| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2839060 | 77 | M | IA | 04/30/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Blood test, Fatigue, Flushing, Magnetic resonance imaging, Phantosmia; Skin disc...
Blood test, Fatigue, Flushing, Magnetic resonance imaging, Phantosmia; Skin discomfort
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I was dealing with flushed head; I was dealing with skin sensation; I was dealing with extreme fatig...
I was dealing with flushed head; I was dealing with skin sensation; I was dealing with extreme fatigue; I was smelling things (odors) that were not there. Initially like oil, then heavy chemical smells day and night/this time the phantom odor (Phantosmia); This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (I was dealing with flushed head), SKIN DISCOMFORT (I was dealing with skin sensation), PAROSMIA (I was smelling things (odors) that were not there. Initially like oil, then heavy chemical smells day and night/this time the phantom odor (Phantosmia)) and FATIGUE (I was dealing with extreme fatigue) in a 77-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Sickness (Patient became less sick, but still something, in January 2020. Before anyone knew what it was. so, it could have been covid). Previously administered products included for Product used for unknown indication: Unspecified vaccine (Luckily patient had not had any side effects on any other types of vaccines); for COVID-19 prophylaxis: Spikevax NOS (Patient started taking the Moderna version as soon as it became available and with no side effects.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS and Unspecified vaccine. Family history included Polio (patient's mother had polio as a girl). In September 2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced PAROSMIA (I was smelling things (odors) that were not there. Initially like oil, then heavy chemical smells day and night/this time the phantom odor (Phantosmia)). In November 2024, the patient experienced FLUSHING (I was dealing with flushed head), SKIN DISCOMFORT (I was dealing with skin sensation) and FATIGUE (I was dealing with extreme fatigue). At the time of the report, FLUSHING (I was dealing with flushed head), SKIN DISCOMFORT (I was dealing with skin sensation), PAROSMIA (I was smelling things (odors) that were not there. Initially like oil, then heavy chemical smells day and night/this time the phantom odor (Phantosmia)) and FATIGUE (I was dealing with extreme fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2024, Blood test: Patient had a blood workup followed by ear/nose/throat. Finding nothing and the physicians basically shrugging their shoulders. On an unknown date, Magnetic resonance imaging: Finding nothing and the physicians basically shrugging their shoulders. No concomitant and treatment medication were reported. Patient had a question concerning the Moderna COVID vaccine. Patient was growing up in the 1950s, patient was 100% pro-vaccine. In Sep-2024, patient had 8th Moderna and within a couple of days, patient was smelling things (odors) that were not there. Initially like oil, then heavy chemical smells day and night. By Nov-2024, patient was dealing with extreme fatigue, flushed head and skin sensation. In Mar-2025 there was a slight improvement, patient got the booster, and all the symptoms had come back, in spades this time the phantom odor (Phantosmia) was like saline water. Patient thought he had not had Covid before. At his age, Patient had a big X on his back for covid, so patient did everything to avoid it. It was unknown if the patient experienced any additional symptoms/events.
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| 2839061 | 72 | F | 04/30/2025 |
COVID19 |
MODERNA |
3043838 |
Fatigue, Injection site bruising, Injection site mass, Injection site pain, Urti...
Fatigue, Injection site bruising, Injection site mass, Injection site pain, Urticaria
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she developed a hive (urticaria) on the right foot/has hives in the middle of the gluteal area; expe...
