| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2865339 | 26 | F | MA | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052741 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Severe
Systemic: Fainting / Unresponsive-Severe
|
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| 2865340 | 14 | F | TN | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
ut8873ja |
Dizziness
Dizziness
|
Systemic: Dizziness / Lightheadness-Mild, Additional Details: After patient received vaccine she fel...
Systemic: Dizziness / Lightheadness-Mild, Additional Details: After patient received vaccine she felt lightheaded/faint. She laid down but was Never was unresponsive. Gave water and a sucker and she recovered quickly.
More
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| 2865342 | 12 | F | MD | 10/13/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
JE74J |
Dizziness
Dizziness
|
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient experienced dizziness/light he...
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient experienced dizziness/light headedness and was helped to the floor by parent. After drinking some water and taking 25 mg benadryl tablet, patient was able to sit up and recovered nicely. Patient never fainted ot lost consciousness. After additional 20 minutes of observation patient was able to leave with parents un assisted.
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| 2865343 | 70 | F | NY | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
my9547 |
Rash, Urticaria
Rash, Urticaria
|
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Rash (hives) on both arms, Other Vacc...
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Rash (hives) on both arms, Other Vaccines: VaccineTypeBrand: influenza - fluad; Manufacturer: sequirus; LotNumber: 407241; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
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| 2865344 | F | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain in extremity, Peripheral swelling
Pain in extremity, Peripheral swelling
|
ARM,was swollen; extremely sore; This non-serious case was reported by a consumer via interactive di...
ARM,was swollen; extremely sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm 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 swelling arm (Verbatim: ARM,was swollen) and pain in arm (Verbatim: extremely sore). The outcome of the swelling arm and pain in arm were not reported. The reporter considered the swelling arm and pain in arm to be related to Shingrix. The company considered the swelling arm and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 28-SEP-2025 The patient received Shingrix vaccine and hole arm was swollen and extremely sore. The batch number was not provided and we and unable to contact the reporter.; Sender's Comments: US-GSK-US2025AMR126223:same reporter, Different patient
More
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| 2865345 | 68 | M | VA | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052733 |
Injection site pruritus, Pruritus, Rash, Urticaria
Injection site pruritus, Pruritus, Rash, Urticaria
|
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Aller...
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: customer has hives on body
More
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| 2865346 | 56 | F | WI | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
8146670 |
Injection site pruritus, Injection site swelling
Injection site pruritus, Injection site swelling
|
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details:...
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: The patient called to report itching and swelling at administration site 2 days following. She asked if taking benadryl for the itching would be ok which I did confirm was ok. Also, I recommended topical steroid cream for itching if needed., Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: GSK; LotNumber: Px3p7; Route: IM; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
More
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| 2865347 | 75 | F | CA | 10/13/2025 |
COVID19 |
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
More
|
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-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: comirnaty pfizer; Manufacturer: pfizer; LotNumber: na0587; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
More
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| 2865348 | 62 | F | MA | 10/13/2025 |
COVID19-2 COVID19-2 |
MODERNA MODERNA |
3052741 3052741 |
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; Product administered at inappropriate site
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, Site: Swelling at Injection Site-Medium, Additional Details: reddness/swelling is under deltoid in a wide strip across front of arm - 1 or both vaccines probably given too low and irritated nerve - pt reports swelling occured a day after vaccine given and its itchy and sore, Other Vaccines: VaccineTypeBrand: flublock; Manufacturer: pfizer; LotNumber: u8832aa; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 10/03/2025
More
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| 2865349 | 72 | F | NJ | 10/13/2025 |
FLU4 FLU4 FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8837DA U8837DA U8837DA U8837DA |
Chills, Cyanosis, Diarrhoea, Dizziness, Eye swelling; Feeling cold, Flushing, He...
Chills, Cyanosis, Diarrhoea, Dizziness, Eye swelling; Feeling cold, Flushing, Headache, Hyperhidrosis, Injection site erythema; Malaise, Mouth swelling, Nausea, Pain, Paraesthesia; Swelling face, Swollen tongue
More
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Site: Redness at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-S...
Site: Redness at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient got vaccine at 10:15am, said felt sick from 1 to 5:30pm, was very cold and warmed up around 8pm. had purple swollen mouth
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| 2865350 | 23 | F | NJ | 10/13/2025 |
FLUC4 |
SEQIRUS, INC. |
406981 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed me before giving the ...
