| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2865400 | 77 | M | CA | 10/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
my9547 my9547 |
Back pain, Eye swelling, Mouth swelling, Rash, Rash macular; Swelling face, Swol...
Back pain, Eye swelling, Mouth swelling, Rash, Rash macular; Swelling face, Swollen tongue, Tenderness
More
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Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Genera...
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: back pain-Severe, Additional Details: gradual symptom onset 10/01: 8p lower back pain resolved with tylenol/cod 10/02: jaw swollen, tender and pink dots on lower back area 10/03:pink dots spread to front of chest and size increase 10/04: pink dots increased in size and covered all body except face 10/05: spots increased in size and spotchy, meshed together as generalized rash. 10/06 pt made appt with doc confirming side effect to vaccine
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| 2865401 | 60 | F | MN | 10/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4ty55 |
Rash, Urticaria
Rash, Urticaria
|
Systemic: Allergic: Rash Generalized-Mild, Systemic: hives generalized-Mild, Additional Details: del...
Systemic: Allergic: Rash Generalized-Mild, Systemic: hives generalized-Mild, Additional Details: delayed reaction to vaccine. per pt symptoms started the next day after getting vaccine. , Other Vaccines: VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi-pastuer; LotNumber: u8889ca; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2865403 | 41 | F | NV | 10/13/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
2NG23 |
Circumstance or information capable of leading to medication error
Circumstance or information capable of leading to medication error
|
Systemic: POSSIBLY WRONG ARM DOCUMENTED-Mild, Additional Details: PT ACCOUNT SHOWED 4 VACCINES DISPE...
Systemic: POSSIBLY WRONG ARM DOCUMENTED-Mild, Additional Details: PT ACCOUNT SHOWED 4 VACCINES DISPENSED BUT SHE ONLY RECEIVED ONE VACCINE. THROUGH CONVERSATION WITH PATIENT SHE SAID PHARMACIST CAME AND VERIFIED VACCINE BEFORE IMMUNIZING AND ASKED FLU/COVID? AND PT VEHEMENTLY SAID NO COVID AT WHICH POINT SHE RECEIVED 1 VACCINE. PT ALSO SAID SHE GOT VACCINE IN RIGHT ARM NOT LEFT AS DOCUMENTED. PHARMACY WAS HAVING MAJOR COMPUTER ISSUES THAT FRIDAY WHICH MAY HAVE CONTRIBUTED TO THE ISSUE.
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| 2865404 | 8 | F | NJ | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052741 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Site: Pain at Injection Site-Mild, Additional Details: adults dose of spikevax covid vaccine was adm...
Site: Pain at Injection Site-Mild, Additional Details: adults dose of spikevax covid vaccine was administered instead of the pediatric dose. no site reaction, adverse event or any side effects were observed
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| 2865405 | 63 | M | OH | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Chills, Nausea, Pain, Pyrexia
Chills, Nausea, Pain, Pyrexia
|
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional...
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: Patient's wife said since recieving the covid and flu shot, pt has had chills, fevers, body aches and nausea few days a week, Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: seqirus,inc; LotNumber: 407000; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 09/14/2025
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| 2865406 | 84 | F | FL | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052154 |
Confusional state, Fall, Hallucination, Pyrexia
Confusional state, Fall, Hallucination, Pyrexia
|
Systemic: Confusion-Severe, Systemic: Fever-Mild, Systemic: had hallucinations and fell-Severe, Addi...
Systemic: Confusion-Severe, Systemic: Fever-Mild, Systemic: had hallucinations and fell-Severe, Additional Details: daughter has complained that all 4 shots at once has caused her mother to have hallucination and to fall. been hospitalized twice since had shots on 9/22. , Other Vaccines: VaccineTypeBrand: Fluzone High dose; Manufacturer: Sanofi-pasteur; LotNumber: ut8820ca; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 09/22/2025, VaccineTypeBrand: prevnar 20; Manufacturer: wyeth/pfizer; LotNumber: ma2505; Route: IM; BodySite: right arm; Dose: 1; VaxDate: 09/22/2025, VaccineTypeBrand: abrysvo act-o-vial; Manufacturer: pfizer; LotNumber: mm9159; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 09/22/2025
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โ | |||||
| 2865407 | 45 | F | TX | 10/13/2025 |
FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. |
406999 406999 |
Asthenia, Injection site discolouration, Injection site pain, Joint injury, Mobi...
