| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2832894 | 70 | F | TX | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Started 3/15/2025 woke up with pain, swelling, and redness at injection site reaching up to the "size of a golfball". no fever, no chills, no heat at the site. Symptoms subsided now to "quarter size" mild redness and mild swelliing. Pt did not take any pain relieve med because "it hasn't got to the point" where she would need to take some for the discomfort.
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| 2832895 | 53 | F | NC | 03/24/2025 |
FLUC4 |
SEQIRUS, INC. |
946618 |
Joint injury
Joint injury
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Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
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| 2832896 | 67 | F | CT | 03/24/2025 |
COVID19 |
MODERNA |
067H21A |
Hypoaesthesia, Paraesthesia
Hypoaesthesia, Paraesthesia
|
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial a...
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient says after receiving Moderna booster, she experienced a lasting effect of tingling all over her body. She went to her neurologist and they weren't able to provide a diagnosis. Since then, she's received other vaccines including Flu and COVID (PIZER) and still experiences the tingling feeling all over although it is much less severe than the first time.
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| 2832897 | 74 | F | MT | 03/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
33FD3 33FD3 |
Arthralgia, Asthenia, Back pain, Hypoaesthesia, Injection site pain; Paraesthesi...
Arthralgia, Asthenia, Back pain, Hypoaesthesia, Injection site pain; Paraesthesia
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Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial a...
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient states had some injection site pain but that went away and is now reporting weakness, tingling, and pain in shoulder/back area. From an injector standpoint vaccine was administered correctly with no issues.
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| 2832898 | 65 | F | CA | 03/24/2025 |
FLU4 |
SANOFI PASTEUR |
U8489DA |
Chills, Influenza like illness, Pyrexia
Chills, Influenza like illness, Pyrexia
|
Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Patient reports being very sick...
Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Patient reports being very sick and experiencing severe flu like symptoms after receiving RSV + COVID + FLU, Other Vaccines: VaccineTypeBrand: COVID 2024-2025 12+; Manufacturer: MODERNA; LotNumber: 3042560; Route: IM; BodySite: LEFT ARM; Dose: 1; VaxDate: 09/12/2024, VaccineTypeBrand: RSV (AREXVY VIAL); Manufacturer: GLAXOSMITHKLINE; LotNumber: EY77C; Route: IM; BodySite: RIGHT ARM; Dose: 1; VaxDate: 09/12/2024
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| 2832899 | 72 | F | MA | 03/24/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
8081260 8081260 |
Arthralgia, Erythema, Injection site erythema, Injection site pain, Pain in extr...
Arthralgia, Erythema, Injection site erythema, Injection site pain, Pain in extremity; Peripheral swelling, Rash
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Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (s...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Joint Pain-Medium, Additional Details: PATIENT INDICATED SWELLING, PAIN AND REDNESS NO BOTH FEET. SEEKED MEDICAL ADVISE, DR ATTRIBUTED IT TO REACTION OF VACCINE. PATIENT WAS ADVISED TO TAKE NSAID TO REDUCE INFLAMATION. AWAITING FOR FOLLOWUP
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| 2832900 | 74 | F | MA | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Injection site erythema, Injection site pain, Injection site swelling, Rash
Injection site erythema, Injection site pain, Injection site swelling, Rash
|
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
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| 2832901 | 40 | F | PA | 03/24/2025 |
HPV9 |
MERCK & CO. INC. |
Y014510 |
Dizziness, Feeling of body temperature change, Flushing, Hyperhidrosis, Tremor
Dizziness, Feeling of body temperature change, Flushing, Hyperhidrosis, Tremor
|
Systemic: Dizziness / Lightheadness-Mild, Systemic: felt hold and cold-Mild, Systemic: Flushed / Swe...
Systemic: Dizziness / Lightheadness-Mild, Systemic: felt hold and cold-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: After administration of HPV Gardasil vaccine, the patient felt hot & cold and also sweaty. She also reported feeling light headed. Patient sat down for 10-15 minutes. Patient was offered water. Patient had said she still felt sweaty and shaky. Patient was able to leave / walk out on her own power. Patient's spouse arrived to transport the patient back home. Patient was informed to go the ER if symptoms relapse or worsen. A follow up voicemail was made to check in on the patient.
