| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2851230 | 71 | F | CT | 07/25/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
99d52 99d52 |
Injection site erythema, Injection site pain, Injection site swelling; Asthenia,...
Injection site erythema, Injection site pain, Injection site swelling; Asthenia, Incorrect route of product administration, Injection site erythema; Injection site erythema, Injection site pain, Injection site swelling; Asthenia, Incorrect route of product administration, Injection site erythema
More
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Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
More
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| 2851231 | 61 | M | ND | 07/25/2025 |
COVID19-2 |
PFIZER\BIONTECH |
L2210 |
Cerebrovascular accident
Cerebrovascular accident
|
Systemic: Stroke-Severe
Systemic: Stroke-Severe
|
โ | |||||
| 2851232 | 57 | F | NY | 07/25/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
99D52 99D52 99D52 99D52 |
Injection site erythema, Injection site pain, Injection site swelling; Inflammat...
Injection site erythema, Injection site pain, Injection site swelling; Inflammation, Injection site swelling, Peripheral swelling, Pruritus; Injection site erythema, Injection site pain, Injection site swelling; Inflammation, Injection site swelling, Peripheral swelling, Pruritus
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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
More
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| 2851233 | 55 | F | FL | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
23AH3 |
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
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|
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| 2851234 | 62 | F | SC | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ft95n |
Arthralgia, Chest pain, Injection site pain, Pain
Arthralgia, Chest pain, Injection site pain, Pain
|
Site: Pain at Injection Site-Severe, Systemic: Pain radiation down shoulder into chest.-Severe, Syst...
Site: Pain at Injection Site-Severe, Systemic: Pain radiation down shoulder into chest.-Severe, Systemic: Joint Pain-Severe, Additional Details: Event started two days after vaccine and has continued. Patient has seen doctor and was told to report. Doctor considering MRI.
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| 2851235 | 26 | F | OH | 07/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
B4J4B |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
More
|
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| 2851236 | 62 | M | MD | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55th4 |
Injection site bruising, Injection site erythema, Injection site pain
Injection site bruising, Injection site erythema, Injection site pain
|
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, Other Vaccines: VaccineTypeBrand: Prevnar 20; Manufacturer: pfizer; LotNumber: lx4482; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 07/11/2025
More
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| 2851237 | 53 | F | CA | 07/25/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
lp4947 lp4947 |
Chills, Injection site bruising, Injection site pain, Injection site reaction, I...
Chills, Injection site bruising, Injection site pain, Injection site reaction, Injection site swelling; Pyrexia, Rash
More
|
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injec...
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe
More
|
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| 2851238 | 27 | M | NV | 07/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946063 |
Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Other Vaccines: Vacc...
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Other Vaccines: VaccineTypeBrand: GARDASIL 9 (HPV); Manufacturer: MERCK; LotNumber: 1965035; Route: IM; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Tdap (BOOSTRIX); Manufacturer: GSK; LotNumber: PD324; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
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| 2851240 | 79 | F | MA | 07/25/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
|
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In...
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt came in to report a decent size rash has appeared on her arm about a week after her pneumonia shot, very red itchy some swelling too
More
|
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| 2851241 | 20 | F | CA | 07/25/2025 |
MENB |
PFIZER\WYETH |
hp9987 |
Anxiety, Flushing, Hyperhidrosis, Vomiting
Anxiety, Flushing, Hyperhidrosis, Vomiting
|
Systemic: vomiting-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Deta...
Systemic: vomiting-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Details: Pt was anxious before the shot. vomited within minutes after the shot. felt better after vomited. He said it was due to his anxiety. gave him water to sip on and had him sit to make sure ok. Mom was with him. He left with Mom about 1/2 hour after vaccine. Mom did not know MD's name and phone number so she will email MD once gets home
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| 2851242 | 65 | F | AL | 07/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3x97j 3x97j |
Anaphylactic reaction, Injection site bruising, Injection site erythema, Injecti...
Anaphylactic reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Pruritus
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-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: n/a
More
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| 2851243 | 54 | F | IL | 07/25/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
ln4927 ln4927 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash; Injection site swelling, Injection site warmth
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-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt started developing rash after 4 days of vaccination at injection site. it was red and hot to touch. it was itchy. at the doctor's appoinment pt was given antibiotic and anti histamine. pt is doing better know. pain still exsist but redness swelling is gone
More
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| 2851244 | 76 | F | NC | 07/25/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
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
More
|
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| 2851246 | 58 | M | FL | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9R397 |
Bell's palsy
Bell's palsy
|
Systemic: Bell's Palsy-Medium
Systemic: Bell's Palsy-Medium
|
โ | |||||
| 2851247 | 36 | M | MA | 07/25/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
Rash
Rash
|
Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient received vaccine on 06/30/2...
Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient received vaccine on 06/30/2025, came in 07/19/2025 to report developed rash 2 weeks post vaccination. Resolved after 3-4 days.
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|
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| 2851248 | 46 | F | FL | 07/25/2025 |
MNQ MNQ MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
z925l4 z925l4 z925l4 z925l4 |
Asthenia, Chills, Dizziness, Fatigue, Flushing; Headache, Hyperhidrosis, Injecti...
Asthenia, Chills, Dizziness, Fatigue, Flushing; Headache, Hyperhidrosis, Injection site bruising, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Lethargy, Nausea, Pruritus; Pyrexia, Somnolence, Syncope, Tremor, Unresponsive to stimuli
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-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: upon receipt of vaccinations patient experienced extreme fatigue, unable to wake up next day, sweating shaking, for the full day, heavy headache. day 2, patient noticed 3 bruised tender to touch, red swelling on the left bicep. day 5, swelling and redness still visible and still tender, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: glaxosmithkline; LotNumber: 9jt4s; Route: intramuscular; BodySite: left deltoid; Dose: 1; VaxDate: 07/14/2025
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| 2851250 | 60 | M | TX | 07/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
9sb34 |
Injection site erythema
Injection site erythema
|
Site: Redness at Injection Site-Mild, Systemic: Wife reported DVT-Severe, Other Vaccines: VaccineT...
Site: Redness at Injection Site-Mild, Systemic: Wife reported DVT-Severe, Other Vaccines: VaccineTypeBrand: Capvaxive; Manufacturer: ; LotNumber: y019158; Route: IM; BodySite: LD; Dose: 1; VaxDate: 07/12/2025
More
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| 2851251 | 63 | F | FL | 07/25/2025 |
PNC20 |
PFIZER\WYETH |
LN4928 |
Joint injury
Joint injury
|
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
|
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| 2851252 | 21 | F | OK | 07/25/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
2004455 2004455 |
Dizziness, Nausea, Seizure, Syncope, Tremor; Unresponsive to stimuli
Dizziness, Nausea, Seizure, Syncope, Tremor; Unresponsive to stimuli
|
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Naus...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild
More
|
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| 2851253 | 64 | F | FL | 07/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
L7Y3G |
Injection site erythema, Injection site pruritus, Pruritus, Pyrexia
Injection site erythema, Injection site pruritus, Pruritus, Pyrexia
|
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Fever-Mild, Other Vaccines: VaccineTypeBrand: Boostrix TDAP; Manufacturer: ; LotNumber: 7936PT; Route: Left; BodySite: ; Dose: ; VaxDate: 07/15/2025, VaccineTypeBrand: Capvaxive; Manufacturer: ; LotNumber: Z006076; Route: Left; BodySite: ; Dose: ; VaxDate: 07/15/2025
More
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| 2851254 | 68 | M | FL | 07/25/2025 |
COVID19 |
PFIZER\BIONTECH |
me6072 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Severe, Systemic: Muscle Weakness of left arm-Severe, Systemic: Weaknes...
Site: Pain at Injection Site-Severe, Systemic: Muscle Weakness of left arm-Severe, Systemic: Weakness-Severe, Additional Details: Patient states they have not been able to lift or use arm normally since vaccine, patient states arm is very painful, states they are having extreme muscle pain in arm.
More
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| 2851255 | 80 | M | VA | 07/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
7RZ45 |
Cough, Dyspnoea
Cough, Dyspnoea
|
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: cough-Mild, Additional Details: Patient cam...
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: cough-Mild, Additional Details: Patient came to pharmacy to inquire that he had rsv shot 4 days ago and for last couple days developed difficulty breathing and cough. Advised him to go to ER if problematic breathing and also contact his doctor to inform them.
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| 2851256 | 66 | F | PA | 07/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
55th4 55th4 |
Asthenia, Confusional state, Fall, Fatigue, Injection site pain; Lethargy, Skin ...
