| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2854309 | 53 | M | VA | 08/15/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EP6955 EP6955 |
COVID-19, Headache, Hypoaesthesia, Pain, Palpitations; Post-acute COVID-19 syndr...
COVID-19, Headache, Hypoaesthesia, Pain, Palpitations; Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test positive, Sensory disturbance, Sleep disorder, Tremor
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Soreness and headache, heart palpitations when lying down to go to sleep. Came down with COVID and ...
Soreness and headache, heart palpitations when lying down to go to sleep. Came down with COVID and then developed Long COVID with numbness in right hand and arm, which then developed with a hand tremor, then developed an internal vibration throughout the whole right arm, The pulsing vibration, will wake me up at night. So I am prescribed Ambien in order to sleep through the night.
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β | |||||
| 2854310 | 11 | M | WV | 08/15/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
2JS53 u8232AA |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
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Patient reported localized injection site reaction including redness, swelling, warmth, tenderness,...
Patient reported localized injection site reaction including redness, swelling, warmth, tenderness, pain and itching Observation and reassurance provided. Advised application of a clean, cool compress to affected site. Recommended over-the-counter analgesic/antipyretic , acetaminophen or ibuprofen as needed for discomfort. Patient instructed to monitor for worsening symptoms, signs of infection, or systemic reaction and to seek immediate care if these occur.
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| 2854311 | 5 | M | CO | 08/15/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
|
Fatigue, Hallucination, visual, Nausea, Nightmare, Pain in extremity; Pyrexia; F...
Fatigue, Hallucination, visual, Nausea, Nightmare, Pain in extremity; Pyrexia; Fatigue, Hallucination, visual, Nausea, Nightmare, Pain in extremity; Pyrexia
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A lot of arm pain and tiredness day of vaccine (after it occurred). He woke up around 11 PM with a h...
A lot of arm pain and tiredness day of vaccine (after it occurred). He woke up around 11 PM with a high fever and hallucinations of spiders crawling all over him and other nightmares. He was like this all night with a fever that didn?t seem responsive to medicine, he was nauseated most of the night and did not throw up.
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| 2854312 | 3 | F | TX | 08/15/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y015551 Y015551 |
Brain natriuretic peptide, Differential white blood cell count, Dyspnoea, Full b...
Brain natriuretic peptide, Differential white blood cell count, Dyspnoea, Full blood count, Metabolic function test; Swelling face, Vomiting
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trouble breathing, swelling of the face within 20 minutes, and then vomiting
trouble breathing, swelling of the face within 20 minutes, and then vomiting
|
β | |||||
| 2854313 | 11 | F | KS | 08/15/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
3E99M 793PT |
Injection site erythema, Injection site swelling, Injection site warmth, Musculo...
Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness; Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
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Reports of redness, swelling, stiffness and warmth at the injection site on the left arm. No other s...
Reports of redness, swelling, stiffness and warmth at the injection site on the left arm. No other symptoms were noted. MOC called office on 07/24/2025 and reported. Dr. gave advice of Ibuprofen for 2 days and if any other concerns come up or doesn't improve to contact office. MOC verbalized understanding and symptoms cleared up.
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| 2854314 | 53 | M | OH | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Fatigue, Hyperthermia, Pollakiuria
Chills, Fatigue, Hyperthermia, Pollakiuria
|
Mild cycles of hyperthermia and chills throughout the night following administration of first dose i...
Mild cycles of hyperthermia and chills throughout the night following administration of first dose in the morning. Generally mild symptoms of fatigue in the 0-24hrs following administration. Frequent urination during 1st evening as well. Body temp nml on day following. Mild fatigue symptoms persist at time of this documentation (s/p 29hrs). All Sxs mild (~Gr 1?).
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| 2854315 | 14 | F | AR | 08/15/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y010656 |
Contusion, Dizziness, Hypotonia, Loss of consciousness, Syncope
Contusion, Dizziness, Hypotonia, Loss of consciousness, Syncope
|
Five minutes after the administration of HPV vaccine at 1420, patient became dizzy and fainted. She...
