| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1890188 | 60 | F | VA | 11/22/2021 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH MODERNA MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FJ1620 030L20A 030L20A 030L20A FJ1620 FJ1620 FJ1620 |
Extra dose administered; Arthralgia, Back pain, Blood test, Electromyogram, Fall...
Extra dose administered; Arthralgia, Back pain, Blood test, Electromyogram, Fall; Gait disturbance, Incorrect dose administered, Inflammation, Magnetic resonance imaging, Muscular weakness; Pain, Post vaccination syndrome; Arthralgia, Back pain, Blood test, Electromyogram, Fall; Gait disturbance, Incorrect dose administered, Inflammation, Magnetic resonance imaging, Muscular weakness; Pain, Post vaccination syndrome
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Error: Wrong Dose of Vaccine - Too High-
Error: Wrong Dose of Vaccine - Too High-
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| 2839357 | 33 | F | MO | 05/04/2025 |
COVID19 MMR |
PFIZER\BIONTECH MERCK & CO. INC. |
md3414 2053173 |
Pain; Pain
Pain; Pain
|
Extreme soreness lasting >7 days
Extreme soreness lasting >7 days
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| 2839358 | 43 | F | UT | 05/04/2025 |
PNC20 |
PFIZER\WYETH |
|
Fatigue, Headache, Malaise, Pain in extremity, Pallor
Fatigue, Headache, Malaise, Pain in extremity, Pallor
|
Pallor, fatigue, malaise, headache, sore arm
Pallor, fatigue, malaise, headache, sore arm
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| 2839359 | 63 | F | FL | 05/04/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Extra dose administered
Extra dose administered
|
The patient received Prevnar 20 on 5/2/2024, and received the same vaccine Prevnar 20 on 5/3/2025
The patient received Prevnar 20 on 5/2/2024, and received the same vaccine Prevnar 20 on 5/3/2025
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| 2839360 | 65 | F | NJ | 05/04/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Hyperhidrosis, Injection site pain, Loss of consciousness, Syncope
Hyperhidrosis, Injection site pain, Loss of consciousness, Syncope
|
patient said vaccine was very painful and then fainted. Patient got sweaty, passed out on chair. I r...
patient said vaccine was very painful and then fainted. Patient got sweaty, passed out on chair. I rubbed patients sternum and she woke up. patient refused help from 911. She accepted water and a cookie. Patient's son said she has fainted before during blood work. I checked her blood pressure and put on a fan to give her fresh air. She left after 45 minutes.
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| 2839361 | 62 | F | IN | 05/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47n3y |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
no adverse reaction, she was given a 3rd dose of shingrix vaccine, she had the first 2 doses in 201...
no adverse reaction, she was given a 3rd dose of shingrix vaccine, she had the first 2 doses in 2019 and 2020. patient had no adverse reaction
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| 2839362 | 79 | F | MN | 05/04/2025 |
FLU3 |
SANOFI PASTEUR |
u8515da |
Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
|
Patient received the vaccine and a few days later she was having pain and difficulty raising her lef...
Patient received the vaccine and a few days later she was having pain and difficulty raising her left arm
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| 2839363 | 38 | M | CO | 05/04/2025 |
HEPAB TYP YF |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
|
Syncope, Tonic clonic movements; Syncope, Tonic clonic movements; Syncope, Tonic...
Syncope, Tonic clonic movements; Syncope, Tonic clonic movements; Syncope, Tonic clonic movements
More
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The 3 above vaccines were administered. Patient experienced what appeared to be syncope with tonic-c...
The 3 above vaccines were administered. Patient experienced what appeared to be syncope with tonic-clonic movement <1 hour after vaccine administration. Patient started to fall as exiting Immunization room and was supported to floor and monitored until EMS arrived and took over supporting patient. Patient did leave with EMS and it is thought that he visited the ER but the outcome once leaving pharmacy is unknown. Called patient to check in on 5/4 and was unable to reach. Left voicemail to return pharmacy call if desired.
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| 2839364 | 54 | M | 05/04/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Extra dose administered
Extra dose administered
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Patient received Prevnar20 on 2/28/24 therefore this is a second (duplicate) dose.
Patient received Prevnar20 on 2/28/24 therefore this is a second (duplicate) dose.