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| 2832902 | 26 | F | TN | 03/24/2025 |
FLU4 |
SANOFI PASTEUR |
UT8506NA |
Seizure, Syncope, Tremor, Unresponsive to stimuli
Seizure, Syncope, Tremor, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional...
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Hx of fainting; given 2 vax in the R arm per prefrence due to scarring/atrophy in L arm. Tdap given 1st then flu with adequate spacing for co-admin. As bandage was being placed for flu vax pt started to lean forward in chair but I was able to catch her and sit her back in the chair. I noted tense muscle and some shaking/seizing (episode aprox 20 sec). Pt states little food during day. Layed her on her back on bench with feet elevated. Pt got picked up and stated would f/u with provider on 3/19, Other Vaccines: VaccineTypeBrand: Tdap (Boostrix); Manufacturer: GSK; LotNumber: DY3K7; Route: Intramuscular; BodySite: Right Arm; Dose: 1; VaxDate: 03/18/2025
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| 2832903 | 59 | F | TX | 03/24/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Contusion, Injection site bruising, Injection site erythema, Injection site pain...
Contusion, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Pruritus
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Came by on 3/19/2025, Her arm is bruised up and said she started having symptoms on 3/18/2025. Gotten the Flu shot and the Capvaxive together together, pt said that she been on flu shot before, first time getting pneuminia shot. We suspect it from the Capvaxive. Called MD and spoken to someone at MD office. Talking to patient on follow up with MD. will schedule with md appointment this week, Other Vaccines: VaccineTypeBrand: Fluvelvax; Manufacturer: ; LotNumber: 946637; Route: Intramusclar; BodySite: Left Arm; Dose: 1; VaxDate: 03/13/2025
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| 2832904 | 23 | F | CA | 03/24/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945662 |
Malaise
Malaise
|
Systemic: feeling unwell, breathing-Medium, Additional Details: Patient states felt unwell the night...
Systemic: feeling unwell, breathing-Medium, Additional Details: Patient states felt unwell the night of the vaccines. Today, 3/19/25, pt states still feeling unwell and has heaving breathing. Advised pt to call MD or go to urgent care., Other Vaccines: VaccineTypeBrand: Pfizer 2024-2025 COVID 12YR+; Manufacturer: Pfizer; LotNumber: LN0590; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 03/13/2025, VaccineTypeBrand: Priorix MMR; Manufacturer: GSK; LotNumber: 342RC; Route: SC; BodySite: Left upper arm; Dose: 1; VaxDate: 03/13/2025, VaccineTypeBrand: Flucelvax 2024-2025; Manufacturer: Seqirus; LotNumber: 946625; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 03/13/2025
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| 2832905 | 11 | F | NC | 03/24/2025 |
COVID19-2 |
PFIZER\BIONTECH |
lm2045 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: pfizer 5-11 yr; Manufactu...
Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: pfizer 5-11 yr; Manufacturer: pfizer; LotNumber: lm2045; Route: im; BodySite: r arm; Dose: unknown; VaxDate: 11/27/2024
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| 2832906 | 25 | F | DC | 03/24/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945662 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Additional Details: patient collapsed and fainted. patient r...
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient collapsed and fainted. patient recovered and responsive after fainting. ems called and patient taken by ems
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| 2832907 | 59 | F | TN | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
x5t42 |
Arthralgia, Injection site pain, Injection site swelling, Joint injury, Mobility...
Arthralgia, Injection site pain, Injection site swelling, Joint injury, Mobility decreased
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-M...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient had limited movement in arm, could not raise it
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| 2832908 | 66 | F | SC | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
k2bb7 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
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Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Inject...
