| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2830761 | FL | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Antibody test
Antibody test
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patient vaccinated with shingrix, and after 1 year shows no immunity for titers; This non-serious ca...
patient vaccinated with shingrix, and after 1 year shows no immunity for titers; This non-serious case was reported by a other health professional via sales rep and described the occurrence of therapy non-responder 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 therapy non-responder (Verbatim: patient vaccinated with shingrix, and after 1 year shows no immunity for titers). The outcome of the therapy non-responder was not applicable. Additional Information: GSK Receipt Date : 06-MAR-2025 Healthcare professional reported that a patient vaccinated with shingrix, and after 1 year shows no immunity for titers.
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| 2830762 | 1.17 | M | AR | 03/12/2025 |
HIBV |
SANOFI PASTEUR |
UJ995AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of an expired product with no reported adverse event; Initial information received on...
administration of an expired product with no reported adverse event; Initial information received on 07-Mar-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 14 months old male patient who had administration of an expired Hib (PRP/T) Vaccine [ACT-HIB] with no reported adverse event. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3) On 06-Mar-2025, the patient received an expired dose 3 of 0.5 ml dose of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection,(Frequency: once, strength=standard, expiry date: 28-feb-2025, lot UJ995AA) via intramuscular route in the left thigh for Immunization, with no reported adverse event. (expired product administered) (latency:same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2830763 | 58 | M | 03/12/2025 |
COVID19 UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
6024MF016A 388532 |
Burning sensation, Injection site bruising, Injection site pain, Needle issue; B...
Burning sensation, Injection site bruising, Injection site pain, Needle issue; Burning sensation, Injection site bruising, Injection site pain, Needle issue
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Burning sensation ๏ฟฝ shoots from top of bicep of mid forearm and occasionally moves; Bruise that ex...
Burning sensation ๏ฟฝ shoots from top of bicep of mid forearm and occasionally moves; Bruise that extended down his entire left bicep; Injection site pain; Injection had no issue once needle was swapped.; This spontaneous case, initially received on 26-Feb-2025, was reported by a non health professional and concerns an adult male patient. Past medical history included High blood pressure, Gout, High cholesterol, prediabetes. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for Drug use for unknown indication, Dose regimen: not reported, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: 388532. Non-company suspect drugs: On 29-Oct-2024, the patient received, Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunization. Anatomical site: left arm, lot number: 6024MF016A Adverse reactions/events and outcomes: On 29-Oct-2024, the patient experienced Injection had no issue once needle was swapped. (outcome: Recovered / Resolved, stop date: 29-Oct-2024). On 02-Nov-2024, the patient experienced Burning sensation ๏ฟฝ shoots from top of bicep of mid forearm and occasionally moves (outcome: Not recovered / Not resolved), Bruise that extended down his entire left bicep (outcome: Not recovered / Not resolved), Injection site pain (outcome: Not recovered / Not resolved). The Non health professional reported that patient received two vaccine in the left arm on 29-Oct-2024. When injecting the novavax vaccine it was discovered that the needle was faulty (needle would not allow injection to occur) and had to be switched out after initial poke to a new needle. Injection had no issue once needle was swapped. Patient stated that over the next few days a bruise developed that extended down his entire left bicep and he started to develop a burning sensation about 3 days after injection. The sensation shoots from top of bicep to mid forearm and occasionally moves down to fingertips and certain movements when patient moves from close to body to out of body can aggravate the sensation, lifting weights or letting arm hang do not aggravate. Patient presented to urgent care on 03-Nov-2024. They did an x ray and could not find anything wrong. Patient started OTC ibuprofen 400 mg every 8 hours as he was unsure that it was helping or if it was more of a placebo effect. Patient went to clinic for an annual check-up on 13-Dec-2024 and prescribed to start physical therapy which he will start on 06-Jan-2025. The physician hopes to do an MRI to get further imaging results after physical therapy was started and discrepancy was identified in the source document. Lab data details: X-ray: Did not have any findings of note Flucelvax (TIV) action taken: Not Applicable Treatment medication: Ibuprofen 400 mg Three times a day Reporter's assessment: The reporter consider event as non-serious and causality was not reported; Reporter's Comments: The causality of all events was assessed related to the administration of Flucelvax (TIV) except needle issue assessed as not related.
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| 2830826 | 70 | F | CT | 03/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8473DA |
Arthralgia, Injected limb mobility decreased, Pain
Arthralgia, Injected limb mobility decreased, Pain
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The day after I had the flu vaccine I woke up with a very sore shoulder and I was having trouble mov...
