| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2853255 | 5 | M | TX | 08/07/2025 |
DT VARCEL |
SANOFI PASTEUR MERCK & CO. INC. |
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Injection site erythema, Lethargy, Pyrexia, Vomiting; Injection site erythema, L...
Injection site erythema, Lethargy, Pyrexia, Vomiting; Injection site erythema, Lethargy, Pyrexia, Vomiting
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The morning after the vaccines were given, our child had a 100๏ฟฝ fever and was lethargic. That afte...
The morning after the vaccines were given, our child had a 100๏ฟฝ fever and was lethargic. That afternoon, he vomited. After the vomiting, it was noticed he had a large red patch at the site of the injections. It was approximately 4 inches in diameter.
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| 2853256 | 1 | F | VA | 08/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Condition aggravated, Febrile convulsion, Generalised tonic-clonic seizure, Pyre...
Condition aggravated, Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia, Unresponsive to stimuli
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Febrile seizure. Fever 101.3F, 1-2 minutes of generalized tonic clonic activity. Unresponsive for 7 ...
Febrile seizure. Fever 101.3F, 1-2 minutes of generalized tonic clonic activity. Unresponsive for 7 minutes after. EMS responded, brought to the hospital. Evaluated by neurology and dose of Trileptal for seizures increased to reduce risk of breakthrough seizures.
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| 2853257 | 16 | F | CA | 08/07/2025 |
IPV MMR TDAP |
SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR |
Y1D03P1 Y017527 U8503AA |
Pallor, Syncope, Tremor; Pallor, Syncope, Tremor; Pallor, Syncope, Tremor
Pallor, Syncope, Tremor; Pallor, Syncope, Tremor; Pallor, Syncope, Tremor
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fainting, shaking, appeared pale
fainting, shaking, appeared pale
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| 2853258 | 1 | M | CA | 08/07/2025 |
HEPA HEPA HEPA MMR MMR MMR VARCEL VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y013120 Y013120 Y013120 Z003401 Z003401 Z003401 Z003883 Z003883 Z003883 |
Asthenia, Bladder catheterisation, Blood glucose normal, Culture urine, Dysstasi...
Asthenia, Bladder catheterisation, Blood glucose normal, Culture urine, Dysstasia; Influenza virus test negative, Irritability, Mobility decreased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Urine ketone body present, White blood cells urine negative; Asthenia, Bladder catheterisation, Blood glucose normal, Culture urine, Dysstasia; Influenza virus test negative, Irritability, Mobility decreased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Urine ketone body present, White blood cells urine negative; Asthenia, Bladder catheterisation, Blood glucose normal, Culture urine, Dysstasia; Influenza virus test negative, Irritability, Mobility decreased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Urine ketone body present, White blood cells urine negative
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Fussy on 8/1 and 8/2. On 8/3, had a hard time standing and pulling himself up. 8/4 - not able to ro...
Fussy on 8/1 and 8/2. On 8/3, had a hard time standing and pulling himself up. 8/4 - not able to roll or get up from a lying position and was weak to the point where head would drop back slightly when lifted. He was taken to Medical Center on 8/4/2025 due to this. Rapid flu, COVID, RSV were negative. POC glucose was 70. Diagnosed with viral syndrome. After ER visit, e started getting fever in the last 2 days (Tm of 101 at Tuesday night). Given tylenol. Last fever 100.1 this am. Not wanting to drink as much or eat. Started with a rash today on his arms. Slightly decreased wet diapers but still breast feeding. He has not stooled for the last few days. No cough, congestion. Strength is better but not yet at his baseline. Had nasal congestion prior to this, but no other prior illness or diarrheal illness.
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| 2853259 | 16 | M | HI | 08/07/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z007212 Y013350 |
Extra dose administered, Product administered to patient of inappropriate age, W...
Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered; Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
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On 08/07/2025, 16 y/o Male patient came in with his mother for his well child exam. At approximately...
On 08/07/2025, 16 y/o Male patient came in with his mother for his well child exam. At approximately 3:25pm, I administered patient with MMRV ProQuad and Varicella Varivax on the Left Arm. Patient was only supposed to get MMR and Varicella separately. I did not notice until 15 minutes after I administered both vaccines that it was the wrong vaccines. Immediately it was reported to APRN who saw the patient for his Well Child Exam. She then reported it to patient and his mother.
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| 2853272 | 10 | M | NC | 08/07/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
D2343 H4279 |
Injection site erythema, Injection site pain, Injection site warmth; Injection s...
Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth
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Treatment Administer Zyrtec, ice to arm, monitor. Symptoms started 8/6/25 around 5pm. Vaccine admini...