Five minutes after the administration of HPV vaccine at 1420, patient became dizzy and fainted. She slumped over in a seated position and slid out of the chair, hitting her head on the floor. The patient quickly regained consciousness. Nurse noted a small, nickel-sized bruise on her forehead, left of midline. Vital signs at 1442 were BP: 102/60 and HR: 67. Mother was provided education on signs/symptoms of a concussion and to go to the ER if any of these occurred. Patient stated that she felt normal and then ambulated out of the clinic without issues at 1500. (name withheld)- Administrator, notified at 1505. (name withheld), RN/Patient Care Manager, notified at 1508 by (withheld name). VAERS form completed on 8/7/2025 and submitted to the IMM program for review.
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| 2854316 | 51 | F | OH | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
|
red , warm, golf ball size at injection site on left arm
red , warm, golf ball size at injection site on left arm
|
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| 2854317 | 56 | F | VA | 08/15/2025 |
HEP |
MERCK & CO. INC. |
Z006339 |
Rash, Throat irritation
Rash, Throat irritation
|
rash to entire body - itchy throat- was given IM Benadryl in afternoon and took po Benadryl at home
rash to entire body - itchy throat- was given IM Benadryl in afternoon and took po Benadryl at home
|
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| 2854318 | 15 | F | OR | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
U028825 |
Amenorrhoea, Hormone level abnormal, Menstruation irregular, Ovarian failure
Amenorrhoea, Hormone level abnormal, Menstruation irregular, Ovarian failure
|
Onset of menses November 2020. Started having irregular periods around spring 2024 and ultimately la...
Onset of menses November 2020. Started having irregular periods around spring 2024 and ultimately last period was November 2024. Has subsequently been diagnosed with primary ovarian failure.
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β | |||||
| 2854319 | 65 | F | NJ | 08/15/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
|
Injection site pain, Pain, Sleep disorder; Injection site pain, Pain, Sleep diso...
Injection site pain, Pain, Sleep disorder; Injection site pain, Pain, Sleep disorder
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I had both the flu and pneumonia shot that day. They were both injected into my upper left arm?.i do...
I had both the flu and pneumonia shot that day. They were both injected into my upper left arm?.i dont know the exact name of the Vaccines?..they warned of some possible injection sight pain, but said it would go away?.it was painful the next day, and now 10 months later my arm is very painful?I can?t sleep on that side?any arm movement causes pain..
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| 2854320 | 62 | F | MI | 08/15/2025 |
FLU3 PNC20 TDAP |
SEQIRUS, INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site oedema, Injection site pruritus; Injecti...
Injection site erythema, Injection site oedema, Injection site pruritus; Injection site erythema, Injection site oedema, Injection site pruritus; Injection site erythema, Injection site oedema, Injection site pruritus
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erythema at site edema pruritis, has been getting worse over past few days
erythema at site edema pruritis, has been getting worse over past few days
|
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| 2854321 | 60 | M | GA | 08/15/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Arthralgia, Hypoaesthesia, Tinnitus
Arthralgia, Hypoaesthesia, Tinnitus
|
Left arm shoulder soreness/sharp pain, left ear numbness and ringing in ear, sounds like water in ea...
Left arm shoulder soreness/sharp pain, left ear numbness and ringing in ear, sounds like water in ear
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| 2854322 | 71 | F | VA | 08/15/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Chills, Fatigue, Injection site erythema, Injection site warmth, Pyrexia
Chills, Fatigue, Injection site erythema, Injection site warmth, Pyrexia
|
patient started having extreme fatigue, fever, chills, body aches about 12 hours after vaccine. Pati...