The day after I had the flu vaccine I woke up with a very sore shoulder and I was having trouble moving my arm into a certain position ..I thought at first that I slept on it wrong. Finally I decided after almost 4 months to see my general practitioner. My doctor thought I should try physical therapy. The physical therapist on 3/3/25 evaluated me and thought I might have tendinitis and is treating me for that. I have had 3 sessions so far. After 5 or so sessions PT will refer me to an orthopedist if I don't show improvement. So far I don't see any change. It is painful to try and move my arm while removing a jacket and trying to move my arm up behind my back (which I cannot do.)I am doing exercises given to me by the physical therapist at home in between PT sessions. No tests have been recommended yet. If I need to see an orthopedist I'm sure tests will be done:
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| 2830827 | 75 | F | PA | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
|
Erythema, Pruritus, Rash, Skin warm, Swelling
Erythema, Pruritus, Rash, Skin warm, Swelling
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Swelling , redness, rash feeling warm to the touch, itching. Some better but still occurring.
Swelling , redness, rash feeling warm to the touch, itching. Some better but still occurring.
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| 2830829 | 71 | F | FL | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ts525 |
Asthenia, Injection site erythema, Injection site pain, Injection site swelling
Asthenia, Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Medium
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| 2830830 | 20 | F | TX | 03/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
l5229 |
Injection site erythema
Injection site erythema
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Site: Redness at Injection Site-Mild, Additional Details: Local injection site reaction. Patient cam...
Site: Redness at Injection Site-Mild, Additional Details: Local injection site reaction. Patient came back after 10 minutes without any symptoms. I asked patient to sit at the vaccination area for addtion 10-15 minutes to monitor for futher reaction. No reaction per patient, no shortness of breath, no pupil dilation, or any reaction. Injection site was reduced and not as red. Checked back again after 5 more minutes and patient is doing fine with no symptoms. Instructed patient to go home and will call back to check on patient in about 2-3 hours.
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| 2830831 | 87 | M | TX | 03/12/2025 |
COVID19 |
PFIZER\BIONTECH |
lp1780 |
Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Confusional state, Dizziness, Syncope, Unresponsive to stimuli
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo...
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
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โ | |||||
| 2830832 | 60 | M | IL | 03/12/2025 |
HEPAB HEPAB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2553x 2553x |
Flushing, Hyperhidrosis, Injection site bruising, Injection site erythema, Injec...
Flushing, Hyperhidrosis, Injection site bruising, Injection site erythema, Injection site pain; Pruritus
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Other Vaccines: VaccineTypeBrand: prevnar20; Manufacturer: ; LotNumber: lk6650; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
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| 2830833 | 62 | M | MA | 03/12/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Joint injury
Joint injury
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Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
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| 2830834 | 18 | M | TX | 03/12/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
9m2r7 |
Injection site pain, Syncope
Injection site pain, Syncope
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Site: Pain at Injection Site-Mild, Systemic: faint-Mild, Additional Details: patient fainted for abo...
Site: Pain at Injection Site-Mild, Systemic: faint-Mild, Additional Details: patient fainted for about 5 seconds
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| 2830836 | 69 | F | MD | 03/12/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013009 Y013009 |
Asthenia, Erythema, Injection site erythema, Injection site pain, Injection site...
Asthenia, Erythema, Injection site erythema, Injection site pain, Injection site swelling; Pain, Swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came back 4 days after vaccine and reported redness, swelling, pain, and feeling weak after the vaccine
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| 2830837 | 65 | F | CA | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
LJ5281 |
Injection site bruising, Injection site erythema, Injection site pruritus, Lymph...
Injection site bruising, Injection site erythema, Injection site pruritus, Lymphadenopathy, Pruritus
More
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at In...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: 3/1/25 patient reported redness and itchiness on site of vaccine administration, she also said lymph nodes felt swollen, recommened she take zyrtec/benadryl and ibu and to moniter and report worsening sx to md.
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| 2830838 | 98 | F | TX | 03/12/2025 |
PNC21 |
MERCK & CO. INC. |
y0113009 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
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| 2830839 | 59 | M | TX | 03/12/2025 |
COVID19 |
MODERNA |
8080469 |
Dysgeusia, Parosmia
Dysgeusia, Parosmia
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Systemic: change in taste and smell-Mild, Additional Details: pickles taste soapy, sweet smells and ...
