| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2856079 | 17 | IN | 08/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Possible administration in unapproved schedule; This non-serious case was reported by a other healt...
Possible administration in unapproved schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 09-OCT-2024, the patient received the 2nd dose of Bexsero. On 09-OCT-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Possible administration in unapproved schedule). The outcome of the drug dose administration interval too short 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: 31-JUL-2025 The medical assistant reported the GSK to request information about the validity of two doses of Bexsero that were given on 15th May 2024 and 09th October 2024 two a 17-year-old patient. The reporter wanted to know if the series was valid. As data was being collected for a possible adverse event, the health care professional started to act in a rude manner and refused to answer questions. after the information was relayed and they were told that the physician had to decide on the clinical scenario, they rudely ended the call and did not provide any more information. The patient received 2nd dose of Bexsero earlier than recommended interval, which led to shortening of vaccination schedule.
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| 2856080 | 74 | F | PA | 08/29/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Bone density decreased, Burning sensation, Headache, Injection site ...
Arthralgia, Bone density decreased, Burning sensation, Headache, Injection site pain; Neuralgia, Osteopenia, Pain, Pain in extremity, Sensitivity to weather change
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osteopenia; bilateral nerve pain; Pain at injection site; early morning headaches/Headache; Body ach...
osteopenia; bilateral nerve pain; Pain at injection site; early morning headaches/Headache; Body ache; Painful arm; Burning sensation at the front of her legs; intermittent bilateral ankle burning at night ankle to the mid part of the shin.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included thyroid disorder and diabetes. Additional patient notes included She was not hypotensive, not on any blood control medication, not on metformin or insulin. Concomitant products included levothyroxine and dapagliflozin propanediol monohydrate (Farxiga). On 09-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 09-JUL-2025, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: early morning headaches/Headache), pain in arm (Verbatim: Painful arm) and general body pain (Verbatim: Body ache). In JUL-2025, the patient experienced burning sensation in joints (Verbatim: intermittent bilateral ankle burning at night ankle to the mid part of the shin.) and burning leg (Verbatim: Burning sensation at the front of her legs). On an unknown date, the patient experienced injection site pain (Verbatim: Pain at injection site), osteopenia (Verbatim: osteopenia) and nerve pain (Verbatim: bilateral nerve pain). The outcome of the injection site pain was not reported and the outcome of the burning sensation in joints, headache, pain in arm, burning leg and general body pain were not resolved and the outcome of the osteopenia and nerve pain were unknown. It was unknown if the reporter considered the injection site pain, burning sensation in joints, headache, osteopenia, nerve pain, pain in arm, burning leg and general body pain to be related to Shingrix. It was unknown if the company considered the injection site pain, burning sensation in joints, headache, osteopenia, nerve pain, pain in arm, burning leg and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 01-AUG-2025 The patient had a Shingrix shot and since she has been having early morning headaches, when she gets up in the morning, she claims she has a headache and gets a cup of coffee and middle of the night she has been experiencing bilateral ankle burning, up from the ankle to the mid part of the shin. She said it's also weather related, if its damp or raining weather it gets worse and the frequency of it was intermittent. The patient was on thyroid medication 75 MCG of levothyroxine. She was still experiencing it. She called in reporting morning she was a friend of the family and told her that the symptoms that she described to did not line up with what would expect from Shingrix vaccine. The reporter cannot find anything related to bilateral ankle neuralgia, its sounds more to like a disc issue. She has no disc issue or osteoporosis but has osteopenia. She just got bone density test done and it showed up as osteopenia not osteoporosis. She walks and exercise but pain she gets in the middle of the night with the ankle and to me its sounds more like neuralgia, not disc related, the reporter stated he/she could be wrong but the issue with her was that she never had it until she took the Shingrix injection. Did not know if its temporal relationship or not, did not know but it's interesting now she took the injection and she has now bilateral nerve pain. She states that she has been experiencing headache, painful injection site, body aches, and a burning sensation at the front of her legs. She states that these symptoms were ongoing intermittently. The burning sensation began a few days ago and was ongoing. The reporter would like to know if there were any reports of this, because the issue here was this, she was pending a 2nd injection. So, if she developing some neuralgia was this a form of Guillain-Barre syndrome. The reporter did not think so, but think about it, it usually affects the back. Covid vaccine from Aztra Zeneca pulled out the vaccine because of that and people end up getting paralysis. So, the reporter not going to recommend that she gets a 2nd dose if this was preamble to potentially to be paralysis for her. The reporter also aware physician for example did not pay attention to black box warning for example ciprofloxacin and they prescribe it has candy drops. She said he had spoken to her primary, and he said he was not aware of any issues happening to other patients, so the reporter did not know if this was a one off or a unique circumstance for her. The reporter did not know if it's indicative of delayed hypersensitivity reaction and might get worse at a 2nd dose. Right now, the reporter told her did not take a 2nd dose and she can wait it out, she has been exposed to chicken pox before and not had any eruption or 2nd occurrence of it since she was a kid. The reporter asked her if she had herniated disc, she said she does not and one feature she never had this neuralgia prior to injection. Did not know if Shingrix activated something in her system she got a small inflammation at the nerve root that gets inflamed at nighttime. She said it was intermittent to me if it was inflamed it would be chronic constant.