Asthenia, Confusional state, Fall, Fatigue, Injection site pain; Lethargy, Skin discolouration, Syncope, Unresponsive to stimuli
More
|
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Sever...
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: woke up on the floor, unconsciously fell out of bed-Severe, Systemic: Weakness-Severe, Additional Details: patient reported a sore arm the night of immunization delivery and took a few ibuprofen. woke up on the floor after going to bed, unaware of falling out of bed, black and blue mark on inner arm. felt extraordinarly fatigued (could not get the strength to get up for 2 hours) next day started to improve and is feeling back to normal as of report date 5 days later.
More
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| 2851257 | 23 | M | CA | 07/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946904 |
Dizziness, Injection site pain, Syncope, Unresponsive to stimuli
Dizziness, Injection site pain, Syncope, Unresponsive to stimuli
|
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting ...
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
More
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| 2851258 | 74 | F | MA | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9n2r2 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
More
|
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 states arm was red, hot, and swollen for 2 weeks around the injection site. The area is slowly improving.
More
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| 2851259 | 0.5 | M | NC | 07/25/2025 |
DTPPVHBHPB DTPPVHBHPB PNC20 PNC20 RV5 RV5 |
MSP VACCINE COMPANY MSP VACCINE COMPANY PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
U8265AA U8265AA LK6653 LK6653 2096661 2096661 |
Full blood count normal, Influenza A virus test negative, Influenza B virus test...
Full blood count normal, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urticaria; Full blood count normal, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urticaria; Full blood count normal, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urticaria
More
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Pt woke up the morning after vaccines with Urticaria to upper and lower extremities and trunk with T...
Pt woke up the morning after vaccines with Urticaria to upper and lower extremities and trunk with TMax fever of 100.5. Provider started Cetirizine with a follow up in 2 days. On 2 day follow up Urticaria and fever are resolved with instructions to continue Cetirizine.
More
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| 2851260 | 1.5 | M | TX | 07/25/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LP4947 LP4947 |
Blood test, Dehydration, Irritability, Lethargy, Lumbar puncture; Urine analysis
Blood test, Dehydration, Irritability, Lethargy, Lumbar puncture; Urine analysis
|
Mom thinks fussiness and lethargy was due to the vaccine. Pt was also found to be dehydrated at the ...
Mom thinks fussiness and lethargy was due to the vaccine. Pt was also found to be dehydrated at the ER, so likely that is the cause, however mom wanted this incident reported.
More
|
โ | |||||
| 2851261 | 4 | FL | 07/25/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
SKB Y49BZ |
Chills, Pyrexia, Vomiting
Chills, Pyrexia, Vomiting
|
7-18-2025 Phone message from Father stating son having fever, chills and vomiting today after receiv...
7-18-2025 Phone message from Father stating son having fever, chills and vomiting today after receiving vaccines yesterday. Call to father and informed him I was return his call - he asked if this was regarding the vaccines and when I replied "yes". The phone was then abruptly disconnected from the other side. Return call x2 attempted and call went to voice mail. No other information was available.
More
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| 2851262 | 14 | F | AZ | 07/25/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Z007847 Z007847 |
Dizziness, Fatigue, Feeling cold, Heart rate decreased, Hypotension; Laboratory ...
Dizziness, Fatigue, Feeling cold, Heart rate decreased, Hypotension; Laboratory test, Loss of consciousness, Loss of personal independence in daily activities, Pallor
More
|
My daughter passed out five minutes after the injection, she has since been pale, low blood pressure...
My daughter passed out five minutes after the injection, she has since been pale, low blood pressure, low heart rate, fatigued, tired, cold, and dizzy. She couldn?t attend school after the dizziness overwhelmed her. She has since been back to the doctor and the doctor ordered lab work done.
More
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| 2851263 | 1 | M | ID | 07/25/2025 |
HIBV |
MERCK & CO. INC. |
X020943 |
Injection site mass
Injection site mass
|
Patient has lump on the left thigh where HIB vaccine was given on 6/26/25. Mother reported this toda...
Patient has lump on the left thigh where HIB vaccine was given on 6/26/25. Mother reported this today. There is no redness at the injection site. Patient does not complain of pain. Mother denies fevers. Patient will be evaluated by Primary care provider.
More
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| 2851264 | 11 | M | NC | 07/25/2025 |
HEPA HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
L4EA4 Y014510 DL4YY 793PT |
Vaccination site erythema, Vaccination site reaction; Vaccination site erythema,...