patient started having extreme fatigue, fever, chills, body aches about 12 hours after vaccine. Patient the had redness at injection site and upper left arm which presented red and hot to touch. Patient followed up with primary care physician, physician believed to be possible allergic reaction. Reaction has improved from 8/12/2025 to 8/15/2025 however, pcp prescribed antibiotic for possible infection for patient to take if no further improvement in the next few days
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| 2854323 | 17 | F | FL | 08/15/2025 |
MENB MENB MNQ MNQ |
PFIZER\WYETH PFIZER\WYETH SANOFI PASTEUR SANOFI PASTEUR |
GX1463 GX1463 U8124AB U8124AB |
Asthenia, Dizziness, Nausea, Pallor, Presyncope; Vision blurred; Asthenia, Dizzi...
Asthenia, Dizziness, Nausea, Pallor, Presyncope; Vision blurred; Asthenia, Dizziness, Nausea, Pallor, Presyncope; Vision blurred
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after injection patient went to checkout and felt his vision was blurry, pale in color, dizzy and wa...
after injection patient went to checkout and felt his vision was blurry, pale in color, dizzy and wanted to vomit, near syncope , felt weak, BP 78/58
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| 2854324 | 12 | F | VA | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
537LH |
Erythema, Pruritus, Skin warm, Swelling
Erythema, Pruritus, Skin warm, Swelling
|
Pt's mother reports pt had redness, itchy, swollen and warm to touch. Mother was instructed to...
Pt's mother reports pt had redness, itchy, swollen and warm to touch. Mother was instructed to apply heat/ice to area, hydrocortisone or bendryl cream for itching and tylenol/motrin for pain.
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| 2854325 | 61 | F | TX | 08/15/2025 |
HEPAB HEPAB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
B9279 B9279 |
Aphasia, Dizziness, Ear pain, Feeling abnormal, Hyperhidrosis; Malaise, Orophary...
Aphasia, Dizziness, Ear pain, Feeling abnormal, Hyperhidrosis; Malaise, Oropharyngeal pain, Paraesthesia, Thought blocking
More
|
pt states when given the injection her fingers started tingling that went up her arm and then to her...
pt states when given the injection her fingers started tingling that went up her arm and then to her head. This caused her to have a fuzzy feeling like her equilibrium was off balance. She did not loose vision this time. Then she developed severe sweating, dizziness, and she lost train of thought while speaking. She couldn't find words to use when speaking. She had sore throat and earache. The symptoms would come on strong and would happen daily. She still has these symptoms daily but they are happening further apart. She says they were like having menopause symptoms. She is not sure if it is a compound of symptoms from having allergies or if all of the symptoms are vaccine related. Her symptoms are not severe enough to contact her physician at this point. If she is not better after the fifth day she will believe she is sick and symptoms were not from the vaccine.
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| 2854326 | 15 | F | SC | 08/15/2025 |
HEP MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
H39Z4 X026328 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse reaction noted or reported - client tolerated injection well
No adverse reaction noted or reported - client tolerated injection well
|
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| 2854327 | 13 | M | SC | 08/15/2025 |
HEP MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
H39Z4 X026328 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse reactions noted or reported - client tolerated injection well
No adverse reactions noted or reported - client tolerated injection well
|
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| 2854328 | 10 | M | SC | 08/15/2025 |
HEP MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
H39Z4 X026328 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse reaction noted or reported - client tolerated injection well
No adverse reaction noted or reported - client tolerated injection well
|
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| 2854329 | 28 | F | WI | 08/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Exposure during pregnancy, Extra dose administered
Exposure during pregnancy, Extra dose administered
|
Patient is 32 weeks pregnant. I gave her a tdap vaccine today to help protect the baby against whoop...
Patient is 32 weeks pregnant. I gave her a tdap vaccine today to help protect the baby against whooping cough when it is born. When I went into the chart to document it. It stated she had already received the vaccine on 7/29/25.
