| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843490 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site rash, Rash
Injection site rash, Rash
|
developed rashes on body around the injection site; developed rashes on body; This non-serious case...
developed rashes on body around the injection site; developed rashes on body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced injection site rash (Verbatim: developed rashes on body around the injection site) and generalized rash (Verbatim: developed rashes on body). The outcome of the injection site rash and generalized rash were not reported. It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingles vaccine. It was unknown if the company considered the injection site rash and generalized rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported that after 2 weeks of getting second dose of Shingles vaccine had developed rashes on body and around the injection site
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| 2843491 | F | IN | 06/02/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
57DD5 |
Incorrect route of product administration
Incorrect route of product administration
|
A 31 years old female patient received Priorix IM instead of subcutaneous.; This non-serious case wa...
A 31 years old female patient received Priorix IM instead of subcutaneous.; 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 31-year-old female patient who received MMR (Priorix) (batch number 57DD5, expiry date 01-DEC-2026) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 31 years old female patient received Priorix IM instead of subcutaneous.). 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: 27-MAY-2025 The reporter reported on 27/MAY/2025 a pharmacist called to report that a 31 years old female patient received Priorix Intramuscular instead of subcutaneous, which led to subcutaneous injection formulation administered by other route.
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| 2843492 | 18 | F | FL | 06/02/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
K4JH7 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
received first dose of Engerix-B but it was the adult dose instead of the pediatric one; received fi...
received first dose of Engerix-B but it was the adult dose instead of the pediatric one; received first dose of Engerix-B but it was the adult dose instead of the pediatric one; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 28-APR-2025, the patient received the 1st dose of Engerix B adult. On 28-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: received first dose of Engerix-B but it was the adult dose instead of the pediatric one) and adult product administered to child (Verbatim: received first dose of Engerix-B but it was the adult dose instead of the pediatric one). The outcome of the overdose and adult product administered to child 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: 28-MAY-2025 Registered Nurse explained that 2 patients that were twins received their first dose of Engerix-B but it was the adult dose instead of the pediatric one, which led to overdose and adult product administered to child. On the day of reporting, the patients received their second dose and that one was the correct pediatric dose. Both patients had the same demographics, even initials for their names. Lot number and expiration date where the same for the first and second dose. The case was linked with case US2025066874, reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025066874:Same reporter US-GSK-US2025066874:Same reporter,Different patient
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| 2843493 | TN | 06/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Bexsero - second dose before 6 months; This non-serious case was reported by a other health professi...
Bexsero - second dose before 6 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st and 2nd dose in the October 2024 to February 2025 timeframe). On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Bexsero - second dose before 6 months). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 28-MAY-2025 Health care professional unsure what to do with patients who completed Bexsero series one month apart in the October 2024 to February 2025 timeframe. Clinic was either made aware or realized dosing change in February 2025. They want to know if those patients need three doses. The patient received 3rd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccine schedule.
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| 2843494 | MO | 06/02/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation issue
Product preparation issue
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Priorix and possible diluent only administration; Priorix and possible diluent only administration...
Priorix and possible diluent only administration; Priorix and possible diluent only administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix and possible diluent only administration) and inappropriate dose of vaccine administered (Verbatim: Priorix and possible diluent only administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 29-MAY-2025 Pharmacist calls to report suspects the diluent only of the Priorix vaccine was administered to a patient because has 1 vial of the lyophilized portion left with no diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. States has no further information or patient details at the moment of call. The Vaccine Administration Facility is the same as Primary Reporter. The adverse event details were asked and declined because were not available at the moment of call.
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| 2843495 | 16 | F | CA | 06/02/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
Z9214 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Menveo extra dose administration; Menveo extra dose administration; This non-serious case was report...