Asthenia, Injection site discolouration, Injection site pain, Joint injury, Mobility decreased; Pain in extremity, Sleep disorder
More
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Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Se...
Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Weakness-Severe, Additional Details: Pt received vaccine on09/09/2023 , came to see me on 09/23/2025 with arm pain and said she cant raise her arm. Puncture mark was black on her left deltoid, slightly to left of center. I told her to see her doctor right away. Dr ordered prednisone and antiinflammatory with gabapentin but she could not tolerate gabapentin. She came to see me on Oct 7 and said she still has bad pain and cant lie on her arm. She will revisit her doctor this week., Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: Sequiris; LotNumber: 406999; Route: IM; BodySite: L deltoid; Dose: 1; VaxDate: 09/09/2025
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| 2865408 | 71 | F | CA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
my9547 |
Immediate post-injection reaction, Injection site bruising, Injection site haemo...
Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site pain, Injection site swelling
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Inje...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came in 10/7/25 showing pharmacist of the large, dark bruise 4 days post immunization. Patient stated a bump immediately formed post injection and she bled. She went home and iced her arm. The bruise is still significant but pain and swelling subsided
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| 2865409 | 74 | M | MI | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
8829ba |
Joint injury
Joint injury
|
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium
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| 2865410 | 65 | F | MO | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
ut8829ba |
Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia
Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbess and t...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbess and tingling in face-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Getting MRI done to determine if okay
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| 2865411 | 36 | F | GA | 10/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5N79Z |
Exposure during pregnancy, Injection site erythema, Product use issue, Wrong pro...
Exposure during pregnancy, Injection site erythema, Product use issue, Wrong product administered
More
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Site: Redness at Injection Site-Mild, Additional Details: PATIENT WAS 34 WEEKS PREGNANT AT THE TIME ...
Site: Redness at Injection Site-Mild, Additional Details: PATIENT WAS 34 WEEKS PREGNANT AT THE TIME OF VACCINE. PT GOT AREXVY INSTEAD OF ABRYSVO VACCINE. DR IS AWARE AN NO CONCERN TO THE PATIENT OR TO THE BABY. NO SPECIAL MONITORING FOR THE PATIENT BEYOND ROUTINE PRENTAL CARE IS NEEDED.
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| 2865412 | 85 | M | IN | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
u8862ba |
Injection site erythema
Injection site erythema
|
Site: Redness at Injection Site-Medium, Additional Details: Patient states a large red area appeared...
Site: Redness at Injection Site-Medium, Additional Details: Patient states a large red area appeared below injection.. states was 2-3 inches by 5-6 inches. It was improving as of 10/07. Was not seen by a provider
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| 2865413 | 39 | F | TX | 10/13/2025 |
FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. |
406999 406999 |
Confusional state, Dizziness, Flushing, Hyperhidrosis, Injection site bruising; ...
Confusional state, Dizziness, Flushing, Hyperhidrosis, Injection site bruising; Injection site erythema, Injection site swelling
More
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Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at I...
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient was sitting and laying on floor for about 20 minutes. she was given water and crackers and left when she felt better
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| 2865414 | 39 | F | IL | 10/13/2025 |
FLUC4 |
SEQIRUS, INC. |
406982 |
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event
More
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Site: Pain at Injection Site-Mild, Additional Details: No adverse effects - only selected pain becau...
Site: Pain at Injection Site-Mild, Additional Details: No adverse effects - only selected pain because I had to select something. Immunization was given to myself as a patient and as the provider by RN before I realized that I would need to sign off on the order. It was my mistake and I updated my manager.
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| 2865415 | F | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Erythema, Pyrexia, Skin erosion
Erythema, Pyrexia, Skin erosion
|
chest became red raw; Fever; This non-serious case was reported by a consumer via interactive digita...
chest became red raw; Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a adult female 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 erythema (Verbatim: chest became red raw) and fever (Verbatim: Fever). The outcome of the erythema and fever were not reported. The reporter considered the erythema and fever to be related to Shingrix. The company considered the erythema and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and had an extremely bad reaction. The chest became red raw and had a fever. The patient refused the follow up shot. The batch number was not provided and we and unable to contact the reporter.
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| 2865417 | 48 | M | AZ | 10/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA0739 NA0739 |
Dizziness, Flushing, Hyperhidrosis, Hypotension, Injection site bruising; Syncop...