she developed a hive (urticaria) on the right foot/has hives in the middle of the gluteal area; experienced fatigue; She also experienced pain at injection site along with a large hard lump and bruising at injection site; She also experienced pain at injection site along with a large hard lump and bruising at injection site; She also experienced pain at injection site along with a large hard lump and bruising at injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE BRUISING (She also experienced pain at injection site along with a large hard lump and bruising at injection site), URTICARIA (she developed a hive (urticaria) on the right foot/has hives in the middle of the gluteal area), FATIGUE (experienced fatigue), INJECTION SITE PAIN (She also experienced pain at injection site along with a large hard lump and bruising at injection site) and INJECTION SITE MASS (She also experienced pain at injection site along with a large hard lump and bruising at injection site) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis. The patient's past medical history included Skin cancer. Previously administered products included for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (she has always taken Pfizer COVID vaccine before). Past adverse reactions to the above products included No adverse effect with Pfizer BioNTech COVID-19 vaccine. On 22-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 22-Apr-2025, the patient experienced INJECTION SITE BRUISING (She also experienced pain at injection site along with a large hard lump and bruising at injection site), FATIGUE (experienced fatigue), INJECTION SITE PAIN (She also experienced pain at injection site along with a large hard lump and bruising at injection site) and INJECTION SITE MASS (She also experienced pain at injection site along with a large hard lump and bruising at injection site). On 23-Apr-2025, the patient experienced URTICARIA (she developed a hive (urticaria) on the right foot/has hives in the middle of the gluteal area). At the time of the report, INJECTION SITE BRUISING (She also experienced pain at injection site along with a large hard lump and bruising at injection site), URTICARIA (she developed a hive (urticaria) on the right foot/has hives in the middle of the gluteal area), FATIGUE (experienced fatigue) and INJECTION SITE MASS (She also experienced pain at injection site along with a large hard lump and bruising at injection site) had not resolved and INJECTION SITE PAIN (She also experienced pain at injection site along with a large hard lump and bruising at injection site) had resolved. No concomitant medications were reported. It was reported that she was taking Moderna vaccine for the first time and always taken Pfizer vaccine before. On the day of vaccination, patient experienced fatigue and that lasted for 2 days. She also experienced pain at injection site along with a large hard lump and bruising at injection site. It was reported that 2 days after vaccine administration, the pain was gone but the bruising and lump still persist. On 23-Apr-2025, 19 hours after vaccination, she developed a hive (urticaria) on the right foot and on 24-Apr-2025, she also had hives in the middle of gluteal area. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.
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| 2839062 | 04/30/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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Vaccination site pain, Wrong product administered
Vaccination site pain, Wrong product administered
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mild/grade one tenderness at the injection site; Administration error to study participant; This is ...
mild/grade one tenderness at the injection site; Administration error to study participant; This is a spontaneous report received from a Physician and an Other HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 21Apr2025 as dose 1, 0.3 ml 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: WRONG PRODUCT ADMINISTERED (non-serious) with onset 23Apr2025, outcome "unknown", described as "Administration error to study participant"; VACCINATION SITE PAIN (non-serious) with onset 23Apr2025, outcome "unknown", described as "mild/grade one tenderness at the injection site". Additional information: On 21Apr2025 a study participant was screened and randomized for an avian flu vaccination study. Study was prepared and ready for administration around the same time for participant (ID withheld), protocol. The drug was given to the study participant in the study in error. The site process, which occurred with this participant, is to prepare per pharmacy manual, label the syringe with the occluding label, participant/study label and place in an opaque box for transport to the exam room for administration. The participant was taken to the exam room and the unblinded team verify the participant's full name and date of birth with the participant and the unblinded study team verify enrollment number syringe label number with the subject chart prior to administration. The double verification of the syringe label enrollment number to the participant chart was done in the preparation area but verification of the syringe to the subject chart again in the exam room was missed. Beginning 22Apr2025, they had placed labels on the opaque box to write the study and participant enrollment number as an additional verification of the contents of the box. The unblinded team would verbally verify the participant enrollment number on the syringe with the chart once in the exam room, prior to administration. This would be done for all studies going forward and all unblinded staff had been retrained to this verification process. The participant, Pl, and the sponsors of both studies were immediately notified of the error. Site would follow the subject for safety purposes which included daily phone contact for 8 days following vaccine administration at least once per month for 6 months following IP administration to document any AEs. The site was awaiting further guidance from Pfizer regarding the participant follow up schedule. The participant did not report any AEs during the 30min post vaccine observation period. The participant was given a copy of the consent for the study IMP they received. Information in email body: Hello - please be advised that per the Clinical team guidance, this erroneous administration of study drug to a non-Pfizer study participant was being reported to Pfizer US Drug Safety. was a blinded study an only the unblinded team was copied on this email as reporter was reporting the unblinded IP assignment for their reference, below. Please note that this participant received only the Pfizer IP (BNT162b8 monovalent (Omicron KP.2) 100 mcg/mL Vial 0.3 mL) - no IP for the other sponsor study they were enrolled in was administered and no safety concerns/reactions had been reported to date. Reporter had attached NTF/summary from the PI/site for your reference. On 23Apr2025: Drug Safety, In follow up to the initial email below, the participant reported mild/grade one tenderness at the injection site and no other symptoms on 23Apr2025. Reporter had included the unblinded site pharmacist/site director on this email who reported this and would report any further safety follow up updates. On 24Apr2025: Please be advised that (patient ID withheld) did not experience the AE or the dosing error. The participant who did does not have an ID as patient was not enrolled in a Pfizer trial but rather another sponsor trial, but received our IP. Apologies for any confusion on this. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2839063 | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Expired product administered
Expired product administered
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administered an expired COVID-19 Comirnaty vaccine; This is a spontaneous report received from an Ot...
administered an expired COVID-19 Comirnaty vaccine; This is a spontaneous report received from an Other HCP, Program ID. A patient (age and gender not provided) 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: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "administered an expired COVID-19 Comirnaty vaccine". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2839064 | 16 | F | MA | 04/30/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
LN05888 LN05888 LN05888 LN05888 |
Brain fog, C-reactive protein increased, Cardiac monitoring, Chest pain, Complem...