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed me before giving the vaccine that she does faint when getting vaccines so I was aware before anything happened. After the vaccine was given she sat for a few minutes but then fainted twice. We didn't need to call the ambulance and she stayed for a few hours waiting for a ride. We didn't feel comfortable letting her go home alone so watched her until her family arrived to pick her up. I called her on Saturday and she said she was feeling a lot better.
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| 2865351 | 32 | F | NC | 10/13/2025 |
FLUC4 |
SEQIRUS, INC. |
407009 |
Injection site erythema, Injection site pain, Injection site swelling, Joint inj...
Injection site erythema, Injection site pain, Injection site swelling, Joint injury
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, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium
More
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| 2865352 | 42 | F | TX | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052784 |
Chills, Headache, Pain, Tachycardia
Chills, Headache, Pain, Tachycardia
|
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Headache-Severe, Systemi...
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Headache-Severe, Systemic: Tachycardia-Medium, Other Vaccines: VaccineTypeBrand: flu, flucelvax; Manufacturer: seqirus; LotNumber: 406981; Route: right deltoid; BodySite: ; Dose: ; VaxDate: 10/02/2025
More
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| 2865354 | 38 | F | OH | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Confusional state, Dizziness, Syncope, Unresponsive to stimuli
|
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo...
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Other Vaccines: VaccineTypeBrand: Fluarix; Manufacturer: GlaxoSmithKline; LotNumber: 73BN2; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 10/05/2025
More
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| 2865357 | 82 | F | CA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Dizziness, Fatigue, Lethargy, Nausea
Dizziness, Fatigue, Lethargy, Nausea
|
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: FELT LIKE ...
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: FELT LIKE PASSING OUT-Mild, Systemic: Nausea-Mild, Other Vaccines: VaccineTypeBrand: FLUAD; Manufacturer: ; LotNumber: 407243; Route: IM; BodySite: ARM; Dose: ; VaxDate: UNKNOWN
More
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| 2865359 | 69 | F | TX | 10/13/2025 |
PNC20 |
PFIZER\WYETH |
z006076 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
|
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, Additional Details: will follow up with pt in 48 hours
More
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| 2865360 | 20 | M | DE | 10/13/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
y020588 y020588 |
Dizziness, Injection site erythema, Injection site pain, Injection site pruritus...
Dizziness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Pruritus, Rash
More
|
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ...
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient noticed increased redness and itching 2 days post vaccine. Pharmacist recommended that patient seek medical attention. Patient went to urgent care and received an rx for doxycyline just in case there was a mild cellulitis infection. Patient reported that the provider thought it was most likely an allergic response not an infection. Patient purchased Claritin otc to take to help mitigate the histamine response., Other Vaccines: VaccineTypeBrand: heplisav-b; Manufacturer: dynavax technologies; LotNumber: 948203; Route: im; BodySite: l arm; Dose: 1; VaxDate: 10/03/2025
More
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| 2865361 | 15 | M | MD | 10/13/2025 |
MNQ |
SANOFI PASTEUR |
u8645aa |
Hypotension, Loss of consciousness
Hypotension, Loss of consciousness
|
Systemic: Hypotension-Severe, Additional Details: patient passed out about 5-10 minutes after the in...
Systemic: Hypotension-Severe, Additional Details: patient passed out about 5-10 minutes after the injection. blood pressure was going down to 91/60 and gradually went back to 116/65 then ems came
More
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| 2865362 | F | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Therapeutic response unexpected
Therapeutic response unexpected
|
no Shingles and they actually assist with amyloid plaques in the brain too.; This non-serious case w...
no Shingles and they actually assist with amyloid plaques in the brain too.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect 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 unexpected therapeutic effect (Verbatim: no Shingles and they actually assist with amyloid plaques in the brain too.). The outcome of the unexpected therapeutic effect was not applicable. Additional Information: GSK Receipt Date: 30-SEP-2025 The patient got both Shingles shots, no shingles and they actually assist with amyloid plaques in the brain too. The batch number was not provided and we and unable to contact the reporter.
More
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| 2865363 | 52 | F | CA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5Y4TL |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
|
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| 2865364 | 66 | F | CA | 10/13/2025 |
PNC20 |
PFIZER\WYETH |
MA2488 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: Va...