Treatment Administer Zyrtec, ice to arm, monitor. Symptoms started 8/6/25 around 5pm. Vaccine administered 8/5/2025. 6 1/2 x 4 inch area of erythema and warmth, tender to touch.
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| 2852888 | 1 | M | TX | 08/06/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
X017486 |
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/No PQC; HCP called to report a VARIVAX TE update for Case 02824314 because the ...
No additional AE/No PQC; HCP called to report a VARIVAX TE update for Case 02824314 because the 'time out of range' was reported incorrectly on 6/18/2025. Caller stated that VARIVAX had been administered on 6/18/2025 after the original TE was reported. For updated TE S; This spontaneous report was received from nurse and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-JUN-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #X017486, expiration date reported 25-JUN-2025 0.5 mL (route of administration and anatomical location of vaccine were not reported), diluted with sterile diluent (lot #, expiration date and dose were not administered) administered for prophylaxis. The dose experienced a temperature excursion. No additional adverse event was reported. Follow-up information was received from the reporter on 11-JUL-2025. This report referes to a 1-year-old male patient. The concomitant therapies administered included Measles vaccine (+) Mumps vaccine (+) Rubella vaccine (MMR), Hepatitis a vaccine (HepA), Pneumococcal vaccine (PVC). The patient was vaccine with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL, administered subcutaneously in his left leg. This report was previously considered as non-valid since no patient's identifiers were reported. Upon follow up information, patient information was reported.
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| 2852889 | F | MA | 08/06/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Erythema, Fatigue, Incorrect route of product administration, Injected limb mobi...
Erythema, Fatigue, Incorrect route of product administration, Injected limb mobility decreased, Injection site warmth; Muscular weakness, Pain, Rash
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vaccination site movement impairment; it was administered subcutaneously rather than intramuscularl...
vaccination site movement impairment; it was administered subcutaneously rather than intramuscularly; warmth at the injection site; fatigue; weakness in legs; a little soreness, but less pain; still a bit red; rash; This spontaneous report was received from a consumer regarding a 56-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 16-JUL-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered subcutaneously in the left arm for vaccination (strength, dose, vaccination scheme, lot number, and expiration date were not reported) (Incorrect route of product administration). Later that evening, the patient experienced warmth at the injection site (Vaccination site warmth), and began to have fatigue (Fatigue), weakness in legs (Muscular weakness), it was not easy to lift her arm (Vaccination site movement impairment), and she broke out in a rash on hear arm that spread (Vaccination site rash). Her doctor prescribed her antibiotics. On an unknown date in July 2025, the patient also experienced a little soreness, but less pain (Pain) and reported that she was still a bit red (Erythema), but much smaller surface area remaining affected. At the time of the reporting, the patient was getting better from the events (recovering). The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
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| 2852890 | NY | 08/06/2025 |
MMR MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
W024967 W024967 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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No additional AE; Lot# valid for PROQUAD; an expired dose of MMRII was inadvertently administered to...
No additional AE; Lot# valid for PROQUAD; an expired dose of MMRII was inadvertently administered to a patient.; This spontaneous report was received from a registered nurse and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) On an unknown date, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot #W024967 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; but valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Product lot number issue) expiration date: 05-Feb-2024 (strength dose number, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). It was confirmed that the vaccine did not undergo any temperature excursions. No adverse events reported.
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| 2852891 | F | NJ | 08/06/2025 |
HEP HEP |
MERCK & CO. INC. MERCK & CO. INC. |
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Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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No other AE; HCP calling to report a patient who received HEPTAVAX-II (RECOMBIVAX HB) in (withheld) ...
No other AE; HCP calling to report a patient who received HEPTAVAX-II (RECOMBIVAX HB) in (withheld) on 27MAY2024 and second dose on 25JUN2025 would like to receive her 3rd dose here in (withheld). She will be receiving a 3rd dose in the form of ENGERIX-B today 28JUL2025.; This spontaneous report was received from a pharmacist and refers to a(n) 37-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-May-2024, in another country, the patient was vaccinated with the first dose of with Hepatitis B Vaccine (Recombinant) (HEPTAVAX-II) (RECOMBIVAX HB). On 25-Jun-2025, the patient received the second dose of with Hepatitis B Vaccine (Recombinant) (HEPTAVAX-II) (RECOMBIVAX HB) (Inappropriate schedule of vaccine administration). Both doses were administered by Unknown route as prophylaxis (anatomical site, lot # and expiration date were not reported). On 28-Jul-2025, she would receive her 3rd dose in the reporter's country, but in the form of ENGERIX-B. No other information provided. No other AE/No PQC. Lot number is being requested and will be submitted if received.