Brain fog, C-reactive protein increased, Cardiac monitoring, Chest pain, Complement factor C3 increased; Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Exercise tolerance decreased, Fatigue; Headache, Insomnia, Nausea, Neurological symptom, Red blood cell sedimentation rate increased; Sinus tachycardia, Tachycardia
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COMIRNATY 2024-25(12Y UP) SYRG PFIZER US PHARM LN0588 , FLUCELVAX TRIVAL 2024-2025 SYR SEQIRUS, IN...
COMIRNATY 2024-25(12Y UP) SYRG PFIZER US PHARM LN0588 , FLUCELVAX TRIVAL 2024-2025 SYR SEQIRUS, INC. Lot # 946621 48 hour onset of symptoms tachycardia, exercise intolerance, excessive fatigue, brain fog, insomnia, headache, nausea and dizziness.
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| 2839065 | 1 | M | UT | 04/30/2025 |
HIBV MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
x017449 x008385 X021638 |
Herpes zoster, Rash; Herpes zoster, Rash; Herpes zoster, Rash
Herpes zoster, Rash; Herpes zoster, Rash; Herpes zoster, Rash
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Rash. That spread down the dermatome, Diagnosed by dermatology as singles. Given Acyclovir (parents ...
Rash. That spread down the dermatome, Diagnosed by dermatology as singles. Given Acyclovir (parents believe). Rash is now resolved and did resolve after a few weeks.
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| 2839074 | 79 | F | CA | 04/30/2025 |
RSV |
PFIZER\WYETH |
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Cough, Diarrhoea, Headache
Cough, Diarrhoea, Headache
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PT HAD DIARRHEA AFTER 2 DAYS OF VACCINATION. SHE ALSO HAD HEADACHE AND COUGHING.
PT HAD DIARRHEA AFTER 2 DAYS OF VACCINATION. SHE ALSO HAD HEADACHE AND COUGHING.
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| 2839075 | 75 | F | CA | 04/30/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0150 EW0150 EW0150 EW0150 EW0150 EW0150 |
Asthenia, Fatigue; Fatigue; Balance disorder, Fatigue, Tremor; Asthenia, Fatigue...
Asthenia, Fatigue; Fatigue; Balance disorder, Fatigue, Tremor; Asthenia, Fatigue; Fatigue; Balance disorder, Fatigue, Tremor; Asthenia, Fatigue; Fatigue; Balance disorder, Fatigue, Tremor
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Debilitatimg chronic fatigue, contnuing to worsen in 2025.
Debilitatimg chronic fatigue, contnuing to worsen in 2025.
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| 2839076 | 25 | F | MS | 04/30/2025 |
MENB |
PFIZER\WYETH |
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Erythema, Migraine, Pain in extremity
Erythema, Migraine, Pain in extremity
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Redness the size of my palm, very noticeable and arm getting more sore days later. Migraine yesterd...
Redness the size of my palm, very noticeable and arm getting more sore days later. Migraine yesterday
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| 2839077 | 41 | F | TN | 04/30/2025 |
COVID19 |
MODERNA |
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Amnesia, Blood test, Cognitive disorder, Magnetic resonance imaging
Amnesia, Blood test, Cognitive disorder, Magnetic resonance imaging
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In July of 2024 I began having cognitive decline, with memory loss.
In July of 2024 I began having cognitive decline, with memory loss.
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| 2839078 | 72 | F | CA | 04/30/2025 |
COVID19 |
MODERNA |
027A21A |
Basal cell carcinoma, Invasive ductal breast carcinoma
Basal cell carcinoma, Invasive ductal breast carcinoma
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Breathing, basal cell carcinoma on my left cheek, and invasive ductal carcinoma, right breast cancer
Breathing, basal cell carcinoma on my left cheek, and invasive ductal carcinoma, right breast cancer
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โ | โ | ||||
| 2839079 | 44 | F | VA | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
paa226428 |
Rash
Rash
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Patient reported full body rash within 24 hours of vaccine
Patient reported full body rash within 24 hours of vaccine
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| 2839080 | 18 | F | TX | 04/30/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
amab030a amab030a |
Cold sweat, Lethargy, Presyncope, Somnolence, Tinnitus; Yawning
Cold sweat, Lethargy, Presyncope, Somnolence, Tinnitus; Yawning
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After vaccine was given, patient was alert and oriented. Patient stood up, walked out of vaccination...
