 from Dr. I drew up diluent but did not combine with powder to form Shingrix vaccine. I administered diluent. I then noticed the powder still in the second vial and realized I had only given diluent, not vaccine. I called pt back to the room from the waiting area and explained the above, apologized. Pt stated understanding, accepted apology. I then correctly prepared Shingrix vaccine and administered to pt.
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| 2820305 | 63 | M | MD | 01/10/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA |
084J21A 053D22A 037F21A 026A21A 025M20A |
Cerebrovascular accident, Death; Cerebrovascular accident, Death; Cerebrovascula...
Cerebrovascular accident, Death; Cerebrovascular accident, Death; Cerebrovascular accident, Death; Cerebrovascular accident, Death; Cerebrovascular accident, Death
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Stroke #1 Apr 2024; Stroke #2 Aug 2024; Stroke #3 Nov 2024; death Nov 2024
Stroke #1 Apr 2024; Stroke #2 Aug 2024; Stroke #3 Nov 2024; death Nov 2024
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โ | โ | ||||
| 2820306 | 74 | F | GA | 01/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered
Extra dose administered
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Patient received 2 doses on Arexvy vaccine on 2/7/24 and 12/30/24
Patient received 2 doses on Arexvy vaccine on 2/7/24 and 12/30/24
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| 2820307 | 70 | M | GA | 01/10/2025 |
COVID19 RSV |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3031707 929PN |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient received 2 doses of the Arexvy (RSV) vaccine on 2/7/24 and 12/30/24.
Patient received 2 doses of the Arexvy (RSV) vaccine on 2/7/24 and 12/30/24.
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| 2820308 | 87 | F | 01/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered
Extra dose administered
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An Arexvy shot was given to the patient on 01/09/2025 while the patient already had 1 dose of Arexvy...
An Arexvy shot was given to the patient on 01/09/2025 while the patient already had 1 dose of Arexvy in the past on 12/202023. Administer and patient were not aware that patient already had one dose, and patient came in based on doctor's recommendation
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| 2820309 | 7 | M | KS | 01/10/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J245K |
Product storage error
Product storage error
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Vaccine deemed not stable due to temperature excursion
Vaccine deemed not stable due to temperature excursion
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| 2820310 | 69 | F | MI | 01/10/2025 |
COVID19 |
MODERNA |
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Cough, Nasopharyngitis
Cough, Nasopharyngitis
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Cough and cold symptoms 6 weeks post vaccine. I don?t feel it is related to the vaccine, just the se...
Cough and cold symptoms 6 weeks post vaccine. I don?t feel it is related to the vaccine, just the season and public exposure.
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| 2820311 | 4 | F | KS | 01/10/2025 |
DTAPIPV FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5H95B J245K |
Product storage error; Product storage error
Product storage error; Product storage error
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Vaccine deemed not stable due to temperature excursion
Vaccine deemed not stable due to temperature excursion
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| 2820313 | 76 | F | ME | 01/10/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM2228 U8519EA |
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa...
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm
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Patient's arm is red, swollen and warm. Advised her to get it checked by medical provider to r...
Patient's arm is red, swollen and warm. Advised her to get it checked by medical provider to rule out cellulitis.
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| 2820314 | 1 | M | KS | 01/10/2025 |
HEPA HIBV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y007472 X022982 |
Product storage error; Product storage error
Product storage error; Product storage error
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Vaccine deemed not stable due to temperature excursion
Vaccine deemed not stable due to temperature excursion
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| 2820315 | 78 | F | MD | 01/10/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. |
3043030 3043030 388490 388490 |
Dizziness, Erythema, Fatigue, Mobility decreased, Pain; Skin warm, Sleep disorde...
Dizziness, Erythema, Fatigue, Mobility decreased, Pain; Skin warm, Sleep disorder, Swelling, Syncope; Dizziness, Erythema, Fatigue, Mobility decreased, Pain; Skin warm, Sleep disorder, Swelling, Syncope
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Tired, lightheaded, collapsed in hallway, can't sleep, excruciating pain, can't raise arm,...
Tired, lightheaded, collapsed in hallway, can't sleep, excruciating pain, can't raise arm, red hot swollenness
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