| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2838291 | 52 | F | MO | 04/28/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Erythema, Peripheral swelling, Skin tightness
Erythema, Peripheral swelling, Skin tightness
|
Patient has redness in right arm, some swelling and states arm feels tight. She was started on Levaq...
Patient has redness in right arm, some swelling and states arm feels tight. She was started on Levaquin 500 mg daily x 7 days, Prednisone 10 mg daily x 5 days on 4/26/25. She was given injection of Decadron 10 mg IM in left gluteus maximus on 4/28/25.
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| 2838292 | 12 | F | MA | 04/28/2025 |
COVID19 |
MODERNA |
3042999 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Moderna Covid vaccine 6 months to 11 years given. It should have been Moderna Spikevax 12 years and ...
Moderna Covid vaccine 6 months to 11 years given. It should have been Moderna Spikevax 12 years and older. The patient is 12
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| 2838293 | 46 | M | MN | 04/28/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
048B21A 048B21A 048B21A 012H21B 012H21B 012H21B |
Acoustic stimulation tests, Asthenia, Blood test, Computerised tomogram, Depress...
Acoustic stimulation tests, Asthenia, Blood test, Computerised tomogram, Depression; Gait disturbance, Incontinence, Libido decreased, Lumbar puncture, Magnetic resonance imaging; Normal pressure hydrocephalus, Pain, Sensory disturbance, Tinnitus; Acoustic stimulation tests, Asthenia, Blood test, Computerised tomogram, Depression; Gait disturbance, Incontinence, Libido decreased, Lumbar puncture, Magnetic resonance imaging; Normal pressure hydrocephalus, Pain, Sensory disturbance, Tinnitus
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Normal Pressure Hydrocephalus - gait disturbance, incontinence, pulsating and "whooshing" ...
Normal Pressure Hydrocephalus - gait disturbance, incontinence, pulsating and "whooshing" sensation in head; also persistent tinnitus; occasional stinging back pain; depression; lack of energy and motivation; diminished sex drive
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| 2838294 | 17 | F | PA | 04/28/2025 |
MENB |
PFIZER\WYETH |
GH4067 |
Immediate post-injection reaction, Pain, X-ray
Immediate post-injection reaction, Pain, X-ray
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Patient had sharp shooting pain immediately after vaccine administration that has continued four day...
Patient had sharp shooting pain immediately after vaccine administration that has continued four days after administration
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| 2838296 | 71 | F | MD | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99HE4 |
Burning sensation, Product preparation issue
Burning sensation, Product preparation issue
|
During a pillbox appointment, I administered 2nd dose of Shingles vaccine. While drawing up the dilu...
During a pillbox appointment, I administered 2nd dose of Shingles vaccine. While drawing up the diluent, I thought I had injected into the lyophilized vial to reconstitute but I believe I injected back into the same diluent vial. After that, I left the room to try and find a smaller needle for administration into the patient. I injected the diluent into the patient, who commented on a "burning sensation" which I attributed to a normal response to Shingles Vaccine. After patient left, I observed the un-reconstituted vial on the counter.
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| 2838297 | 67 | F | KS | 04/28/2025 |
PNC20 |
PFIZER\WYETH |
LX2497 |
Erythema, Mobility decreased, Pain in extremity, Skin warm
Erythema, Mobility decreased, Pain in extremity, Skin warm
|
PATIENT STATED THAT ARM HAS BEEN PAINFUL SINCE GETTING INJECTION. PATIENT UPPER ARM IS RED IN SPOTS ...
PATIENT STATED THAT ARM HAS BEEN PAINFUL SINCE GETTING INJECTION. PATIENT UPPER ARM IS RED IN SPOTS AND WARM TO THE TOUCH. PATIENT STATES THAT IT IS HARD TO LIFT HER ARM. PATIENT IS IN CLINIC NOW SEEING PROVIDER
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| 2838298 | 23 | F | 04/28/2025 |
MNQ |
SANOFI PASTEUR |
|
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient due for MMR, MenQuadfi administer invertedly. Suspect error originated at ordering phase. No...
Patient due for MMR, MenQuadfi administer invertedly. Suspect error originated at ordering phase. No adverse symptoms.