Menveo extra dose administration; Menveo extra dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Z9214, expiry date 21-JAN-2026) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. Previously administered products included Menveo (received first dose on 03-APR-2019). On 19-MAR-2025, the patient received the 3rd dose of Menveo. On 27-SEP-2023, the patient received the 2nd dose of Menveo. On 27-SEP-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Menveo extra dose administration). On 19-MAR-2025, the patient experienced extra dose administered (Verbatim: Menveo extra dose administration). The outcome of the extra dose administered and extra dose administered were not applicable. Additional Information: GSK receipt date: 29-MAY-2025 Clinic supervisor wanted to know how to proceed after a patient received an extra dose of Menveo (1 vial). The patient received three doses in total and given that the patient was already within the 2 to 55 years-old range of age for 1 dose only administration, in reality received two extradoses (one given intentionally and the other inadvertently), which led to extra dose administered. The vaccine administration facility was the same as primary reporter. Only one lot number and expiration date provided (for the third dose).
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| 2843496 | 13 | F | CA | 06/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
T9TL9 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Adult dose to a pediatric PX; Overdose; This non-serious case was reported by a nurse via call cente...
Adult dose to a pediatric PX; Overdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 13-year-old female patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 15-DEC-2025) for prophylaxis. Previously administered products included Havrix (1st dose received on 26th June 2023). On 24-MAY-2025, the patient received the 1st dose of Havrix adult. On 24-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose to a pediatric PX) 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: 29-MAY-2025 On of our patients well not a patient from us, but we have a mobile unit event, and a young lady was given a Havrix vaccine, the Hep A, she was 13, but she was given the vaccine for 19 and up, which led to adult product administered to child and overdose. HCP reported that the patient received the Havrix vaccine on 24-May-2025. Also, they mentioned that the patient had a prior Hep A vaccine in 26-Jun-2023, but they are not sure if this was also Havrix. So, this is the 2nd Hep A dose that the patient receive Also, HCP mentioned that as this was a mobile event, the place where the patient get the dose was in (they didn't provide any specific.
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| 2843497 | FL | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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has a patient that apparently had the first dose 5 years ago; This non-serious case was reported by ...
has a patient that apparently had the first dose 5 years ago; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (apparently had the first dose 5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has a patient that apparently had the first dose 5 years ago). The outcome of the incomplete course of vaccination was not reported. Additional Information: GSK receipt date: 29-MAY-2025 A physician wants to know the efficacy of Shingrix if the patient waits over a year for their second dose. She also wants to know when it's recommend it to repeat the two doses. She mentioned that she had a patient that apparently had the first dose 5 years ago. She wants to know if she could give this patient the two doses so the patient could have the over the 90 percent efficacy. No further information was provided. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. .
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| 2843498 | CA | 06/02/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
7hg2a |
Incorrect dose administered, Product preparation error
Incorrect dose administered, Product preparation error
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possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent...
possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent; possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) (batch number 7hg2a, expiry date 01-JAN-2026) for prophylaxis. On 29-MAY-2025, the patient received Priorix. On 29-MAY-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent) and inappropriate dose of vaccine administered (Verbatim: possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered 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: 30-MAY-2025 Nurse practitioner reported that there was a possibility that a patient might have received Priorix reconstituted with Merck's MMR vaccine diluent one day prior to the reporting date, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. She was still gathering information. No patient details or other information available at this time.
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| 2843499 | 1.25 | IN | 06/02/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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No adverse event, Product preparation issue
No adverse event, Product preparation issue
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Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportio...
Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportion not administered with no reported adverse event; Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportion not administered with no reported adverse event; Initial information received on 20-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves a 15 months old and unknown gender patient to whom nurse reconstituted the hib powder portion of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] with an unknown liquid and liquid dtap/ipvportion not administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of hib powder portion of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization for patient 15 months old (Immunisation) as nurse reconstituted with an unknown liquid and liquid dtap/ipvportion not administered with no reported adverse event (product preparation error) (single component of a two-component product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA150688:
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| 2843500 | MA | 06/02/2025 |
IPV |
SANOFI PASTEUR |
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No adverse event, Product storage error
No adverse event, Product storage error
|
temperature excursion of open ipol; temperature of 9.6 degrees C for 11 minutes with no reported adv...
temperature excursion of open ipol; temperature of 9.6 degrees C for 11 minutes with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves temperature excursion of open IPV (VERO) [IPOL]; temperature of 9.6 degrees C for 11 minutes with no reported adverse event. No patient's involved. On an unknown date, the caller reported that an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) for prophylactic vaccination (Immunisation) had temperature excursion with temperature of 9.6 degrees C for 11minutes with no reported adverse event (product storage error). Reportedly- extended stability data covers the excursion, There was no previous excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2843505 | 74 | F | TN | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Herpes zoster, Injection site erythema, Injection site pain, Pain in extremity, ...
Herpes zoster, Injection site erythema, Injection site pain, Pain in extremity, Skin warm
More
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Area hurt when injected and was sore right then. The sight was warm and red around the area. ARM WA...
Area hurt when injected and was sore right then. The sight was warm and red around the area. ARM WAS PAINFULL FOR 3 DAYS AND RED AT THE AREA WHERE SHOT WAS GIVEN.
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| 2843510 | 1 | F | NC | 06/02/2025 |
MMR |
MERCK & CO. INC. |
Y018703 |
Ear infection, Erythema, Pyrexia, Rash, Skin warm
Ear infection, Erythema, Pyrexia, Rash, Skin warm
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On 5/5/25, my 1 year old daughter was administered 12 month shots including the MMR vaccine. She was...
On 5/5/25, my 1 year old daughter was administered 12 month shots including the MMR vaccine. She was also diagnosed with a double ear infection and prescribed amoxicillin. On the morning of 5/13/25, small bumps (roughly dime size) erupted on her face, back of the neck, arms and legs. I took her to the doctor; we were told she had a reaction to amoxicillin and to stop taking it. On 5/14/25, the rash had progressively gotten worse and the majority of her body was bright red and warm to the touch; a low grade fever was also observed now. I took her to the doctor; we were told with the progression of the rash and added fever, it was a reaction to the MMR vaccine that roughly 6% of children experience.
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| 2843511 | 55 | F | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Injection site pain, Pain, Swelling
Arthralgia, Injection site pain, Pain, Swelling
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I received the shingles vaccine two days ago. Besides pain at the injection site, left shoulder, whi...
I received the shingles vaccine two days ago. Besides pain at the injection site, left shoulder, which was expected, I now have developed swelling and pain just below my left clavicle. I had no trauma or other incident to explain this pain and swelling at this location.
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| 2843512 | 71 | F | OH | 06/02/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood test, Computerised tomogram normal, Gait disturbance, Lymph node pain, Lym...
Blood test, Computerised tomogram normal, Gait disturbance, Lymph node pain, Lymphadenopathy; Pain
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I was due for a COVID booster and I didn't get it. All of my lymph nodes are swelling up very l...
I was due for a COVID booster and I didn't get it. All of my lymph nodes are swelling up very large and are painful. My doctor said it was from the COVID vaccine. It's been going on a month this week ?? I can't walk in the late afternoon because it hurts so much. All I can do is sit or lay down to get some relief from it.
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| 2843513 | M | MN | 06/02/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Blindness unilateral, Blood test, Brain fog, COVID-19, Cough; Dizziness, Drainag...
Blindness unilateral, Blood test, Brain fog, COVID-19, Cough; Dizziness, Drainage, Dyspnoea, Eye infection, Fatigue; Ileus, Intensive care, Laboratory test, Limb discomfort, Neuropathy peripheral; Organ failure, Pancreatitis, Pancreatitis necrotising, Post procedural infection, Renal pain; Tinnitus
More
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I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received t...