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| 2852892 | 08/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Drug hypersensitivity, Erythema, Feeling hot, Peripheral swelling
Drug hypersensitivity, Erythema, Feeling hot, Peripheral swelling
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My arm is completely swollen, red and very hot; My arm is completely swollen, red and very hot; My a...
My arm is completely swollen, red and very hot; My arm is completely swollen, red and very hot; My arm is completely swollen, red and very hot; some kind of allergy; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 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: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "My arm is completely swollen, red and very hot"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "some kind of allergy". Additional information: Patient received last fall, the Pfizer COVID vaccine Comirnaty, that one and patient had a reaction in the other arm. The arm was completely swollen, red and very hot. So, patient need to know what if, ingredients were the same in those vaccines, also asked if anything in there. Because patient definitely have some kind of allergy. The COVID patient got last fall, Oct2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2852902 | 13 | F | VT | 08/06/2025 |
MNQ MNQ MNQ |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8325AB U8325AB U8325AB |
Atrial fibrillation, Dizziness, Headache, Hyperventilation, Inappropriate affect...
Atrial fibrillation, Dizziness, Headache, Hyperventilation, Inappropriate affect; Injection site erythema, Injection site warmth, Panic reaction, Presyncope, Rash; Rash macular
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Patient very upset before vaccination. Vaccination administered. Following vaccination developed a 5...
Patient very upset before vaccination. Vaccination administered. Following vaccination developed a 5-8cm area of warmth and erythema at the site. Also developed some macular and hive-like lesions on neck and chest. Patient reported feeling dizzy and pre-syncopal. I was called in to the room to assess the patient. She was well appearing but hyperventilating and laughing. No evidence of anaphylaxis. Ongoing injection site reaction and urticarial lesions on neck. No resp. distress. No changes in vitals. No angioedema. After about 10-15 minutes injection site reaction lighter and less warm. 50mg of Benadryl was given out of abundance of caution. Lesions on neck resolved (they resolved in 10 minutes or less). Patient then rested ate some food and had some juice and was feeling better. At about 30 minutes post immunization the patient reports that she developed a headache and began hyperventilating. 325 mg Tylenol given. Advised and demonstrated slow deep breathing. She was advised to lay back down and to rest with close monitoring. Vitals remained stable and without reported or observed s/s of anaphylaxis. After this rest period x 30 minutes. She was allowed to depart. At this time injection site reaction was almost completely gone. No further rashes, and no s/s of anaphylaxis. She did report feeling fatigued from Benadryl and panic from previous.
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| 2852903 | 32 | M | CA | 08/06/2025 |
HEP MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
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Hepatitis B antibody positive, Laboratory test normal, Rash pruritic, Sexually t...
Hepatitis B antibody positive, Laboratory test normal, Rash pruritic, Sexually transmitted disease test, Skin discolouration; Hepatitis B antibody positive, Laboratory test normal, Rash pruritic, Sexually transmitted disease test, Skin discolouration; Hepatitis B antibody positive, Laboratory test normal, Rash pruritic, Sexually transmitted disease test, Skin discolouration
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At the early months of 2024, I observed a few purplish bumps on both of my arms, sometimes they'...
At the early months of 2024, I observed a few purplish bumps on both of my arms, sometimes they're itchy. I went to facility, where I had all STD tests, but everything came out clean. I went to health center, where more lab tests was done, and everything yet came out clean. The doctor referred me to a dermatologist and went to few and then a dermatology center, where I was prescribed BETAMETHASONE DIPROPIONATE OINTMENT USP (AUGMENTED), 0.05%, which had an effect on the bumps. But every time the ointment runs out the bumps came out in large numbers and on all parts of my body...
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| 2852907 | F | 08/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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never received 2nd dose; This non-serious case was reported by a consumer via call center representa...
never received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (she received the first dose of Shingrix in Feb 2023). The patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 22-JUL-2025 Consumer stated that she received the first dose of Shingrix in Feb 2023, but she never received the second dose. Patient DOB and initials were not available. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2852908 | 08/06/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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I just took it and got very ill; This non-serious case was reported by a consumer via interactive di...
I just took it and got very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced illness (Verbatim: I just took it and got very ill). The outcome of the illness was not reported. It was unknown if the reporter considered the illness to be related to RSV vaccine. It was unknown if the company considered the illness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 29-JUL-2025 This case was reported by a patient via interactive digital media. The patient just took Respiratory Syncytial Virus vaccine and got very ill. The patient was very close to ending up at the hospital.