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: gsk; LotNumber: dy3k7; Route: IM; BodySite: right arm; Dose: ; VaxDate: 03/18/2025
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| 2832909 | 53 | M | FL | 03/24/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
xn575 xn575 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Neuralgia; Pain
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Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injecti...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Patient still reporting pain post 17 days of vaccination, pain has been averaging 7/10 on scale of 10. Nerve pain radiating from hand to shoulder, Other Vaccines: VaccineTypeBrand: capvaxine; Manufacturer: merck; LotNumber: xn575; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 03/03/2025
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| 2832910 | 23 | F | FL | 03/24/2025 |
TYP TYP |
SANOFI PASTEUR SANOFI PASTEUR |
x2a231m x2a231m |
Asthenia, Dizziness, Fatigue, Hypotension, Lethargy; Nausea, Presyncope, Syncope...
Asthenia, Dizziness, Fatigue, Hypotension, Lethargy; Nausea, Presyncope, Syncope, Tremor, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: 911 was called to further evaluate hypotension and near syncope event. ekg done in clinic, wnl. patient and family refused to be taken to ED. patient monitored in clinic for 30 min returned to baseline, departed home with family. could not clear note without putting a response, there was no redness, swelling, pain, brusing, noted at injection site
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| 2832911 | 13 | CO | 03/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Dizziness, Fall, Head injury, Syncope, Unresponsive to stimuli
Dizziness, Fall, Head injury, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient became lightheaded while walki...
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient became lightheaded while walking out of pharmacy with his mom. Fell and bumped his head. Came to and mom declined calling 911 and drove him to the clinic nearby right away. Attempted to call patient but haven't heard back.
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| 2832912 | 77 | F | MD | 03/24/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
y019157 y019157 |
Erythema, Injection site erythema, Injection site pain, Injection site swelling,...
Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain; Pruritus, Pyrexia, Skin warm, Swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Systemic: Swelling, pain,redness, warm to touch.-Mild, Additional Details: Patient present to the pharmacy on 3/19 at approx.430pm stating she was just seen in the ER for adverse reaction to Capvaxive. Her arm wa visible red, and swollen. The area affected was approxiate 2 to 3 inches below the site of injection. She was given antibx at the ER. I also recommended benadryl which she purchased. The area had the appearance of a covid arm.
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| 2832913 | 54 | F | CA | 03/24/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 Y019158 |
Chills, Dizziness, Fatigue, Headache, Injection site bruising; Injection site er...
Chills, Dizziness, Fatigue, Headache, Injection site bruising; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lethargy; Nausea, Pyrexia, Vomiting
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Other Vaccines: VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: 5Y9CA; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
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| 2832914 | 65 | F | NJ | 03/24/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013009 Y013009 |
Erythema, Fatigue, Injection site erythema, Injection site pain, Injection site ...
Erythema, Fatigue, Injection site erythema, Injection site pain, Injection site swelling; Lethargy, Pain, Pain in extremity, Peripheral swelling
More
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: pain,swelling,redness in arm-Severe, Additional Details: patient reported pain,swelling,redness in left arm. visited urgent care. recd cephalexin. then since pain didn't subside, went to hospital
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| 2832915 | 56 | F | WA | 03/24/2025 |
PNC20 |
PFIZER\WYETH |
lx2497 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: see dr for treatment.
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| 2832916 | 30 | F | CA | 03/24/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7kd5b 7kd5b |
Amnesia, Injection site pain, Loss of consciousness, Seizure, Syncope; Unrespons...
Amnesia, Injection site pain, Loss of consciousness, Seizure, Syncope; Unresponsive to stimuli
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Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild,...
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Patient fainted after receiving 2nd dose of vaccine, she passed out a few seconds and had convulsion. Then she opened her eyes and asked what happened. Paramedic came and took over., Other Vaccines: VaccineTypeBrand: vaqta; Manufacturer: merck; LotNumber: y017625; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2832917 | 67 | F | OK | 03/24/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Dysgeusia, Immediate post-injection reaction
Dysgeusia, Immediate post-injection reaction
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Patient felt weird immediately after and could taste the vaccine and feel it move through arm, hand ...
Patient felt weird immediately after and could taste the vaccine and feel it move through arm, hand and upper back...she can still taste the vaccine and feels strange.
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| 2832918 | 4 | F | NC | 03/24/2025 |
MMR |
MERCK & CO. INC. |
X007688 |
Expired product administered
Expired product administered
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Patient was administered three private vaccines on 3/19/2025 including MMR vaccine per recommended s...
