| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843568 | 1.33 | M | AR | 06/02/2025 |
PNC20 |
PFIZER\WYETH |
LX443 |
Injection site swelling
Injection site swelling
|
leg swelling at the injection site with redness and warmth. Mom used benadryl cream and ice over the...
leg swelling at the injection site with redness and warmth. Mom used benadryl cream and ice over the course of 2 days
More
|
||||||
| 2843569 | 65 | F | 06/02/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z005765 Z005765 Z005765 |
Asthenia, Blood sodium decreased, Chest X-ray normal, Computerised tomogram neck...
Asthenia, Blood sodium decreased, Chest X-ray normal, Computerised tomogram neck, Full blood count normal; Headache, International normalised ratio normal, Metabolic function test normal, Mobility decreased, Nausea; Pain in extremity, Prothrombin time normal, Troponin normal, Urine analysis normal, Vomiting
More
|
Sore arm started evening of the vaccine that progressively worsened over time. Around midnight on M...
Sore arm started evening of the vaccine that progressively worsened over time. Around midnight on May 25, patient reports weakness and the inability to get out of bed to go to the bathroom. The headache was described as the worst headache ever experienced. Patient had nausea and vomiting and generalized weakness. Patient admitted to ED around 8am. Patient administered ketorolac IV one dose along with diphenhydramine which helped with headache. Patient was discharged around noon. Patient's headache was gone the next day but after a week from this incidence she still reports fatigue.
More
|
|||||||
| 2843570 | 12 | F | OH | 06/02/2025 |
HPV9 |
MERCK & CO. INC. |
X019196 |
Expired product administered
Expired product administered
|
The Medical Assistant assigned to the provider accidentally administered an expired vaccine to a pat...
The Medical Assistant assigned to the provider accidentally administered an expired vaccine to a patient. The vaccine is ineffective, and the patient needs to get another dose of the medication.
More
|
||||||
| 2843571 | 13 | F | WI | 06/02/2025 |
HEP MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
95BJ9 Y012077 |
No adverse event; No adverse event
No adverse event; No adverse event
|
ProQuad vaccine was administered to patient on 05/30/2025. Patient is 13 years old, and ProQuad is n...
ProQuad vaccine was administered to patient on 05/30/2025. Patient is 13 years old, and ProQuad is not routinely recommended for this age group. No adverse reaction observed at the time. Patient will be monitored as appropriate. Provider has been informed.
More
|
||||||
| 2843572 | 41 | F | 06/02/2025 |
HPV9 MMR TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y018389 4N222 EB499 |
Chills, Pain, Pain in extremity, Pyrexia; Chills, Pain, Pain in extremity, Pyrex...
Chills, Pain, Pain in extremity, Pyrexia; Chills, Pain, Pain in extremity, Pyrexia; Chills, Pain, Pain in extremity, Pyrexia
More
|
Patient called on 6/2/25 to report allergic reaction that began evening of 6/1/25 after receiving va...
Patient called on 6/2/25 to report allergic reaction that began evening of 6/1/25 after receiving vaccines. Patient described fever, body ache, chills, sore arm. Patient states that fever has resolved at this time but body soreness is still present.
More
|
|||||||
| 2843573 | 53 | F | MI | 06/02/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945663 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Patient received 2nd dose only 2 weeks after first dose. @nd dose invalid due to be given too soon....
Patient received 2nd dose only 2 weeks after first dose. @nd dose invalid due to be given too soon. Patient only stated they felt tired no other reaction noted.
More
|
||||||
| 2843574 | 8 | M | PA | 06/02/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8009AB |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Administered combo vaccine to an 8-year-old patient that is only indicated for ages 4-6, so he shoul...
Administered combo vaccine to an 8-year-old patient that is only indicated for ages 4-6, so he should have received DTaP and IPV as separate injections. No adverse events or side effects reported by patient or his parents. Steps have been taken within the office to avoid this error in the future.
More
|
||||||
| 2843575 | 1 | M | WI | 06/02/2025 |
HEPA |
MERCK & CO. INC. |
X026666 |
Expired product administered
Expired product administered
|
expired vaccines was administered to patient. vaccine expired on 5/29/2025
expired vaccines was administered to patient. vaccine expired on 5/29/2025
|
||||||
| 2843576 | 0.92 | F | MO | 06/02/2025 |
MMR MMR MMR MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y 014095 Y 014095 Y 014095 Y 014095 Y 014095 |
Adenoidal hypertrophy, Blood culture negative, Body temperature increased, CSF c...