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| 2852909 | 1.58 | M | 08/06/2025 |
MNQ |
SANOFI PASTEUR |
U8351CA |
Wrong product administered
Wrong product administered
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VACCINATION ERROR - WRONG VACCINE ADMINISTERED
VACCINATION ERROR - WRONG VACCINE ADMINISTERED
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| 2852910 | 20 | F | SC | 08/06/2025 |
COVID19 |
MODERNA |
013m20a |
Intra-uterine contraceptive device insertion
Intra-uterine contraceptive device insertion
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Reported Symptoms: 10005103:BLEEDING; 10027334:MENSTRUATION ABNORMAL; Narrative: "She tells me ...
Reported Symptoms: 10005103:BLEEDING; 10027334:MENSTRUATION ABNORMAL; Narrative: "She tells me she had a continuous period for about 6-8 weeks after she took the Moderna covid shot, so she does not want any more vaccines. She was on oral contraceptives at the time and had to switch her birth control to IUD after this happened." Other Relevant HX: Other: prolonged menses
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| 2852911 | 63 | F | SC | 08/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
036c21a 033c21a |
Rash; Rash
Rash; Rash
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Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
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| 2852912 | 75 | M | WV | 08/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75GZ7 |
Dyspnoea, Pharyngeal swelling, Respiratory depression, Throat tightness
Dyspnoea, Pharyngeal swelling, Respiratory depression, Throat tightness
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Reported Symptoms: 10038678:RESPIRATORY DEPRESSION; 10040604:SHORTNESS OF BREATH; 10043528:THROAT TI...
Reported Symptoms: 10038678:RESPIRATORY DEPRESSION; 10040604:SHORTNESS OF BREATH; 10043528:THROAT TIGHTNESS; Narrative: Patient received 2nd dose of Zoster vaccine 4/18/25. Patient had received first dose 1/2025 with no documented concerns. However, after administration of 2nd dose patient experienced noted throat swelling and SOB. No documented medications used to alleviate symptoms. No further documented concerns. Other Relevant HX: Other: SOB and throat swelling
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| 2852913 | F | FL | 08/06/2025 |
RSV |
PFIZER\WYETH |
LG9829 |
Device connection issue, Needle issue, Soft tissue foreign body
Device connection issue, Needle issue, Soft tissue foreign body
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Reported Symptoms: 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT ...
Reported Symptoms: 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; 10069327:PRODUCT QUALITY ISSUE; Narrative: Nurses reported RSV vaccine "coming apart in their hands" when attempting to screw the diluent into the vaccine vial with the enclosed adapter. In one case, a nurse reported administering the vaccine but when pulling the syringe away from the patient's arm, the needle and leur lock adapter" stayed in the patient's arm." Further testing of the product revealed that the plastic leur lock adapter must be "clicked in" to the glass syringe slip tip to ensure it stays seated and if it is not clicked in, it can slide off. This was reported to the manufacturer as well. Other Relevant HX: Other: issue with product
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| 2852914 | F | GA | 08/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Swelling, Urticaria
Swelling, Urticaria
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Reported Symptoms: 10042674:SWELLING; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTIC...
Reported Symptoms: 10042674:SWELLING; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA; SWELLING
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| 2852915 | M | DC | 08/06/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Anaphylactic reaction
Anaphylactic reaction
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Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: An 88yo female with PMH which included hypothyro...
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: An 88yo female with PMH which included hypothyroidism, HTN, HLD, chronic anxiety, chronic GERD, HX of smoking 40+ years. The patient recently moved from (withheld) and presented to clinic on March 26, 2025 to get her medication refilled (transferred from another clinic) and established care. During the visit the PCC - RN's note included "vaccine discussed and patient informed to bring in immunization status" The RN also reported the patient had a historical ADR of Influenza vaccine induced anaphylaxis. No other detailed information was provided regarding the vaccine type (mfc, lot # exp) when, where and by whom it was administered. Other Relevant HX: Other: ANAPHYLAXIS
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| 2852916 | M | OK | 08/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
NG5FM |
Hypoaesthesia, Vomiting
Hypoaesthesia, Vomiting
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Reported Symptoms: 10047700:VOMITING; 10049800:NUMBNESS IN FEET; Narrative: Other Relevant HX: Other...
Reported Symptoms: 10047700:VOMITING; 10049800:NUMBNESS IN FEET; Narrative: Other Relevant HX: Other: VOMITING; NUMBNESS in feet
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| 2852917 | 61 | M | FL | 08/06/2025 |
RSV |
PFIZER\WYETH |
LH4508 |
Lymph node pain, Oral pruritus, Pruritus, Tongue pruritus
Lymph node pain, Oral pruritus, Pruritus, Tongue pruritus
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Reported Symptoms: 10037087:PRURITUS; Narrative: Per 3/21/2025 ambulatory secure messaging, the pati...