Patient was administered three private vaccines on 3/19/2025 including MMR vaccine per recommended schedule by this RN. Prior to preparation of vaccines and after retrieval from cold storage, they were all double checked by RN. Upon documentation of administration, it was discovered lot number of MMR not in database. (But this is an occasional occurrence from purchasing). The lot number was inactive as it expired five days prior on 3/14/2025 but it was still in the freezer in the regular basket. I immediately sequestered the remaining expired vaccine in a brown bag and labeled DO NOT USE, EXPIRED. Dr. informed immediately upon discovery. When going to select the vaccines from the freezer, there was no Proquad in stock. This was not mentioned earlier by any other staff. This caused RN to select individual MMR & Varicella plus the Kinrix. So not only are we out of Proquad but also MMR now. State nurse was informed 3/20/25. The dose will need to be repeated, not less than 28 days. Mother was called and informed on 3/21/2025 and is agreeable to repeat in future.
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| 2832919 | 2 | M | AK | 03/24/2025 |
DTAP HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9KB9G A3X2K |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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swelling, pain, redness and warmth left thigh starting within 12 hours of shot, progressing until d...
swelling, pain, redness and warmth left thigh starting within 12 hours of shot, progressing until day3 , then resolving
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| 2832920 | 0.5 | F | CA | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Extra dose administered
Extra dose administered
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Pt came in for shots, advised parents that pt did not need vaccines, but that the state vaccine syst...
Pt came in for shots, advised parents that pt did not need vaccines, but that the state vaccine system showed that they were due for covid vaccine. Parents were unsure of what vaccines pt received and consented to receiving dose of Covid vaccine. Upon further review from Supervisor on 3/24/2025, pt had already received 1st dose of covid vaccine on 1/13/2025, but there was an error in system that did not populate vaccine into the state vaccine system.
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| 2832921 | 03/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Encephalomyelitis
Encephalomyelitis
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Myleoencephalitis; This serious case was reported by a consumer via interactive digital media and de...
Myleoencephalitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of encephalomyelitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced encephalomyelitis (Verbatim: Myleoencephalitis) (serious criteria disability and GSK medically significant). The outcome of the encephalomyelitis was not reported. It was unknown if the reporter considered the encephalomyelitis to be related to Shingles vaccine. The company considered the encephalomyelitis to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter reported that he/she knew two people (2 patients) now who have got the Shingles shot and one to two weeks later got myleoencephalitis and now they were disabled.; Sender's Comments: Encephalomyelitis is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
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| 2832922 | M | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain
Injection site pain
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Sever Pain in Left Arm at injection site 3 months later; This non-serious case was reported by a con...
Sever Pain in Left Arm at injection site 3 months later; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-DEC-2024, the patient received the 1st dose of Shingrix (left arm). On 29-DEC-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sever Pain in Left Arm at injection site 3 months later). The outcome of the injection site pain was not resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 14-MAR-2025 Consumer reported that he took the first dose of Shingrix vaccine and experienced severe pain in left arm at injection site 3 months later. Reporter also mentioned that they did not want to get second shot because of ongoing pain from first shot.
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| 2832923 | 53 | F | NC | 03/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Product preparation issue, Tremor
Product preparation issue, Tremor
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right arm shaking; Inappropriate reconstitution technique/gave the patient only sterile water instea...
right arm shaking; Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine; Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine; This non-serious case was reported by a pharmacist and described the occurrence of tremor limb in a 53-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 14-MAR-2025, the patient received Priorix (right deltoid). On 14-MAR-2025, less than a day after receiving Priorix, the patient experienced tremor limb (Verbatim: right arm shaking), inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine) and inappropriate dose of vaccine administered (Verbatim: Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine). The outcome of the tremor limb was not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. The reporter considered the tremor limb to be related to Priorix and Priorix Pre-Filled Syringe Device. The company considered the tremor limb to be related to Priorix and Priorix Pre-Filled Syringe Device. 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: 14-MAR-2025 The reporter stated she gave the patient only sterile water instead of the vaccine Priorix. The Priorix was not reconstituted, only the sterile water was injected in R deltoid which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The patient's right arm was shaking a little after that. The pharmacist wants to know what else she can do next.