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| 2838299 | 31 | F | KS | 04/28/2025 |
MMR |
MERCK & CO. INC. |
Y015552 |
Contraindication to vaccination, Exposure during pregnancy
Contraindication to vaccination, Exposure during pregnancy
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MMR vaccination inadvertently administered to patient. EDD or birth weight unavailable.
MMR vaccination inadvertently administered to patient. EDD or birth weight unavailable.
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| 2838300 | 32 | F | DC | 04/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
B0005 048A21A |
Abortion spontaneous, Exposure during pregnancy; Abortion spontaneous, Exposure ...
Abortion spontaneous, Exposure during pregnancy; Abortion spontaneous, Exposure during pregnancy
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Client experienced 2 miscarraiges weeks after being vaccinated. Was not aware she was pregnant at ...
Client experienced 2 miscarraiges weeks after being vaccinated. Was not aware she was pregnant at the time of being vaccinated. The first loss was at 15wks 0d shew she was vaccinated on 3/15/2021 loss the developing fetus on June 3 2021. The second loss was she was vaccinated on 1/14/2025 the loss occurred on 4/19/2025 after being vaccinated on 1/14/2025 at 15wks 3d. This is the only common denominator. She has had 2 normal healthy at term pregnancies in 2015 and 2018.
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โ | โ | ||||
| 2838301 | 50 | F | IN | 04/28/2025 |
PNC15 |
MERCK & CO. INC. |
|
Erythema, Mass, Pain, Pruritus
Erythema, Mass, Pain, Pruritus
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Extreme soreness, baseball size lump and redness, itching
Extreme soreness, baseball size lump and redness, itching
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| 2838302 | 32 | F | ME | 04/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945657 |
Rash
Rash
|
TM reports she got Heplisav B shot and a rash started on her torso that day. It slowly progressed a...
TM reports she got Heplisav B shot and a rash started on her torso that day. It slowly progressed and spear to under her arms. She denies shortness of breath. Rash to upper truck and extremities only. Upon speaking with her she was 3 days post shot with a rash at that time, was improving.
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| 2838304 | 1.25 | F | TX | 04/28/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
GG39 D |
Injection site swelling, Injection site warmth
Injection site swelling, Injection site warmth
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Swelling and increase warmth of the right thigh
Swelling and increase warmth of the right thigh
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| 2838305 | 18 | F | FL | 04/28/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
49M9N U8256BA |
Eye discharge, Eye pain, Ocular hyperaemia, Swelling of eyelid, Vision blurred; ...
Eye discharge, Eye pain, Ocular hyperaemia, Swelling of eyelid, Vision blurred; Eye discharge, Eye pain, Ocular hyperaemia, Swelling of eyelid, Vision blurred
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04/25/2025 patient sent a portal message that on 04/24/2025 she started with severe pain in both eye...
04/25/2025 patient sent a portal message that on 04/24/2025 she started with severe pain in both eyes, redness, and production of mucous. Had a lot of pain and blurry vision. both eyes swollen shut. Went to see OD
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| 2838306 | 52 | M | AZ | 04/28/2025 |
COVID19 |
MODERNA |
017F21A |
Blister, Pain, Scab, Secretion discharge
Blister, Pain, Scab, Secretion discharge
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he says he developed bubbling blisters on his feet between his toes and the edges of his ankles and ...
he says he developed bubbling blisters on his feet between his toes and the edges of his ankles and soles of his feet. They will pop and ooze and then dry up. He tried everything. Its kind of like a poison. These have migrated to his bottom side (buttocks and outer thighs) They come out in long painful swirls. This has continued for four years. His doctors have looked at them but do not know what they are or how to treat them. He is going to ask his doctors to send him to a specialist for treatment.
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โ | |||||
| 2838307 | 78 | F | TX | 04/28/2025 |
COVID19 |
MODERNA |
8080803 |
Blood glucose normal, Dizziness, Hyperhidrosis
Blood glucose normal, Dizziness, Hyperhidrosis
|
Pt previously had pfizer vaccinations, last dose 5/2022 - okay with moderna. given 1105 pt waited in...