Reported Symptoms: 10037087:PRURITUS; Narrative: Per 3/21/2025 ambulatory secure messaging, the patient stated: "I first noticed something happening with my throat/mouth. If felt like my mouth and tongue had this itch or more like a sensation of one, and my glands in my neck seemed swollen because they hurt. So, I took some tylenol. A little while after that, my face started to itch around my mouth. That's when I took benadryl, and it calmed down the itch in my face some, but it's still slightly there, and in my mouth". Other Relevant HX: Other: PRURITUS
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| 2852918 | 64 | M | 08/06/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y5X9T Y5X9T |
Arthralgia, Gait disturbance, Headache, Joint swelling, Pain in extremity; Perip...
Arthralgia, Gait disturbance, Headache, Joint swelling, Pain in extremity; Peripheral swelling
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Reported Symptoms: 10003239:ARTHRALGIA; 10014210:EDEMA; 10042674:SWELLING; Narrative: Patient report...
Reported Symptoms: 10003239:ARTHRALGIA; 10014210:EDEMA; 10042674:SWELLING; Narrative: Patient reported since he received his 3rd hepatitis B vaccine dose (2/26/25) he had pain and swelling right hand for two days, then the same pain and swelling in left hand the following 3 days, then pain and swelling ("like a bad sprain") with his right foot and ankle. The swelling in hands resolved with time. He reported difficulty walking with the pain/swelling in his foot and ankle. He also reported headaches but no fever. At a primary care visit in April 2025, these symptoms were no longer reported. Other Relevant HX: Other: edema/swelling
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| 2852919 | 74 | M | PA | 08/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8437DA |
Death, Myocardial infarction
Death, Myocardial infarction
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Reported Symptoms: 10011906:DEATH; 10028596:MYOCARDIAL INFARCTION; Narrative: Patient received influ...
Reported Symptoms: 10011906:DEATH; 10028596:MYOCARDIAL INFARCTION; Narrative: Patient received influenza vaccination earlier in the day. Patient's spouse reported patient experienced a "heart attack" later in the day and passed away Other Relevant HX: Other: myocardial infarction
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| 2852920 | 50 | F | FL | 08/06/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4927 LN4927 |
Erythema, Erythema multiforme, Injection site erythema, Injection site irritatio...
Erythema, Erythema multiforme, Injection site erythema, Injection site irritation, Injection site pain; Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
More
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Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; Narrative: Patien...
Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient received prevnar20 vaccine on 3/7/25. On 3/11/25 the patient called the clinical contact center "to report having a skin reaction to her Pneumonia vaccination administered on Friday, 3/7/25 in her left arm. She states it was initially a little sore and red but she noticed yesterday she had developed red, itchy welts. The swelling has now affected her entire bicep area and is warm and tender to the touch. She denies any shortness of breath or facial swelling". Per urgent care not " Recommended treatment with topical triamcinolone, hydroxyzine antihistamine". Per 3/12 PCP note "Symptoms started afternoon of 03/8/2025: itching and scratching of arm at injection site. Developed hives, redness, and irritation at injection site. Some mild puffiness notes on contralateral arm, though less severe than injection site." Other Relevant HX: Other:
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| 2852921 | 52 | F | TX | 08/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JT54Y |
Pruritus, Rash
Pruritus, Rash
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Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other:
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| 2852980 | F | TN | 08/06/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Diarrhoea, Dizziness, Fatigue, Headache, Injection site bruising; Injection site...
Diarrhoea, Dizziness, Fatigue, Headache, Injection site bruising; Injection site erythema, Injection site induration, Malaise, Nausea, Pyrexia; Vertigo, Vomiting
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extreme fatigue, stayed in the bed and got up to go to the bathroom; diarrhea; real horrible headach...