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| 2832924 | F | PA | 03/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Incorrect route of product administration
Incorrect route of product administration
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Priorix was given intramuscularly instead of subcutaneously; This non-serious case was reported by a...
Priorix was given intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 58-year-old female patient who received MMR (Priorix) for prophylaxis. On 12-MAR-2025, the patient received Priorix (intramuscular). On 12-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was given intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route 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: 14-MAR-2025 The Pharmacist reported that a Priorix vaccine was given intramuscularly instead of subcutaneously which led to, subcutaneous injection formulation administered by other route. The batch number and expiry date was not provided. No other details were available.
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| 2832925 | M | TX | 03/24/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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got his 2nd dose which is off schedule; This non-serious case was reported by a consumer via call ce...
got his 2nd dose which is off schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix adult) for prophylaxis. Previously administered products included Twinrix (received 1st dose in November 2024). On 13-MAR-2025, the patient received the 2nd dose of Twinrix adult. On 13-MAR-2025, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: got his 2nd dose which is off schedule). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-MAR-2025 The reporter called and stated he got his Twinrix vaccine in November 2024 and received 2nd dose on 13th March 2025 which was off schedule. Doses were supposed to be given 0, 1 and 6 months. The patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
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| 2832926 | F | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Paraesthesia
Paraesthesia
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Needle prick feeling all over; This non-serious case was reported by a consumer and described the oc...
Needle prick feeling all over; This non-serious case was reported by a consumer and described the occurrence of prick pain feeling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypothyroidism (has hypothyrodism). Concomitant products included levothyroxine sodium (Synthroid). On 04-FEB-2025, the patient received Shingrix. On 11-MAR-2025, 35 days after receiving Shingrix, the patient experienced prick pain feeling (Verbatim: Needle prick feeling all over). The outcome of the prick pain feeling was not resolved. It was unknown if the reporter considered the prick pain feeling to be related to Shingrix. It was unknown if the company considered the prick pain feeling to be related to Shingrix. Additional Information: GSK Receipt Date: 16-MAR-2025 A female patient received the Shingrix vaccine and had a needle prick feeling all over. The patient received Synthroid vaccine for hyperthyroidism.
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| 2832927 | IL | 03/24/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Neonatal respiratory distress syndrome
Neonatal respiratory distress syndrome
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respiratory issues in newborn; This non-serious case was reported by a pharmacist via call center re...
respiratory issues in newborn; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of respiratory disorder neonatal in a neonate patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy (transplacental). On an unknown date, an unknown time after receiving Arexvy, the patient experienced respiratory disorder neonatal (Verbatim: respiratory issues in newborn). The outcome of the respiratory disorder neonatal was not reported. It was unknown if the reporter considered the respiratory disorder neonatal to be related to Arexvy. It was unknown if the company considered the respiratory disorder neonatal to be related to Arexvy. See case US2025030425 for details regarding the mother case. Additional Information: GSK Receipt Date: 12-MAR-2025 The pharmacist mentioned that a patient received Arexvy while she was pregnant and now, the newborn had respiratory issues. The pharmacist asked if GlaxoSmithKline had any study showing a correlation of giving Arexvy to pregnant women and respiratory issues in newborns.; Sender's Comments: US-GSK-US2025030425:Mother case
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| 2832928 | 03/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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sore arm; This non-serious case was reported by a consumer via interactive digital media and describ...
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for himself/herself. Patient had taken the vaccine a few years ago, and other than a sore arm, he/she had no problems.