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| 2856082 | IN | 08/29/2025 |
MEN MENB |
UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
|
Bexsero, interchangeability with Menquadfi; This non-serious case was reported by a other health pro...
Bexsero, interchangeability with Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. The patient's past medical history included splenectomy. In AUG-2024, the patient received Bexsero. On an unknown date, the patient received Menquadfi. On an unknown date, an unknown time after receiving Bexsero and Menquadfi, the patient experienced interchange of vaccine products (Verbatim: Bexsero, interchangeability with Menquadfi). The outcome of the interchange of vaccine products 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: 13-AUG-2025 A patient received a booster dose for Bexsero on August 2024 because of a splenectomy. The patient was indicated another booster on August 2025 which had not been administered till the time of reporting, hcp asked information to make clinical decision. Later on the call mentioned Bexsero was given as a booster after the patientοΏ½s first normal schedule was with Menquadfi.
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| 2856083 | 18 | F | WI | 08/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and...
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 18-year-old female patient who did not receive Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (patient had 1st dose on 1st August 2022). The patient did not receive the 2nd dose of Bexsero, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination 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: 13-AUG-2025 Reporter just had a question about Bexsero. They had a pt who got 1 dose on 1st August 2022. Had too much time passed to give the 2nd dose. Till the time of reporting patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
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| 2856084 | M | MI | 08/29/2025 |
HEP HEPAB |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
|
Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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patients received Heplisav-B in the end of April and Twinrix on 8.8.25; This non-serious case was re...
patients received Heplisav-B in the end of April and Twinrix on 8.8.25; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 08-AUG-2025, the patient received Twinrix. In APR-2025, the patient received Heplisav b. On 08-AUG-2025, an unknown time after receiving Twinrix and an unknown time after receiving Heplisav b, the patient experienced interchange of vaccine products (Verbatim: patients received Heplisav-B in the end of April and Twinrix on 8.8.25). The outcome of the interchange of vaccine products 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: 19-AUG-2025 The pharmacist asked which vaccine give first and how much time in between doses to wait after one of her patients received Heplisav-B in the end of April and Twinrix on 8th August 2025 which led to interchange of vaccine products. The reporter also mentioned that the patient missed a Heplisav-B dose on time, so adverse event details were retrieved.
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| 2856085 | 0.5 | M | 08/29/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
EJ577 |
Expired product administered
Expired product administered
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a Pediarix dose, which had expired, was accidentally given to a 6 month old male patient; This non-s...
a Pediarix dose, which had expired, was accidentally given to a 6 month old male patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number EJ577, expiry date 13-AUG-2025) for prophylaxis. Previously administered products included Pediarix (received 1st dose of vaccine on an unknown date). On 18-AUG-2025, the patient received the 2nd dose of Pediarix. On 18-AUG-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: a Pediarix dose, which had expired, was accidentally given to a 6 month old male patient). The outcome of the expired vaccine used 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: 20-AUG-2025 A physician contacted GlaxoSmithKline to report that a Pediarix dose, which had expired, was accidentally given to a 6-month-old patient, which led to expired vaccine used. The reporter wanted to know if GlaxoSmithKline had any data to share. They did request to remain anonymous but did consent to receive follow up to the following phone number, on Monday, Wednesday and Friday.
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| 2856086 | OH | 08/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Late second dose; This non-serious case was reported by a pharmacist via call center representative ...
Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patients received 1st dose of vaccine between AUG-2023 and AUG-2024). The patients did not receive the 2nd dose of Shingrix. The patients had incomplete course of vaccination (Verbatim: Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 Pharmacist called to report that might be like five patients over 65 years of age, between male and female that were administered with a first dose of Shingrix vaccine between AUG-2023 and AUG-2024. The reporter wanted to know do they need to revaccinate or restart the vaccination schedule, was there any percentage drop on effectiveness. No specific vaccination date or details, patient demographics and further information were provided. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
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| 2856087 | 40 | M | 08/29/2025 |
COVID19 |
MODERNA |
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Cardiomegaly
Cardiomegaly
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Patient died from an enlarged heart after receiving a Moderna COVID shot; This spontaneous case was ...