Vaccination site erythema, Vaccination site reaction; Vaccination site erythema, Vaccination site reaction; Vaccination site erythema, Vaccination site reaction; Vaccination site erythema, Vaccination site reaction
More
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LOCALIZED ALLERGIC REACTION. RIGHT UPPER ARM RECIEVED HEP A AND MENINGO VACCINES. ERYTHEMATOUS INDU...
LOCALIZED ALLERGIC REACTION. RIGHT UPPER ARM RECIEVED HEP A AND MENINGO VACCINES. ERYTHEMATOUS INDURATED PATCH ON RIGHT UPPER EXTREMITY SURROUNDING THE VACCINE SITES 16CM X 16CM. SIMILAR PATCH ON LEFT UPPER EXTREMITY WHERE HPV AND TDAP WERE ADMINISTERED 9CM X 5CM.
More
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| 2851265 | 63 | F | SC | 07/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FJ6369 FJ6369 |
Arthralgia, COVID-19, Diarrhoea, Expired product administered, Joint swelling; S...
Arthralgia, COVID-19, Diarrhoea, Expired product administered, Joint swelling; Skin odour abnormal, Vomiting
More
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Course of events as follows: 2nd Dose:2-25-25 1. A middle aged female Pharmacist with white hair pic...
Course of events as follows: 2nd Dose:2-25-25 1. A middle aged female Pharmacist with white hair picked up a vial with a small amount of fluid left in it from the counter. It had been sitting on the counter prior to my arrival. *I questioned her as to why it was on the counter instead of in the refrigerator and she advised it was fine and had another dose left in it. She drew the dose into the needle advised her shift was ending soon and handed it to a tech in ^trainng" to administer into my arm. 2. Mind you it was 4:30PM in the afernoon and left out on the counter for God only knows how long! 3. I asked her if I should anticipate any side effects from the Vax and she said," No that it was highly unlikely."
More
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| 2851266 | 74 | M | AL | 07/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN 6205 EN 6205 |
Brain fog, COVID-19, Chronic sinusitis, Paranasal sinus discomfort, SARS-CoV-2 t...
Brain fog, COVID-19, Chronic sinusitis, Paranasal sinus discomfort, SARS-CoV-2 test positive; Tinnitus
More
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Chronic sinusitus, chronic sinus pressure, Tinnius, slight brain fog
Chronic sinusitus, chronic sinus pressure, Tinnius, slight brain fog
|
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| 2851267 | 16 | M | TX | 07/25/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
7mn4c d2343 |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
|
passed out about 5 min after vaccine
passed out about 5 min after vaccine
|
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| 2851271 | MO | 07/25/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y019171 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No symptoms reported; patient who received improperly stored PROQUAD on 06/13/2025.; This spontaneou...
No symptoms reported; patient who received improperly stored PROQUAD on 06/13/2025.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2025, the patient was vaccinated with improperly stored (6.3 F for 16 minutes) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection at a dose of 0.5 mL, lot #Y019171, expiration date: 18-MAY-2026 (route of administration and anatomical location were not reported) for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiry date were not reported). No symptoms reported. This is one of several reports received from the same reporter.
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| 2851272 | FL | 07/25/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z004454 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous ...
No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-Jul-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection (lot #Z004454, expiration date: 13-Feb-2027), 1 dosage form (1 dose) (route of administration, anatomical site and dose number in series were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided), administered as prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36.5 Fahrenheit for 2 hours, 21 minutes and 0 seconds (Product storage error). No previous excursion was not reported. No adverse event. This is one of several reports from the same source.
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| 2851273 | 58 | F | 07/25/2025 |
PNC21 |
MERCK & CO. INC. |
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Erythema, Injection site discomfort, Rash
Erythema, Injection site discomfort, Rash
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she also noticed redness and a rash; she also noticed redness and a rash; felt "some injection ...
she also noticed redness and a rash; she also noticed redness and a rash; felt "some injection site discomfort" shortly after administration which "seemed typical"; This spontaneous report was received from a consumer and refers to herself, a 58-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included estrogens conjugated (PREMARIN), progesterone), pregabalin (LYRICA), rosuvastatin . On 08-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 0.5 mL administered by unknown route (vaccination site, lot # and expiration date were not reported) for pneumococcal conjugate vaccine. On 08-Jul-2025, the patient felt some injection site discomfort shortly after administration which seemed typical. On 15-jul-2025 (today), she also noticed redness and a rash. The patient reported to a health care professional (HCP) who recommended she took a picture, apply ice, and topical diphenhydramine (BENADRYL). HCP treating the adverse event (AE) provided permission to contact. The patient did have name of administering HCP at the time of the call. No additional AE and no product quality complaint (PQC) was noted. At the reporting time, the patient had not recovered from the reported adverse events. The causal relationship between the adverse events and the suspect vaccine was not reported. Lot # is being requested and will be submitted if received.