Pt previously had pfizer vaccinations, last dose 5/2022 - okay with moderna. given 1105 pt waited in clinic for 15min with no issues then left. at 1130 came back reporting excessive sweating and light dizziness. states she did not eat yet today but had coffee and water. pt brought in to clinic, vitals normal, blood glucose normal. pt drank water and after 3-4min pt felt normal again. husband was called to clinic to drive her. patient stated she felt full symptom resolution and was okay to leave. advised to fu with er if symptoms reoccur and to fu with her pcp.
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| 2838308 | 48 | M | CA | 04/28/2025 |
FLU3 HEP MMR TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
NG5FM T5D73 Y004114 3RE73 Y017062 |
Hyperhidrosis, Hyporesponsive to stimuli, Pallor; Hyperhidrosis, Hyporesponsive ...
Hyperhidrosis, Hyporesponsive to stimuli, Pallor; Hyperhidrosis, Hyporesponsive to stimuli, Pallor; Hyperhidrosis, Hyporesponsive to stimuli, Pallor; Hyperhidrosis, Hyporesponsive to stimuli, Pallor; Hyperhidrosis, Hyporesponsive to stimuli, Pallor
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Client experienced a 10 second episode of decrease responsiveness, pallor and diaphoresis 3 minutes ...
Client experienced a 10 second episode of decrease responsiveness, pallor and diaphoresis 3 minutes after receiving vaccine. Vital signs remained stable.
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| 2838309 | 4 | M | DE | 04/28/2025 |
DTAPIPV DTAPIPVHIB |
SANOFI PASTEUR SANOFI PASTEUR |
u8209cb uk168ab |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
i was told to call mother to apologize for the incorrect vaccine. just got extra tetanus vaccine but...
i was told to call mother to apologize for the incorrect vaccine. just got extra tetanus vaccine but no harm as per the Dr.
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| 2838310 | 56 | F | CO | 04/28/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LK6650 5R3PB |
Erythema, Injection site erythema, Skin warm; Erythema, Injection site erythema,...
Erythema, Injection site erythema, Skin warm; Erythema, Injection site erythema, Skin warm
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erythema around injection site started day of vaccine, now 6 days post vaccination redness has sprea...
erythema around injection site started day of vaccine, now 6 days post vaccination redness has spread down the entire arm & is warm to touch. denies fever, chills. no drainage, no pain, no itching.
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| 2838311 | 29 | F | AL | 04/28/2025 |
TDAP |
SANOFI PASTEUR |
U8115AA |
Dizziness, Nausea, Vomiting
Dizziness, Nausea, Vomiting
|
30 minutes past injection time, the donor stated that she felt nauseous and lightheaded. Donor asked...
30 minutes past injection time, the donor stated that she felt nauseous and lightheaded. Donor asked for an emesis bag, vomited in the bag. Donor then stated that she felt better and left under own volition. Medical staff was unable to perform any vitals or post immunization reaction treatment due to the donor leaving.
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| 2838312 | 1 | F | CT | 04/28/2025 |
VARCEL |
MERCK & CO. INC. |
Y015101 |
Circumstance or information capable of leading to medication error, Scratch, Und...
Circumstance or information capable of leading to medication error, Scratch, Underdose
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Patient moved unexpectedly. Mom thought she had her, but patient was a lot stronger, so she moved in...
Patient moved unexpectedly. Mom thought she had her, but patient was a lot stronger, so she moved in the process of getting vaccine. did not receive full dose. Did sustain superficial scratch from the needle. Band-Aid applied to area. Provider notified to assess.
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| 2838313 | 53 | F | CA | 04/28/2025 |
HPV9 |
MERCK & CO. INC. |
Y018398 |
Pain in extremity, Product administered to patient of inappropriate age
Pain in extremity, Product administered to patient of inappropriate age
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Pt received HPV vaccine on 03/20/2025. Provider was informed about pt receiving vaccine at 3/20/25 v...