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| 2839365 | 66 | F | PA | 05/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Erythema, Rash, Skin warm, Swelling
Erythema, Rash, Skin warm, Swelling
|
red, hot, swollen, rash
red, hot, swollen, rash
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| 2839366 | 66 | F | KY | 05/04/2025 |
FLU3 |
SANOFI PASTEUR |
u8519ca |
Gait disturbance, Guillain-Barre syndrome, Pain in extremity, Paraesthesia
Gait disturbance, Guillain-Barre syndrome, Pain in extremity, Paraesthesia
|
Received the vaccine and a few days later while laying in bed noticed tingling in her feet, the ting...
Received the vaccine and a few days later while laying in bed noticed tingling in her feet, the tingling progressed to painful stabbing pain which made it hard to walk. This went on for months as it slowly got better. Her doctor suspects it was a milder case of Guillain-Barr๏ฟฝ Syndrome.
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| 2839367 | 47 | F | FL | 05/04/2025 |
PNC20 |
PFIZER\WYETH |
LG5577 |
Cellulitis, Injected limb mobility decreased, Pain in extremity
Cellulitis, Injected limb mobility decreased, Pain in extremity
|
Patient reported pain and loss of motion that began day after immunization in left arm. Unsure when ...
Patient reported pain and loss of motion that began day after immunization in left arm. Unsure when but patient reported she sought treatment at ED and was treated successfully for cellulitis.
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| 2839368 | 74 | M | NE | 05/04/2025 |
COVID19 |
MODERNA |
3044069 |
Injection site cellulitis, Injection site erythema, Injection site pain
Injection site cellulitis, Injection site erythema, Injection site pain
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Pt developed redness, pain and erythema at site, then cellulitis at the site and in the arm
Pt developed redness, pain and erythema at site, then cellulitis at the site and in the arm
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| 2839369 | 65 | F | CA | 05/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
7L3ST |
Contusion, Mass, Skin warm
Contusion, Mass, Skin warm
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Bruising with lump underneath, warmth that dissipated after 1 week
Bruising with lump underneath, warmth that dissipated after 1 week
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| 2839383 | 66 | F | CA | 05/04/2025 |
COVID19 |
MODERNA |
3044069 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
REDNESS AND SWEELING AT INJECTION SITE. INJECTION SITE IS TENDER TO TOUCH. (RECOMEND BENADRYL AND WA...
REDNESS AND SWEELING AT INJECTION SITE. INJECTION SITE IS TENDER TO TOUCH. (RECOMEND BENADRYL AND WAIT AND SEE)
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| 2839384 | 71 | M | WA | 05/04/2025 |
COVID19 |
MODERNA |
034C21A |
Magnetic resonance imaging heart, Myocarditis, Pericarditis
Magnetic resonance imaging heart, Myocarditis, Pericarditis
|
Pericarditis with slight myocarditis, treated with Prednisone.
Pericarditis with slight myocarditis, treated with Prednisone.
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โ | |||||
| 2839385 | 64 | F | AZ | 05/04/2025 |
PNC20 TDAP VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LX4484 D4J9L 47N3Y |
Discomfort, Throat irritation, Throat tightness; Discomfort, Throat irritation, ...
Discomfort, Throat irritation, Throat tightness; Discomfort, Throat irritation, Throat tightness; Discomfort, Throat irritation, Throat tightness
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Patient reported Discomfort , Scratchy throat and closing up 30 minutes after immunization. Epipen w...
Patient reported Discomfort , Scratchy throat and closing up 30 minutes after immunization. Epipen was administered and Patient stabilized by emergency personnel.
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| 2839386 | 34 | M | PA | 05/04/2025 |
ANTH ANTH |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
300215a 300215a |
Arthralgia, Discomfort, Hypoaesthesia, Mobility decreased, Pain; Pain in extremi...
Arthralgia, Discomfort, Hypoaesthesia, Mobility decreased, Pain; Pain in extremity, Sleep disorder
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Significant shoulder pain including soreness and inability to move arm for several weeks after vacci...