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| 2854330 | 75 | F | 08/15/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Muscle spasms, Pain in extremity
Muscle spasms, Pain in extremity
|
patient complains of ongoing soreness and cramping in the arm following vaccine
patient complains of ongoing soreness and cramping in the arm following vaccine
|
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| 2854331 | 4 | F | SC | 08/15/2025 |
DTAP HEPA IPV VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. |
Y7JC3 H3N97 Y1A201M Z003766 |
Injection site erythema, Injection site warmth; Injection site erythema, Injecti...
Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth
More
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On 08/14/2025 the mother of the client brought the client into the health department stating that th...
On 08/14/2025 the mother of the client brought the client into the health department stating that the client received vaccines at the health department on 08/11/2025 and requested to have a nurse look at the client's left leg. The client's left anterior leg from mid-thigh to top of knee appeared mildly reddened with mild swelling and felt mildly warm to touch. These symptoms are noted on the Vaccine Information Statements as possible side effects for the vaccines that are documented as having been administered in the client s left leg on 08/11/2025. The mother denied the child experiencing fever. The child was smiling, active, talking, and playing with a toy while in the health department on 08/14/2025. The mother of the client was instructed to follow up with client's personal medical provider and voiced understanding.
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| 2854332 | 64 | M | OK | 08/15/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FG3527 FG3527 |
Balance disorder, Blood glucose increased, Brain fog, Dyspnoea, Executive dysfun...
Balance disorder, Blood glucose increased, Brain fog, Dyspnoea, Executive dysfunction; Hypertension, Palpitations
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Palpitations, High BP, Shortness of Breath, Higher than normal Glucose levels, Brain Fog, Loss of Ex...
Palpitations, High BP, Shortness of Breath, Higher than normal Glucose levels, Brain Fog, Loss of Executive Function, Loss of BalanceοΏ½ Treated symptoms, alternative functional treatment (supplements, frequencies, etc.) Improvement after 8 months. However in April of 2025 many of the same symptoms have recurred and are not yet resolved.
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β | |||||
| 2854333 | 89 | F | NY | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash, Rash pruritic
Rash, Rash pruritic
|
Patient received the Shingrx on 7-28-25 and 5 days later she started breaking out in a rash. First o...
Patient received the Shingrx on 7-28-25 and 5 days later she started breaking out in a rash. First on her arms and back and then it spread to her legs and trunk, finally breaking out on her face. She said the rash was very itchy and called her doctor who advised her to use benadryl until she could be seen. Once seen the doctor could not identify the rash and gave her prednisone 20mg for 5 days on August 8 2025
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| 2854334 | 86 | M | TN | 08/15/2025 |
RSV VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LN5470 Z3AH3 |
Guillain-Barre syndrome; Guillain-Barre syndrome
Guillain-Barre syndrome; Guillain-Barre syndrome
|
Adverse reaction to Shingrix vaccine causing cute inflammatory demyelinating polyradiculoneuropathic...
Adverse reaction to Shingrix vaccine causing cute inflammatory demyelinating polyradiculoneuropathic form of Guillain Barre syndrome per medical chart
More
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β | |||||
| 2854335 | 62 | F | WI | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
Patient reported some swelling and redness at site starting after injection that has remained.
Patient reported some swelling and redness at site starting after injection that has remained.
|
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| 2854336 | 83 | F | GA | 08/15/2025 |
PNC21 RSV |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
z002626 z7ng7 |
Contusion, Limb injury, Pain, Product administered at inappropriate site; Contus...
Contusion, Limb injury, Pain, Product administered at inappropriate site; Contusion, Limb injury, Pain, Product administered at inappropriate site
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Patient received RSV and Pneumonia vaccines on 07/28/2025. Initially, no pain was felt, but later ex...
Patient received RSV and Pneumonia vaccines on 07/28/2025. Initially, no pain was felt, but later experienced pain, throbbing, and bruising. Ice application was ineffective, leading to an ER visit where a shoulder injury was diagnosed due to high administration. Prescribed Tylenol and Tramadol for pain, advised to follow-up with PCP. Patient still in pain, not upset. Apologized and documented incident for follow-up.