Patient died from an enlarged heart after receiving a Moderna COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Patient died from an enlarged heart after receiving a Moderna COVID shot) in a 40-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (Patient died from an enlarged heart after receiving a Moderna COVID shot) (seriousness criterion death). The reported cause of death was enlarged heart. An autopsy was performed. The autopsy-determined cause of death was died of enlarged heart. No concomitant medications were provided. It was reported that the patient passed away from the Moderna COVID shot at 40 years of age. They came out with a warning, and he did not want to get the shot. It was his first shot. He had an EKG 3 months before he got the shot. The patient was found dead in the basement where he used to live. There was no long-term study on these things. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-788906 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788906:invalid case for many people; Reported Cause(s) of Death: Enlarged heart; Autopsy-determined Cause(s) of Death: Died of enlarged heart
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| 2856088 | MN | 08/29/2025 |
RSV |
PFIZER\WYETH |
LG9827 |
Product physical issue
Product physical issue
|
fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken...
fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken/Returned photo was reviewed and the glass syringe was noticed to be cracked not broken for Abrysvo; The initial case was missing the following minimum criteria: Reportable AE. Upon receipt of follow-up information on 21Aug2025, this case now contains all the required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. This report involves rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LG9827, Expiration Date: 31Oct2025) intramuscular for immunisation, Device Lot Number: LG9827, Device Expiration Date: 31Oct2025. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken/Returned photo was reviewed and the glass syringe was noticed to be cracked not broken for Abrysvo". Causality for "fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken/returned photo was reviewed and the glass syringe was noticed to be cracked not broken for abrysvo" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The reporter said that they had an Abryso vaccine fell apart upon trying to reconstitute it, it fell apart upon trying to reconstitute it and the product off hit together like it came apart so, they could not continue to use. When probed for any side effects, the reporter stated that It was not given to the patient its just they couldn't physically use the product, they reported to request a replacement product when this happened. Reason of replacement, the reporter stated that because the product broken as they were trying to reconstitute it, they were unable to use the vaccine. The reporter confirmed that vaccine was not administered to any patient. Dose: 120microgram. The reporter stated that they still had the product and could return it. Received photo information included Vial lot: LG9827 (exp 2025/10); Diluent lot: HN8587 (exp 2026/09). Returned photo was reviewed and the glass syringe was noticed to be cracked not broken for Abrysvo.
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| 2856089 | F | 08/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chronic inflammatory demyelinating polyradiculoneuropathy
Chronic inflammatory demyelinating polyradiculoneuropathy
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COVID-19 vaccine-related Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); This is a...
COVID-19 vaccine-related Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); This is a spontaneous report received from a Consumer or other non HCP. An adolescent female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "COVID-19 vaccine-related Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)". The clinical course was reported as follows: PANZYGA was prescribed for CIDP, start date: 01Feb2021. Therapeutic measures were taken as a result of chronic inflammatory demyelinating polyradiculoneuropathy. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2856090 | M | 08/29/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
|
Death; Death
Death; Death
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passed away; This is a spontaneous report received from a Consumer or other non HCP from License Par...
passed away; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020540 (BioNTech), 2025SA224373 (Sanofi). A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, hospitalization, medically significant), outcome "fatal", described as "passed away". The date and cause of death for the patient were unknown. No autopsy was performed. Additional information: Initial information received on 30Jul2025 regarding an unsolicited non-valid serious courtesy case received from a consumer/non-hcp (healthcare professional). This case involves an unknown age male patient who began experiencing issues; ended up in the hospital; could not return home immediately and passed away, after receiving Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone high dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B high dose Subvirion vaccine Suspension for injection in pre-filled syringe and also received an unknown dose of suspect COVID-19 vaccine not produced by (name withheld) formulation-unknown both with (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient who began experiencing issues; ended up in the hospital; could not return home immediately (Adverse event NOS) and passed away (Death NOS) (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the event of adverse event NOS was Fatal for the event of Death NOS. Seriousness Criteria- This event was assessed as medically significant and was leading to death (death NOS). The patient was hospitalized for this event of (Adverse event NOS) and medically significant. Company Comment 04Aug2024: This case involves an unknown age male patient who reported to be began experiencing issues; ended up in the hospital; could not return home immediately and passed away, after receiving Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone high dose]. Based on available information as no latency, cause of death, autopsy reports, medical history and concomitant medications provided, the event is not assessed to vaccine. Batch/lot number is not provided, and it cannot be obtained. BNT162B2 is under agreement with BIONTECH SE.; Reported Cause(s) of Death: Unknown cause of death
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| 2856091 | 7 | M | PA | 08/29/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
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Kinrix was given instead of Tdap and Polio. Pt is 7 and over the age range to receive Kinrix.