extreme fatigue, stayed in the bed and got up to go to the bathroom; diarrhea; real horrible headache, very dizzy, full blown vertigo, then spiked a low grade fever Tuesday, diarrhea, and then nausea and vomiting; local reaction red and hot to touch, bigger than 2 half a dollars put together, and it got hard, not uncommon for me when I get vaccines; Arm is still red and bruised; Arm is still red and bruised; This spontaneous report was received from a Nurse and refers to a(n) 78-year-old female patient. The patient's medical history included history of gout and anaphylactic reaction to penicillin in 2012. The patient's concurrent conditions included irritable bowel syndrome (IBS), cirrhosis, seasonal asthma, drug hypersensitivity, and allergy to yellow dye in food and any medication. Historical drugs included penicillin. Concomitant medications included metoprolol, potassium chloride, omeprazole (PRILOSEC), acetylsalicylic acid (BABY ASPIRIN), alopurinol, amlodipine and colesevelam. Historical vaccines included pneumococcal vaccine conj 7v (CRM197) (PREVNAR). The patient had second shot of shingles with symptoms. On 07-Jul-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered intramuscularly (dose, vaccination site, lot # and expiration date were not reported) to prevent pneumococcal pneumonia. On 07-Jul-2025, the patient got sick. On that day (Monday evening), the patient developed a real horrible headache, she was very dizzy, had full blown vertigo (vertigo). On 08-JUL-2025 (Tuesday), the patient spiked a low grade fever, experienced diarrhea, and then nausea and vomiting, extreme fatigue (diarrhoea; fatigue). She stayed in the bed and got up to go to the bathroom and was so nauseated and had a lot of over the counter medicine due to history of stomach issues that she was able to manage. On an unspecified date in July 2025, she had a local reaction which was red and hot to touch, bigger than 2 half a dollars put together, and it got hard (Skin reaction; Erythema). This was not uncommon for her when she get vaccines. The problem was how sick she got. On 12-Jul-2025 (Saturday), the patient got better and came alive. Her headache got better. On 13-Jul-2025 (yesterday), she felt pretty decent and there was no temperature today. The patient was concerned if there was something with her health that contraindicated. The physician was informed and their take was as followed: "the nurse (the patient) said it sounds like maybe she had contracted a virus and or part vaccine reaction and a virus." Additionally, the patient reported the following: "I do have cirrhosis and never had abnormal blood work, never had jaundice or hepatitis, I am 78 years old, second shot of shingles had symptoms but nothing was like this. I am a retired LPN and I am in tune medically, is that a vaccine that needs to be massaged into the muscle, the injector massaged the site after injection, red streaks and bruising and looked like it was going to abscess, she massaged for a while and hard at the physician's. I had normal blood work and no symptoms prior to the shot." Her arm was still red and bruised (contusion). The nurse also asked about contraindications and any other information and was concerned if her history of anaphylaxis to penicillin or her medications interacted, and informed there was no information from the database as she was a retired nurse but wanted to ask her physician for more information. No additional adverse event (AE) and no product quality complaint (PQC) was noted. At the reporting time, the patient was recovering from the reported adverse events with the exception of skin reaction, erythema and contusion, as her arm was still red and bruised. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the reported adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received. This is one of two cases received from the same reporter and referring to the same patient.
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| 2852981 | FL | 08/06/2025 |
VARCEL |
MERCK & CO. INC. |
Z004455 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse event; MVCC agent transferred medical assistant who reported VARIVAX involved in temperat...
No adverse event; MVCC agent transferred medical assistant who reported VARIVAX involved in temperature excursion has been administered to multiple patients since being involved in the excursion. Caller provided patient information for each dose administered, also see; This spontaneous report was received from an Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. It was reported that on 07-Jul-2025, the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Z004455, expiration date: 13-Feb-2027 was involved in temperature excursion of 36.5F for the time frame of 2 hours 21 minutes. On an unknown date in July 2025, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Z004455, expiration date: 13-Feb-2027 (dose, units and route of administration were not reported), which was reconstituted with sterile diluent (lot# and expiration date were not reported) and administered for prophylaxis. There was no additional adverse event. Lot # (regarding sterile diluent) is being requested and will be submitted if received.
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| 2852982 | F | TN | 08/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Ill-defined disorder
Ill-defined disorder
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second shot of shingles had symptoms but nothing was like this; This spontaneous report was received...
second shot of shingles had symptoms but nothing was like this; This spontaneous report was received from a nurse and refers to a female patient who was currently 78 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported (current medical history, concurrent conditions and concomitant therapies were captured in case #2309018). On an unknown date, the patient was vaccinated with the second shot of Zoster Vaccine Live (ZOSTAVAX) (reported as, second shot of shingles) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. On an unspecified date, the patient had symptoms after the second shot of shingles (ill-defined disorder). The outcome of the adverse event was not provided. The action taken with the suspect vaccine was not applicable. The causal relationship between the reported adverse event and Zoster Vaccine Live (ZOSTAVAX) was not reported. Lot # is being requested and will be submitted if received. This is on of two cases received from the same reporter and referring to the same patient.
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| 2852983 | TN | 08/06/2025 |
MMR |
MERCK & CO. INC. |
X024177 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE; HCP called to report patient was administered expired dose of MMR-II.; This sponta...
No additional AE; HCP called to report patient was administered expired dose of MMR-II.; This spontaneous report has been received from a physician, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 04-AUG-2025, the patient was vaccinated with an expired dose (Expired product administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) plus sterile diluent (lot number X024177, expiration date: 11-JUN-2025) at a dose of 0.5 milliliter (ml), administer in Left Thigh as prophylaxis. No additional adverse events were reported in the patient.