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| 2854337 | 69 | M | CA | 08/15/2025 |
COVID19 |
MODERNA |
3042646 |
Fumbling, Memory impairment
Fumbling, Memory impairment
|
Neurological. Patient first noticed minor fumbling with their fingers at their laptop the morning af...
Neurological. Patient first noticed minor fumbling with their fingers at their laptop the morning after the vax. Patient is a neuroscientist and musician. On the evening after the vax, patient attempted a practice session at the piano and could not remember long passages from pieces previously well-established in memory, including pieces played fluently the night before the vax. Impairment still ongoing today, two days after vax. No other evidence of amnesia or cognitive impairment, brain fog, confusion, etc. Impairment at the piano was/is profound. Patient's speculation as a neuroscientist is that it reflects cerebellar inflammation/neuropathy affecting muscle memory stored in cerebellum.
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| 2854338 | 50 | F | NC | 08/15/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
3303080 3303080 3303080 3303080 |
Arthralgia, Asthenia, Brain fog, Cognitive disorder, Fatigue; Gastrointestinal d...
Arthralgia, Asthenia, Brain fog, Cognitive disorder, Fatigue; Gastrointestinal disorder, General physical health deterioration, Imaging procedure abnormal, Inflammatory marker increased, Laboratory test abnormal; Loss of personal independence in daily activities, Mobility decreased, Myositis, Neuralgia, Pyrexia; Undifferentiated connective tissue disease
More
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Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to ...
Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine οΏ½ two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (1οΏ½2+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
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β | β | ||||
| 2854339 | 3 | F | ID | 08/15/2025 |
DTAP DTAP MMR MMR |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
|
Confusional state, Injection site pain, Injection site rash, Irritability, Muscu...
Confusional state, Injection site pain, Injection site rash, Irritability, Muscular weakness; Musculoskeletal stiffness, Pyrexia; Confusional state, Injection site pain, Injection site rash, Irritability, Muscular weakness; Musculoskeletal stiffness, Pyrexia
More
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Fever over 101 for 3 days, muscle weakness, pain at injection site, leg stiffness, rash 3 days after...
Fever over 101 for 3 days, muscle weakness, pain at injection site, leg stiffness, rash 3 days after injection on and around injection site, irritability, confusion.
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| 2854350 | 78 | M | WA | 08/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
75F74 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
It was administered for the second time in error on 08/13/25. The first dose was administered on 9/2...
It was administered for the second time in error on 08/13/25. The first dose was administered on 9/25/24. The patient is not reporting any side effects or concerns but he is aware of the mistaken second dose.
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| 2854351 | 13 | F | CA | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
Y015560 |
Cyanosis, Dizziness
Cyanosis, Dizziness
|
Within 5 min after vaccine administration, patient felt dizziness/lightheadedness and her lips turne...
Within 5 min after vaccine administration, patient felt dizziness/lightheadedness and her lips turned blue. She was directed to lay down on exam room bed, was given sugar containing drink, and rested around 10 min. After 15 min her lips were back to pink, denied dizziness/lightheadedness, and she felt she was back to normal.
More
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| 2854352 | 24 | F | WV | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
1965035 |
Syncope
Syncope
|
Patient fainted within 2 minutes after administration that lasted 5 minutes
Patient fainted within 2 minutes after administration that lasted 5 minutes
|
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| 2854353 | 26 | F | OH | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
y010656 |
Dizziness, Loss of consciousness, Syncope, Tremor
Dizziness, Loss of consciousness, Syncope, Tremor
|
gardacil vaccine administered at 3:43 pm...patient experienced a syncope episode at 3:44 pm. the pa...
gardacil vaccine administered at 3:43 pm...patient experienced a syncope episode at 3:44 pm. the patient "woke up" one minute later, she was shaky and lightheaded. pharmacy staff gor her cold water and sat with her for 15 minutes, she felt better and said that she has had other syncope episodes while receiving other vaccinations and during blood draws. she admitted that she usually warns the medical staff...but today "felt confident" and decided not to tell the pharmacy staff that syncope may occur.