Systemic: change in taste and smell-Mild, Additional Details: pickles taste soapy, sweet smells and citrus can be smelled, no earthy smells. , Other Vaccines: VaccineTypeBrand: fluzone trivalent; Manufacturer: sanofi; LotNumber: ut8506na; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: 11/09/2024
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| 2830840 | 76 | F | NJ | 03/12/2025 |
COVID19 |
MODERNA |
3042560 |
Joint injury
Joint injury
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Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
|
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| 2830841 | 64 | M | PA | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
LG5577 |
Arthralgia, Injection site pain, Myalgia
Arthralgia, Injection site pain, Myalgia
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Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient states...
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient states they have lasting muscle/joint pain from the vaccine. Reported having this start shortly after vaccine and lasting. Stated he had no other issues with any of his other vaccines, just this one. Vaccine administration was correct and in the correct location, not placed in too high or too low. Side effects are reported from the vaccine itself
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| 2830842 | 77 | F | IN | 03/12/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
EC2R9 |
Chills, Hypertension, Pain
Chills, Hypertension, Pain
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Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Hypertension-Medium
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Hypertension-Medium
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| 2830843 | 50 | F | NJ | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
bp74j |
Feeling cold, Injection site erythema, Injection site pain, Pain
Feeling cold, Injection site erythema, Injection site pain, Pain
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Ge...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium
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| 2830844 | 45 | F | CA | 03/12/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945661 |
Dizziness, Injection site pain, Nausea
Dizziness, Injection site pain, Nausea
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Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medi...
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium
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| 2830845 | 81 | M | MA | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
lk6655 |
Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient had syncope episode resulting in patinet being unresponsive for about 2 to 3 minutes appeared to have also stopped breathing momentarily but pulse was present-after rubbing patients chest he regained breathing and EMT's arrived to transport patient to ER. Spoke with patient this evening 5 hours post event-states he was released by ER and is doing well.
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| 2830846 | 76 | F | MI | 03/12/2025 |
COVID19-2 |
PFIZER\BIONTECH |
lp1780 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Rash
More
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
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| 2830847 | 76 | F | TX | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
m7g39 |
Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Eye swelling, Mouth swelling, Swelling face, Swollen tongue
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
|
โ | |||||
| 2830848 | 57 | M | OR | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
hm0310 |
Eye swelling, Lip swelling, Mouth swelling, Swelling face, Swollen tongue
Eye swelling, Lip swelling, Mouth swelling, Swelling face, Swollen tongue
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Swelling of...
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Swelling of lips. No other symptoms
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| 2830849 | 83 | M | PA | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55TH4 |
Abdominal discomfort, Diarrhoea
Abdominal discomfort, Diarrhoea
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Systemic: Diarrhea-Medium, Additional Details: PATIENT RECEIVED SHINGRIX YESTERDAY, 3/4. TODAY HE RE...
Systemic: Diarrhea-Medium, Additional Details: PATIENT RECEIVED SHINGRIX YESTERDAY, 3/4. TODAY HE REPORTS HAVING DIARRHEA + STOMACH UPSET. HE HASNT HAD TO TAKE ANY MEDICATION.
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| 2830850 | 44 | M | FL | 03/12/2025 |
MMR MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3d72s 3d72s |
Dizziness, Flushing, Headache, Hyperhidrosis, Hypotension; Nervousness, Pallor, ...
Dizziness, Flushing, Headache, Hyperhidrosis, Hypotension; Nervousness, Pallor, Panic reaction, Tremor
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMT arrived states not from vaccine more from panic nervousness. after resting bp came back up and face color came back from pale, Other Vaccines: VaccineTypeBrand: heplisav-b; Manufacturer: ; LotNumber: 945659; Route: im; BodySite: right; Dose: ; VaxDate: UNKNOWN
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| 2830851 | 19 | M | NC | 03/12/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
A274J |
Anaphylactic reaction
Anaphylactic reaction
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Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient states that after he received th...
Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient states that after he received the vaccine he left the store and walked across the street when he started to feel the signs of anaphylaxis. He estimated it had been about 10-15 minutes after the vaccine was given, and that is when he called 911. He was picked up by ambulance that gave him epinephrine and took him to the emergency room where he was treated.
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โ | |||||
| 2830852 | 40 | M | OH | 03/12/2025 |
FLUC4 |
SEQIRUS, INC. |
946636 |
Concussion, Dizziness, Fall, Loss of consciousness, Presyncope
Concussion, Dizziness, Fall, Loss of consciousness, Presyncope
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Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient had vasovagal reaction to va...
Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient had vasovagal reaction to vaccinations and fell upon standing, lost consciousness briefly and exhibited signs of concussion. Called 911 and taken to ER. Dr. reported that he was released and is doing well now., Other Vaccines: VaccineTypeBrand: twinrix; Manufacturer: gsk; LotNumber: m4b34; Route: intramuscular; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: ipol; Manufacturer: sanofi; LotNumber: x1c891m; Route: subcutaneous; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: boostrix; Manufacturer: gsk; LotNumber: dy3k7; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
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| 2830853 | 65 | F | FL | 03/12/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Injection site erythema, Injection site pruritus, Paraesthesia, Pruritus, Rash
Injection site erythema, Injection site pruritus, Paraesthesia, Pruritus, Rash
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: ...
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: CUSTOMER GOT THE CAPVAXIVE SHOT ON 2/28. THE NEXT DAY HER ARM GOT RED LIKE FLUSHING AND HAD MODERATE ITCH. CUSTOMER REPORTED ON 3/5 AND DIDN'T TAKE ANY MEDICATION. PRH ADVISED TO TAKE BENADRYL AND IF THAT DOESNT MAKE IT BETTER IBN COUPLE HOURS THEN GO TO URGENT CARE. FOLLOWED UP THE SAME DAY AND HUSBAND SAID SHE IS BETTR. FOLLOWED UP AGAIN 0N 3/6 AND HUSBAND SAID THE REDNESS AND ITCH DISAPPEARED. THEY WE VERY NICE.
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| 2830854 | 59 | F | PA | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55th4 |
Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Additional Details: MD gave pt rx for doxycycline
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| 2830855 | 50 | F | MI | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
KB2YT |
Injection site pruritus, Pruritus
Injection site pruritus, Pruritus
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Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)...
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: pt contacted the pharmacy today to state that the area where the vaccine was given was very itchy. the pt said no redness or swelling or pain just itchy. counselled pt to contact her dr if this continues to be problematic or uncomfortable and advised trying a hydrocortisone cream to the itchy area to see if it will relieve the symptoms.
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| 2830856 | 58 | F | VA | 03/12/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Angioedema, Asthenia, Injection site erythema, Injection site swelling, Pain; Pr...
Angioedema, Asthenia, Injection site erythema, Injection site swelling, Pain; Pruritus, Rash
More
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itc...
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Fever-Mild, Systemic: Weakness-Medium, Additional Details: PATIENT CAME IN ON 03/07/2025 AT 2:30 PM AND REPORTED THAT THE INJECTION SITE CAUSED REDNESS AND RASH AND SHE COULDN'T GET OUT OF BED FOR 2 DAYS SINCE THE VACCINE HAS BEEN ADMINISTERED. BENEDRYL WAS GIVEN TO THE PATIENT TO SUBDUE THE ALLERGIC REACTION, Other Vaccines: VaccineTypeBrand: PNEUMOCOCCAL 21-VALENT; Manufacturer: MERCK SHARP & DOHME LLC; LotNumber: Y019158; Route: INTRAMUSCULAR; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
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| 2830857 | 65 | F | TX | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
LG5575 |
Injection site pain, Pain
Injection site pain, Pain
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Site: Pain at Injection Site-Medium, Additional Details: Pain at injection site when lifting arm or ...
Site: Pain at Injection Site-Medium, Additional Details: Pain at injection site when lifting arm or carrying someting, Other Vaccines: VaccineTypeBrand: FLUZONE HIGH-DOSE; Manufacturer: ; LotNumber: U8524DA; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
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| 2830858 | 65 | F | ME | 03/12/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
j9493 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: pt reports that after recieving the vaccine, she had swelling, redness, and pain at injection site. also expressed she had some muscle spasms/twitching, which have since gone away. the rash however did not. she went to her pcp office to get the rash examined. they drew a black circle around the injection site/rash to keep an eye on its expansion. since, the rash has continued to travel down her left arm where it it gives an itching/burning sensation. she has used claratin/benadryl
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| 2830859 | 78 | F | MI | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
kb2yt |
Injection site pain, Pain in extremity
Injection site pain, Pain in extremity
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Site: Pain at Injection Site-Mild, Additional Details: pt said vaccined at 12pm by midnight experi...