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| 2852984 | MD | 08/06/2025 |
DTPPVHBHPB PNC15 RV1 |
MSP VACCINE COMPANY MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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the infant did not experience any adverse issues or side effects from the administered vaccines; VAX...
the infant did not experience any adverse issues or side effects from the administered vaccines; VAXELIS, VAXNEUVANCE, and ROTATRIX were all inadvertently administered to a 6-day-old infant; This spontaneous report was received from a physician and refers to a 6-day-old patient of unknown gender. The patient was a full-term baby (born at a gestation of 37 weeks). The patient's medical history or concomitant therapies were not reported. On 04-AUG-2025, the patient was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection, pneumococcal 15-valent conjugate vaccine (VAXNEUVANCE) suspension for injection and rotavirus vaccine live oral 1v (ROTARIX), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported) (Product administered to patient of inappropriate age). The patient did not experience any adverse issues or side effects from the administered vaccines and was otherwise doing well. Lot# is being requested and will be submitted if received.
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| 2852985 | 5 | M | IN | 08/06/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
YN2X2 Z006278 |
Injection site erythema, Injection site irritation, Injection site pain, Injecti...
Injection site erythema, Injection site irritation, Injection site pain, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site irritation, Injection site pain, Injection site urticaria, Injection site warmth
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Small red irritation started at injection site two days afterwards. Grew into a large 4-5? diameter ...
Small red irritation started at injection site two days afterwards. Grew into a large 4-5? diameter welt/hive that was hot to the touch and extremely painful. The next morning the circle was even larger, but started to subside after two doses of allergy meds and ibuprofen.
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| 2852986 | 16 | M | IL | 08/06/2025 |
MNP |
PFIZER\WYETH |
LX50414 |
Chills, Headache, Mass, Pain
Chills, Headache, Mass, Pain
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HEADACHE,BODY ACHES,CHILLS,AND LUMP
HEADACHE,BODY ACHES,CHILLS,AND LUMP
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| 2852987 | 16 | M | IL | 08/06/2025 |
MNP |
PFIZER\WYETH |
LX50414 |
Chills, Headache, Mass, Pain
Chills, Headache, Mass, Pain
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HEADACHE,BODY ACHES, CHILLS, AND LUMP
HEADACHE,BODY ACHES, CHILLS, AND LUMP
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| 2852988 | 08/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination, Pain in extremity
Incomplete course of vaccination, Pain in extremity
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more pain in my arm. First shot, my arm ached for days; This serious case was reported by a consumer...
more pain in my arm. First shot, my arm ached for days; This serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: more pain in my arm. First shot, my arm ached for days) (serious criteria other: Serious as per reporter). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. The company considered the pain in arm to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-JUL-2025 The patient had bad reaction (arm ached for days) from first shot and opted out of second one.; Sender's Comments: The company considers that there was no reasonable possibility that the event Pain in extremity may have been caused by Shingrix. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2852989 | 61 | M | AR | 08/06/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
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| 2852990 | 2 | M | 08/06/2025 |
DTAPIPVHIB HEPA |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UK216AB L4EA4 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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GIVEN BEFORE DUE DATE
GIVEN BEFORE DUE DATE
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| 2852991 | 79 | M | IA | 08/06/2025 |
COVID19 |
PFIZER\BIONTECH |
6H9702 |
Death
Death
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Resident passed away
Resident passed away
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โ | |||||
| 2852992 | 10 | M | TN | 08/06/2025 |
TDAP |
SANOFI PASTEUR |
3ca30c1 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Pt received inadvertent dose of Tdap. Pt and father were counseled and monitored for 20 minutes in c...
Pt received inadvertent dose of Tdap. Pt and father were counseled and monitored for 20 minutes in clinic.
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| 2852993 | 11 | F | SD | 08/06/2025 |
HPV9 HPV9 MNQ MNQ TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
y019751 y019751 u8438aa u8438aa u8618aa u8618aa |
Fall, Full blood count, Metabolic function test, Pallor, Unresponsive to stimuli...
Fall, Full blood count, Metabolic function test, Pallor, Unresponsive to stimuli; Vision blurred; Fall, Full blood count, Metabolic function test, Pallor, Unresponsive to stimuli; Vision blurred; Fall, Full blood count, Metabolic function test, Pallor, Unresponsive to stimuli; Vision blurred
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Pt was given 3 vaccines. Was sitting on the exam table. After injections child states she felt fine ...