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| 2854354 | 5 | M | CA | 08/15/2025 |
MMRV |
MERCK & CO. INC. |
Z008867 |
Injection site rash, Injection site swelling, Pyrexia
Injection site rash, Injection site swelling, Pyrexia
|
fever x24 hours, self-resolved. rash and swelling at site of injection
fever x24 hours, self-resolved. rash and swelling at site of injection
|
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| 2854355 | 68 | F | SC | 08/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KR75K |
Extra dose administered
Extra dose administered
|
This was a duplication. Pt did not need an additional tdap. Previous tdap was administered 2/17/25 ...
This was a duplication. Pt did not need an additional tdap. Previous tdap was administered 2/17/25 (Boostrix).
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| 2854356 | 33 | F | NE | 08/15/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
|
Diarrhoea, Pain, Vomiting; Diarrhoea, Pain, Vomiting
Diarrhoea, Pain, Vomiting; Diarrhoea, Pain, Vomiting
|
Body aches, diarrhea, vomiting
Body aches, diarrhea, vomiting
|
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| 2854357 | 53 | F | WI | 08/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3J2S2 3J2S2 |
Dizziness, Erythema, Flushing, Immediate post-injection reaction, Pain; Peripher...
Dizziness, Erythema, Flushing, Immediate post-injection reaction, Pain; Peripheral swelling, Pruritus, Pyrexia, Tenderness
More
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Immediate reaction/allergy Yes : Onset within 4 hours of inch Yes : Pain, redness; pain was sever...
Immediate reaction/allergy Yes : Onset within 4 hours of inch Yes : Pain, redness; pain was severe like it will explode Yes : Skin symptoms like flushing, itching No hives No : Breathing problems No : Low blood pressure , lightheadedness, near fainting or fainting Later reaction/allergy Onset within the next day Right arm swelling, pain, tenderness, expanding, redness, warmth 38.7F highest fever; no chills, sweats Still with itching No external hives No : Breathing problems No : Low blood pressure , lightheadedness, near fainting or fainting
More
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| 2854358 | 61 | F | CA | 08/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
EY77C |
Chest pain, Confusional state, Dizziness, Fatigue, Headache
Chest pain, Confusional state, Dizziness, Fatigue, Headache
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PATIENT REPORTS DEVELOPING SYMPTOMS 2 HOURS AFTER RECEIVING VACCINE. MOST NOTABLE IS CHEST PAIN, HEA...
PATIENT REPORTS DEVELOPING SYMPTOMS 2 HOURS AFTER RECEIVING VACCINE. MOST NOTABLE IS CHEST PAIN, HEADACHE, FATIGUE, DIZZINESS, AND CONFUSION. PATIENT STATES SHE HAD TO GO TO EMERGENCY ROOM.
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| 2854428 | 18 | F | TX | 08/15/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
A5AD4 |
Muscle spasms, Pain in extremity
Muscle spasms, Pain in extremity
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Muscle spasms up left arm into neck and down back. Improved the next day but pain continued in arm. ...
Muscle spasms up left arm into neck and down back. Improved the next day but pain continued in arm. Worse with movement. Treatments include rest, cool compress, 800mg ibuprofen q6hr advised to notify of any numbness, tingling or color changes start steroid 4mg dose pack. Return to clinic if symptoms do not improve
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| 2854033 | CA | 08/14/2025 |
HPV9 |
MERCK & CO. INC. |
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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 who was under the age of 9 but not below 5 years of age was administered the GARDASIL 9 vacc...
patient who was under the age of 9 but not below 5 years of age was administered the GARDASIL 9 vaccine.; GARDASIL 9 vaccine was administered to the patient per recommendation from "allergy or infection"; No additional AE/PQC; This spontaneous report was received from a Physician and refers to a Child patient of unknown gender who was under the age of 9 but not below 5 years old (Product administered to patient of inappropriate age). The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date (Also reported as several years ago), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9) (strength, doses, frequency, route of administration, site of administration, lot #, and expiration date were not provided) per recommendation from allergy or infection (Product use in unapproved indication). No additional adverse event reported.