Kinrix was given instead of Tdap and Polio. Pt is 7 and over the age range to receive Kinrix.
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| 2856092 | 64 | F | MI | 08/29/2025 |
HEPA |
MERCK & CO. INC. |
|
Underdose
Underdose
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Gave a pediatric dose, inadequate dose per age group
Gave a pediatric dose, inadequate dose per age group
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| 2856093 | 50 | F | MA | 08/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523J |
Injection site erythema, Product administered at inappropriate site
Injection site erythema, Product administered at inappropriate site
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PT REPORTS MEDICAL ASSISTANT HE "TROUBLE GETTING IT IN HER DELTOID" SO MOVED TO HER LONG E...
PT REPORTS MEDICAL ASSISTANT HE "TROUBLE GETTING IT IN HER DELTOID" SO MOVED TO HER LONG END UPPER TRICEP BRACHII MUSCLE. NEXT PATIENT CAME IN AND C/O REDNESS. DR EXAMINED PT AND FOUND IT WAS A NORMAL VACCINE REACTION. THERE WAS A SMALL PINK AREA. WE ARE REPORTING TO THE INJECTION ERROR
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| 2856094 | 50 | F | MN | 08/29/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Blood test, Cellulitis, Erythema, Pain in extremity, Peripheral swelling; Pyrexi...
Blood test, Cellulitis, Erythema, Pain in extremity, Peripheral swelling; Pyrexia, Ultrasound scan
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Red, swollen left arm, fever, arm pain 9/10 for over 5 days cellulitis .
Red, swollen left arm, fever, arm pain 9/10 for over 5 days cellulitis .
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| 2856095 | 4 | M | OH | 08/29/2025 |
DTAPIPV DTAPIPV DTAPIPV DTAPIPV MMRV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
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Blood test normal, Electrocardiogram normal, Eye movement disorder, Gait disturb...
Blood test normal, Electrocardiogram normal, Eye movement disorder, Gait disturbance, Hypotonia; Pallor, Posture abnormal, Presyncope, Somnolence; Blood test normal, Electrocardiogram normal, Eye movement disorder, Gait disturbance, Hypotonia; Pallor, Posture abnormal, Presyncope, Somnolence; Blood test normal, Electrocardiogram normal, Eye movement disorder, Gait disturbance, Hypotonia; Pallor, Posture abnormal, Presyncope, Somnolence
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The vaccines were given at his pediatrician's office on July 16th at his yearly checkup. Pedia...
The vaccines were given at his pediatrician's office on July 16th at his yearly checkup. Pediatrician's name is MD located at the Clinic Medical Building. He was given the vaccine the same time as his twin sister. I kept an eye on both of them throughout the rest of the day and evening. The next day I dropped them off at their school summer camp. I got a call from his teacher who had him in class the prior year, so she knew him and his personality, and she told me that he kept putting his head down saying he was going to sleep. They were having trouble keeping him awake and he looked pale. My husband and I immediately drove to the school to pick him up. When I got there he had his head laying on a desk, there was a teacher with him, he was extreamly pale and could barely walk. I carried him to the car and we decided to take him home so he could sleep the rest of the day and I could watch him. We get in the car and not 2 minutes later his eyes start rolling in the back of his head and his head starts to droop, as if he's passing out or going to sleep. He has no color in his face or lips. We do a quick u turn to the nearest emergency room down the street which is the Medical Center. He couldn't walk and was like a limp doll. They immediatly took us in and started taking blood pressure and other general stats. I mentioned multiple times to every nurse and doctor that the only thing that could cause this would be the vaccines he received the day before. Every single person dismissed me. As we stayed in the hospital, he slowly started to gain color back. They did do, I believe, an EkG on him - I know they checked his heart and did blood work and they told me they couldn't find anything wrong with him. By this point, we've been in the emergency room for around an hour and he's doing better. They discharged us, and that was it. I called his pediatrician's office and they also dismissed my concern for the vaccine. About a month later, he experienced the same occurrence where he almost passed out, and I took him to the nearest Urgent Care where they said everything was fine with him. I would hope at this point everything is fine. But going foward I am unsure I want to finish vaccinations.
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| 2856096 | 62 | F | ND | 08/29/2025 |
PNC21 |
MERCK & CO. INC. |
Z006889 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
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Patient has a round rash around the injection site. slight amount of swelling, redness, and itching...