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| 2832929 | 03/24/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Mobility decreased, Nasopharyngitis, Pain, Pain in extremity
Mobility decreased, Nasopharyngitis, Pain, Pain in extremity
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catching a bad cold; Aching body all over; All extremeties hurt; difficulty moving; This non-serious...
catching a bad cold; Aching body all over; All extremeties hurt; difficulty moving; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: catching a bad cold), general body pain (Verbatim: Aching body all over), pain in extremity (Verbatim: All extremeties hurt) and mobility decreased (Verbatim: difficulty moving). The outcome of the cold and mobility decreased were not reported and the outcome of the general body pain and pain in extremity were resolving. It was unknown if the reporter considered the cold, general body pain, pain in extremity and mobility decreased to be related to Arexvy. It was unknown if the company considered the cold, general body pain, pain in extremity and mobility decreased to be related to Arexvy. Additional Information: GSK Receipt Date : 14-MAR-2025 This case was reported by a patient via interactive digital media. Physical symptoms were catching a bad cold. Aching body all over. All extremities hurt , difficulty moving. However once he/she started moving the soreness dissipated.
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| 2832930 | 03/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster; Herpes zoster
Herpes zoster; Herpes zoster
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shingrix 2nd does while having active shingles; shingrix 2nd does while having active shingles; This...
shingrix 2nd does while having active shingles; shingrix 2nd does while having active shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingrix 2nd does while having active shingles) and drug use for unapproved indication (Verbatim: shingrix 2nd does while having active shingles). The outcome of the shingles was not reported and the outcome of the drug use for unapproved indication was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 17-MAR-2025 The reporter reported that consequences of receiving the Shingrix 2nd doses while having active shingles, which led to drug use for unapproved indication.
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| 2832931 | 03/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; one has had shingles 5 times, the other two once and two times; This ...
Suspected vaccination failure; one has had shingles 5 times, the other two once and two times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the specified number of patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: one has had shingles 5 times, the other two once and two times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a reporter via interactive digital media. Reporter stated that they had 3 friends (patients) who got the Shingles injection, and one had shingles 5 times, the other two had once and two times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2832932 | 03/24/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; got shingles; This serious case was reported by a consumer via intera...
Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient got both Shingles shots and got shingles after the last one. The patient had shingles now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st and 2nd dose).
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| 2832933 | 03/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Asthenia, Herpes zoster, Pain, Scar, Vaccination failure
Asthenia, Herpes zoster, Pain, Scar, Vaccination failure
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Suspected vaccination failure; right now I am on my 3rd bout with Shingles; leave scars; This seriou...
Suspected vaccination failure; right now I am on my 3rd bout with Shingles; leave scars; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: right now I am on my 3rd bout with Shingles) and scar (Verbatim: leave scars). The outcome of the vaccination failure and scar were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and scar to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that, right now he/she was on his/her 3rd bout with shingles. The patient got the Shingles shots, and it probably help, but he/she really could not tell. The patient stated shingles were very painful, zap you of your energy and leave scars. The patient felt absolutely useless when he/she had them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2832934 | 03/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspeceted vaccination failure; I got the vaccine and I got shingles anyway twice; This serious case...
Suspeceted vaccination failure; I got the vaccine and I got shingles anyway twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine and I got shingles anyway twice). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and he/she got shingles anyway twice. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2832935 | 03/24/2025 |
COVID19 VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Feeling abnormal; Feeling abnormal
Feeling abnormal; Feeling abnormal
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Three days of wretched misery ensued.; This non-serious case was reported by a consumer via interact...
Three days of wretched misery ensued.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. The patient's past medical history included shingles (I had shingles in summer 2018). On an unknown date, the patient received Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Three days of wretched misery ensued.). The outcome of the feeling abnormal was resolved (duration 3 days). It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had shingles in summer 2018, eventually got the vaccine in 2023. Same day as covid booster. Three days of wretched misery ensued. It was unknown if the reporter considered the feeling abnormal to be related to Covid-19 vaccine.
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| 2832936 | 03/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via in...
Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by the reporter via interactive digital media. The reporter stated that he/she had two doses of Shingrix shingles vaccine and low and behold got the shingles. The reporter further stated that the same thing happened to a coworker (patient). This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with case US2025AMR033210 from the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). US-GSK-US2025AMR033210:different patient/ same reporter US-GSK-US2025AMR033210:different patient/same reporter
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| 2832937 | 16 | F | CA | 03/24/2025 |
MEN MENB |
UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS |
UNK DD72H |
Dehydration, Dyskinesia, Nausea, Peripheral coldness; Dehydration, Dyskinesia, N...