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| 2851274 | VA | 07/25/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms or side effects were reported by HCP; HCP reporting that a patient received a dose of im...
No symptoms or side effects were reported by HCP; HCP reporting that a patient received a dose of improperly stored VARIVAX. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the VARIVAX was administered following the excursion. HCP reported; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 16-JUN-2025, the patient received a dose of improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y019318, has been verified to be valid, expiration 21-NOV-2026) 0.5 mL (route, anatomical location were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported). The health care professional (HCP) reported that she did not know the date the excursion occurred, but knew the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was administered following the excursion. No symptoms or side effects were reported. The operator of device was HCP. It was reported that the temperature was 52.2 farenheit (F), it was unknown time frame.
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| 2851275 | VA | 07/25/2025 |
MMRV |
MERCK & CO. INC. |
Z003309 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms or side effects were reported by HCP. No additional AE; HCP reporting that a patient rec...
No symptoms or side effects were reported by HCP. No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 14-JUL-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL, administered for prophylaxis (lot number Z003309 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date not provided but upon internal validation established as 21-JUL-2026; formulation, route of administration, vaccination scheme frequency and anatomical site of injection were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot number were not reported). The vaccine was administered following a temperature excursion (TE) that occurred at 52.2 degree Fahrenheit (F) (Product storage error). The time frame of the TE was unknown by the reporter. No symptoms, side effects or additional adverse events were reported for the patient. No additional information was provided. This is one of several reports from the same reporter.
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| 2851277 | NV | 07/25/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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a 2 month old was administered CAPVAXIVE; no adverse event; This spontaneous report was received fro...
a 2 month old was administered CAPVAXIVE; no adverse event; This spontaneous report was received from a medical assistant referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection (lot #Z003579, expiration date: 07-Sep-2026) (168 mcg/ml) administered as prophylaxis (dose, and route of administration were not reported) (Product administered to patient of inappropriate age). No adverse effects were reported (no adverse event).
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| 2851278 | 12 | M | MS | 07/25/2025 |
HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Alopecia, Alopecia areata, Alopecia totalis; Alopecia, Alopecia areata, Alopecia...
Alopecia, Alopecia areata, Alopecia totalis; Alopecia, Alopecia areata, Alopecia totalis; Alopecia, Alopecia areata, Alopecia totalis
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neurological injuries; autonomic injuries; extreme pain; Alopecia totalis/alopecia areata/hair loss/...
neurological injuries; autonomic injuries; extreme pain; Alopecia totalis/alopecia areata/hair loss/autoimmune injuries,autoimmunne disorder; Information has been received from a lawyer regarding a case in litigation and refers to an adolescent (exact age was not provided) male patient (pt). The pt's concurrent conditions, medical history and concomitant therapies were not provided. Prior to receiving his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, the pt had no autoimmune, autonomic, or neurological issues. He was a healthy young man, who played baseball daily and was not being followed for any serious medical conditions. On 28-AUG-2014, at the age of 12 years old, the pt was vaccinated with the first dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact doses, routes of administration, anatomical locations, lot numbers and expiration date were not reported). On 03-NOV-2014, he received the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported) and on 30-MAR-2015 (at the age of 14 years old, conflicting information), the pt was vaccinated with the third dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported). All doses were administered for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), with the pt's mother consent and the pt's physician (referred to as a doctor) recommendation. On 12-JUN-2015, the pt was seen at acupuncture clinic for hair loss that started approximately two weeks earlier. The pt's mother reported that she first noticed the hair loss after a recent haircut. In June 2015, the pt's parents took him to the university for an evaluation of his hair loss and he was treated with a triamcinolone (KENALOG) injection. The pt's hair loss persisted and his parents brought him back to acupuncture clinic on 29-JUN-2015, 03-JUL-2015, and 14-JUL-2015. As the hair loss persisted, on 15-JUL-2015 (also reported as 15-JUL-2025, conflicting information), the pt was seen by dermatologist for alopecia areata on the scalp and was administered a second round of steroid injections. A third round of injections was performed on 12-AUG-2015. Ultimately, the pt was diagnosed with alopecia totalis on 10-SEP-2015. As a result of his post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities that a normal young person would enjoy. He faced significant stigmatization due to his hair which has drastically affected his social life. He has also undergone numerous treatments to try and reverse the damage which have caused him extreme pain. Based upon his chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to alopecia totalis. The pt contended that his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused him to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to alopecia totalis, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The outcome of all events was considered to be not recovered. The reporter considered all events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling.