Site: Pain at Injection Site-Mild, Additional Details: pt said vaccined at 12pm by midnight experienned severe leg pain, continued into next day which pt ended up going to emergency due to the severity of the leg pain
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| 2830860 | 57 | F | RI | 03/12/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LG5579 LG5579 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus; Rash pruritic, Skin warm
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: Pt presented at pharmacy on 3-07-25, following vaccine administration on 3-05-25. Pt sought consulation on a 2X2 circular, red rash that appeared to be swollen. Pt states the rash is itchy and feels warm to touch. Pt will be following up with provider on Weds, 3-12-25. In the meantime, Rph suggested pt use diphenhydramine 25 mg every 6 hours if needed to alleviate symptoms. , Other Vaccines: VaccineTypeBrand: Boostrix TDAP; Manufacturer: GSK; LotNumber: XW575; Route: Intramuscular; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
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| 2830861 | 52 | F | MA | 03/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
99d52 99d52 |
Asthenia, Chills, Dizziness, Fatigue, Hyperhidrosis; Lethargy, Nausea
Asthenia, Chills, Dizziness, Fatigue, Hyperhidrosis; Lethargy, Nausea
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Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-M...
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: EXCESSIVE SWEATY PALMS, NAUSEA-Medium, Systemic: Weakness-Mild
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| 2830862 | 67 | M | CT | 03/12/2025 |
SMALLMNK SMALLMNK SMALLMNK |
BAVARIAN NORDIC BAVARIAN NORDIC BAVARIAN NORDIC |
96867 96867 96867 |
Asthenia, Cellulitis, Erythema, Fatigue, Injection site bruising; Injection site...
Asthenia, Cellulitis, Erythema, Fatigue, Injection site bruising; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lethargy; Malaise, Pain in extremity, Pyrexia, Skin warm
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium, Systemic: pt states has not felt well past 2 days-Medium, Systemic: Weakness-Mild, Additional Details: patient showed arm today to me , told me it had been hurting and he had felt ill but getting better. it looked way to red and spreading to me. it was warm to the touch more so than his other skin. he has cardiac issues and i urged him to go to urgent care today which he did. dr said it was cellulitis and prescribed an antibiotic , Other Vaccines: VaccineTypeBrand: moderna/spike vax covid; Manufacturer: moderna; LotNumber: 3043157; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 03/04/2025
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| 2830863 | 63 | F | NJ | 03/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3bh5k |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Mild
Site: Pain at Injection Site-Mild
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| 2830864 | 60 | M | NJ | 03/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4h79y |
Rash
Rash
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Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
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| 2830865 | 21 | M | TX | 03/12/2025 |
ANTH HEP JEV1 MMR |
EMERGENT BIOSOLUTIONS GLAXOSMITHKLINE BIOLOGICALS INTERCELL AG MERCK & CO. INC. |
300215A T5D73 JEV23K07E Y009782 |
Computerised tomogram head normal, Eye movement disorder, Fall; Computerised tom...
Computerised tomogram head normal, Eye movement disorder, Fall; Computerised tomogram head normal, Eye movement disorder, Fall; Computerised tomogram head normal, Eye movement disorder, Fall; Computerised tomogram head normal, Eye movement disorder, Fall
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A few minutes after his vaccination at the front desk, patient rolled his eyes back and fell backwar...
A few minutes after his vaccination at the front desk, patient rolled his eyes back and fell backward onto the floor. Based line vital signs were obtained and were normal, provider did head exam and palpation throughout the head for head trauma injury and other injury throughout his body. Patient stayed in the clinic for 2-hours for further observation. Patient denies head/neck pain, tenderness, headache, nauseous or vomiting, neurologic symptoms, and other injury. Both Canadian head CT tool and Nexus head CT instrument were negative 0. DVPRS pain scale was 0 pain. Patient was discharged without any finding, he refused for ER visit, and all vital signs obtained were normal.
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| 2830866 | 63 | F | PA | 03/12/2025 |
PNC20 |
PFIZER\WYETH |
lg5577 |
Contusion, Hypoaesthesia
Contusion, Hypoaesthesia
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patient has a large bruise and a numb/"asleep" feeling going all the way down her arm
patient has a large bruise and a numb/"asleep" feeling going all the way down her arm
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| 2830867 | 39 | F | 03/12/2025 |
FLU3 |
SEQIRUS, INC. |
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Arthralgia, Product administered at inappropriate site
Arthralgia, Product administered at inappropriate site
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The vaccine was administered into the right arm, IM. Patient experienced immediate pain and felt a p...