After vaccine was given, patient was alert and oriented. Patient stood up, walked out of vaccination room to lobby and sat down. Patient's mother came to get pharmacist to say patient almost fainted. Upon viewing patient, she exhibited signs of lethargy, cold clammy skin, continuous yawning, and difficulty keeping eyes open. Patient also stated she had constant ear ringing. Offered to call 911 and ambulance, but patient's mother declined and wanted to take patient to hospital herself. Helped patient walk to vehicle and watched as party left parking lot heading to hospital. Called for welfare check 2 days later but received no answer. Left voicemail for call back.
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| 2839081 | 69 | F | MI | 04/30/2025 |
RSV |
PFIZER\WYETH |
HM9855 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse event reported by patient. This reporting is due to finding that patient had previously ...
No adverse event reported by patient. This reporting is due to finding that patient had previously received Arexvy RSV vaccine at another facility approx. 1 year prior (08/15/2023)
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| 2839082 | 57 | M | TX | 04/30/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
344J3 |
Asthenia, Brain fog, Chills, Dizziness, Pyrexia
Asthenia, Brain fog, Chills, Dizziness, Pyrexia
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Fever, chills, dizziness, full body weakness, foggy thinking
Fever, chills, dizziness, full body weakness, foggy thinking
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| 2839086 | 17 | F | LA | 04/30/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 |
Injection site erythema
Injection site erythema
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2 x 3 area of erythema at injection site, mild swelling and tenderness, warm to touch.
2 x 3 area of erythema at injection site, mild swelling and tenderness, warm to touch.
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| 2839087 | 0.42 | M | CA | 04/30/2025 |
DTPPVHBHPB RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. |
U7623AA Y014320 |
Injection site discolouration, Injection site erythema, Injection site induratio...
Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling; Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
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Day of vaccine: 2 hard knots under skin on LVL, swollen and red (mother has pics) Day 2: little bum...
Day of vaccine: 2 hard knots under skin on LVL, swollen and red (mother has pics) Day 2: little bumps to the site (mother has pictures) One week after decreased but now has black spots.
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| 2839205 | 1 | F | NY | 04/30/2025 |
MMRV |
MERCK & CO. INC. |
Y003882 |
Decreased appetite, Irritability, Malaise, Pyrexia, Rash morbilliform
Decreased appetite, Irritability, Malaise, Pyrexia, Rash morbilliform
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Developed Rubella Rash, Low Grade Fever, Malaise, Decrease Appetite, Fussy.
Developed Rubella Rash, Low Grade Fever, Malaise, Decrease Appetite, Fussy.
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| 2838406 | 4 | M | 04/29/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y019173 Y019173 |
Erythema, Injection site erythema, Injection site pain, Pruritus, Rash; Rash ery...
Erythema, Injection site erythema, Injection site pain, Pruritus, Rash; Rash erythematous, Rash papular
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raised, flat, red spots in a rash pattern on his abdomen; and his feet and hands were noticeably red...
raised, flat, red spots in a rash pattern on his abdomen; and his feet and hands were noticeably red; injection site on the left arm was noticeably red and appeared tender; raised, flat, red spots in a rash pattern on his abdomen; Viral reaction; injection site on the left arm was noticeably red and appeared tender; itching on his hands and feet; This spontaneous report was received from a consumer or other non-health professional and refers to a 4-year-old male patient (reporter's son). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid;Pertussis vaccine acellular;Polio vaccine inact;Tetanus vaccine toxoid (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Polio vaccine inact;Tetanus vaccine toxoid (DTAP/IPV) . On 31-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y019173, expiration date: 27-Jun-2024) 0.5 mL in left Arm, diluted with sterile diluent (MERCK STERILE DILUENT) (indication, expiration date, and lot # were not reported) for prophylaxis. On 02-Apr-2025 (also reported as this morning), the patient complained of itching on his hands and feet, and his feet and hands were noticeably red. The injection site on the left arm was noticeably red and appeared tender. He went to daycare as scheduled and was observed by his daycare teachers to behave normally all day, with continued reporting of his hands being itchy. Reporter reported these symptoms to his pediatric doctor, who advised her to keep an eye on it and schedule a follow up if we had concerns. In that evening reporter noted raised, flat, red spots in a rash pattern on his abdomen. The injection site on the left arm was more red and tender looking than in the morning. The rash did not seem to be making him uncomfortable, but she had a follow up virtual visit with his pediatrician to report the rash out of concern that it might be an allergic reaction to a vaccine component. The pediatrician advised that it did not appear to be an allergic reaction, but that it appeared to be a rash common with viral reactions. The pediatrician advised continued monitoring of the rash and to follow up if my son developed sores in or around his mouth or difficulty eating. At the reporting time, the outcome of the events was unknown. The causal relationship between all the events and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was not provided.