Patient has a round rash around the injection site. slight amount of swelling, redness, and itching. Patient reports small amount of pain but mostly itching. Patient was prescrived hydroxyzine for the itching and hyrdrocortisone cream.
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| 2856097 | 6 | M | WY | 08/29/2025 |
TDAP |
SANOFI PASTEUR |
U8274AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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No reaction, child should have received Dtap
No reaction, child should have received Dtap
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| 2856098 | 52 | F | AL | 08/29/2025 |
COVID19 COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN JANSSEN |
2110218 2110218 2110218 2110218 |
Alopecia, Aphasia, Autoimmune disorder, Biopsy skin, Feeding disorder; Gait inab...
Alopecia, Aphasia, Autoimmune disorder, Biopsy skin, Feeding disorder; Gait inability, Generalised oedema, Laboratory test normal, Loss of personal independence in daily activities, Mobility decreased; Muscular weakness, Musculoskeletal disorder, Rash, Rash vesicular, SARS-CoV-2 test; Walking aid user
More
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When they gave me the shot in the arm, it made its way to my neck. After that i swelled up and it wa...
When they gave me the shot in the arm, it made its way to my neck. After that i swelled up and it was my whole body and then i got a rash on my face, chest, arms . The rash looked like blisters. I ended up where i couldn't move my legs or walk and i couldn't use my hands and arms and i couldn't speak or eat. And then my family doctor she did everything she could and all the test and could not help me with anything because it was not showing anything. Then she sent me to the hospital. They did a Covid test and sent me home. My husband had to help me to get in the truck and called the doctor and they sent me to another hospital. I found out i have 2 auto immune disease. I was in the hospital for a month and half, The did a biopsy on my left leg. Since i was there i can not get up or do anything i cant even bathe myself. They gave me steroids. When i got out the husband my husband got me 2 walkers and shower chair and i ended up going to the disease doctor and now i am taking a medication for one and shots for the other one. I still cant open up anything with my hands and i still have a rash. And i lost all of my hair.
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| 2856099 | 17 | M | VA | 08/29/2025 |
MNQ |
SANOFI PASTEUR |
68574AA |
Seizure
Seizure
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Client's mother contacted the school nurse to notify her that student had a seizure in the car ...
Client's mother contacted the school nurse to notify her that student had a seizure in the car on the way home from the school. Per discussion with the father at the follow up call on 8/29 he had 2 seizures that he witnessed in the car.
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| 2856100 | 5 | F | NH | 08/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
GE974 |
Wrong product administered
Wrong product administered
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Provider ordered MMRV for a patient but MMR was given.
Provider ordered MMRV for a patient but MMR was given.
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| 2856101 | 17 | F | TX | 08/29/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LX2636 U8562AA |
Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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Provider ordered Influenza vaccine and Trumemba vaccine, however the medical assistant administered ...
Provider ordered Influenza vaccine and Trumemba vaccine, however the medical assistant administered Menquadfi and Trumemba. Pt was up to date on Meningitis series. Provider and pt made aware of medication error.
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| 2856102 | 11 | M | 08/29/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
343DD |
Swelling face
Swelling face
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Patient received Menveo injection in the right deltoid and shortly after his right facial cheek beca...
Patient received Menveo injection in the right deltoid and shortly after his right facial cheek became puffy. Mom was concerned about this because of patient's medical history with mast cell issues. Patient's PCP evaluated him at the office check out area. Mom gave him a dose of Benadryl (50mg capsule) and we gave a dose of IM Decadron along 30 minutes of supervision. No difficulties breathing and no swallowing problems noted.
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| 2856103 | 62 | F | NC | 08/29/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK UNK UNK |
Blood test normal, Chest discomfort, Condition aggravated, Headache, Heart rate ...
Blood test normal, Chest discomfort, Condition aggravated, Headache, Heart rate increased; Hot flush, Hypersensitivity, Insomnia, Palpitations, Rash; Urticaria; Anxiety, Chest discomfort, Cold flash, Condition aggravated, Confusional state; Headache, Hot flush, Hypersensitivity, Malaise, Palpitations; Panic reaction, Rash vesicular, Stress, Urticaria; Blood test normal, Chest discomfort, Condition aggravated, Headache, Heart rate increased; Hot flush, Hypersensitivity, Insomnia, Palpitations, Rash; Urticaria; Anxiety, Chest discomfort, Cold flash, Condition aggravated, Confusional state; Headache, Hot flush, Hypersensitivity, Malaise, Palpitations; Panic reaction, Rash vesicular, Stress, Urticaria
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These symptoms im reporting came afterv the second shingles shot. 24 hours after having shot i devel...