Pt received HPV vaccine on 03/20/2025. Provider was informed about pt receiving vaccine at 3/20/25 visit by nursing manager on 03/20/2025. Pt was contacted after visit that date and care giver was informed about the event with no further questions. On 3/28/25, received message pt had a question about the vaccine. Spoke with pt about the HPV vaccine event. Pt was informed provider was informed about this immunization being given by RN Manager and from safety aspect provider has no concerns regarding the patient receiving the vaccine; provider stated that the vaccine just isn't as effective due to patient's age. Pt verbalized understanding. Pt states her arm feels sore from vaccine but denies any other concerns. Pt was informed she may feel sore as this is an intramuscular injection and can have some soreness for a few days. Pt was informed RN spoke with caregiver as well about it. Pt expressed understanding and had no other further questions at the end of the call.
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| 2838314 | 52 | F | NC | 04/28/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Feeling cold, Headache, Pyrexia, Rash macular
Feeling cold, Headache, Pyrexia, Rash macular
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Patient experienced fever, chills, and headache for 1 week since vaccination. Also developed red blo...
Patient experienced fever, chills, and headache for 1 week since vaccination. Also developed red blotchy patches on the arm of the injection.
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| 2838315 | 13 | F | TN | 04/28/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
y013469 u8259aa ky27j |
Blindness, Syncope; Blindness, Syncope; Blindness, Syncope
Blindness, Syncope; Blindness, Syncope; Blindness, Syncope
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4/28/25 Patient received TDAP, HPV, and Menquadfi vaccines. Patient and mother was at checkout windo...
4/28/25 Patient received TDAP, HPV, and Menquadfi vaccines. Patient and mother was at checkout window when event occurred at approximately 1:32pm. Mom stated that she needed help because patient was fainting. office Supervisor called code blue at 1:32 pm. RN got a chair for patient and helped lower her to sit in chair. Mom stated that she said she could not see and started to faint. Someone retrieved the ammonia smelling stuff. Patient opened her eyes while sitting in chair. Someone completed blood pressure and I placed pulse ox on patient. vitals at 1:35 pm were blood pressure of 70/52, pulse 75, spo2 97%. Someone retrieved water for patient. They also give patient a wet and cool napkin to place on her head. Vitals at 1:40pm were blood pressure of 94/58, pulse 82, spo2 98%. Patient stated that she was feeling better. mom was given information about fainting and vaccines. Mom states that patient faints often. Mom and patient was escorted out to vehicle by someone.
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| 2838316 | 75 | F | OH | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
Md3414 |
Injection site pain, Paraesthesia, Peripheral swelling
Injection site pain, Paraesthesia, Peripheral swelling
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The patient experience some tingling and said her hand swelled up some later that day. Her arm start...
The patient experience some tingling and said her hand swelled up some later that day. Her arm started to bruise as well around the site. The swelling in hand subsided and has gone away entirely but there is some bruising around the site. Her shoulder area feels fine and not painful . But still tender in the bruised area which has yellowed some since last week.
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| 2838317 | 54 | M | NC | 04/28/2025 |
PNC21 PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z002626 Z002626 Z002626 Z002626 |
Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia...
Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia, Pyrexia; Injection site cellulitis, Injection site rash; Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia, Pyrexia; Injection site cellulitis, Injection site rash
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Severe muscle aches and low-grade fever for 36 hours after vaccine. Low grade fever for following 2...
Severe muscle aches and low-grade fever for 36 hours after vaccine. Low grade fever for following 2 nights. Redness in arm below injection site that was red, itchy, and warm. Improved over the next 3 days.
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| 2838318 | 84 | F | DE | 04/28/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Rash
Rash
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full body rash that required doctor visits and treatment
full body rash that required doctor visits and treatment
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| 2838319 | 64 | M | AZ | 04/28/2025 |
COVID19 |
JANSSEN |
|
Atrial fibrillation, Dizziness
Atrial fibrillation, Dizziness
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I had no symptoms after the vaccine. And then all of a sudden after to vaccine i felt light headed d...
I had no symptoms after the vaccine. And then all of a sudden after to vaccine i felt light headed drying dishes ]. Someone took my blood pressure and it was not what it should be i went a saw my heart doctor and i found out a Afib
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| 2838320 | 3 | F | CA | 04/28/2025 |
PPV PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y016291 Y016291 Y016291 |
Chills, Cough, Decreased activity, Decreased appetite, Erythema; Gait disturbanc...