Adenoidal hypertrophy, Blood culture negative, Body temperature increased, CSF culture negative, Clonus; Computerised tomogram head normal, Coronavirus test positive, Culture urine negative, Electroencephalogram normal, Endotracheal intubation; Gaze palsy, HCoV-HKU1 infection, Intensive care, Lethargy, Magnetic resonance imaging head normal; Mastoid effusion, Muscle twitching, Pharyngeal disorder, Respiratory viral panel, Seizure; Tonsillar hypertrophy
More
|
On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted sta...
On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted state). Mom noticed patient suddenly became lethargic with rightward gaze deviation, clonic movement of R arm, which spread to involve her full body. EMS gave two doses Versed with cessation of seizure for total duration of 20 minutes. She had a temp of 101.7F at that time. At Hospital, had L arm clonic movement, leftward gaze and intermittent twitching. Received two doses of IV lorazepam and Keppra bolus, was intubated and started on Versed drip. She was transferred to another level of care Hospital and admitted to the PICU. Started on Keppra, had continuous video EGG without seizure activity. She remained intubated for brain MRI, which was reassuring, then extubated and weaned to room air. Transitioned from Keppra to Klonopin by discharge. Received IV ceftriaxone, vancomycin and acyclovir while blood, urine and CSF studies were pending. She had mostly returned to baseline neurologic status by discharge on 4/30/25. She has since followed up with Pediatric Neurology on 5/12/25. She had an EEG on 5/7/25 that was normal for her age.
More
|
โ | โ | ||||
| 2843577 | 54 | F | MN | 06/02/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
No adverse event
No adverse event
|
No Adverse effects from employee.
No Adverse effects from employee.
|
||||||
| 2843578 | 1.67 | M | CO | 06/02/2025 |
HIBV |
SANOFI PASTEUR |
UK169AB |
Product preparation error
Product preparation error
|
When the Medical Assistant mixed the vaccine, the wrong sterile diluent was used.
When the Medical Assistant mixed the vaccine, the wrong sterile diluent was used.
|
||||||
| 2843579 | 4 | M | AS | 06/02/2025 |
DTAPIPV UNK |
SANOFI PASTEUR UNKNOWN MANUFACTURER |
u8209cb Z007210 |
Urticaria; Urticaria
Urticaria; Urticaria
|
URTICARIA DEVELOPED WITHIN ONE HOURPOST VACCINATION WITH MMRV AND QUADRACEEL. NO ANAPHYLACTIC SYMPTO...
URTICARIA DEVELOPED WITHIN ONE HOURPOST VACCINATION WITH MMRV AND QUADRACEEL. NO ANAPHYLACTIC SYMPTOMS. TREATED WITH BENADRYL AND CETRIZINE.RESOLVED WITHIN 24 HOURS
More
|
||||||
| 2843580 | 12 | M | ID | 06/02/2025 |
MNQ |
SANOFI PASTEUR |
U8361AA |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Patient was given second dose of Menquadfi too early. No adverse reactions reported.
Patient was given second dose of Menquadfi too early. No adverse reactions reported.
|
||||||
| 2843581 | 60 | F | PA | 06/02/2025 |
PNC21 TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
Y019158 |
Injection site bruising, Injection site swelling, Injection site warmth; Injecti...
Injection site bruising, Injection site swelling, Injection site warmth; Injection site bruising, Injection site swelling, Injection site warmth
More
|
Red to purple bruising 6"x4" in diameter on LEFT upper arm, as described by patient. Area...
Red to purple bruising 6"x4" in diameter on LEFT upper arm, as described by patient. Area swollen and continues to be warm to touch.
More
|
||||||
| 2843582 | 2 | M | ID | 06/02/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
GG39D |
Extra dose administered
Extra dose administered
|
I gave a DTaP thinking it was his 4th dose of DTaP; however, it was his 5th dose of DTaP upon furthe...
I gave a DTaP thinking it was his 4th dose of DTaP; however, it was his 5th dose of DTaP upon further determination through another source.
More
|
||||||
| 2843583 | 66 | F | MO | 06/02/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased,...
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities; Musculoskeletal stiffness
More
|
Patient had injection site pain immediately following administration as she normally does after immu...