Significant shoulder pain including soreness and inability to move arm for several weeks after vaccine administration. After that the pain continued to persist though some limited range of motion has returned. Pain continues to be a dull ache almost 4 months post administration with some numbness and also inability to sleep on left side due to pain. Continued issue with range of motion, pain and discomfort even when not moving arm. Pain could be described as numb ache but sometimes increase to sharp pain radiating down arm
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โ | |||||
| 2839325 | NM | 05/03/2025 |
DTPPVHBHPB RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. |
U7947AA 2088619 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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patient was administered ROTATEQ & VAXELIS during a temperature excursion.; No additional AE rep...
patient was administered ROTATEQ & VAXELIS during a temperature excursion.; No additional AE reported.; This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 24-Apr-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Oral solution (lot #2088619, expiration date: 09-Mar-2026) 1 dosage form (1 dose), administered by Oral route and with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), Suspension for injection (lot #U7947AA, expiration date: 20-Oct-2026) 1 dosage form (1 dose; strength 0.5 mL) (route of administration not reported), both as Prophylaxis. However, the reporter stated that these doses underwent a temperature excursion at 0๏ฟฝC for 1 hour, no previous excursions had occurred, no additional events or details reported.; Reporter's Comments:
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| 2839326 | IA | 05/03/2025 |
MMRV |
MERCK & CO. INC. |
X023401 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No additional AE/PQC reported; Nurse called to report that an expired dose of PROQUAD was administer...
No additional AE/PQC reported; Nurse called to report that an expired dose of PROQUAD was administered to 1 patient. Caller stated the product expired 3/20/2025 and was administered 4/30/2025. Caller stated product was never involved in a temperature excursion. Caller stated no pa; 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 30-APR-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot #X023401, expiration date: 20-Mar-2025 (expired product administered) (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). It was reported that product was never involved in a temperature excursion. No adverse events reported.
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| 2839327 | 14 | F | NJ | 05/03/2025 |
VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL 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. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y013346 Y013346 Y013346 Y013346 |
Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperatur...
Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered; Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered; Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered; Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered; Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered; Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered; Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia; Body temperature increased, Exposure to communicable disease, Extra dose administered
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Might have autoimmune disease; A HCP called to inquire how soon a patient (who is simultaneously bei...
Might have autoimmune disease; A HCP called to inquire how soon a patient (who is simultaneously being worked up for an unknown autoimmune disease) could or would develop a fever after receiving an injection of VARIVAX. The HCP stated a patient was administered a dose of VARIVAX; the dose of VARIVAX should not have been administered on 04/30/2025, because the patient had already received two prior doses of VARIVAX on 09/18/2005 and 04/06/2009; COVID; This spontaneous report was received from a physician and refers to a 34-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-SEP-2005, the patient was vaccinated with first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, lot number and expiration date were not reported), 06-APR-2009, with the second dose (dose, lot number and expiration date were not reported) and on 30-APR-2025, with the third dose (valid lot number Y013346, expiration date: 02-AUG-2026) 0.5 mL, once, subcutaneously, all of them with sterile diluent (BAXTER STERILE DILUENT) (dose, lot number and expiration date were not reported) for vaccination due to an exposure to chickenpox approximately 7-8 days ago, but had two prior vaccinations in the past and the HCP who administered misread the chart and gave a third vaccine (prophylaxis). On an unknown date, the patient was worked up for an unknown autoimmune disease), on 30-APR-2025, she developed a fever (pyrexia) of 101.5 degrees Fahrenheit about 2 hours after the vaccine, on a unknown date in April 2025 (reporter as about one month ago) the patient had COVID, so she did not think the fever was related to COVID and the facility was going to also test the patient for the flu. The person who administered the vaccine read the patient's medical record incorrectly and the dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) should not have been administered on 30-APR-2025, because the patient had already received two prior doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) on 18-SEP-2005 and 06-APR-2009 (extra dose administered). The patient did not report any other adverse issues or side effects from the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) administered on 30-APR-2025 and the healthcare provider (HCP) was not aware of the patient having experienced any adverse issues or side effects from the prior doses either. At the reporting time, the outcome of the events was not provided. The causal relationship between the events Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and sterile diluent (BAXTER STERILE DILUENT) was not provided. Upon internal review, the event autoimmune disease was determined to be medically significant.
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| 2839328 | M | CA | 05/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MG5S9 |
Product preparation issue
Product preparation issue
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Shingrix adjuvant only administered; Shingrix adjuvant only administered; This non-serious case was ...