Dizziness, Flushing, Hyperhidrosis, Hypotension, Injection site bruising; Syncope
More
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Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Faintin...
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: seqirus; LotNumber: 948395; Route: im; BodySite: left deltoid; Dose: ; VaxDate: 10/08/2025
More
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| 2865418 | 77 | F | CA | 10/13/2025 |
COVID19-2 COVID19-2 |
MODERNA MODERNA |
3052155 3052155 |
Dizziness, Fatigue, Heart rate irregular, Lethargy, Muscular weakness; Pain
Dizziness, Fatigue, Heart rate irregular, Lethargy, Muscular weakness; Pain
|
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Additional Detai...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Pt received vaccine at pharmacy with no issues. Overnight, pt began to experience intense pain, weak legs and irregular heartbeat as described by the emergency room.
More
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| 2865419 | 31 | F | VA | 10/13/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
9FG5M |
Joint injury
Joint injury
|
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium
|
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| 2865420 | 74 | M | FL | 10/13/2025 |
FLUA4 |
SEQIRUS, INC. |
407264 |
Syringe issue
Syringe issue
|
Systemic: Vaccine leaked from syringe. Gave another injection so patient received full dose-Mild, A...
Systemic: Vaccine leaked from syringe. Gave another injection so patient received full dose-Mild, Additional Details: n/a, Other Vaccines: VaccineTypeBrand: Arexy; Manufacturer: GSK; LotNumber: 2293b; Route: IM; BodySite: Deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Mnexspike; Manufacturer: Moderna; LotNumber: 3052036; Route: IM; BodySite: Deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Boostrix; Manufacturer: GSK; LotNumber: h4279; Route: IM; BodySite: Deltoid; Dose: ; VaxDate: UNKNOWN
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| 2865421 | 30 | M | NJ | 10/13/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
2ng23 |
Hypotension, Nausea, Syncope, Unresponsive to stimuli
Hypotension, Nausea, Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
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| 2865422 | 30 | F | VA | 10/13/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH MODERNA MODERNA MODERNA |
na4452 na4452 na4452 |
Extra dose administered, Injection site bruising, Wrong product administered; Ex...
Extra dose administered, Injection site bruising, Wrong product administered; Exposure during pregnancy, Extra dose administered, Foetal non-stress test normal, Headache, Pain; Respiratory tract congestion, Rhinorrhoea, Ultrasound antenatal screen normal, Wrong product administered; Extra dose administered, Injection site bruising, Wrong product administered; Exposure during pregnancy, Extra dose administered, Foetal non-stress test normal, Headache, Pain; Respiratory tract congestion, Rhinorrhoea, Ultrasound antenatal screen normal, Wrong product administered
More
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Site: Bruising at Injection Site-Mild, Systemic: nothing noticed-Mild, Additional Details: i acciden...
Site: Bruising at Injection Site-Mild, Systemic: nothing noticed-Mild, Additional Details: i accidently gave her 2 covid shots instead of covid and flu, Other Vaccines: VaccineTypeBrand: covid19; Manufacturer: pfizer; LotNumber: na4452; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 10/08/2025
More
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| 2865423 | 77 | F | FL | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
6315mf002c |
No adverse event, Product storage error
No adverse event, Product storage error
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Systemic: none reported. vaccine had temperature excursion-Mild, Additional Details: no adverse effe...
Systemic: none reported. vaccine had temperature excursion-Mild, Additional Details: no adverse effects were reported but the vaccine had a temperature excursion during delivery and it was not reported to our store until after we had already given it to the patient.
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| 2865424 | 61 | M | WI | 10/13/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3052671 3052671 |
Brain oedema, Encephalitis, Loss of consciousness, Malaise, Visual impairment; V...
Brain oedema, Encephalitis, Loss of consciousness, Malaise, Visual impairment; Vomiting
More
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Systemic: Encephalitis-Severe, Additional Details: Patient had gotten both vaccines at 4 pm on 9/19/...
Systemic: Encephalitis-Severe, Additional Details: Patient had gotten both vaccines at 4 pm on 9/19/2025. At around 4 am the patient had started feeling very sick and vomiting. The patient has visual changes and had passed out. The patient's fiance had called the paramedics and was transported to the hospital and was found to have encephalitis. The patient remained in the hospital for 2 days and is still requiring a follow up MRI for the brain swelling. The neurologist believes swelling to be due to a viral issue. , Other Vaccines: VaccineTypeBrand: Flu- Flucelvax 2025-2025; Manufacturer: Seqirus; LotNumber: 406999; Route: Intramuscular; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
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โ | |||||
| 2865425 | 69 | F | MA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
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-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Inject...