Patient had injection site pain immediately following administration as she normally does after immunizations, however 2-3 hours following administration the pain began to spread to her shoulder and create stiffness. It kept getting worse for 1-2 weeks, but then stopped getting worse and has been a constant and stable pain for about three weeks. She still cannot move her arm above her shoulder. She reached out to her PCP a couple weeks ago and his office told her to make an appointment if it did not improve. She said she has not had time to make an appointment and can't miss any more work for additional doctor's appointments. She said it does still impact her daily activity, but does not interfere with sleep (aside from it being more difficult to get out of bed).
More
|
||||||
| 2843584 | 6 | F | 06/02/2025 |
IPV VARCEL |
SANOFI PASTEUR MERCK & CO. INC. |
|
No adverse event, Wrong patient; No adverse event, Wrong patient
No adverse event, Wrong patient; No adverse event, Wrong patient
|
No adverse event occurred, this event was a medication/vaccine error. The pt was ordered to have Hep...
No adverse event occurred, this event was a medication/vaccine error. The pt was ordered to have Hep B and MMR but was given Varicella and Polio (ordered for sister present at time of visit). Both siblings were in the exam room.
More
|
|||||||
| 2843585 | 27 | M | MI | 06/02/2025 |
ANTH ANTH |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
|
Condition aggravated, Cough, Ear infection, Encephalitis, Hypersensitivity; Mali...
Condition aggravated, Cough, Ear infection, Encephalitis, Hypersensitivity; Malignant melanoma, Tinnitus, Upper-airway cough syndrome
More
|
Melanoma with unknown primary, encephalitis of the brain, various allergies, post nasal drip with co...
Melanoma with unknown primary, encephalitis of the brain, various allergies, post nasal drip with cough, tinnitus, ear infections.
More
|
โ | โ | โ | |||
| 2843586 | 31 | F | NV | 06/02/2025 |
COVID19 |
MODERNA |
B0005 |
Malaise
Malaise
|
States felt "unwell" day of vaccination. No other symptoms indicated.
States felt "unwell" day of vaccination. No other symptoms indicated.
|
||||||
| 2843587 | 18 | F | NM | 06/02/2025 |
MNQ |
SANOFI PASTEUR |
U799688 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
the child did not have any adverse reactions to the medication, after she had left the clinic is whe...
the child did not have any adverse reactions to the medication, after she had left the clinic is when I realized that I had given the wrong meningococcal vaccine for the wrong age.
More
|
||||||
| 2843588 | 47 | F | MA | 06/02/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Chills, Fatigue, Influenza like illness, Injection site erythema, Lymphadenopath...
Chills, Fatigue, Influenza like illness, Injection site erythema, Lymphadenopathy; Myalgia, Pain in extremity, Pyrexia, Throat irritation, Upper-airway cough syndrome
More
|
I received the CAPVAXIVE (21-valent pneumococcal conjugate) vaccine on Saturday, May 31st around 3:0...
I received the CAPVAXIVE (21-valent pneumococcal conjugate) vaccine on Saturday, May 31st around 3:00 PM at a pharmacy. The vaccine was administered as part of an immunological workup due to suspected immune dysfunction (possible CVID or MCAS), to evaluate my ability to mount an appropriate antibody response. Within 24 hours, I developed significant arm pain and redness at the injection site, which progressively worsened rather than improved. By 36?48 hours post-injection, the pain had intensified and spread from the deltoid area down into the lower bicep, with visible redness and swelling. I also experienced chills, deep fatigue, and flu-like symptoms, leading me to go to bed at 4:45 PM the following day. As of today (just under 48 hours post-vaccine), I continue to have significant fatigue, a low-grade fever, mild throat irritation, postnasal drip, and swollen lymph nodes? all localized to the left side only, corresponding with the arm where the vaccine was administered. The red area on my arm is about the size of a palm. For symptom management, I?ve used Zyrtec (cetirizine), famotidine, as well as Advil (ibuprofen) every 4?6 hours. This combination makes it possible to lift my arm, but the pain returns between doses. I plan to go to bed early again due to ongoing fatigue. No formal medical evaluation yet. Symptoms are still active at the time of this report.
More
|
||||||
| 2843590 | 21 | F | NV | 06/02/2025 |
COVID19 |
MODERNA |
B0005 |
Unevaluable event
Unevaluable event
|
None known
None known
|
||||||
| 2843591 | 9 | F | ID | 06/02/2025 |
HEP TD VARCEL |
MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
X004819 U7745AA X018954 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
I misunderstood that patient needed a 3rd Tetanus, due to no childhood doses and had only 2 tetanus ...