Shingrix adjuvant only administered; Shingrix adjuvant only administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number MG5S9, expiry date 30-MAR-2027) for prophylaxis. On 18-APR-2025, the patient received Shingrix. On 18-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-APR-2025 The clinical manager called today to report that the adjuvant portion of the Shingrix vaccine was administered to a patient on April 18, 2025 which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2839336 | 21 | F | FL | 05/03/2025 |
HPV9 TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
y015179 u8232aa |
Cold sweat, Lip discolouration, Pallor, Syncope, Unresponsive to stimuli; Cold s...
Cold sweat, Lip discolouration, Pallor, Syncope, Unresponsive to stimuli; Cold sweat, Lip discolouration, Pallor, Syncope, Unresponsive to stimuli
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Within 5 minutes after vaccines, patient had syncope event with pale, clammy skin and gray lips. Sh...
Within 5 minutes after vaccines, patient had syncope event with pale, clammy skin and gray lips. She was still breathing but unresponsive for about 3 minutes. It took about 45 minutes for recovery with monitoring by local EMS.
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| 2839337 | 62 | F | OH | 05/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
|
Red, swollen and hot spreading down arm.
Red, swollen and hot spreading down arm.
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| 2839338 | 20 | F | FL | 05/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
EB499 |
Feeling abnormal, Hyperhidrosis, Loss of consciousness, Tremor
Feeling abnormal, Hyperhidrosis, Loss of consciousness, Tremor
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Patient 20 years old got a Boostrix vaccine (Tdap) on left arm (intramuscular) today 5/3/25 around 1...
Patient 20 years old got a Boostrix vaccine (Tdap) on left arm (intramuscular) today 5/3/25 around 10:10 am and a few minutes after the vaccine she lost conscious and started having slight tremors that lasted a few seconds. After her tremors she said she felt like sweating and felt " weird" . She had to sit down for a few more minutes until a friend came to pick her up
More
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| 2839339 | 5 | M | CO | 05/03/2025 |
FLU3 MNQ |
SEQIRUS, INC. SANOFI PASTEUR |
|
Oxygen saturation decreased, Unresponsive to stimuli, Vomiting; Oxygen saturatio...
Oxygen saturation decreased, Unresponsive to stimuli, Vomiting; Oxygen saturation decreased, Unresponsive to stimuli, Vomiting
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Vomiting, unresponsive, low oxygen saturation
Vomiting, unresponsive, low oxygen saturation
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| 2839340 | 75 | F | GA | 05/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Injection site pain
Injection site pain
|
Patient was previously vaccinated with Arexvy October 06, 2023. Patient is not experiencing any adv...
Patient was previously vaccinated with Arexvy October 06, 2023. Patient is not experiencing any adverse events at this time, other than typical mild arm soreness at the injection site.
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| 2839341 | 80 | M | MD | 05/03/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Gait inability
Gait inability
|
PER PT WIFE WAS UNABLE TO WALK FOR A COUPLE OF DAYS
PER PT WIFE WAS UNABLE TO WALK FOR A COUPLE OF DAYS
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| 2839342 | 62 | F | MD | 05/03/2025 |
COVID19 |
MODERNA |
8081260 |
Gait disturbance
Gait disturbance
|
PER PATIENT WAS BARLEY ABLE TO WALK FOR A COUPLE OF DAYS
PER PATIENT WAS BARLEY ABLE TO WALK FOR A COUPLE OF DAYS
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| 2839343 | 56 | F | FL | 05/03/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
xn575 |
Inappropriate schedule of product administration, Pain in extremity
Inappropriate schedule of product administration, Pain in extremity
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Spoke to patient about getting second dose of vaccine (Boostrix) since initial was given 2/5/25. Pat...
Spoke to patient about getting second dose of vaccine (Boostrix) since initial was given 2/5/25. Patient only reported having sore arm.
More
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| 2839344 | 12 | M | 05/03/2025 |
MNQ |
SANOFI PASTEUR |
|
Arthralgia, Axillary pain, Injection site discolouration, Peripheral swelling, T...
Arthralgia, Axillary pain, Injection site discolouration, Peripheral swelling, Thrombotic thrombocytopenic purpura
More
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Arm swelling and pain under axilla and extending to elbow. TTP. Pink patches distal to injection si...
Arm swelling and pain under axilla and extending to elbow. TTP. Pink patches distal to injection site.