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| 2838407 | NY | 04/29/2025 |
HEPA |
MERCK & CO. INC. |
X025482 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional adverse event; expired dose of VAQTA was administered to a patient; This spontaneous r...
No additional adverse event; expired dose of VAQTA was administered to a patient; This spontaneous report was received from a nurse 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. On 17-APR-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) first dose, (exact dose administered, anatomical route of administration were not reported) (lot #X025482, who had been verified to be a valid lot number and expiration date reported and validated as 12-APR-2025) as prophylaxis (expired product administered). No additional adverse event.
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| 2838408 | 17 | F | NV | 04/29/2025 |
HPV9 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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HCP called to report a female who received their first dose of GARDASIL 9 in August of 2024 at the a...
HCP called to report a female who received their first dose of GARDASIL 9 in August of 2024 at the age of 17 has not received any subsequent doses since. No symptoms reported. Caller did not have any other information to provide at the time of the; No additional adverse event reported; This spontaneous report was received from a pharmacist and refers to a 17-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unspecified date in August 2024, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), 0.5 mL (.5 ml), (lot # and expiration date were not reported) as prophylaxis, and had not received any subsequent doses since (inappropriate schedule of product administration). No additional adverse event.
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| 2838409 | CT | 04/29/2025 |
MMR MMR MMR MMR VARCEL 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. |
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Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps...
Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive; Antibody test negative, Bone marrow transplant, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
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No evidence of immunity to measles or varicella.; No evidence of immunity to measles or varicella.; ...
No evidence of immunity to measles or varicella.; No evidence of immunity to measles or varicella.; Caller reported that patient had their bone marrow completely reconstituted during leukemia treatment resulting in lack of immunity. / boosters of VARIVAX in 2013 and MMR-II in 2015 following leukemia treatments.; This spontaneous report was received from a physician, regarding a 17-year-old patient of unknown gender. The patient's medical history and concomitant medication were not reported. Concurrent conditions included Leukemia (in remission). On 2008, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), at a dose of 0.5 mL as prophylaxis in combination with sterile diluent. And also on the same year, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), also at a dose of 0.5 ml as prophylaxis in combination with sterile diluent (strengths, doses, schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported). Then on 2013, the patient received a booster of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and on 2015 a booster of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), this following leukemia treatment. On an unspecified date, they ran titers on the patient for measles, mumps, rubella, and varicella. There was evidence of immunity to mumps and rubella, but no evidence of immunity to measles or varicella. Caller reported that patient had their bone marrow completely reconstituted during leukemia treatment resulting in lack of immunity. The outcome of the events was not provided. No symptoms reported. The causal relationship between the events and suspect vaccines was not provided.
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| 2838410 | 04/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I got the vaccine honey but I still got them; This serious case was r...
Suspected vaccination failure; I got the vaccine honey but I still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine honey but I still got them). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine honey but still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2838419 | 15 | M | MP | 04/29/2025 |
COVID19 HPV9 |
PFIZER\BIONTECH MERCK & CO. INC. |
LN0590 Y008119 |
Urticaria; Urticaria
Urticaria; Urticaria
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Patient developed diffuse hives shortly after receiving the COVID and HPV vaccine. I saw him the mor...
Patient developed diffuse hives shortly after receiving the COVID and HPV vaccine. I saw him the morning after injaction adn the hives have persisted. No other symptoms. Patient was diagnosed with atypical pneumonia at the visit he received the vaccines and was prescribed azithromycin. He had not yet taken the medication when the rash arose
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| 2838420 | 0.5 | F | GA | 04/29/2025 |
DTAPHEPBIP HIBV PNC15 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
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Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability,...
Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability, Pyrexia
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High fever 4 hours after receiving vaccines at 6 mo. well visit. Fever of 103 and extreme fuzziness ...
High fever 4 hours after receiving vaccines at 6 mo. well visit. Fever of 103 and extreme fuzziness for greater than 3 hours.