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: BOOSTRIX TDAP; Manufacturer: ; LotNumber: PX3P7; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: ; VaxDate: 09/26/2025
More
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| 2865365 | 85 | F | PA | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Injection site haemorrhage, Injection site pain, Injection site swelling
Injection site haemorrhage, Injection site pain, Injection site swelling
|
Site: Bruising at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details...
Site: Bruising at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Gave patient immunization in the left deltoid muscle. After removal of the injection, injection site bled. Once blood was cleaned a "bubble" formed at the site of injection. Patient was instructed to sit for 15 min after vaccine. Patient did not experience any allergic reaction. Patient did not feel signs or symptoms of anaphylaxis. Called patient from home two hours later. Site did not get worse and patient has felt no reactions to the vaccine. Pt instructed to seek ER if symptoms develop., Other Vaccines: VaccineTypeBrand: flu (Fluzone); Manufacturer: Sanofi-Pasteur; LotNumber: U8862AA; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 09/29/2025
More
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| 2865366 | 59 | F | VA | 10/13/2025 |
COVID19-2 |
PFIZER\BIONTECH |
na4452 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Medium
Systemic: Fainting / Unresponsive-Medium
|
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| 2865367 | 77 | F | NC | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
u88800ba |
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
More
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| 2865368 | 64 | F | PA | 10/13/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
2009681 2009681 |
Burning sensation, Cellulitis, Chills, Injection site erythema, Injection site p...
Burning sensation, Cellulitis, Chills, Injection site erythema, Injection site pain; Pain in extremity, Pyrexia
More
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Chills-Severe...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Pt wrote these on a paper: got vaccine on 10/1, all ok when i left. oct 1 night, i had some pain in left arm, next day at work i was experiencing chills and had a fever of 103 f, took motrin. On oct 3, whole day it felt like arm on fire, continued with tylenol and motrin, that night, my daughter who is a resident and declared i have cellulitis, doctor ordered keflex 500mg 7 wk 4 cap a day, my arm is still very red and i continue to have burning pain with meds but no fever and chills
More
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| 2865369 | 60 | F | PA | 10/13/2025 |
RSV |
PFIZER\WYETH |
mn0307 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
|
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ...
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: Flu (Flucelvax); Manufacturer: Seqirus; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Covid (Comirnaty); Manufacturer: Pfizer; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
More
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| 2865370 | 77 | F | CA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5y9ca |
Hypoaesthesia, Injection site pain, Joint injury, Muscular weakness, Paraesthesi...
Hypoaesthesia, Injection site pain, Joint injury, Muscular weakness, Paraesthesia
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: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient reports that her right arm has prolonged numbess, tingling, and weakness. Has visited the doctor and diagnosed with neurological disability due to vaccine. Patient is to undergo physical therapy.
More
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โ | |||||
| 2865371 | 73 | F | NV | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
na4452 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
|
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Other Vaccines: Vaccine...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: Fluzone High Dose; Manufacturer: ; LotNumber: UT8763FA; Route: IM; BodySite: Right arm; Dose: n/a; VaxDate: 10/06/2025
More
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| 2865372 | 67 | M | NJ | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3051995 |
Injection site bruising, Injection site swelling
Injection site bruising, Injection site swelling
|
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pa...
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient had experienced bruise/swelling (Site Reactions to Vaccine). Patient was observed and swelling reduced after 2-3 minutes. No other symptoms were observed.
More
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| 2865373 | 39 | M | MN | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
8146670 |
Dizziness, Syncope, Unresponsive to stimuli
Dizziness, Syncope, Unresponsive to stimuli
|
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient felt dizzy after getting 2 shots and sat down on floor. It was discussed and decided to hold off on the third sheduled shot. He sat for awhile and was offered water/sugar. When he was ready he stood up to got sit on the bench, but as he started walking he fell to the ground as if he fainted. He was immediately responsive saying he was okay and after a few minutes was helped to the bench to steady himself. After about 15 minutes he walked out of store on his own., Other Vaccines: VaccineTypeBrand: Fluzone; Manufacturer: Sanofi; LotNumber: U8889CA; Route: IM; BodySite: Left Arm; Dose: N/A; VaxDate: 10/06/2025
More
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| 2865374 | 55 | F | CA | 10/13/2025 |
COVID19-2 COVID19-2 COVID19-2 |
MODERNA MODERNA MODERNA |
NA0587 NA0587 NA0587 |
Inflammation, Injection site bruising, Injection site erythema, Injection site p...