More
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| 2839345 | 69 | M | FL | 05/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Injection site erythema, Injection site induration, Injection site mass, Injecti...
Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
More
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Raised hard red lump at site of injection (right arm), about the size of half a deck of cards, warm ...
Raised hard red lump at site of injection (right arm), about the size of half a deck of cards, warm to the touch, within 24 hours of getting the vaccine.
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| 2839346 | 65 | M | OH | 05/03/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Injected limb mobility decreased, Injection site pain
Injected limb mobility decreased, Injection site pain
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patient had pain in left deltoid later the same day after injection that persisted for at least 4 we...
patient had pain in left deltoid later the same day after injection that persisted for at least 4 weeks. pain 8/10 and was unable to lift his arm. first seen by PCP on 5/2/25 (about 4 weeks after injection). pain is improving but still 2/10. he declined imaging of area. no evidence of infection or DVT. suspect intramuscular hematoma vs localized reaction to vaccine.
More
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| 2839347 | 65 | F | WA | 05/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
F35Y5 |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
|
Patient had normal reaction on day 1, mild redness/warmth/swelling. By day 2, swelling border had in...
Patient had normal reaction on day 1, mild redness/warmth/swelling. By day 2, swelling border had increased , and by day 3 (Monday), border was between 2-3 inches. Patient went to the prescriber office and they decided to treat for possible cellulitis vs strong reaction to vaccine. Patient had possible reaction to doxycycline (mild rash) so was changed to cephalexin on 4/30/25. Had noticed slight improvement on doxycycline
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| 2839349 | 64 | F | WI | 05/03/2025 |
HEP VARZOS |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
945664 EK225 |
Pain in extremity, Rash; Pain in extremity, Rash
Pain in extremity, Rash; Pain in extremity, Rash
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Patient said that she had a very sore arm on her left side (side shingrix was given) and developed a...
Patient said that she had a very sore arm on her left side (side shingrix was given) and developed a rash on her upper body, her left arm and left arm pit. She noticed the rash on 4/21/25 and went to urgent care. At urgent care, she was prescribed prednisone.
More
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| 2839350 | 50 | F | TX | 05/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75X22 |
Influenza like illness, Injection site erythema, Injection site warmth
Influenza like illness, Injection site erythema, Injection site warmth
|
Patient called reporting "flu like symptoms", redness at the injection site, and warmth at...
Patient called reporting "flu like symptoms", redness at the injection site, and warmth at the injection site. Patient reports taking TYLENOL to help with these symptoms, and she does feel better now (5/2/25)
More
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| 2839351 | 61 | M | FL | 05/03/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
4DS4N |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
This error involves a 3rd dose of Twinrix that was administered 4 months early. First dose: 11/2/24 ...
This error involves a 3rd dose of Twinrix that was administered 4 months early. First dose: 11/2/24 2nd dose: 12/7/24 3rd dose: 1/13/25 instead of May (This VAERS report)
More
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| 2839352 | 60 | M | NY | 05/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5yr3p |
Rash, Rash pruritic
Rash, Rash pruritic
|
Patient had a widespread rash develop over his legs that was very itchy within a week of getting the...
Patient had a widespread rash develop over his legs that was very itchy within a week of getting the vaccine. He said that it mostly improved over the course of 2-3 weeks but has one itchy section by his ankle that his never improved until this day.
More
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| 2839353 | 89 | M | FL | 05/03/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2412 |
Acne, Furuncle, Pruritus
Acne, Furuncle, Pruritus
|
PATIENT SAID HIS RIGHT ARM ITCHES AND NOW HE HAS A PIMPLE/BOIL WHITE WHITE PUS THE SIZE OF A BLACK ...
PATIENT SAID HIS RIGHT ARM ITCHES AND NOW HE HAS A PIMPLE/BOIL WHITE WHITE PUS THE SIZE OF A BLACK PEPPER. RECOMMENDED HIM TO GO TO A DOCTOR AND GET ANTIBIOTIC JUST IN CASE. HE SAID HE DOES NOT WANT TO. TOLD HIM TO USE NEOSPORIN JUST IN CASE. HE SAID HE WILL GO TO THE DOCTOR IF IT GETS WORSE. REPEATED TO HIM THAT HE SHOULD GO AS SOON AS POSSIBLE IF HE'S CONCERN. REPORTING AS SOON AS HE INFORM US TODAY.