Chills, Cough, Decreased activity, Decreased appetite, Erythema; Gait disturbance, Induration, Lethargy, Otitis media, Pyrexia; Rhinorrhoea, Tenderness, Vomiting, Weight bearing difficulty
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Day 1 started with localized redness, increased in size on day 2 with difficulty walking which becam...
Day 1 started with localized redness, increased in size on day 2 with difficulty walking which became refusal to bear weight by day 5. Developed fever to 103, runny nose and dry cough, chills, lethargy, vomiting from da2-5. Currently still symptomatic. Seen on 04/28/2025 with presence of Otitis media, redness 6 cm with underlying induration of very tender 10 to 12 cm diameter. Decreased activity and lethargy, decreased appetite throughtout
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| 2838321 | 38 | M | WA | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac failure, Laboratory test
Cardiac failure, Laboratory test
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Heart failure
Heart failure
|
โ | โ | โ | |||
| 2838322 | 2 | F | MO | 04/28/2025 |
HEPA |
MERCK & CO. INC. |
Y008338 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse event to report. Patient was inadvertently given a 3rd dose of Hepatitis A vaccine that w...
No adverse event to report. Patient was inadvertently given a 3rd dose of Hepatitis A vaccine that was not needed.
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| 2838323 | 40 | M | WI | 04/28/2025 |
COVID19 FLU3 TDAP |
MODERNA SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
3046731 U8523CA PG3RP |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Patient received duplicate vaccines. Patient received Tdap, flu, and covid 11/19/24. Patient didn...
Patient received duplicate vaccines. Patient received Tdap, flu, and covid 11/19/24. Patient didn't state he had these and it wasn't pulling up in system right away. After vaccines were given 04/28/25, nurse went to document and noticed vaccines needed to be reconciled. Then it was updated in system and showed patient had the same vaccines 11/19/24. Patient was called and informed of the situation.
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| 2838324 | 78 | F | AZ | 04/28/2025 |
PNC20 |
PFIZER\WYETH |
LX4483 |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
|
Left Arm became red from injection site to elbow and was warm to the touch.
Left Arm became red from injection site to elbow and was warm to the touch.
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| 2838325 | 25 | M | CA | 04/28/2025 |
COVID19 TYP YF |
PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
MD3414 Y2A021M UK125AA |
Limb discomfort, Pain, Tenderness; Limb discomfort, Pain, Tenderness; Limb disco...
Limb discomfort, Pain, Tenderness; Limb discomfort, Pain, Tenderness; Limb discomfort, Pain, Tenderness
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Patient reports the following: on Tuesday (4/22/25) 1 day after vaccination felt achy and tired, and...
Patient reports the following: on Tuesday (4/22/25) 1 day after vaccination felt achy and tired, and on Wednesday (4/23/25) 2 days after vaccines noticed tenderness under left arm when applying deodorant. Called on Friday (4/25/25) 4 days after vaccines to discuss symptoms. Also notes discomfort in the underarm area when raising or extending left arm. Not getting worse, but noticeable. No enlarged lymph nodes on palpation of the area per patient. No fever or other systemic symptoms. Assessment - Symptoms are consistent with lymphadenopathy under the left arm following 2 vaccinations, including covid vaccine to the left arm. Rxn has been reported in 15% of vaccinations and usually resolves within 1 week. Asked patient to monitor, hydrate, and treat symptoms with pain reliever as needed, and to report back on 4/28/25 (monday) on progress and to seek medical care if symptoms worsen. Followed up with patient on 4/28/25 who self described 30% improvement in symptoms under his left arm. Only painful if lifts arm and extends over his head. Pt spoke with his primary care Dr who is not overly concerned, MD told pt most likely swollen lymph gland from vaccine and to make appt if no further improvement in a few days. Pt taking 1 advil per day for pain. I told pt to check in with us in a few days (Wednesday 4/30/25)
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| 2838326 | 3 | M | AR | 04/28/2025 |
DTAPIPV HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ 5ja57 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Given Kinrix at 3y 9m old and manufacturer specifies to be given from 4y-6y. Medication error, no si...
Given Kinrix at 3y 9m old and manufacturer specifies to be given from 4y-6y. Medication error, no signs or symptoms of adverse reaction from patient.