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| 2838421 | 64 | M | CA | 04/29/2025 |
COVID19 |
PFIZER\BIONTECH |
hn0477 |
Arthritis, Contusion, Pain in extremity
Arthritis, Contusion, Pain in extremity
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pt complains of arm pain. Patient returned a year later after vaccine was administered. Upon checkin...
pt complains of arm pain. Patient returned a year later after vaccine was administered. Upon checking with patient's physician, physician stated pt has a severe arthritis. Also, noted at the time of reporting, pt had a greenish blue bruise.
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| 2838466 | 13 | F | TN | 04/29/2025 |
MMR |
MERCK & CO. INC. |
y018703 |
Dizziness, Fall
Dizziness, Fall
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Patient was in the vaccine room with her mother and two younger sisters who were both getting the sa...
Patient was in the vaccine room with her mother and two younger sisters who were both getting the same vaccination. Patient seemed to be fine after I injected the vaccine. She then swapped a seat with her younger sister so the sister can vaccinated. The patient was watching me give the vaccine when she got lightheaded, dizzy and fell from the chair on the ground. I advised the mom to keep her hand under the patient's head. I monitored the patient for any allergic reaction and loss of consciousness while the store manager on duty called EMS. EMS took over from their and monitored the patient. After about 30minutes EMS team asked the parents if they want to take their daughter to the ER. Parents declined and said they will monitor her at home. The patient came back to the pharmacy with her dad the next night and seemed to be doing well.
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| 2838467 | 60 | F | MI | 04/29/2025 |
MMR PNC20 VARZOS |
MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
X026328 LC5484 ME424 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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The patient was given the Shingrix vaccine instead of the MMR vaccine. After being notified of the m...
The patient was given the Shingrix vaccine instead of the MMR vaccine. After being notified of the mistake, she returned to the clinic and received the MMR vaccine.
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| 2838468 | 13 | F | MI | 04/29/2025 |
HPV9 |
MERCK & CO. INC. |
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Joint stiffness, Mobility decreased, Pain, X-ray
Joint stiffness, Mobility decreased, Pain, X-ray
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Stiffness in joint. Loss of mobility and extreme prolonged pain going well beyond normal timeframe.
Stiffness in joint. Loss of mobility and extreme prolonged pain going well beyond normal timeframe.
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| 2838469 | 0.17 | M | 04/29/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
B532G |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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DTap, Hep B, Polio combination (Pediarix) given incorrectly in place of single DTaP. No treatment g...
DTap, Hep B, Polio combination (Pediarix) given incorrectly in place of single DTaP. No treatment given. Per conversation with client's mother on 4/28/25, child had no symptoms/signs of adverse reaction post vaccination.
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| 2838470 | 33 | F | TN | 04/29/2025 |
YF YF YF YF YF YF |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UK133AB UK133AB UK133AB UK133AB UK133AB UK133AB |
Chills, Cough, Dyspnoea, Headache, Vomiting; Asthma, Chills, Condition aggravate...
Chills, Cough, Dyspnoea, Headache, Vomiting; Asthma, Chills, Condition aggravated, Cough, Dyspnoea; Headache, Vomiting; Chills, Cough, Dyspnoea, Headache, Vomiting; Asthma, Chills, Condition aggravated, Cough, Dyspnoea; Headache, Vomiting
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Pt started having shortness of breath and coughing a few hours after receiving the vaccine a rescue ...
Pt started having shortness of breath and coughing a few hours after receiving the vaccine a rescue inhaler has been ineffective. Pt had one episode of vomiting the next day. Mild chills and intermittent headache noted.
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| 2838471 | 67 | F | NC | 04/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
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pt states that the same day the injection site became the size of a quarter then it kept growing. Af...
pt states that the same day the injection site became the size of a quarter then it kept growing. After about 3 weeks it was about 4" x 3" in size. It was red, hot hard and very painful. She contacted the pharmacy and was told to report it. It took about 4 months for it to completely disappear. She will contact her PCP about getting getting second dose.
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| 2838472 | 46 | F | IA | 04/29/2025 |
HPV9 MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y012864 222H3 |
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
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Patient was too old to receive HPV vaccine; no adverse events reported or noted.
Patient was too old to receive HPV vaccine; no adverse events reported or noted.
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| 2838473 | 50 | M | IA | 04/29/2025 |
HPV9 MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y012864 222H3 |
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
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patient was over the recommended age limit for HPV vaccine; no adverse events reported or noted
patient was over the recommended age limit for HPV vaccine; no adverse events reported or noted
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| 2838474 | 46 | M | IA | 04/29/2025 |
HPV9 MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y012864 222H3 |
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
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Patient was over the recommended age for HPV vaccine; no adverse events reported or noted.