More
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| 2839354 | 61 | M | 05/03/2025 |
PNC21 RSV TDAP VARZOS |
MERCK & CO. INC. PFIZER\WYETH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y019157 LN5485 U8366AA H97H2 |
Erythema, Pain, Pharyngeal swelling, Swelling face; Erythema, Pain, Pharyngeal s...
Erythema, Pain, Pharyngeal swelling, Swelling face; Erythema, Pain, Pharyngeal swelling, Swelling face; Erythema, Pain, Pharyngeal swelling, Swelling face; Erythema, Pain, Pharyngeal swelling, Swelling face
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Patient received 4 vaccines and next day came to pharmacy complaining about throat swelling, redness...
Patient received 4 vaccines and next day came to pharmacy complaining about throat swelling, redness on the administered arm and pain. His face was swollen and had redness on the right arm. Reecommended to urgent care to further treatment if needed. Patient did receive 3 more vaccines and those were give on left arm
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| 2839189 | F | IA | 05/02/2025 |
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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No additional adverse event (AE)); HCP calling to inquire about a patient who received the first GAR...
No additional adverse event (AE)); HCP calling to inquire about a patient who received the first GARDASIL 9 vaccine in 2017 and presents now for a second dose; This spontaneous report was received from a pharmacist and refers to a 24-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On an unknown date in 2017, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, administered as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). It was stated that the patient presented now (on an unknown day in April 2025) for a second dose of the previous mention vaccine (inappropriate schedule of product administration). No additional adverse event was reported (No adverse event).
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| 2839190 | F | KY | 05/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain in extremity
Pain in extremity
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arm soreness after administration; This non-serious case was reported by a nurse via call center rep...
arm soreness after administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm soreness after administration). The outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date : 28-APR-2025 The patient experienced arm soreness after administration of Shingrix. This case was linked with case US2025051115 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025051115:SAME REPORTER
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| 2839241 | 16 | F | PR | 05/02/2025 |
MNP |
PFIZER\WYETH |
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Dizziness, Presyncope
Dizziness, Presyncope
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The patient had a vasovagal dizziness; This is a spontaneous report received from a Nurse from a sal...
The patient had a vasovagal dizziness; This is a spontaneous report received from a Nurse from a sales representative. A 16-year-old female patient (not pregnant) received meningococcal group abcwy vaccine (PENBRAYA), on 10Mar2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRESYNCOPE (non-serious) with onset 10Mar2025, outcome "recovered" (10Mar2025), described as "The patient had a vasovagal dizziness". Therapeutic measures were taken as a result of presyncope. Additional Information: The patient did not receive any other vaccines on the same date as the suspect vaccine. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. The patient had a vasovagal dizziness treatment received for event vasovagal dizziness protocol, including lifting patient legs. Patient do not have known allergies. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.
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| 2839245 | 24 | IA | 05/02/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
X010523 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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No adverse effects were reported/ no additional AE; VARIVAX was inadvertently administered to a pati...
No adverse effects were reported/ no additional AE; VARIVAX was inadvertently administered to a patient on 4/30/2025, with an expiration date of 4/11/2025.; This spontaneous report was received from a Nurse and refers to a 24-year-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On 30-APR-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection (lot #X010523, expiration date: 11-APR-2025) at a dose of 0.5 mL (route of administration not provided) reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose description, lot # and expiration date were not reported) for prophylaxis (expired vaccine administered). No adverse effects were reported.
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| 2839246 | 71 | F | FL | 05/02/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Chills, Eye discharge, Eyelid function disorder, Nasal ulcer, Ophthalmic herpes ...
Chills, Eye discharge, Eyelid function disorder, Nasal ulcer, Ophthalmic herpes zoster; Photophobia, Pyrexia, Seizure, Somnolence, Stomatitis
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high fever; shingles infection in left eye which has not resolved in over 7 months; convulsing; had...