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| 2854034 | F | VA | 08/14/2025 |
MMRV |
MERCK & CO. INC. |
Y019173 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms or side effects were reported; a patient received a dose of improperly stored PROQUAd; T...
No symptoms or side effects were reported; a patient received a dose of improperly stored PROQUAd; This spontaneous report was received from a Nurse and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. On 16-Jul-2025, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHa) (involved lot # was Y019173, expiration date: 18-May-2026 [verified to be valid]); 0.5 ml/ series, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was 52.2 degrees Fahrenheit (F) and time frame was unknown by reporter. There was no previous temperature excursion, nor report of adverse effect or product quality complaint involved.
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| 2854035 | VA | 08/14/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; HCP reporting that a patient received a dose of improperly stored VARIVAX.; This s...
No additional AE; HCP reporting that a patient received a dose of improperly stored VARIVAX.; This spontaneous report was received from a 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. On 02-JUL-2025, the patient was vaccinated with an improperly storage of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), as a dose of 0.5 ml (route of administration and anatomical location was not reported, lot number Y019318, which was verified to be valid, and expiration date on 21-NOV-2026) (0.5mL) for prophylaxis, the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot number and expiration date not reported.). The administered dose of the vaccine experienced a temperature excursion 52.2 degrees Fahrenheit for unknown minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.
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| 2854036 | VA | 08/14/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP reporting that a patient received a dose of improperly stored VARIVAX; No additional AE; This sp...
HCP reporting that a patient received a dose of improperly stored VARIVAX; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant therapies was not reported. On 16-JUL-2025, the patient received a dose of improperly stored with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5ml (lot #Y019318, who had been verified to be a valid lot number, expiration date reported and validated as 21-NOV-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine temperature was 52.2F, and there was no information about the date the excursion occurred (Product storage error). There was no information about previous temperature excursion. No additional adverse events.
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| 2854037 | 08/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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i had my first dose of shingrix in October 2024, can I still get my second dose 10 months later; Thi...
i had my first dose of shingrix in October 2024, can I still get my second dose 10 months later; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in Oct-2024). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: i had my first dose of shingrix in October 2024, can I still get my second dose 10 months later). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The patient had first dose of Shingrix in October 2024. And wanted to know if he/she could still get second dose 10 months later. Till the time of reporting the patient did not receive second dose of Shingrix which led to incomplete course of vaccination.
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| 2854038 | M | FL | 08/14/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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late second dose/got their 1st dose in Dec 2024, 2nd dose in May 2025; This non-serious case was rep...
late second dose/got their 1st dose in Dec 2024, 2nd dose in May 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received in DEC-2024). In MAY-2025, the patient received the 2nd dose of Twinrix. In MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose/got their 1st dose in Dec 2024, 2nd dose in May 2025). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-JUL-2025 and 30-JUL-2025 The reporter reported a patient was late for his second dose of Twinrix due to being out of the country, which led to lengthening of vaccination scheduled. The 3rd dose of Twinrix had not yet been administered to the patient. This case had been linked to the case US2025097739, reported by the same reporter.; Sender's Comments: US-GSK-US2025097739:Same reporter/Diffrent patient
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| 2854039 | F | 08/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Biopsy, COVID-19, Drug ineffective, Investigation, Lichen planus
Biopsy, COVID-19, Drug ineffective, Investigation, Lichen planus
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infected with COVID-19 the next month; infected with COVID-19 the next month; vaccine-associated vul...