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| 2838327 | 57 | F | NV | 04/28/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Erythema, Feeling hot, Swelling
Erythema, Feeling hot, Swelling
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Patient reported to pharmacy on 04/28/2025, and stated that she has redness, swelling, felt feverish...
Patient reported to pharmacy on 04/28/2025, and stated that she has redness, swelling, felt feverish for several days after the injection on the 16th of April. Patient self treated and stated things settled down over the course of 5 to 7 days, never obtained medical or pharmacy assessment during time of reaction.
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| 2838329 | ID | 04/28/2025 |
MMRV |
MERCK & CO. INC. |
Y014436 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; a patient received improperly stored vaccine; This spontaneous report was received...
no adverse event; a patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 25-Mar-2025, the patient was vaccinated with 1 dose of improperly stored vaccine of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y014436, expiration date: 22-Feb-2026), diluted with sterile diluent (MERCK STERILE DILUENT), administered as prophylaxis (dose, strength, and route of administration) (improper storage of product in use). The vaccine was exposed to temperature excursion (Temperature: 14.92 F, Time frame: 1 hour 40 minutes) on an unknown date. There was no previous temperature excursion. No adverse event was reported (no adverse event).
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| 2838330 | TX | 04/28/2025 |
HPV9 |
MERCK & CO. INC. |
X005579 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No additional AE; a patient who was inadvertently administered GARDASIL 9 at less than the indicated...
No additional AE; a patient who was inadvertently administered GARDASIL 9 at less than the indicated age; This spontaneous report was received from a physician and refers to 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-Mar-2024, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) 0.5 mL (valid lot #X005579, expiration date: 30-Nov-2024) (route of administration was not provided) for prophylaxis at less than the indicated age (product administered to patient of inappropriate age). No additional adverse event (AE) was reported.
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| 2838331 | F | NY | 04/28/2025 |
BCG |
ORGANON-TEKNIKA |
Y011796 |
Poor quality product administered, Product preparation error
Poor quality product administered, Product preparation error
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poor quality product administered; HCP states that they did not receive any DILUENT with the orders ...
poor quality product administered; HCP states that they did not receive any DILUENT with the orders and do not have lot and expiration dates for the DILUENT they used to reconstitute; This spontaneous report was received from a health care professional (HCP) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with bacille Calmette-Guerin (TICE BCG LIVE) for an unknown indication. On 13-Feb-2025, the patient had poor quality product administered (Poor quality product administered); 2 lots were reported: lot #Y011796, expiration date: 03-Jul-2025 and lot #y017668 expiration date: 23-OCT-2025. Upon receipt of the bacille Calmette-Guerin (TICE BCG LIVE) they found that the powder in all the vials was "as hard as a rock and stuck to the bottom of the vials", color was cream white. They reconstituted and administered 3 of them. HCP states that they did not receive any diluent with the orders and do not have lot and expiration dates for the diluent they used to reconstitute (Product preparation error). No further information provided.
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| 2838332 | CA | 04/28/2025 |
MMR |
MERCK & CO. INC. |
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Contraindication to vaccination
Contraindication to vaccination
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HCP calling to state that they gave the MMR-II vaccine to an individual who has Multiple Sclerosis a...
HCP calling to state that they gave the MMR-II vaccine to an individual who has Multiple Sclerosis and has an unspecified autoimmune disease. After administering the MMR-II they were told the patient is also immunocompromised. HCP did not provide fur; they gave the MMR-II vaccine to an individual who has Multiple Sclerosis and has an unspecified autoimmune disease; This spontaneous report was received from a pharmacist and refers to a 36-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included multiple sclerosis, and an unspecified autoimmune disease. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis (Contraindicated product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not reported). The reporter stated that after administering measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) they were told the patient was also immunocompromised. The outcome of the event was not reported. The causal relationship between the event and the suspect vaccine reconstituted with the suspect sterile diluent (MERCK STERILE DILUENT) was not provided. Upon internal review, the event of immunocompromised was determined to be medically significant.