high fever; shingles infection in left eye which has not resolved in over 7 months; convulsing; had chills; sores in mouth; sore in nose; sleeping for an entire day; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: shingles infection in left eye which has not resolved in over 7 months) (serious criteria GSK medically significant), convulsion (Verbatim: convulsing) (serious criteria GSK medically significant and clinically significant/intervention required), fever (Verbatim: high fever), sleepiness (Verbatim: sleeping for an entire day), chills (Verbatim: had chills), mucosal sores (Verbatim: sores in mouth) and nasal ulcer (Verbatim: sore in nose). In AUG-2024, the outcome of the fever was resolved and the outcome of the sleepiness was resolved (duration 1 day). The outcome of the ophthalmic herpes zoster was not resolved and the outcome of the convulsion, chills, mucosal sores and nasal ulcer were resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, convulsion, fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix. The company considered the ophthalmic herpes zoster and convulsion to be unrelated to Shingrix. It was unknown if the company considered the fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix. Additional Information: GSK Receipt Date: 24-APR-2025 The patient indicated that she got Shingrix shot 2 at a pharmacy. She said that less than 12 hours after the shot she began experiencing adverse reactions such as she had a high fever 102.6 for two days. She remembers sleeping for an entire day. She had chills and was convulsing such that her husband wanted to take her to hospital. But with extra blankets and changing the house temperature she was able to manage. She got sores inside her mouth and also inside her nose which she said were gross, horrible. She indicated that her left eye was running and that she could not even open her eye, so she went to urgent care. She had a shingles infection in her left eye that has persisted for over 7 months, and this was causing sensitivity to light. She did not had the lot number but she provided the name of the pharmacy and the pharmacy's phone number as the pharmacy should had the lot number on file. She went to the eye doctor twice a week and was prescribed numerous unspecified medications, but none have worked to clear the infection; Sender's Comments: Ophthalmic herpes zoster and Seizure are unlisted events which are considered unrelated to GSK vaccine Shingrix.
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| 2839247 | F | 05/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Abdominal pain, Dizziness, Headache, Hepatic enzyme increased, Vomiting
Abdominal pain, Dizziness, Headache, Hepatic enzyme increased, Vomiting
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Severely elevated liver enzymes; dizziness; Abdominal pain; headache; vomiting; This serious case wa...
Severely elevated liver enzymes; dizziness; Abdominal pain; headache; vomiting; This serious case was reported by a consumer and described the occurrence of elevated liver enzymes in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 16-APR-2025, the patient received the 1st dose of Shingles vaccine. On 16-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced elevated liver enzymes (Verbatim: Severely elevated liver enzymes) (serious criteria hospitalization), dizziness (Verbatim: dizziness) (serious criteria hospitalization), abdominal pain (Verbatim: Abdominal pain) (serious criteria hospitalization), headache (Verbatim: headache) (serious criteria hospitalization) and vomiting (Verbatim: vomiting) (serious criteria hospitalization). The outcome of the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting were resolving. It was unknown if the reporter considered the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting to be related to Shingles vaccine. It was unknown if the company considered the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-APR-2025 The patient took shingles vaccine and was hospitalized with abdomen pain, dizziness, vomiting, nausea, and severely elevated liver enzymes. She also mentioned, she had to have her blood drawn numerous times to make sure but becoming more stable. Reporter mentioned she was taken off all medications in the hospital due to potential increase in liver enzyme.; Sender's Comments: Hepatic enzyme increased and Dizziness are unlisted events which are considered unrelated to GSK Shingles vaccine. Abdominal pain, Headache and Vomiting are listed events which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications and investigation details) are considered unrelated to GSK Shingles vaccine.
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| 2839248 | F | WI | 05/02/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK |
Eye swelling, Feeling abnormal, Headache, Herpes zoster, Incomplete course of va...
Eye swelling, Feeling abnormal, Headache, Herpes zoster, Incomplete course of vaccination; Loss of consciousness, Malaise, Pain, Pruritus, Rash; Eye swelling, Feeling abnormal, Headache, Herpes zoster, Incomplete course of vaccination; Loss of consciousness, Malaise, Pain, Pruritus, Rash
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passed out; Shingles; She had declined to take the second dose of Shingrix; This serious case was re...