Patient was over the recommended age for HPV vaccine; no adverse events reported or noted.
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| 2838475 | 1.17 | M | KY | 04/29/2025 |
MMR |
MERCK & CO. INC. |
X011431 |
Unevaluable event
Unevaluable event
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none
none
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| 2838476 | 40 | F | NJ | 04/29/2025 |
TDAP |
SANOFI PASTEUR |
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Wrong product administered
Wrong product administered
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I was told I was being given a tetanus shot it was not explained to me they were giving me the combi...
I was told I was being given a tetanus shot it was not explained to me they were giving me the combination shot that included pertussis. I have never received the pertussis vaccination and even had a note in my file as a child that said I needed to be kept home if there was an outbreak of whooping cough. I did not consent to receiving the TDAP vaccination and would not have consented to receiving it. If they did not have the Td vaccine in the hospital I would have completely declined the vaccine as what caused my wound does not have a high risk for tetanus. I realized I was given the incorrect vaccine about 7 hours after when I was reading my discharge papers, I contacted the hospital who said they would do their own investigation to find out why I was not told what medication I was being given but of course there is no way to take back the vaccine.
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| 2838477 | 29 | F | TN | 04/29/2025 |
HPV9 |
MERCK & CO. INC. |
y012921 |
Injection site pain
Injection site pain
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pain and soreness at injection site continues 26 days after administration
pain and soreness at injection site continues 26 days after administration
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| 2838479 | 20 | F | PA | 04/29/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
4T93R |
Hypotension, Muscle tightness, Seizure like phenomena, Syncope, Unresponsive to ...
Hypotension, Muscle tightness, Seizure like phenomena, Syncope, Unresponsive to stimuli
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Patient reported prior to receiving the vaccine that she has fainted before/during vaccines. Vaccine...
Patient reported prior to receiving the vaccine that she has fainted before/during vaccines. Vaccine was administered around 11:10am. After the vaccine was administered, within a minute (11:12am) she started to faint/appeared to almost be seizing rather than a full dead-weight drop (tensed up in the arms of the pharmacist/technican attending to her). The patient was shaken in an attempt to wake her, however, she was not responsive. When she came to she stated she was "okay" but continued to fade in and out. She was laid on the floor as to follow vaccine training until paramedics arrived. Paramedics arrived by 11: 25am and checked her vitals. They found her blood pressure was low (unknown specific value) and took her on the stretcher to ensure that she would get the proper approval that she is okay. Further reactions unknown.
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| 2838480 | 64 | F | NJ | 04/29/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y010372 Y010372 |
Dizziness, Ear pain, Feeling abnormal, Headache, Pruritus; Rhinorrhoea, Vulvovag...
Dizziness, Ear pain, Feeling abnormal, Headache, Pruritus; Rhinorrhoea, Vulvovaginal pruritus
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Patient received the vaccination on 4/28/25 at 4:00PM. After receiving MMR vaccination dose number...
Patient received the vaccination on 4/28/25 at 4:00PM. After receiving MMR vaccination dose number 1. about 5 minutes afterwards she stated, " I don't feel right ". She then stated, " I feel fuzzy in the head". I assisted her to the exam table and laid her in supine position. Vitals taken every 5 minutes were stable and consistent with no fluctuations present. No visible rashes present on body or chest. Reported no shortness of breath, chest pain, difficulty breathing, nausea, or vomiting. NO swelling of face, lips or tongue noted. She reported that she was feeling better and wanted to drive home. She called the following day on 4/29/25 at 8:30AM and stated she had to go to the emergency room last night at 10:00PM because she was having chest tightness and feeling short of breath. She also reported severe headache, left ear pain and itchiness in the right ear and runny nose. States after receiving steroid injection in the ER she felt itchiness in the vaginal area and rectum. She was reportedly seen in the emergency room prescribed steroids and was sent home afterwards and reported she was feeling better. She states she is still experiencing mild headaches and feeling dizzy. She was advised by our provider to follow up with her PCP and if it persists return to the emergency room
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| 2838481 | 20 | M | WA | 04/29/2025 |
FLU3 HEP TDAP |
SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
UT8434JA 945665 L5229 |
Loss of consciousness, Pallor; Loss of consciousness, Pallor; Loss of consciousn...
Loss of consciousness, Pallor; Loss of consciousness, Pallor; Loss of consciousness, Pallor
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Patient denied having syncope in the past. No records of vaccinations, in state database nor that pa...