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| 2851279 | F | TX | 07/25/2025 |
HPV9 |
MERCK & CO. INC. |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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No additional AE; Consumer reports she received her first dose of GARDASIL 9 in February of this yea...
No additional AE; Consumer reports she received her first dose of GARDASIL 9 in February of this year and has not had her second dose yet. No adverse effects reported. No other information provided. No additional AE. No PQC.; This spontaneous report was received from a patient and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown day in February 2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot # and expiration date were not reported) as prophylaxis. At the time of the report, she had not received her second dose yet (inappropriate schedule of product administration). No adverse effects were reported. No other information was provided. No additional adverse event was reported.
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| 2851280 | 07/25/2025 |
TDAP |
UNKNOWN MANUFACTURER |
UNK |
Incorrect route of product administration
Incorrect route of product administration
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incorrect route of vaccine administration; This non-serious case was reported by a physician via cal...
incorrect route of vaccine administration; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a adolescent patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine (subcutaneous). On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced intramuscular formulation administered by other route (Verbatim: incorrect route of vaccine administration). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date:11-JUL-2025 The reporter called to report a possible incorrect route of vaccine administration. The reporter stated that Boostrix was possibly administered sub-q, which led to intramuscular formulation administered by other route. The reporter also stated that what if needle was only inserted halfway for an adolescent, what if needle hit the bone. The reporter stated vaccine administered was Tdap but was unable to verify if the medication administered was Boostrix. The reporter declined to provide any information.
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| 2851281 | F | NY | 07/25/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK |
Computerised tomogram abdomen normal, Flank pain, Mononucleosis heterophile test...
Computerised tomogram abdomen normal, Flank pain, Mononucleosis heterophile test positive, Ultrasound abdomen normal, Vaccination failure; Zoster sine herpete; Computerised tomogram abdomen normal, Flank pain, Mononucleosis heterophile test positive, Ultrasound abdomen normal, Vaccination failure; Zoster sine herpete
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Suspected vaccination failure/ lack of drug effect; internal shingles; currently experiencing flank ...
Suspected vaccination failure/ lack of drug effect; internal shingles; currently experiencing flank pain/ intense pain/ it's been over 2 weeks of stabbing pain without a rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included mononucleosis (tested positive for mononucleosis). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ lack of drug effect) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: internal shingles) and flank pain (Verbatim: currently experiencing flank pain/ intense pain/ it's been over 2 weeks of stabbing pain without a rash). The outcome of the vaccination failure and zoster sine herpete were unknown and the outcome of the flank pain was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the zoster sine herpete and flank pain to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 11-JUL-2025 The patient self-reported this case for herself. The consumer (patient) had received the complete series of Shingrix vaccine few years ago but was unsure of the dates and did not have the lot numbers of the medication. The patient stated prior to receiving Shingrix complete vaccine series she was diagnosed with a case of shingles on her spine (date not disclosed). The patient stated she presented to her local emergency department for flank pain and the pain was located on the front and back of her waist. She did not have a rash only intense pain. It had been over 2 weeks of stabbing pain without a rash. The patient stated the emergency department ruled out an issue with her spleen or her pancreas. Patient stated blood work was done, and she was tested positive for mononucleosis. However, the consumer stated she was told by the emergency department physician the flank pain she was experiencing might be an internal case of shingles. The consumer stated she was now in her 3rd week experiencing this flank pain that could not be explained after an ultrasound or a CT of the abdomen. The only explanation was shingles pain without the rash. The consumer stated the emergency room physician did not prescribe an antiviral medication. The consumer stated GlaxoSmithKline could contact the pharmacy that administered the vaccine to obtain that information. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding zoster sine herpete were unknown at the time of reporting. No further information was provided or obtained.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule and regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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| 2851282 | F | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Erythema, Swelling
Erythema, Swelling
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Redness; Swelling; This non-serious case was reported by a physician via sales rep and described the...