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Other Vaccines: VaccineTypeBrand: Fluzone High-Dose 2025-26; Manufacturer: Sanofi-Pasteur; LotNumber: U8859AA; Route: IM; BodySite: Upper Left arm deltoid muscle; Dose: 1; VaxDate: 10/01/2025
More
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| 2865426 | 51 | F | MN | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
na0738 |
Headache, Mobility decreased, Neck pain
Headache, Mobility decreased, Neck pain
|
Systemic: neck pain with loss of range of motion on right side-Medium, Systemic: Headache-Severe, Ad...
Systemic: neck pain with loss of range of motion on right side-Medium, Systemic: Headache-Severe, Additional Details: Patent called on 10/6/25 to report headache over the weekend and neck pain, mostly on right side, which was side with covid vaccine. Recommende pt call primary. Primary reached patient on 10/7/25 and recommened urgent care visit. Neurological exam was normal, headache was decreased but there was some decrease of range of motion in neck. Cyclobenzaprine prescribed. Pt report doing better today. Md unsure if related to vaccine. , Other Vaccines: VaccineTypeBrand: Fluzone; Manufacturer: Sanofi; LotNumber: u8767aa; Route: IM; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
More
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| 2865427 | 63 | F | NC | 10/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
2293b |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
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: pt saw pharmacist , possible injection was given to low on arm according to pharmacist
More
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| 2865429 | 48 | F | MN | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
my9548 |
Joint injury, Shoulder injury related to vaccine administration
Joint injury, Shoulder injury related to vaccine administration
|
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Visited Cli...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Visited Clinic and was diagnosed with SIRVA
More
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| 2865430 | 30 | F | VA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Injection site bruising, Injection site erythema, Injection site inflammation, I...
Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
More
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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, Site: Swelling at Injection Site-Medium, Additional Details: Flu/Covid given same day & later in day started to feel burning & swelling @ injection area. Presented next day to 2 Pharmacist (withheld) & (withheld) to reveal current status of injection area: a considerable circle aboiut 2 inches in diameter of a red & raised inflammed skin. Says main issue is burning feeling in skin & has been using ice since the previous day to try to alleviate the heat & inflammation. Noted area in question was not near deltoid but close to elbow; was improper technique., Other Vaccines: VaccineTypeBrand: Flu (Fluarix); Manufacturer: Glaxosmithkline; LotNumber: JE74J; Route: Intramuscular; BodySite: Right Arm; Dose: 1; VaxDate: 10/07/2025
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| 2865431 | 81 | M | FL | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
ut8820aa |
Injection site bruising
Injection site bruising
|
Site: Bruising at Injection Site-Mild, Additional Details: patient is on blood thinner, his whole ar...
Site: Bruising at Injection Site-Mild, Additional Details: patient is on blood thinner, his whole arm bruised up after vaccination, i alerted him to see his md to double check
More
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| 2865433 | 76 | F | UT | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93KK4 |
Injection site erythema, Injection site pruritus, Rash
Injection site erythema, Injection site pruritus, Rash
|
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Other Vaccines: VaccineTypeBrand: Fuzone High-Dose; Manufacturer: Sanofi; LotNumber: U8800AA; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 10/06/2025
More
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| 2865434 | 92 | F | FL | 10/13/2025 |
FLUA4 |
SEQIRUS, INC. |
407264 |
Asthenia, Dizziness, Syncope, Tremor, Unresponsive to stimuli
Asthenia, Dizziness, Syncope, Tremor, Unresponsive to stimuli
|
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shak...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Mild
More
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| 2865435 | 79 | M | VA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
x5t42 |
Arthralgia, Injection site pain, Pain in extremity, Product administered at inap...
Arthralgia, Injection site pain, Pain in extremity, Product administered at inappropriate site
More
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Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: shot was given...
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: shot was given high on the shoulder and the patient is still having pain in his arm
More
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โ | |||||
| 2865436 | 9 | M | CA | 10/13/2025 |
FLUC4 |
SEQIRUS, INC. |
948394 |
Cellulitis, Injection site erythema, Injection site pain, Injection site swellin...
Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
More
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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: mom described as injection site swollen, per rx diagnosis cellulitis of left upper limb, per school nurse allergic rxn
More
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| 2865437 | 51 | F | CA | 10/13/2025 |
PNC21 |
MERCK & CO. INC. |
z006076 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
|
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Inje...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
More
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| 2865438 | 60 | M | MO | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
TS525 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
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 ALSO HAS A FREESTYLE LIBRE 3 SENSOR ON THIS ARM. PT WENT TO URGENT CARE AND DR SAID BACTERIAL INFECTION DUE TO DIRTY NEEDLE OR SIGHT NOT CLEAN ENOUGH. DR TOLD HIM THIS HAPPENS ALL THE TIME WE GAVE HIM HIS ANTIBIOTIC AND MEDROL DOSE PACK FREE OF HIS INSURANCE COPAY
More
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| 2865439 | 77 | F | NJ | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
U8800AA |
Dyspnoea, Hypersensitivity
Dyspnoea, Hypersensitivity
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Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Unsure if received Epipen or be...
Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Unsure if received Epipen or benadryl but assume so because of allergic reaction. aslo not sure of severity but need to input to submit. Did not get at store and indicated no issues when they left. Pt got fluzone hd at 1030am and called at 330 pm stating she was being transported to er with trouble breathing. Spoke to md with patient and advised the vaccine and manufacturer that was given.
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| 2865440 | 65 | M | IA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9648 |
Chest discomfort, Chest pain, Chills, Injection site pain, Pyrexia
Chest discomfort, Chest pain, Chills, Injection site pain, Pyrexia
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Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ...
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: Pt states that he experienced sharp chest pain, fever, and chills. Pt ended up going to the ER to review symptoms. Pt notified pharmacy of adverse reaction. Documenting experience.
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| 2865441 | 82 | M | KY | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Injection site bruising, Injection site erythema
Injection site bruising, Injection site erythema
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Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild
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| 2865442 | 65 | M | CA | 10/13/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
u8859aa u8859aa |
Asthenia, Dizziness, Headache, Injection site pain, Pain; Pain in extremity, Pai...
Asthenia, Dizziness, Headache, Injection site pain, Pain; Pain in extremity, Pain in jaw, Pyrexia, Rash
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Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / ...
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: patient had fever for 3 weeks, pain in leg,jaw and headache. patient had rash in the back.-Medium, Systemic: Weakness-Medium, Additional Details: patient daughter called for the vaccine record. patient had fever, pain in leg and jaw. patient had developed rash on the back. patient is been hospitalized for almost week now. Patient is under observation and waiting for the diagnosis form doctor per daughter.
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| 2865443 | 56 | M | MA | 10/13/2025 |
COVID19 COVID19 COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
6315MF002C 6315MF002C 6315MF002C 6315MF002C |
Arthralgia, Asthenia, Chills, Dizziness, Fatigue; Flushing, Headache, Hyperhidro...
Arthralgia, Asthenia, Chills, Dizziness, Fatigue; Flushing, Headache, Hyperhidrosis, Hypoaesthesia, Lethargy; Neurological symptom, Pain, Paraesthesia, Pyrexia, Sleep disorder; Tremor
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Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadnes...
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: Patient noted previous MD has diagnosed him with "systemic vaccine injury" - causing neurological issues. Patient did research and wanted to still try to get NOVAVAX vaccine and stated that he had numbness/tingling on hands, in addition to previously selected ADRs/outcomes. Patient had follow up with providers after vaccination and assured patient it was likely common side effects but will continue to monitor outpatient. Patient stated they will keep pharmacy updated on progress/recovery.
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| 2865445 | 81 | F | WV | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
U8862BA |
Injection site erythema, Injection site inflammation, Injection site swelling
Injection site erythema, Injection site inflammation, Injection site swelling
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details:...
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient report having a swelling, inflammed and red arm since October 06, 2025 untill now, Other Vaccines: VaccineTypeBrand: Prevnar; Manufacturer: Pfizer; LotNumber: MA2505; Route: IM; BodySite: Right deltoid; Dose: ; VaxDate: UNKNOWN
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| 2865446 | 55 | F | CA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5y4tl |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
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| 2865447 | 34 | M | RI | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
na4457 |
Dizziness, Syncope, Unresponsive to stimuli
Dizziness, Syncope, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
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| 2865448 | 77 | M | CA | 10/13/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
xa35y xa35y |
Cough, Fatigue, Hypersomnia, Influenza like illness, Lethargy; Pain, Respiratory...