infected with COVID-19 the next month; infected with COVID-19 the next month; vaccine-associated vulvovaginal lichen planus; This is a literature report. This case report presents a 66-year-old female exhibiting symptoms of vulvovaginal burning, pain, inflammation, and bleeding which were ultimately attributed to lichen planus possibly correlating with the administration of COVID-19 vaccination. Methods: A 66-year-old female with a remote medical history of stage 1 endometrial cancer treated with total hysterectomy and bilateral salpingo-oophorectomy, vulvar herpetic lesions, and psoriasis presented to her dermatologist with a new complaint of "unbearable pain", dyspareunia, vaginal bleeding, irritation, and burning with urination and showering. She used nystatin cream per dermatologist recommendation with minimal relief. After persistence of symptoms for 12 months, in Apr2023, the patient presented to her sexual medicine gynecologist who started her on clobetasol 0.05% ointment for erosive VLP. This was based on a clinical exam and a punch biopsy. Of note, the patient had received multiple doses of the Pfizer COVID-19 vaccine (two vaccines in Feb2021,a booster in Nov2021, and an additional booster in 2022) and symptoms began soon after. Results: Repeat punch biopsies were consistent with a diagnosis of erosive VLP. The patient was subsequently started on six weeks of systemic corticosteroids and pelvic floor therapy and local estrogen therapy. Patient responded well to therapy and no longer reported dyspareunia. She then received her fifth vaccine (Moderna) in Sept2023, was infected with COVID-19 the next month, and experienced a recurrence of VLP shortly after. Patient returned to the gynecologist in Jan2024 and received hydrocortisone vaginal suppositories to help manage the recurrence. By Jun2024, the patient was using tacrolimus and receiving intralesional steroid injections. She is currently feeling better, is sexually active with no issues, and reports minimal pain. Conclusions: This case report highlights the importance of including mucocutaneous complications like VLP on the differential diagnoses if a patient presents similarly after vaccine administration. While there is no current evidence establishing a causal link between COVID-19 vaccination and LP, the timeline of this patient's disease progression and previous case reports of similar instances indicate that the vaccines may potentially serve as a significant triggering factor for the onset or recurrence of this condition. However, the benefits of COVID-19 vaccination greatly outweigh this potential risk, making it a crucial tool for the health and safety of a population.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Covid-19, Drug ineffective, Lichen planus and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500160983 Same article/patient/drug and different event;
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| 2854051 | 17 | M | MO | 08/14/2025 |
MNQ MNQ MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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Dizziness, Seizure like phenomena, Syncope; Dizziness, Fall, Head injury, Seizur...
Dizziness, Seizure like phenomena, Syncope; Dizziness, Fall, Head injury, Seizure; Dizziness, Seizure like phenomena, Syncope; Dizziness, Fall, Head injury, Seizure
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Syncopal episode, dizziness, seizure like activity,
Syncopal episode, dizziness, seizure like activity,
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| 2854056 | 08/14/2025 |
HPV4 |
MERCK & CO. INC. |
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Mobility decreased, Pain
Mobility decreased, Pain
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"Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I w...
"Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all."; I can't move my arm because of the pain.; "Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all."; Information has been received from Business Partner/CRO on 08-Aug-2025. This spontaneous report was received from a/an Consumer or other non health professional 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 an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Suspension for injection (lot # and expiration date were not reported). The patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), for the treatment of prophylaxis. On an unknown date, the patient experienced "Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all.". On an unknown date, the patient experienced I can't move my arm because of the pain.. On an unknown date, the patient experienced "Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all.". At the reporting time, the outcome of "Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all.", I can't move my arm because of the pain. and "Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all." was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was reported as not applicable. The causal relationship between the event of "Why don't they provide more information about Gardasil? Yesterday, after the vaccine, I was fine, but now I can't move my arm because of the pain. This pain is not normal at all." and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of I can't move my arm because of the pain. and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. This is an invalid case as it pertained a social media case in which reporter was not able to be contacted and there were no patient identifiers.
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