Redness; Swelling; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-MAY-2025, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness) and swelling (Verbatim: Swelling). On 16-JUL-2025, the outcome of the erythema and swelling were resolved. The reporter considered the erythema and swelling to be related to Shingrix. The company considered the erythema and swelling to be related to Shingrix. Additional Information: GSK receipt date: 16-JUL-2025 The patient experienced redness and swelling.
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| 2851283 | 9 | M | IA | 07/25/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB064A |
Product preparation issue
Product preparation issue
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patient received the liquid conjugate component only for Menveo; patient received the liquid conjuga...
patient received the liquid conjugate component only for Menveo; patient received the liquid conjugate component only for Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 9-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX) and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9). On 15-JUL-2025, the patient received the 1st dose of Menveo (intramuscular). On 15-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received the liquid conjugate component only for Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received the liquid conjugate component only for Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 and 17-JUL-2025 The reporter was a nurse who called to report that a male patient had received only the liquid conjugate component of Menveo in his left leg on 15th July 2025, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The patient had also received Boostrix and Gardasil 9 at the same visit on 15th July 2025. All the information that was provided about this adverse event was reported.; Sender's Comments: US-GSK-US2025091789:same reporter, Different patient
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| 2851284 | M | FL | 07/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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received his first dose in February of 2020 and his 2nd in May of 2025; This non-serious case was re...
received his first dose in February of 2020 and his 2nd in May of 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in February 2020). In MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received his first dose in February of 2020 and his 2nd in May of 2025). In MAY-2025, the outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 22-JUL-2025 The nurse reported that the patient received his first dose of Shingrix in February of 2020 and his 2nd dose in May of 2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2851285 | F | 07/25/2025 |
COVID19 RVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Allergy to vaccine, Contusion, Rash erythematous; Allergy to vaccine, Contusion,...
Allergy to vaccine, Contusion, Rash erythematous; Allergy to vaccine, Contusion, Rash erythematous
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Small rash on leg above ankle/rash erythematous/rash is red; Allergy to vaccine; Contusion; This non...
Small rash on leg above ankle/rash erythematous/rash is red; Allergy to vaccine; Contusion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of red rash in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis and Dupilumab for nasal polyp. Concurrent medical conditions included nasal polyp. On an unknown date, the patient received RSV vaccine and COVID-19 VACCINE. In JUN-2024, the patient received Dupilumab (subcutaneous). On an unknown date, less than 9 months after receiving RSV vaccine and COVID-19 VACCINE and between 3 and 4 months after receiving Dupilumab, the patient experienced red rash (Verbatim: Small rash on leg above ankle/rash erythematous/rash is red), allergy to vaccine (Verbatim: Allergy to vaccine) and contusion (Verbatim: Contusion). The outcome of the red rash, allergy to vaccine and contusion were unknown. The reporter considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the reporter considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the reporter considered the red rash and contusion to be related to Dupilumab. The company considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the company considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the company considered the red rash and contusion to be related to Dupilumab. Additional Information: GSK receipt date: 27-JUN-2025 In 2024 the patient developed a non-serious events 'a reaction that started 5-6 months ago, could be due to RSV vaccine broke out in rash broken blood vessels now appear darker and spreading, small red patch on her leg spread larger to her ankle and knee' (contusion) (rash erythematous) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab,Covid-19 vaccine and RSV vaccine. In 2024 the patient developed a non-serious event 'small rash on leg above ankle' (rash) and 'a new allergy to covid vaccine' (allergy to vaccine) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Covid-19 vaccine. The patient stated that the rash was red but no itching. The patient saw her doctor when the patch was small but has not followed up since. Corrective treatment was not reported for all events. No additional information was provided.
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| 2851286 | FL | 07/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Wrong product administered
Wrong product administered
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patient got Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via oth...
patient got Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On an unknown date, the patient received Bexsero and did not receive Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient got Bexsero instead of Menquadfi). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 14-JUL-2025 The pharmacist reported that the patient was supposed to get an injection of Menquadfi but got Bexsero instead, which led to, wrong vaccine administered. The reporter mentioned that the patient still wanted to get Menquadfi. The reporter wants to find out if there were any drawbacks to patient getting Menquadfi at these points.
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