Cough, Fatigue, Hypersomnia, Influenza like illness, Lethargy; Pain, Respiratory tract congestion
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Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: congestio...
Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: congestion, cough, heavy flu like symptoms was sleeping more than usual for 2 days after vax-Severe, Other Vaccines: VaccineTypeBrand: fluzone hd 2025-2026; Manufacturer: sanofi; LotNumber: ut8763fa; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: mnexspike 2025-2026; Manufacturer: moderna; LotNumber: 3052036; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
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| 2865449 | 31 | M | MA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
na4452 |
Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie...
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had 3 Vaccines tonight 10/09/2025. He felt a little light headed after the vaccines. Pt sat down in waiting area after vaccines then he fainted for a minute. He refused when he was asked to get ambulance and his partner refused that we call EMS. Him and his partner said this happens every time he gets vaccinated. Pt watied till he was better and got his color back then his partner drove him back home., Other Vaccines: VaccineTypeBrand: Boostrix TDAP Vaccine; Manufacturer: Glaxosmithkline; LotNumber: 292H2; Route: IM; BodySite: Right deltoid; Dose: unknown; VaxDate: 10/09/2025, VaccineTypeBrand: Fluarix 2025-2026; Manufacturer: Glaxosmithkline; LotNumber: 2NG23; Route: IM; BodySite: Left deltoid; Dose: unknown; VaxDate: 10/09/2025
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| 2865450 | 53 | M | CA | 10/13/2025 |
PNC20 |
PFIZER\WYETH |
MA2488 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injecti...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt received Prevnar 20 on the Right arm on Wednesday evening (10/1/25). On Sun 10/5/2025, pt came in to pick up meds for reactions thats when Rph on duty discovered the adverse effect of 2-3 in warm to touch redness around the injection site. Patient denied any difficulty breathing nor pain. Pt's number on file went straight to VM so Rph couldn't follow up and check on pt's improvement or wellbeing. Rph left message. Rph reached out to doctor office but didn't get to talk to the office yet.
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| 2865451 | M | 10/13/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Respiratory syncytial virus infection, Vaccination failure
Respiratory syncytial virus infection, Vaccination failure
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hospitalized with rsv; Suspected vaccination failure; This serious case was reported by a consumer v...
hospitalized with rsv; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, less than a month after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: hospitalized with rsv) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by a consumer via interactive digital media. The reporter reported that the patient got RSV vaccine and 3 weeks later he was hospitalized with respiratory syncytial virus infection. The reporter said that please avoid this vaccine. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of respiratory syncytial virus infection was unknown at the time of reporting. The batch number was not provided and we and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, Less than a month after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
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| 2865452 | 66 | F | TX | 10/13/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
mn0315 mn0315 |
Chest discomfort, Chest pain, Chills, Dizziness, Headache; Pyrexia
Chest discomfort, Chest pain, Chills, Dizziness, Headache; Pyrexia
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Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / ...
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Other Vaccines: VaccineTypeBrand: fluzone HD; Manufacturer: ; LotNumber: UT8829BA; Route: IM; BodySite: Left deltoid; Dose: 1; VaxDate: 10/07/2025, VaccineTypeBrand: Mnexspike 25-26; Manufacturer: ; LotNumber: 3052154; Route: IM; BodySite: Right deltoid; Dose: 1; VaxDate: 10/07/2025, VaccineTypeBrand: Prevnar 20; Manufacturer: ; LotNumber: ma2506; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 10/07/2025
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| 2865453 | 31 | F | CO | 10/13/2025 |
FLUC4 |
SEQIRUS, INC. |
498394 |
Injected limb mobility decreased, Joint injury, Loss of personal independence in...
Injected limb mobility decreased, Joint injury, Loss of personal independence in daily activities, Product administered at inappropriate site
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Additional Details: Patient rep...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Additional Details: Patient reports and confirmed by MD that vaccine was injected into the biceps tendon, patient is now in PT for limited mobility and reduced activities of daily living.
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| 2865454 | 53 | F | CA | 10/13/2025 |
COVID19-2 |
PFIZER\BIONTECH |
na0587 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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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
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