Inflammation, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Pain, Rash, Skin warm, Swelling; Tenderness
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, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: TENDER, PROGESSIVE SWELLING, INFLAMMED/HOT AREA-Medium, Additional Details: DIAGNOSIS AFTER DOCTOR VISIT: CELLULITIS OF THE UPPER LEFT ARM , Other Vaccines: VaccineTypeBrand: HEPLISAV-B; Manufacturer: DYNAVAX; LotNumber: 946912; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: 1; VaxDate: 10/03/2025, VaccineTypeBrand: SHINGRIX; Manufacturer: GSK; LotNumber: 5YNCA; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: 1; VaxDate: 10/03/2025, VaccineTypeBrand: ABRYSVO; Manufacturer: PFIZER; LotNumber: MD0315; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: 1; VaxDate: 10/03/2025
More
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| 2865375 | 71 | F | NY | 10/13/2025 |
FLU4 |
SANOFI PASTEUR |
ut8829ba |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt ...
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt was red and puffy at injection site, required no treatment
More
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| 2865376 | 53 | F | OH | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052671 |
Injection site bruising, Injection site pain
Injection site bruising, Injection site pain
|
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Other Vaccines: VaccineTy...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: Fluarix; Manufacturer: GlaxoSmithKline; LotNumber: 2CA5M; Route: IM; BodySite: Left deltoid; Dose: ; VaxDate: UNKNOWN
More
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| 2865378 | VA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
should I go ahead with the second shot or start a new two-shot; This non-serious case was reported b...
should I go ahead with the second shot or start a new two-shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: should I go ahead with the second shot or start a new two-shot ). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 30-SEP-2025 The patient got my first Shingrix shot in 2019, but had been unaware until recently that was supposed to get a second shot. The patient said that after six years, should go ahead with the second shot or start a new two-shot cycle.
More
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| 2865379 | 78 | F | CA | 10/13/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
az2a3 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe
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| 2865381 | 59 | F | MN | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052087 |
Diarrhoea, Pain
Diarrhoea, Pain
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Systemic: Body Aches Generalized-Severe, Systemic: Diarrhea-Severe
Systemic: Body Aches Generalized-Severe, Systemic: Diarrhea-Severe
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| 2865382 | 13 | F | OH | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Dizziness, Syncope, Tremor, Unresponsive to stimuli
Dizziness, Syncope, Tremor, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shak...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium
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| 2865384 | 69 | M | FL | 10/13/2025 |
PNC21 |
MERCK & CO. INC. |
z010457 |
Arthralgia, Joint injury, Pain, Pain in extremity
Arthralgia, Joint injury, Pain, Pain in extremity
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Says after ...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Says after vaccine for 1 month has been having extreme pain that radiates from shoulder down to forearm, Other Vaccines: VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: u8800ba; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 08/31/2025
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| 2865385 | 31 | M | PA | 10/13/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
7CF5M |
Dizziness, Flushing, Hyperhidrosis, Visual impairment
Dizziness, Flushing, Hyperhidrosis, Visual impairment
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Ch...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe
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| 2865387 | 55 | F | WI | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
More
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Injections for three vaccines given on 10/2/25. No issues noted until 10/6/25 where a rash had appeared, about 2 inches wide that is raised/red/warm/itches. She did apply an ice pack and that helped but it came back once ice was stopped. Discussed continuing ice and considering a benadryl dose if itching is severe and or applying topical hydrocortisone. she said she would try iceing more and call back if any further issues continued since she was at work., Other Vaccines: VaccineTypeBrand: Capvaxive; Manufacturer: merck sharp; LotNumber: z009681; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 10/02/2025, VaccineTypeBrand: Flucelvax; Manufacturer: seqirus; LotNumber: 948412; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
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| 2865388 | 79 | M | MO | 10/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
my9548 my9548 |
Injection site bruising, Injection site discolouration, Injection site erythema,...
Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Joint injury
More
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Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Mild, Site: Pain at Injecti...