Pt was given 3 vaccines. Was sitting on the exam table. After injections child states she felt fine and tolerated the injections well. Was not worked up or anxious about vaccines. Child and mother walked out of exam room and up to the front of the clinic. Child stated to her mother that her vision was blurry, then proceeded to fall backwards hitting the floor. Child unresponsive for a couple seconds, then responds to name. Pale in color. Child had eaten a good breakfast this am and has not been ill. Has not taken any medication. Child given juice and ice pack applied to her neck. child sat up slowly after 5-8 minutes. Child brought back to exam room, snack given and blood drawn. Lab work normal. Examined by nurse practitioner. Child feels fine and left clinic with mother.
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| 2852994 | 38 | F | OH | 08/06/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z004302 Z004302 Z004302 |
Aphasia, Blood culture, Chest pain, Computerised tomogram head, Computerised tom...
Aphasia, Blood culture, Chest pain, Computerised tomogram head, Computerised tomogram heart; Diarrhoea, Diplegia, Dizziness, Dysarthria, Heart rate increased; Laboratory test, Pyrexia, Sepsis, Supraventricular tachycardia, Vomiting
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Heart rate ranging from 170-180s, pain in chest, dizziness. Paralysis of hand, arms and legs, slurri...
Heart rate ranging from 170-180s, pain in chest, dizziness. Paralysis of hand, arms and legs, slurring/aphasia. EMS call with two doses of IV Adenosine administered without success en route to hospital. Defibrillator pads administered, unused. IV administration of Magnesium and Potassium in emergency room upon arrival. Spiked fever and was treated for sepsis with Vancomycin and Azteronam. Heart rate lowered to 150s once admitted to the hospital but required further medication to lower resting HR. Anti clot injections administered. Vomiting and diarrhea treated with Zofran and fluids. SVT as a result of elevated heart rate.
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| 2852995 | 11 | F | OH | 08/06/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y020464 U8573AA 4CA28C1 |
Arthralgia, Injection site mass, Injection site pain, Pain; Arthralgia, Injectio...
Arthralgia, Injection site mass, Injection site pain, Pain; Arthralgia, Injection site mass, Injection site pain, Pain; Arthralgia, Injection site mass, Injection site pain, Pain
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Patient initially developed a lump in her right deltoid muscle with soreness where the vaccine was g...
Patient initially developed a lump in her right deltoid muscle with soreness where the vaccine was given. The lump resolved in a few days. She continues to have right upper arm/deltoid pain and also right shoulder pain (anterior and posterior shoulder) with movement, especially with lifting her arm above her hand and playing volleyball. She feels the pain with movement is worsening over time. She came in for an appointment due to the pain today (2 weeks post vaccination). She has tried ibuprofen, tylenol, and ice- which help for a short time then the pain (only with activity) returns. I referred her today to physical therapy for the pain.
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| 2852996 | 14 | M | 08/06/2025 |
HPV9 |
MERCK & CO. INC. |
Y014510 |
Syncope
Syncope
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Administered 2/2 HPV vaccine, monitored while in the exam room with mom following vaccine. Dr. still...
Administered 2/2 HPV vaccine, monitored while in the exam room with mom following vaccine. Dr. still had part of exam left and was in room with patient and mom, about 5 minutes after receiving the vaccine he had a syncopal episode with LOC for 10-15 seconds and a small convulsion. He was sitting on the exam table at the time and was able to lie down quickly. Lollipops and water given to patient, both tolerated well.
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| 2852997 | 1 | F | 08/06/2025 |
MMR |
MERCK & CO. INC. |
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Rash morbilliform
Rash morbilliform
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Widespread morbilliform rash without itching, pain, or altered behavior starting on 8/4 and leading ...
Widespread morbilliform rash without itching, pain, or altered behavior starting on 8/4 and leading to office visit on 8/6
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| 2852998 | 17 | F | 08/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Local reaction
Local reaction
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large local reaction several days after vaccination consistent with cellulitis
large local reaction several days after vaccination consistent with cellulitis
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| 2852999 | 64 | F | SC | 08/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Angioedema, Local reaction, Urticaria
Angioedema, Local reaction, Urticaria
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Urticaria and Angioedema, Local reaction then face and neck
Urticaria and Angioedema, Local reaction then face and neck
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| 2853000 | 11 | F | WY | 08/06/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site discolouration, Injection site erythema, Injection site reaction,...
Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling, Skin exfoliation
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Since at least the day after, and continuing until NOW (still there) it has been one month tomorrow ...
Since at least the day after, and continuing until NOW (still there) it has been one month tomorrow and the injection site is still raised and red. The redness has subsided in the month but still there today AUG 6th. The skin was raised, red, and peeling. Now, after nearly one month, it is still discolored and raised, but the flaking has subsided mostly.
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