I misunderstood that patient needed a 3rd Tetanus, due to no childhood doses and had only 2 tetanus at that point. It was discussed with father at the time - because database indicated complete. He agreed to get 3rd dose for child.
More
|
||||||
| 2843592 | 66 | F | NM | 06/02/2025 |
MMR |
MERCK & CO. INC. |
NDC: 00006-4681 |
Abdominal pain, Arthralgia, Decreased appetite, Fatigue, Nausea
Abdominal pain, Arthralgia, Decreased appetite, Fatigue, Nausea
|
Six days after shot began extreme fatigue. It has continued. Days 7 to 10 systemic joint pain. I tri...
Six days after shot began extreme fatigue. It has continued. Days 7 to 10 systemic joint pain. I tried 2 days of Aleve but it didn't help as much as the advil I took today. Days 8 to 10 abdominal pain, nausea, and low appetite.
More
|
||||||
| 2843593 | 0.5 | M | TX | 06/02/2025 |
FLU3 HEPA PNC20 RV5 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
ut8459ja c24b9 hr3650 y003996 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
More
|
Given Havrix instead of Vaxelis. Not old enough for Vaxelis.
Given Havrix instead of Vaxelis. Not old enough for Vaxelis.
|
||||||
| 2843594 | 14 | M | TN | 06/02/2025 |
MMRV |
MERCK & CO. INC. |
Y017514 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
RN administered the Varivax vaccine and ProQuad vaccine on the same day. RN thought that she was adm...
RN administered the Varivax vaccine and ProQuad vaccine on the same day. RN thought that she was administering MMR instead of ProQuad, but administered ProQuad (MMRV) and Varivax together. RN spoke to MD after the event around 11:15. RN notified the pt and the pt guardian that the pt received 2 doses of Varicella. Pt was monitored for 20 min after the event. No adverse outcomes were noted. RN gave pt strict return to clinic / ED protocol if pt develops a rash, fever > 101 F, difficulty breathing, facial swelling, or other concerning symptoms.
More
|
||||||
| 2843595 | 62 | M | AZ | 06/02/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LN4927 47N34 |
Rash; Rash
Rash; Rash
|
On May 7, 2025, pt received Prevnar 20 and Shingrix vaccines. On June 2, 2025, pt came to the pharma...
On May 7, 2025, pt received Prevnar 20 and Shingrix vaccines. On June 2, 2025, pt came to the pharmacy to report a rash that he developed 4 days after receiving the vaccines. Pt has been only using a moisturizer cream to help with the rash. Advised pt to take Zyrtec or Benadryl and use hydrocortisone cream 1% and if symptoms persist or worsen to seek medical help. Pt verbalized understanding. Pt did not report any allergies and states he is not taking any medications.
More
|
||||||
| 2843596 | 1.92 | F | ID | 06/02/2025 |
COVID19 |
PFIZER\BIONTECH |
LN6739 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Dose 3 given 3 weeks after dose 2 instead of waiting the 8 weeks.
Dose 3 given 3 weeks after dose 2 instead of waiting the 8 weeks.
|
||||||
| 2843597 | 4 | M | CA | 06/02/2025 |
DTAP |
SANOFI PASTEUR |
3CA20C1 |
Erythema, Peripheral swelling, Pruritus, Skin warm
Erythema, Peripheral swelling, Pruritus, Skin warm
|
Per mom after patient recived vaccine, patients arm began to swell up. The next day mom notice patie...
Per mom after patient recived vaccine, patients arm began to swell up. The next day mom notice patient's arm got red and itchy and the arm felt warm. Mom had been giving Motrin for pain and it looked to be helping patient per mom.
More
|
||||||
| 2843606 | 45 | F | 06/02/2025 |
PNC20 |
PFIZER\WYETH |
|
Dermatitis, Injection site erythema, Injection site pain, Vasculitis
Dermatitis, Injection site erythema, Injection site pain, Vasculitis
|
Development of pain and redness at injection site; Development of pain and redness at injection site...