These symptoms im reporting came afterv the second shingles shot. 24 hours after having shot i developed a bad headache, rapid heart beat/palpitations, and a tightness in chest and increased hot flashes in the evening during sleep. This continued everyday at approximately the same time every evening around 5 pm. After reading on website that these were more severe side effects i took myself to the emergency room on 8/19.They did absolutely nothing for me. I was sent home. These symptoms continues and then on Aug 21st i broke out with hives all over my left arm. This too was a symptom associated with the second shingles shot. However the site said these are an allergic reaction to shot. 3 days ago i developed a small rash under my arm which at first looked like a bug bite, but we think its a rash from the shot. the headaches have subsided but im still experiencing palpitations, tightness in chest and sleepless nights.
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| 2856104 | 7 | F | TX | 08/29/2025 |
HPV9 |
MERCK & CO. INC. |
Y010466 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt was given HPV at 7 years old, no adverse reactions noted
Pt was given HPV at 7 years old, no adverse reactions noted
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| 2856105 | 55 | F | MA | 08/29/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
JF7DM |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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One of our staff administered the incorrect vaccine. The staff administered DTAP instead of TDAP. Pa...
One of our staff administered the incorrect vaccine. The staff administered DTAP instead of TDAP. Patient was observed for 15 mins no adverse reaction noted. I contacted CDC recommendation to give correct vaccine TDAP. Pt was notified and agreeable to accept TDAP vaccine. Tolerated vaccine well.
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| 2856106 | 56 | F | TN | 08/29/2025 |
PNC21 |
MERCK & CO. INC. |
2004302 |
Influenza like illness, Injection site haematoma
Influenza like illness, Injection site haematoma
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patient says she had a "huge" hematoma on her arm at the site of the injection and had flu...
patient says she had a "huge" hematoma on her arm at the site of the injection and had flu-like symptoms for 2 days. The hematoma has resolved as of a visual inspection on 8/29/2025. The flu-like symptoms resolved on 8/26/2025
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| 2856107 | 11 | F | TN | 08/29/2025 |
DTAP |
SANOFI PASTEUR |
2CA77C1 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient was administered Daptacel instead of Tdap. No adverse reactions.
Patient was administered Daptacel instead of Tdap. No adverse reactions.
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| 2856108 | 82 | M | NJ | 08/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Dizziness, Fatigue, Muscle spasms, Myalgia
Dizziness, Fatigue, Muscle spasms, Myalgia
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Painful muscle cramping; heavy fatigue; and dizziness
Painful muscle cramping; heavy fatigue; and dizziness
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| 2856109 | 5 | F | WA | 08/29/2025 |
DTAPHEPBIP IPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. |
9C295 Y019530 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse reactions were reported; however, the child received extra doses of Hep B and IPV that we...
No adverse reactions were reported; however, the child received extra doses of Hep B and IPV that were not needed.
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| 2856110 | 64 | F | NY | 08/29/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Peripheral swelling
Peripheral swelling
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Patient states she received the vaccine 5/16/2025 on right arm. Afterwards she developed swelling in...
Patient states she received the vaccine 5/16/2025 on right arm. Afterwards she developed swelling in the right arm that lasted a few weeks. It resolved on its on.
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| 2856111 | 12 | M | OK | 08/29/2025 |
HPV9 MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
Y015560 SJS53 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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Both vaccines given in Left upper arm, returned to clinic on 8/29/25, left upper arm swollen, red, a...
Both vaccines given in Left upper arm, returned to clinic on 8/29/25, left upper arm swollen, red, and hot to touch. Area of redness, swelling, and heat approx. 7 inches in length and 4-5 inches in width. Client advised to present to urgent care of choice and have left arm evaluated
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| 2856112 | 73 | F | KS | 08/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
NR4T5 |
Injection site erythema, Injection site swelling, Injection site warmth, Local r...
Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
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Patient called at 9:15 am today (8/29/25) to report that she received her first Shingrix dose on 8/2...
Patient called at 9:15 am today (8/29/25) to report that she received her first Shingrix dose on 8/27/25. Beginning the next day on 8/28/25, she began having a reaction where the injection site (right arm) is red, swollen, and warm feeling. This reactionhas lasted over 24 hours and has not gotten any worse but also not getting any better. The patient does not report any systemic effects, no difficulty breathing. The patient told me that she is going to reach out to her PCP to find out if the reaction needs any treatment. We discussed apply ice to reduce the swelling while she waits to hear from her PCP. ------- ------- ------- ------- FOLLOW UP BY PHONE TO SEE HOW PT. DOING: Per patient 8/29/25 11:34 am, followed up to see how she is going. She called her provider (name withheld) and the nurse told her to apply ice. It is a local reaction. The dr. did not have any appt. to see the pt. until next Wednesday at 4:00 pm. The patient decided to watch and wait, and because it will take so long to see her PCP for this acute problem... the pt. plans to seek care at an urgent care if the reaction worsens or does not improve. She received the vaccine on 8/27/25 at 10:21 am and first noticed the reaction when she woke up at 6:00 am on 8/28/25. The reaction has been stable since that time, not getting any worse or any better.