Patient denied having syncope in the past. No records of vaccinations, in state database nor that patient brought. Flu, Tdap and Heplisav-B #1 vaccines administered. Tolerated well despite anxiety with needles. After administering the vaccines, venous blood collection began. During blood collection, patient passed out as 1st (of 2 vials were being collected). Right before he passed out, stated, "I feel like I'm going to pass out." Then immediately his skin turned pale and started sliding down out of the phlebotomy chair. Needle taken out safely after tourniquet was removed. Ensured patient was safe and did not slide out of chair while calling for more assistance. 1 more RN and 1 MA arrived. Ammonia towelette used on patient who continued to slide out of chair, so he was lowered to the ground in a sitting position against the chair/cabinet, and his body convulsed a couple of times. We supported his head so it didn't hit against the cabinet/chair. Within 20-30 seconds, patient regained consciousness. Patient states he did not eat yet that day. Patient was assisted to lie down on yoga mat. Color gradually came back and then pale again with repeated bouts of nausea. Emesis x3-5 after attempting to drink some water and eating 1 graham cracker. Patient stayed in employee health clinic until his Grandma was able to come get him roughly 40 min. after he contacted her to pick him up. Patient was assisted to Grandma's suv by MA and RN who administered the vaccines and was doing the blood draw. Wheelchair was used to safely bring patient to Grandma's suv. Instructed Grandma to seek medical care/call 911 if needed if patient's nausea didn't improve and he was still light headed. The following day (4/23,) patient was "almost back to 100% with a tiny bit of nausea." Patient reports being able to keep food down since the night before (4/22).
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| 2838482 | 83 | F | WA | 04/29/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
8080803 8080803 |
Fall, Fatigue, Feeling jittery, Head injury, Injection site erythema; Joint inju...
Fall, Fatigue, Feeling jittery, Head injury, Injection site erythema; Joint injury
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She noticed her arm was red from the injection site almost to her elbow (COVID Arm). She is very tir...
She noticed her arm was red from the injection site almost to her elbow (COVID Arm). She is very tired. She felt jittery on the inside. On 4/25/25 Patient fell in the early AM hit her head and knee (not sure if this is related to her vaccine).
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| 2838483 | 0.83 | M | VA | 04/29/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Wrong product administered
Wrong product administered
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Incorrect Vaccine administered. Treatment: Tylenol
Incorrect Vaccine administered. Treatment: Tylenol
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| 2838484 | 28 | F | NY | 04/29/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004089 |
Disturbance in attention, Vision blurred
Disturbance in attention, Vision blurred
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Client called office after taking 1 dose of oral typhoid complaining of blurry vision and inability ...
Client called office after taking 1 dose of oral typhoid complaining of blurry vision and inability to stay focused. Client advised to stop medication and to seek out medical treatment from PCP or ER
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| 2838485 | 23 | M | NJ | 04/29/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
GC3NH |
Underdose
Underdose
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Ped dose instead of adult dose
Ped dose instead of adult dose
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| 2838486 | 27 | M | NJ | 04/29/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
GC3NH |
Underdose
Underdose
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Ped dose instead of adult dose
Ped dose instead of adult dose
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| 2838487 | 16 | F | NM | 04/29/2025 |
MNQ |
SANOFI PASTEUR |
U8494AA |
Fatigue, Headache, Malaise, Oropharyngeal pain, Sneezing
Fatigue, Headache, Malaise, Oropharyngeal pain, Sneezing
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mom called the day after and said that pt got "very sick", she started with sneezing, sore...
mom called the day after and said that pt got "very sick", she started with sneezing, sore throat, having a headache and feeling tired about 4-5 hours after vaccine injection. No reaction site pain. no lethargy. no difficulty breathing
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| 2838488 | 11 | F | NM | 04/29/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y008119 U8494AA 4K7JP |
Cough, Headache; Cough, Headache; Cough, Headache
Cough, Headache; Cough, Headache; Cough, Headache
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Pt was already reporting a slight cough, thought to be related to allergies. The next day after inje...
Pt was already reporting a slight cough, thought to be related to allergies. The next day after injection, the mom called our clinic and was worried that pt was coughing and having a headache. No injection site reaction. no severe difficulty breathing.
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| 2838489 | 8 | M | ID | 04/29/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Product storage error
Product storage error
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Vaccine stored inappropriately
Vaccine stored inappropriately
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| 2838490 | 19 | F | MI | 04/29/2025 |
MMRV |
MERCK & CO. INC. |
y008283 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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This was an administration error. The patient was given MMRV and this vaccine is suppose to be give...
This was an administration error. The patient was given MMRV and this vaccine is suppose to be given from 12 months of age to 12 years. Patient did not experience any adverse events.
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