Development of pain and redness at injection site; Development of pain and redness at injection site; Development of vasculitis/dermatitis on both legs; Development of vasculitis/dermatitis on both legs; This is a spontaneous report received from a Consumer or other non HCP. A 45-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for immunisation. The patient's relevant medical history included: "Lupus SLE" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergy to shellfish" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 14May2025; COLCHICINE, start date: 12Feb2025. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 22May2025, outcome "recovering" and all described as "Development of pain and redness at injection site"; DERMATITIS (non-serious), VASCULITIS (non-serious) all with onset 22May2025, outcome "recovering" and all described as "Development of vasculitis/dermatitis on both legs". Therapeutic measures were taken as a result of dermatitis, vasculitis including the use of steroid ointment for legs. Additional information: Development of pain and redness at injection site that persists over 1 week. Development of vasculitis/dermatitis on both legs 2 days after administration. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||
| 2843607 | 41 | F | TX | 06/02/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Vaginal haemorrhage
Vaginal haemorrhage
|
After the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years; This i...
After the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "After the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years". The event "after the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years" required physician office visit. Patient mentioned route of administration as: arm, unknown if left or right side. Other Conditions/ products mentioned as No; Investigations mentioned as: No. Calling about Covid Vaccination, Pfizer Covid Vaccination. The patient received the vaccine 2 years ago. Patient also been bleeding since got the vaccination. She has been having vaginal bleeding for the two years. Have been seen by several specialist not just one. When attempted to clarify if there was a specific one to provide she stated her primary doctor she just moved. Other Conditions: At the time took the vaccination was a very health woman. Was not taking any medications. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Confirmed had the bleeding with the first vaccination. After the first vaccination she had the vaginal bleeding, but she was not aware why she was going through it. The patient was not allergic to any previous vaccination, medications, food or other products. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500111472 same patient, reporter, vaccine/ different dose/event;
More
|
||||||
| 2843608 | F | MO | 06/02/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
|
had covid; had covid; This is a spontaneous report received from a Consumer or other non HCP. A fem...
had covid; had covid; This is a spontaneous report received from a Consumer or other non HCP. A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||
| 2843610 | F | 06/02/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
has long Covid symptoms; has long Covid symptoms; This is a spontaneous report received from a Consu...
has long Covid symptoms; has long Covid symptoms; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00368 (Novavax). A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has long Covid symptoms". Clinical course: Reporter stated she was trying to find a Novavax vaccine for her daughter before she was travelling to (redacted). She stated her daughter "needs to get the Novavax because she reacted very badly to Pfizer and everything". She did not mention if daughter has had any Novavax Covid-19 vaccine previously. She also stated that her daughter "has long Covid symptoms and can't have the other two vaccines. No follow-up attempts are possible. Batch/Lot number is not provided, and it cannot be obtained
More
|
||||||||
| 2843611 | 9 | F | MA | 06/02/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UJ807AA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
inappropriate use due to administering Pentacel when the same patient was 7 and 9 years old with no ...
inappropriate use due to administering Pentacel when the same patient was 7 and 9 years old with no reported adverse event; Initial information received on 30-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 years old female patient who was inappropriately use administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] when the patient was 7 and 9 years old with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine (Hepatitis a vaccine) and Varicella zoster vaccine live (Oka/Merck) (Varivax) for Immunisation. On 24-Feb-2025, the patient received 0.5mL (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection ((lot UK168AA, expiry date 31-Oct-2025) via intramuscular route in the deltoid NOS (not other specified) and on 11-Apr-2023 she also received 0.5mL (dose 2) of vaccine (lot UJ807AA, expiry date 01-Oct-2023) (frequency once and strength standard) via intramuscular route in the deltoid NOS for Immunisation. On 24-Feb-2025, the patient was inappropriately administered with pentacel when the same patient was 7 and 9 years old with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, the reporter called to ask a question regarding the administration of Pentacel. She mentioned that the patient came from another country and she was behind her routine vaccines. Patient needed DTAP, IPV, and HIB. Pentacel was first given when the patient was 7 years old and now that she's 9 years old. Reporter asked if it was okay or if the patient needs to be re-vaccinated. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
|
||||||
| 2843612 | 4 | M | ID | 06/02/2025 |
MMRV |
MERCK & CO. INC. |
Y008284 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Proquad given within 28 days after Flumist vaccine
Proquad given within 28 days after Flumist vaccine
|
||||||
| 2843613 | 32 | M | MN | 06/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MZ474 |
Underdose
Underdose
|
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
|
||||||
| 2843614 | 71 | F | 06/02/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
PG3RP 9L944 |
Blister, Fatigue, Vomiting; Blister, Fatigue, Vomiting
Blister, Fatigue, Vomiting; Blister, Fatigue, Vomiting
|
Patient states that the evening of her vaccinations, she experienced vomiting that lasted for severa...