The vaccine was administered into the right arm, IM. Patient experienced immediate pain and felt a popping sensation ("Like a grape popping in shoulder") which persisted for several months. Patient has seen PT for shoulder pain. Upon my evaluation of patient and clinical history, the shoulder pain is most consistent with SIRVA, likely due to site placement and administration of the vaccine too high.
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| 2830868 | 76 | F | ME | 03/12/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y007613 Y007613 |
Chest discomfort, Dizziness, Feeling hot, Flushing, Injection site pain; Nausea
Chest discomfort, Dizziness, Feeling hot, Flushing, Injection site pain; Nausea
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pain at injection site, nausea, lightheaded, feeling flushed and hot, dizziness, discomfort to chest
pain at injection site, nausea, lightheaded, feeling flushed and hot, dizziness, discomfort to chest
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| 2830869 | 50 | F | 03/12/2025 |
COVID19 |
JANSSEN |
211D21A |
Neuropathy peripheral, Vaccination complication
Neuropathy peripheral, Vaccination complication
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Patient's EMR states patient is unable to receive further vaccination from COVID-19 due to neur...
Patient's EMR states patient is unable to receive further vaccination from COVID-19 due to neuropathy caused by vaccination. Unclear of onset.
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| 2830870 | 22 | F | TN | 03/12/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y009782 X024648 |
Hypoaesthesia, Musculoskeletal stiffness, Rash, Rash pruritic, Swelling; Hypoaes...
Hypoaesthesia, Musculoskeletal stiffness, Rash, Rash pruritic, Swelling; Hypoaesthesia, Musculoskeletal stiffness, Rash, Rash pruritic, Swelling
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Left arm has quarter sized rash. This did not occur on the day of the vaccine admin. which was on 2/...
Left arm has quarter sized rash. This did not occur on the day of the vaccine admin. which was on 2/27/25. It occured on 3/11/25. It is itchy and she has been applying hydrocortisone to area. Right side where the mmr was given, she has a stiff neck as well a bump behind the right ear that has local numbness. no swelling or redness or rash involvment.
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| 2830871 | 31 | F | PA | 03/12/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN |
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Arthralgia, Back pain, Blood test, Colonoscopy, Computerised tomogram; Dizziness...
Arthralgia, Back pain, Blood test, Colonoscopy, Computerised tomogram; Dizziness, Endoscopy, Food allergy, Gastrointestinal disorder, Gluten sensitivity; Magnetic resonance imaging, Milk allergy, Neck pain, Pain, Stool analysis; Tremor, Ultrasound scan, Urine analysis, Visual impairment, Weight decreased; X-ray; Arthralgia, Back pain, Blood test, Colonoscopy, Computerised tomogram; Dizziness, Endoscopy, Food allergy, Gastrointestinal disorder, Gluten sensitivity; Magnetic resonance imaging, Milk allergy, Neck pain, Pain, Stool analysis; Tremor, Ultrasound scan, Urine analysis, Visual impairment, Weight decreased; X-ray
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Tremors, GI issues, allergies to beef, chicken, pork, eggs, gluten, soy, dairy, and much more, dizzy...
Tremors, GI issues, allergies to beef, chicken, pork, eggs, gluten, soy, dairy, and much more, dizzy spells, all the time pain, pain when i get too cold/hot, constant joint pain, changes in eye sight, pain in the base of my neck that leads down my back
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| 2830872 | 49 | M | MA | 03/12/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0176 EW0175 |
Cardiac arrest, Implantable defibrillator insertion, Myocarditis
Cardiac arrest, Implantable defibrillator insertion, Myocarditis
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Cardiac arrest myocarditis
Cardiac arrest myocarditis
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โ | โ | ||||
| 2830873 | F | 03/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dyspnoea
Dyspnoea
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Patient received 2 Pfizer vaccines in March 2021. Later in Oct 30, 2021 patient went to ER for short...
Patient received 2 Pfizer vaccines in March 2021. Later in Oct 30, 2021 patient went to ER for shortness of breath. ER note does not link a correlation to the vaccine however chart has been updated to state an allergy to the COVID vaccine for shortness of breath. Further information not available.
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| 2830874 | 72 | F | ND | 03/12/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52R7B |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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Pt. reports arm swelling and pain since injection that has worsened over the last week.
Pt. reports arm swelling and pain since injection that has worsened over the last week.
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