passed out; Shingles; She had declined to take the second dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety, macular degeneration, gastroesophageal reflux disease, allergy and cholesterol. Concomitant products included paroxetine, pantoprazole, montelukast, atorvastatin, ascorbic acid;betacarotene;cupric oxide;tocopheryl acetate;zinc oxide (Preservision), colecalciferol (Vitamin D 3), vitamins nos (Multivitamin) and paraffin (Mineral). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced passed out (Verbatim: passed out) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: She had declined to take the second dose of Shingrix). The outcome of the passed out and shingles were unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the passed out and shingles to be related to Shingrix. The company considered the passed out to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date : 21-APR-2025 She reported that she received one dose of SHINGRIX about 5 or 6 years ago. Two weeks later she noted a severe headache. The following morning she had a swollen right eye. The rash on her face and side of head, into her hair line followed soon after. She stated that she was sick for 2 months. She stated the pain during this time was the worst she had ever experienced. The itching and weird feeling lasted a few months more. She reported that she had a visit with her Ophthalmologist during this time and passed out in the chair due to the close quarters and too many people in the room. She had declined to take the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
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| 2839249 | M | 05/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Aneurysm, Autoimmune disorder, Death
Aneurysm, Autoimmune disorder, Death
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Autoimmune disorder; he had an aneurysm and died; This serious case was reported by a consumer via s...
Autoimmune disorder; he had an aneurysm and died; This serious case was reported by a consumer via sales rep and described the occurrence of autoimmune disorder in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced autoimmune disorder (Verbatim: Autoimmune disorder) (serious criteria death, GSK medically significant and other: Serious as per reporter) and aneurysm (Verbatim: he had an aneurysm and died) (serious criteria death). The patient died in APR-2025. The reported cause of death was autoimmune disorder and aneurysm. It was unknown if the reporter considered the autoimmune disorder and aneurysm to be related to Shingrix. The company considered the autoimmune disorder and aneurysm to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 29-APR-2025 The reporter was a neighbor of the patient who died. Reporter reported that after taken Shingrix, patient developed an autoimmune disorder in which he was prescribed continued use of steroids. An unknown amount of time later he had an aneurysm and died. The reporter stated death was sometime in last week (from the date of reporting) he/she thought and believed due to an aneurysm.; Sender's Comments: Autoimmune disorder and Aneurysm are unlisted events which are considered unrelated to GSK vaccine Shingrix.; Reported Cause(s) of Death: Autoimmune disorder; Aneurysm
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| 2839250 | 05/02/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Aphasia, Cardiac arrest, Guillain-Barre syndrome, Intensive care, Loss of contro...
Aphasia, Cardiac arrest, Guillain-Barre syndrome, Intensive care, Loss of control of legs; Paralysis
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cardiac arrest; GBS/could not talk/lost control of legs; This serious case was reported by a consume...
cardiac arrest; GBS/could not talk/lost control of legs; This serious case was reported by a consumer via interactive digital media and described the occurrence of cardiac arrest in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In JUN-2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced cardiac arrest (Verbatim: cardiac arrest) (serious criteria hospitalization, GSK medically significant and life threatening) and guillain barre syndrome (Verbatim: GBS/could not talk/lost control of legs) (serious criteria hospitalization and GSK medically significant). The outcome of the cardiac arrest and guillain barre syndrome were not reported. The reporter considered the cardiac arrest and guillain barre syndrome to be related to Shingles vaccine. The company considered the cardiac arrest and guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. Patient took the first shot in June of 2022 and 10 days later lost control of legs and went to emergency room. Patient came down with the worst side effects of shot Guillain Barre syndrome and spent 6 weeks in the hospital, one week in ICU. Patient went into cardiac arrest and almost died and was completely paralyzed and could not talk. Patient stated that it was from the shot and was done with all shots.; Sender's Comments: Cardiac arrest and Guillain-Barre syndrome are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
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| 2839251 | 05/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Inflammation, Surgery
Inflammation, Surgery
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inflammatory tailspin; This serious case was reported by a consumer via interactive digital media an...
inflammatory tailspin; This serious case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had Shingles 4 years before vaccine). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced inflammation (Verbatim: inflammatory tailspin) (serious criteria clinically significant/intervention required). The outcome of the inflammation was not reported. It was unknown if the reporter considered the inflammation to be related to Shingles vaccine. The company considered the inflammation to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles then got the Shingles vaccine 4 years later. The patient stated he/she even spaced the two doses out a little further in hopes of not having any side effects. The vaccine was horrible. The patient stated, sent his/her body into an inflammatory tailspin resulting in surgery to correct. The patient stated that shingles was worse than childbirth, but the reaction to the vaccine was much easier.; Sender's Comments: Inflammation is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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