Patient states that the evening of her vaccinations, she experienced vomiting that lasted for several days, in addition to fatigue and blisters on her scalp. She indicated that these symptoms persisted for one week following vaccinations.
More
|
|||||||
| 2843615 | 34 | M | MN | 06/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
1Z474 |
Underdose
Underdose
|
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITS A VACCINATION
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITS A VACCINATION
|
||||||
| 2843616 | 57 | M | MN | 06/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MZ474 |
Underdose
Underdose
|
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
|
||||||
| 2843617 | 65 | M | MN | 06/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MZ474 |
Underdose
Underdose
|
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
|
||||||
| 2843618 | 55 | F | MN | 06/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
mz474 |
Underdose
Underdose
|
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
|
||||||
| 2843619 | 65 | F | FL | 06/02/2025 |
RSV |
PFIZER\WYETH |
LN4P2 |
Arthralgia, Mobility decreased, Pain in extremity
Arthralgia, Mobility decreased, Pain in extremity
|
arm pain, patient claims she can not lift arm or stretch arm out with pain, joint pain
arm pain, patient claims she can not lift arm or stretch arm out with pain, joint pain
|
||||||
| 2843620 | 55 | F | CO | 06/02/2025 |
JEV1 TYP |
INTERCELL AG SANOFI PASTEUR |
jev23ko7e y2a021m |
Dizziness, Gait disturbance, Hypoaesthesia, Nausea, Vomiting; Dizziness, Gait di...
Dizziness, Gait disturbance, Hypoaesthesia, Nausea, Vomiting; Dizziness, Gait disturbance, Hypoaesthesia, Nausea, Vomiting
More
|
on 5-30-25 the patient contacted her doctor and stated that she had nausea and vomiting and dizzines...
on 5-30-25 the patient contacted her doctor and stated that she had nausea and vomiting and dizziness. Her right arm, leg, and foot felt numb and she felt like her foot was slapping when she walked. She reported to the doctor that she was better on 6-2-25
More
|
||||||
| 2843626 | 50 | F | NV | 06/02/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
unknown unknown unknown unknown 5y4tl 5y4tl 5y4tl 5y4tl |
Chills, Injection site cellulitis, Injection site erythema, Injection site pain,...
Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth, Nausea, Pyrexia, Rash; Cellulitis, Chills, Influenza like illness, Injection site erythema, Pain; Pyrexia; Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth, Nausea, Pyrexia, Rash; Cellulitis, Chills, Influenza like illness, Injection site erythema, Pain; Pyrexia
More
|
Cellulitus at injection site diagnosed by PCP requiring antibiotics and steroid. Belly rash after 48...
Cellulitus at injection site diagnosed by PCP requiring antibiotics and steroid. Belly rash after 48 hours. Prednisone and Clindamycin prescribed. Sore injection site within hours of injection. Fever, chills, nausea began 12 hours after injection and lasted 48 hours. 24 hours after injection, injection site was red(1"), swollen, hot, painful. Redness was approximately 1". By hour 48, redness was 2". By hour 72, redness was 3". Saw my PCP at hour 72 and he said it is infected and prescribed me antibiotics and steroids.
More
|
||||||
| 2843627 | 60 | F | FL | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Peripheral swelling, Skin reaction, Tenderness
Peripheral swelling, Skin reaction, Tenderness
|
Pt showed up to pharmacy with large read , swollen area on left arm. tender to the touch
Pt showed up to pharmacy with large read , swollen area on left arm. tender to the touch
|
||||||
| 2843628 | 57 | F | NM | 06/02/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LW1951 445TK |
Blister, Rash pruritic; Blister, Rash pruritic
Blister, Rash pruritic; Blister, Rash pruritic
|
Full body itchy rash with small blisters, started 11 days after vaccination and lasted for several w...
Full body itchy rash with small blisters, started 11 days after vaccination and lasted for several weeks. Did not require treatment.