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| 2838333 | 04/28/2025 |
MMR |
MERCK & CO. INC. |
Y012439 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; The HCP reports that a patient was administered MMR II today that occurred in a te...
no adverse event; The HCP reports that a patient was administered MMR II today that occurred in a temperature excursion. The DILUENT used to reconstitute the vaccine lot/exp is unknown. No other information is available surrounding this case. This ca; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, lot #Y012439, expiration date: 16-Jul-2026 (strength, dose number, route, and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The temperature excursion was: 11๏ฟฝC, Time frame: 1 hour 0 minutes 0 seconds and it was unknown if There was a previous temperature excursion. No adverse event reported.
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| 2838334 | F | PA | 04/28/2025 |
HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. |
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Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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She received one dose 7/2007 and the second dose 9/2007; This spontaneous report was received from a...
She received one dose 7/2007 and the second dose 9/2007; This spontaneous report was received from a Physician Assistant on 24-Apr-2025 and refers to a currently 29-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. In 2007, the patient was vaccinated with 2 doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) for prophylaxis, first dose in July 2007, second dose in September 2007 (strength, dose, route, lot # and expiration date were not reported) (Inappropriate schedule of product administration). Lot # is being requested and will be submitted if received.
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| 2838335 | WA | 04/28/2025 |
HEPA |
MERCK & CO. INC. |
X024966 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AEs or PQC reported.; Caller reported patient received an expired dose of VAQTA. No a...
No additional AEs or PQC reported.; Caller reported patient received an expired dose of VAQTA. No additional AEs or PQC reported.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Apr-2025, the patient received the hepatitis A vaccine, Inactivated Injection (VAQTA) 1 mL, lot #X024966 administered by Intramuscular route for prophylaxis, which was expired on 23-Mar-2025 (Expired product administered). No adverse event was reported.
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| 2838336 | 13 | F | NY | 04/28/2025 |
HPV9 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Provider requesting information on administering a second dose of GARDASIL 9 to a patient. She state...
Provider requesting information on administering a second dose of GARDASIL 9 to a patient. She states that the patient received their first dose 2/21/2020 when she was 13 years old. She is now requesting to finish the series. No additional AE, no PQC; No additional AE; This spontaneous report has been received from a physician regarding a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 21-FEB-2020, when the patient was 13 years old, she was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The patient is now requesting to finish the series, and the healthcare provider requested information on administering the second dose (Inappropriate schedule of product administration). No additional adverse event was reported.
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| 2838337 | F | OH | 04/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Encephalitis
Encephalitis
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encephalitis; This serious case was reported by a other health professional and described the occurr...
encephalitis; This serious case was reported by a other health professional and described the occurrence of encephalitis in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 04-OCT-2024, the patient received Arexvy. On 27-NOV-2024, 54 days after receiving Arexvy, the patient experienced encephalitis (Verbatim: encephalitis) (serious criteria hospitalization and GSK medically significant). On 10-JAN-2025, the outcome of the encephalitis was resolved (duration 1 month 14 days). It was unknown if the reporter considered the encephalitis to be related to Arexvy. The company considered the encephalitis to be unrelated to Arexvy. Additional Information: GSK receipt date: 22-APR-2025 The reporter reported that the extensive work up in hospital and after the hospital. On high-dose steroids for about 8 weeks. On the day of reporting in the office patient was fully recovered. The reporter reported that the patient complete work up without another diagnosis. The patient was in hospital for encephalitis unspecified to unspecified. The expiry date of Arexy was unknown.; Sender's Comments: Encephalitis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
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| 2838338 | 04/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Bell's palsy
Bell's palsy
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About a month after the 2nd shot I developed Bell's palsy; This serious case was reported by a ...
About a month after the 2nd shot I developed Bell's palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (got the 2 shingles shots about 6 months apart). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: About a month after the 2nd shot I developed Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was resolved (duration 6 weeks). It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. The company considered the bell's palsy to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 20-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got the 2 shingles shots about 6 months apart and about a month after the 2nd shot he/she developed bell's palsy. Patient stated that he/she was thankful, it went away after about 6 weeks, but indicated that it was worth getting the shots.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2838339 | F | CA | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chills
Chills
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shivering; This non-serious case was reported by a consumer via call center representative and descr...
shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included depression and suicidal ideation. Family history included shingles (Patient father had Shingles in the past). In FEB-2022, the patient received the 1st dose of Shingrix. In FEB-2022, less than a day after receiving Shingrix, the patient experienced shivering (Verbatim: shivering). The outcome of the shivering was resolved (duration 1 day). It was unknown if the reporter considered the shivering to be related to Shingrix. It was unknown if the company considered the shivering to be related to Shingrix. Linked case(s) involving the same patient: US2024137579 Additional Information: GSK Receipt Date: 23-APR-2025 The patient added that she also experienced shivering with dose one Shingrix. The shivering started within 24 hours of receiving vaccine and resolved in a day.; Sender's Comments: US-GSK-US2024137579:same patient
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| 2838340 | F | TX | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334Y |
Blister
Blister
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Blisters on nose and on back; This non-serious case was reported by a nurse via sales rep and descri...
Blisters on nose and on back; This non-serious case was reported by a nurse via sales rep and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y) for prophylaxis. On 03-APR-2025, the patient received the 1st dose of Shingrix (unknown deltoid). On 03-APR-2025, less than a day after receiving Shingrix, the patient experienced blister (Verbatim: Blisters on nose and on back). The outcome of the blister was unknown. The reporter considered the blister to be related to Shingrix. The company considered the blister to be related to Shingrix. Additional Information: GSK receipt date: 17-APR-2025 The patient experienced blisters on nose and on her back.
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| 2838341 | 51 | F | FL | 04/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Chills, Erythema, Headache, Inappropriate schedule of product administration, Mo...
Chills, Erythema, Headache, Inappropriate schedule of product administration, Mobility decreased; Pain, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
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sore arm; Swollen arm; red arm; warm arm; Fever; Chills; body ache; Headache; she cannot move her ar...
sore arm; Swollen arm; red arm; warm arm; Fever; Chills; body ache; Headache; she cannot move her arm well; late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in July of last year). On 14-APR-2025, the patient received the 2nd dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: red arm), skin warm (Verbatim: warm arm), fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: body ache), headache (Verbatim: Headache), mobility decreased (Verbatim: she cannot move her arm well) and drug dose administration interval too long (Verbatim: late dose). The outcome of the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, headache and mobility decreased were unknown and the outcome of the general body pain was resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix. It was unknown if the company considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 18-APR-2025 The patient received her second dose of Shingrix on Monday. She stated that after her dose, she experienced a sore, swollen, red, warm arm, fever, chills, body ache and headache. She also states that she cannot move her arm well. She received her first dose of Shingrix in July of last year which led to drug dose administration interval too long. Other Conditions were reported as unknown.
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| 2838342 | F | MA | 04/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
H2522 |
Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resona...
Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resonance imaging normal, Vestibular function test normal
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Got dizzy; This non-serious case was reported by a consumer and described the occurrence of dizzines...
Got dizzy; This non-serious case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number H2522, expiry date APR-2025) for prophylaxis. Concurrent medical conditions included hypertension. Concomitant products included lisinopril dihydrate (Lisinopril). On 06-SEP-2023, the patient received Arexvy. On 06-SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Got dizzy). The outcome of the dizziness was not resolved. It was unknown if the reporter considered the dizziness to be related to Arexvy. It was unknown if the company considered the dizziness to be related to Arexvy. Additional Information: GSK receipt date: 22-APR-2025 The patient got dizzy one hour after Arexvy shot and had continued dizziness even till the time of reporting. She had seen a neurologist for Computerized Tomogram scan and Magnetic resonance imaging which were negative and an inner ear specialist with vestibular testing etc, all were negative. The reporter asked about how many reported cases had continued dizziness and when do the reproter expect this to subside. The symptom was not treated.
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| 2838343 | 38 | F | GA | 04/28/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
3D72S |
Product storage error
Product storage error
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patient given MMR(Priorix) that was frozen prior to reconstitution; This non-serious case was report...
patient given MMR(Priorix) that was frozen prior to reconstitution; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 38-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. Concomitant products included Priorix. On 10-MAR-2025, the patient received Priorix (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug 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: 15-APR-2025 Reporter stated that patient given MMR (Priorix) that was frozen prior to reconstitution, which led to incorrect storage of drug. This case is 1 of 6 cases reported by same reporter.
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