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| 2856113 | 43 | M | CA | 08/29/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
90677 90677 |
Consciousness fluctuating, Dizziness, Electroencephalogram normal, Headache, Hyp...
Consciousness fluctuating, Dizziness, Electroencephalogram normal, Headache, Hyperhidrosis; Impaired driving ability, Stress, Syncope
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Went to facility for annual physical, and was forced to get the Prevnar20 vaccine even though I have...
Went to facility for annual physical, and was forced to get the Prevnar20 vaccine even though I have had it as a child. Felt light headed after the vaccine was administered. Fainted and went in and out of consciousness. When consciousness was regained was sweating heavily as if I had a mini fever, but after a few minutes of sitting down, I felt normal again. Incident caused the doctor to send a driver medical evaluation to the DMV to take away my driver's license without a brain scan EEG evaluation performed. Have experienced frequent headaches every 2-3 days and mental and physical stress has been experienced ever since this traumatizing incident occured.
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| 2856114 | 5 | M | IN | 08/29/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Discomfort, Irritability, Product administered at inappropriate site
Discomfort, Irritability, Product administered at inappropriate site
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Mother did request that vaccine be given in leg at time of visit. Mother phoned after leaving clinic...
Mother did request that vaccine be given in leg at time of visit. Mother phoned after leaving clinic to inform clinic manager of her concern regarding the placement of the injection. Mother has knowledge of vaccine sites and states injection was given on the top of the leg not laterally. Patient was experiencing discomfort and fussiness following the injection. Immunization coordinator spoke with mother on the day after event. Mother relates her child is doing fine but she wanted to let someone know so retraining of staff nurse administering vaccine can occur .
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| 2856115 | 45 | F | MI | 08/29/2025 |
TDAP |
SANOFI PASTEUR |
U8670BA |
Erythema, Pain, Swelling
Erythema, Pain, Swelling
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Swelling of 2" diameter, erythema, pain - greater than expected
Swelling of 2" diameter, erythema, pain - greater than expected
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| 2856117 | 76 | F | MO | 08/29/2025 |
PNC20 |
PFIZER\WYETH |
lx4482 |
Cellulitis, Product administered at inappropriate site
Cellulitis, Product administered at inappropriate site
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Patient was diagnosed with cellulitis and provided with clindamycin prescription 08/29/2025. Additio...
Patient was diagnosed with cellulitis and provided with clindamycin prescription 08/29/2025. Additionally, during examination by MD and PharmD it was apparent the shot was administered too low.
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| 2856118 | 0.33 | F | NY | 08/29/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
UK330AA MF0416 2117044 |
Enema administration, Intussusception, Laparoscopy, Ultrasound abdomen abnormal,...
Enema administration, Intussusception, Laparoscopy, Ultrasound abdomen abnormal, Vomiting; Enema administration, Intussusception, Laparoscopy, Ultrasound abdomen abnormal, Vomiting; Enema administration, Intussusception, Laparoscopy, Ultrasound abdomen abnormal, Vomiting
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The patient presented to the ER with vomiting and found to have intussusception on ultrasound. The i...
The patient presented to the ER with vomiting and found to have intussusception on ultrasound. The intussusception did not resolve with air enema x 2 attempts and subsequently had a exploratory laparoscopy which discovered spontaneous resolution, not requiring further surgical intervention. Child was discharged home in stable condition.
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| 2856119 | 41 | M | WY | 08/29/2025 |
HEP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4BX39 EB499 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Client received an incorrect vaccine at this appointment. Tdap given--client was due for Hepatitis ...
Client received an incorrect vaccine at this appointment. Tdap given--client was due for Hepatitis B #3. Client notified of error at appointment. Received 3rd dose of adult Hepatitis B at this appointment.
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| 2856120 | 4 | F | AZ | 08/29/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8383AB Z007578 |
Injection site erythema, Injection site swelling, Local reaction; Injection site...
Injection site erythema, Injection site swelling, Local reaction; Injection site erythema, Injection site swelling, Local reaction
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Patient developed a localized reaction on her L thigh with redness and swelling. Redness started on ...
Patient developed a localized reaction on her L thigh with redness and swelling. Redness started on 8/27/25 and was reported to doctors office on 8/28/25. Patients mom was recommended to use ice on the area and give the patient Tylenol for discomfort if any. Patient came to clinic to see the doctor on 8/29/25.