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild, Additional Details: Patient called and mentioned he had gotten Partially dark areas around the injection site today. , Other Vaccines: VaccineTypeBrand: fluzone high dose; Manufacturer: sanofiy pasteur; LotNumber: ut8820ca; Route: Intramuscular; BodySite: Left deltoid; Dose: 1; VaxDate: 09/30/2025
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| 2865389 | 86 | F | IN | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
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| 2865391 | 48 | F | TX | 10/13/2025 |
FLUC4 |
SEQIRUS, INC. |
948412 |
Accident at work, Chills, Injection site pain, Injury associated with device
Accident at work, Chills, Injection site pain, Injury associated with device
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Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Additional Details: The detailed incident ...
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Additional Details: The detailed incident that prompted this report are as follows: I was the pharmacist on duty on 10/2/25 from 8am-8pm. I was actively giving vaccines to the patients and towards the evening I told my tech that the sharps container is getting filled up and he got side-tracked and forgot to replace it. He gave 3 more flu shots without replacing the sharps container and when it was my turn to administer to my patient, I did not see a used needle sticking out of the sharps container and it stuck me.
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| 2865392 | 62 | F | WV | 10/13/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3052663 3052663 |
Chills, Injection site erythema, Injection site pain, Injection site swelling, N...
Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea; Pyrexia
More
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: no taste-Severe, Systemic: Nausea-Severe, Other Vaccines: VaccineTypeBrand: Fluarix 2025-2026 syringe; Manufacturer: GSK; LotNumber: 39R9B; Route: Intramuscular; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
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| 2865393 | 68 | F | KY | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
Chills, Confusional state, Headache, Pain
Chills, Confusional state, Headache, Pain
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Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, System...
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Headache-Severe, Other Vaccines: VaccineTypeBrand: Fluzone High Dose; Manufacturer: Sanofi; LotNumber: UT8829BA; Route: Intramuscular; BodySite: Arm; Dose: NA; VaxDate: 09/09/2025
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| 2865394 | 77 | M | IN | 10/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052734 |
Injection site pain, Pain in extremity
Injection site pain, Pain in extremity
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Site: Pain at Injection Site-Severe, Additional Details: Pain was so severe in both arms that he had...
Site: Pain at Injection Site-Severe, Additional Details: Pain was so severe in both arms that he had to go to the ER, despite applying ice to areas and trying other things to help at home first. He was prescribed Tramadol and Prednisone., Other Vaccines: VaccineTypeBrand: fluzone high-dose; Manufacturer: sanofi-pasteur; LotNumber: u88628a; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2865395 | 62 | F | CT | 10/13/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
8146367 8146367 |
Asthenia, Body temperature increased, Chills, Fatigue, Injection site erythema; ...
Asthenia, Body temperature increased, Chills, Fatigue, Injection site erythema; Injection site rash, Lethargy, Rash
More
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Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-M...
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: rash/redness right upper arm-Mild, Systemic: Weakness-Severe, Additional Details: patient was reporting the adverse reaction symptoms are diminishing as time goes on with/in 24 hrs temp of 103 f, 2 days later temp drop to 101 f. on day 3 she just has the rash about 2-3inch area, Other Vaccines: VaccineTypeBrand: flublok; Manufacturer: sanofi-pasteur; LotNumber: tfaa2543; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
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| 2865396 | F | 10/13/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; my sister got the shots and after got the shingles.; This serious cas...
Suspected vaccination failure; my sister got the shots and after got the shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Additional patient notes included Ethnicity: unknown. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: my sister got the shots and after got the shingles.). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date :01-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that his/her sister got the shots and after got the shingles. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2865397 | 54 | F | NV | 10/13/2025 |
PNC20 |
PFIZER\WYETH |
ma2488 |
Cellulitis, Injection site pain, Injection site swelling
Cellulitis, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Pt got cellulitis after vaccine and had to go to ER the day after the injection to get antibiotics. Manager spoke to pt when pt came in and she is feeling better after abx therapy., Other Vaccines: VaccineTypeBrand: fluarix; Manufacturer: glaxosmithkline; LotNumber: 2ca5m; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
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| 2865399 | 29 | F | KY | 10/13/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
2ca5n |
Urticaria
Urticaria
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Systemic: Patient left message stating hives on face, no difficulty breathing and had taken benadryl...
Systemic: Patient left message stating hives on face, no difficulty breathing and had taken benadryl, called and had to leave message stating to seek care if progresses, difficulty breathing or worsening, etc-Medium, Other Vaccines: VaccineTypeBrand: mnexspike; Manufacturer: moderna; LotNumber: 3052586; Route: im; BodySite: right arm; Dose: 1; VaxDate: 10/06/2025
More
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