More
|
||||||
| 2843629 | 50 | F | CA | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Arthralgia, Mobility decreased
Arthralgia, Mobility decreased
|
ON 05-23-25, SHINGRIX VACCINE WAS ADMINISTERED BY RPH. PT HAD CONTACTED RPH: IN REGARDS TO HER CONCE...
ON 05-23-25, SHINGRIX VACCINE WAS ADMINISTERED BY RPH. PT HAD CONTACTED RPH: IN REGARDS TO HER CONCERN OF EXPERIENCING PAIN ALONG LEFT SHOULDER JOINT AREA, AND THE INABILITY TO LIFT HER LEFT ARM ON 5-23-25 AROUND 5:45 PM. RPH HAD ADVISED HER MAY BE POSSIBLE SIDE EFFECT OF MUSCLE TENDERNESS AT INJECTION SITE, AND TO APPLY A COLD COMPRESS AND TAKE OTC IBUPROFEN IF TOLERATED. RPH, HAD ADVISED PT IF PAIN BECOMES SEVERE TO IMMEDIATELY CONTACT HER MD AND SEEK MEDICAL ATTENTION. ON 5-24-25, PT WAS PRESCRIBED MEDROL DOSE PACK BY HER NP. PRESCRIBER BELIEVES THAT VACCINE WAS ADMINISTERED TOO HIGH UP THE SHOULDER REGION IN THE SHOULDER CAPSULE CAUSING HER CHRONIC PAIN, LIMITED SHOULDER MOVEMENT, AND NERVE PAIN. PT HAS BEEN IN CHRONIC PAIN, AND WAS UNABLE TO SIGNIFICANTLY MOVE HER LEFT ARM FROM 5-23-25 TO 5-28-25. ON 5-28-25, PT WAS ALSO COMPLAINING OF SHARP PAIN RADIATING DOWN HER LEFT ARM. AS OF 6-2-25, PT INDICATED SHE IS ABLE TO MOVE HER SHOULDER, AND PAIN HAS SUBSIDED BUT NOT COMPLETELY. HOWEVER, SHE IS NOT ABLE TO PLACE ANY RESISTANCE (WEIGHT) ALONG THE LEFT ARM/ SHOULD REGION. SHOULDER IS STILL SORE.
More
|
||||||
| 2843630 | 21 | F | OR | 06/02/2025 |
TYP |
BERNA BIOTECH, LTD. |
US-VIV 2300013 |
Blood test, Dyspnoea, Hypersensitivity, Paraesthesia oral, Pharyngeal paraesthes...
Blood test, Dyspnoea, Hypersensitivity, Paraesthesia oral, Pharyngeal paraesthesia
More
|
Severe allergic reaction, onset approximately 5-7 minutes following ingestion of the oral capsule. S...
Severe allergic reaction, onset approximately 5-7 minutes following ingestion of the oral capsule. Symptoms began with tingling in the mouth/throat, and quickly progress to difficulties breathing within a minute. EpiPen was administered quickly, less than 5 minutes after the reaction started. Patient was conscious and showing minimal symptoms when ambulance arrived. Patient was transferred a local ER, and was given intravenous methylprednisone, diphenhydramine, and fomatidine. Patient was monitored for approximately 4 hours, and no further events or complications occurred. Patient was sent home with a 5-day course of prednisone, and instructions to take OTC Benadryl as needed for at least 5 days.
More
|
||||||
| 2843631 | 59 | M | OR | 06/02/2025 |
PNC21 |
MERCK & CO. INC. |
|
Fatigue
Fatigue
|
Excessive fatigue
Excessive fatigue
|
||||||
| 2843632 | 79 | M | CA | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Acne, Chest discomfort, Herpes zoster
Acne, Chest discomfort, Herpes zoster
|
Had 2 dots of Shingles awhile back in Feb./Mar. 2025 after taking Zoster vaccine many years ago. Dr...
Had 2 dots of Shingles awhile back in Feb./Mar. 2025 after taking Zoster vaccine many years ago. Dr. suggested getting a 3rd shot and when I went to pharmacy, they said I never had Shingrix and should get 2 shots, 2nd after 2-6 months. About 2 weeks after getting shot I felt that same pimple/dot on my chest that I had Shingles back in Feb.Mar. and it feels the same discomfort. It is still there and uncomfortable, but 2nd dot has not turned up as yet. This seems like it should not happen and when researching on internet was directed to submit this adverse reaction but getting Shingles in same spot 2nd time after taking dose 1 of Shingrix
More
|