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| 2856121 | 21 | M | NJ | 08/29/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Product preparation issue
Product preparation issue
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VACCINE WAS NOT MIXED BEFORE GIVEN TO THE PATIENT
VACCINE WAS NOT MIXED BEFORE GIVEN TO THE PATIENT
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| 2856122 | 12 | M | NC | 08/29/2025 |
HEPA HPV9 IPV MNQ VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. |
MB599 Y Y1A212M U8 Z005456 |
Extra dose administered, No adverse event, Wrong patient received product; Extra...
Extra dose administered, No adverse event, Wrong patient received product; Extra dose administered, No adverse event, Wrong patient received product; Extra dose administered, No adverse event, Wrong patient received product; Extra dose administered, No adverse event, Wrong patient received product; Extra dose administered, No adverse event, Wrong patient received product
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RN called different client's name and patient stood up. RN did not verify name or DOB before a...
RN called different client's name and patient stood up. RN did not verify name or DOB before administering three vaccines- Hep A, Polio IPV, and Varicella. Patient was already up to date on series for those vaccines and parent reported no adverse effects in the past. RN identified mistake and parent agreed for patient to receive needed vaccines- HPV and Meningococcal.
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| 2856123 | 12 | F | MD | 08/29/2025 |
HPV9 |
MERCK & CO. INC. |
Y010802 |
Balance disorder, Dizziness, Fall, Pallor
Balance disorder, Dizziness, Fall, Pallor
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Patient became dizzy and pale lost balance and fell backwards
Patient became dizzy and pale lost balance and fell backwards
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| 2856124 | 31 | F | WI | 08/29/2025 |
TDAP |
SANOFI PASTEUR |
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Exposure during pregnancy, Pain, Pain in extremity
Exposure during pregnancy, Pain, Pain in extremity
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I was 28w5d pregnant (due date of 10/25/25) at the time of receiving the TDAP vaccine. I had pain in...
I was 28w5d pregnant (due date of 10/25/25) at the time of receiving the TDAP vaccine. I had pain in my arm from the start, but was told it was normal for it to hurt for 2-3 days. It has now been 3 weeks and the pain has not gone away and is worse when I move/lift my arm. I have tried taking tylenol and massaging my arm, but nothing has seemed to help and certain movements have made the pain worse.
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| 2856125 | 34 | F | SC | 08/29/2025 |
JEV1 |
INTERCELL AG |
JEV23M11E |
Deafness unilateral, Tinnitus
Deafness unilateral, Tinnitus
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Patient states she had ringing in her left ear that started on 28 Aug 2025; which was contact. The n...
Patient states she had ringing in her left ear that started on 28 Aug 2025; which was contact. The next morning the patient woke up and couldn't not hear anything out of the same ear.
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| 2856126 | 71 | F | NH | 08/29/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
Contusion, Erythema, Skin warm, Swelling
Contusion, Erythema, Skin warm, Swelling
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Redness, bruising, warm to touch, swelling.
Redness, bruising, warm to touch, swelling.
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| 2856127 | 69 | F | AL | 08/29/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781AA |
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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4-5 inch hard lump on arm where vaccine was administered, warm/red/raised
4-5 inch hard lump on arm where vaccine was administered, warm/red/raised
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| 2856128 | 4 | F | GA | 08/29/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
52D72 Z009076 |
Injection site erythema, Injection site induration, Injection site pruritus, Inj...
Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
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Pt developed itchiness, redness and swelling surrounding Kinrix injection site to left anterior thig...
Pt developed itchiness, redness and swelling surrounding Kinrix injection site to left anterior thigh 1 day after administration. Mom states she wasn't too worried about it until this morning when the area looked larger. The size in diameter of induration is approximately 3 inches. No other signs or symptoms.
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| 2856129 | 1.25 | F | MI | 08/29/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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KINRIX (DTAP/IPV) WAS GIVEN TO THIS PATIENT IN ERROR AS IT IS NOT APPROVED FOR THE AGE OF THE PATIEN...
KINRIX (DTAP/IPV) WAS GIVEN TO THIS PATIENT IN ERROR AS IT IS NOT APPROVED FOR THE AGE OF THE PATIENT. NO KNOWN ADVERSE EFFECTS ARE KNOWN.
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| 2856130 | 39 | F | AR | 08/29/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8737 |
Computerised tomogram, Electrocardiogram, Electroencephalogram, Magnetic resonan...
Computerised tomogram, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging, Retinal artery occlusion
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Retina artery occlusion
Retina artery occlusion
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β | β |