Dehydration, Dyskinesia, Nausea, Peripheral coldness; Dehydration, Dyskinesia, Nausea, Peripheral coldness
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Nausea; she presented cold toes; body jerking; presented dehydration; This non-serious case was repo...
Nausea; she presented cold toes; body jerking; presented dehydration; This non-serious case was reported by a physician via call center representative and described the occurrence of nausea in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. Co-suspect products included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for prophylaxis. On 05-MAR-2025, the patient received Bexsero and MENQUADFI. In MAR-2025, less than 2 weeks after receiving Bexsero, the patient experienced nausea (Verbatim: Nausea), cold feet (Verbatim: she presented cold toes), jerkiness (Verbatim: body jerking) and dehydration (Verbatim: presented dehydration). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the nausea, cold feet, jerkiness and dehydration were unknown. It was unknown if the reporter considered the nausea, cold feet, jerkiness and dehydration to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the nausea, cold feet, jerkiness and dehydration to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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-MAR-2025 The Vaccine Administration Facility is the same as Primary Reporter A sales representative communicated on behalf of the health care provider in charge of the case to report an adverse event with Bexsero vaccine. The doctor did not fully believed what patient was presenting, but the patient went to the Emergency Room and the situation was really dramatic The patient presented cold toes, body jerking, nausea and although she was with body jerking, she was able to talk and being normally. The father of the patient pulled over on the side of the road because the patient started presenting these symptoms and took her to the Emergency Room where, she received 2 doses of Benadryl and presented dehydration. The father of the patient was blaming the doctor for giving Bexsero and Menquadfi at the same time. The sales representative only wanted to the report the case and agent asked for a phone number to contact the health care provider and also asking if she was ok to being contacted, to which sales representative replied that would be great, providing her office phone number. Then, the agent called the health care provider and confirmed the information provided by the sales representative and gather the essential information to create the adverse event report. The health care provider did not share any more symptoms. It was unknown if the reporter considered the adverse events to be related to Menquadfi.
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| 2832938 | 15 | M | WA | 03/24/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
CT3Z7 |
Incorrect dose administered, Product administered to patient of inappropriate ag...
Incorrect dose administered, Product administered to patient of inappropriate age
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Maladministration of Adult Dose on an Pediatric Patient; Overdose; This non-serious case was reporte...
Maladministration of Adult Dose on an Pediatric Patient; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 15-year-old male patient who received HBV (Engerix B adult) (batch number CT3Z7, expiry date 13-FEB-2027) for prophylaxis. On 12-MAR-2025, the patient received the 3rd dose of Engerix B adult. On 12-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Maladministration of Adult Dose on an Pediatric Patient) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were 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: 14-MAR-2025 The patient came and was due to the Engerix-B third dose, and adult dose was given to the pediatric patient, which led adult product administered to child and overdose. The reporter consented to follow up.
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| 2832939 | F | TX | 03/24/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Patient did not not receive the second dose yet; This non-serious case was reported by a pharmacist ...
Patient did not not receive the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received on 14th September 2024). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient did not not receive the second dose yet). 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: 14-MAR-2025 The pharmacist stated that a patient received their first dose of Twinrix on 14th September 2024 and they have not received their second dose yet. This was the first dose of a Hepatitis A or Hepatitis B vaccine so far for this patient. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
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| 2832940 | M | 03/24/2025 |
COVID19 |
MODERNA |
|
Condition aggravated, Inflammation, Lumbar radiculopathy
Condition aggravated, Inflammation, Lumbar radiculopathy
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unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so...
unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot; unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it; Moderna caused inflammation that irritated his issues with his nerves in his spines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LUMBAR RADICULOPATHY (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot), CONDITION AGGRAVATED (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it) and INFLAMMATION (Moderna caused inflammation that irritated his issues with his nerves in his spines) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Spinal operation (Patient had 3 failed spine surgeries.). Previously administered products included for Product used for unknown indication: Pfizer; for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Moderna and Pfizer. Concurrent medical conditions included Lumbar radiculopathy. On 04-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUMBAR RADICULOPATHY (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot), CONDITION AGGRAVATED (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it) and INFLAMMATION (Moderna caused inflammation that irritated his issues with his nerves in his spines). At the time of the report, LUMBAR RADICULOPATHY (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot) and CONDITION AGGRAVATED (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it) had not resolved and INFLAMMATION (Moderna caused inflammation that irritated his issues with his nerves in his spines) outcome was unknown. No concomitant medication was reported. Patient's wife mentioned that her husband had not a bad reaction to the Moderna. he had Moderna and Pfizer before, but he has an underlying issue with Lumbar Radiculopathy, he had 3 failed spine surgeries and the last time he had a Moderna vaccine on 04-Oct-2024. Patient always has pain running down from his back all the way to his foot, it was part of his problem, why patient had the surgeries and unfortunately, he was worse than before. It was really sad, it did not work to take pills, so he did not do it. When patient had the last shot, he had a bit of neuropathy, so he started to have like these tangling sensations on the bottom of his foot, which was kind of unusual for him. So, he had Moderna before, all the shots ever had, he was very careful, since he has underlying medical conditions, still wearing masks and never had COVID. But his wife asked doctor, he said like it sounds like maybe the Moderna caused inflammation that irritated his issues with his nerves in his spine and so he agreed with her for switch to Novavax next time. Patient has some medical procedures coming up where he has to be unmasked on 31-Mar and then he has another one at the end of April. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-783234, US-MODERNATX, INC.-MOD-2025-783235 (E2B Linked Report).; Reporter's Comments: The patient's underlying lumbar radiculopathy remains a major confounder as it was stated that the patient had three failed spine surgeries in his medical history. However, the patent's physician suspected that vaccine caused "inflammation" which further caused aggravation of lumbar radiculopathy. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783234:Patient 2 of 3 (Reporter's son) US-MODERNATX, INC.-MOD-2025-783235:Invalid case for multiple patient's
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| 2832941 | M | 03/24/2025 |
COVID19 |
MODERNA |
|
Vaccination site pain
Vaccination site pain
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minor side effects/minor soreness at the injection site; This spontaneous case was reported by a pat...
minor side effects/minor soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) outcome was unknown. Not Provided The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. It was unknown if the patient experienced any additional symptoms or events. No concomitant medication was reported. No treatment medication was reported. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-783390 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783390:Same patient but different product
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| 2832942 | M | 03/24/2025 |
COVID19 |
MODERNA |
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Vaccination site pain
Vaccination site pain
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minor side effects/minor soreness at the injection site; This spontaneous case was reported by a pat...
minor side effects/minor soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minor side effects/minor soreness at the injection site) had resolved. The concomitant medication was not reported by reporter. Patient had all of the COVID vaccinations and all of the COVID vaccinations he had were Moderna vaccinations and he was satisfied with the outcome and the side effects. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-783399 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783399:Same patient but different product
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| 2832943 | 73 | F | CA | 03/24/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
023m20A 023m20A |
Asthenia, Fatigue, Impaired work ability, Platelet count, Thrombocytosis; Visual...
Asthenia, Fatigue, Impaired work ability, Platelet count, Thrombocytosis; Visual impairment
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I developed thrombocytosis [high platelets] that has caused permanent injuries; chronic fatigue and ...
I developed thrombocytosis [high platelets] that has caused permanent injuries; chronic fatigue and weakness; persistent impaired vision; these conditions have severely impacted my daily life, overall well-being and my ability to work; chronic fatigue; This spontaneous case was reported by a patient and describes the occurrence of THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 016B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue). At the time of the report, THROMBOCYTOSIS (I developed thrombocytosis [high platelets] that has caused permanent injuries), ASTHENIA (chronic fatigue and weakness), VISUAL IMPAIRMENT (persistent impaired vision), IMPAIRED WORK ABILITY (these conditions have severely impacted my daily life, overall well-being and my ability to work) and FATIGUE (chronic fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: High (caused permanent injuries). No concomitant medications were reported. The patient had to take hydroxy urea for the rest of my life, that had side effects as well.
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