I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received the covid vaccine in fall of 2021 and also the booster shot. i got covid in February 2022. I got pancreatitis on May 2, 2022. All my organs shut down and i was in the ICU for 9 days and suffered multiple illeus and 40 days hospitalized. That lead to necrotizing pancreatitis. After going in for a second opinion, doctors got me into surgery to drain a liter and a half of fluid. a second follow up surgery lead to a infection and my organ attempted to shut down again. After multiple surgeries and infections, i got covid again. One infection penetrated my eye and nearly caused a detached retina. I can no longer see out of my right eye after 56 years. It took over a year to recover, but I continue to have a cough from covid. I have had multiple blood tests and body function tests since then. I am experiencing dizziness, cough, tinnitus, neuropathy, kidney pain, shortness of breath, brain fog and the most unexplained side effect of bouts where i randomly feal completely exhausted. My legs feel like they weigh a hundred pounds. No doctor has been able to explain it. My GI doctor says it is not from the pancreatitis or enzyme deficiency. My endocrinologist can't explain it. My family doctor has done several tests and they can't figure it out. I was relatively healthy before getting this vaccine. Now i have these side effect symptoms that can't be explained. More studies need to be done on these side effects and this vaccine reevaluated.
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โ | โ | โ | ||||
| 2843514 | 75 | M | CA | 06/02/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Abnormal dreams, Chills, Dizziness, Influenza like illness, Myalgia; Sleep disor...
Abnormal dreams, Chills, Dizziness, Influenza like illness, Myalgia; Sleep disorder, Tremor
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I had a RSV vaccination yesterday, 5/31/2025. Last night I had a severe side effect, flu type syndro...
I had a RSV vaccination yesterday, 5/31/2025. Last night I had a severe side effect, flu type syndrome, which I woke up in the middle of the night to find my body shivering and trembling badly, muscle aches also. Immediately I pulled a comforter to cover me and it took perhaps 10 minutes for my body to calm down. I could not sleep for a long time, even when I fell asleep eventually I had some king of dream over and over again, which had the same symptoms as I got flu or severe cold. This morning I felt light-headed and had to lie down most of time to ease the problems.
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| 2843535 | 0.08 | ID | 06/02/2025 |
RVX |
UNKNOWN MANUFACTURER |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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no reports of the patient experiencing any medical concerns or symptoms after being administered the...
no reports of the patient experiencing any medical concerns or symptoms after being administered the dose of ROTATEQ earlier than recommended schedule; a patient was administered their first dose of ROTATEQ today, 5/8/2025, at the age of 5 weeks and 3 days old; This spontaneous report was received from a medical assistant and refers to a 5-week-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 08-May-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 mL (2 mL / three dose series) (lot # and expiration date were not reported) for prophylaxis, which was earlier than the recommended age of 6 weeks old as stated on the patient information (PI) leaflet (product administered to patient of inappropriate age). The Medical Assistant confirmed there have been no reports of the patient experiencing any medical concerns or symptoms after being administered the dose of the suspect vaccine earlier than recommended schedule (no adverse event). Consent granted for correspondence. No additional information provided. Lot # is being requested and will be submitted if received.
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| 2843536 | OH | 06/02/2025 |
HPV9 |
MERCK & CO. INC. |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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Pharmacist calling with a report of an adverse event regarding GARDASIL 9. Pharmacist stated that a...
Pharmacist calling with a report of an adverse event regarding GARDASIL 9. Pharmacist stated that a patient's schedule was interrupted after their first dose was administered in 2022 and did not complete the vaccination series as recommended. Phar; the patient has not reported any medical concern regarding interruption in their series of Gardasil 9; This spontaneous report was received from a pharmacist 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 in 2022, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), 0.5 mL (route of administration, lot # and expiration date were not reported) for prophylaxis, however, the patient did not continued the vaccination schedule (inappropriate schedule of product administration). No adverse event was reported.
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| 2843537 | 47 | M | TX | 06/02/2025 |
HEP |
MERCK & CO. INC. |
X026485 |
Expired product administered
Expired product administered
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No symptoms reported.; 47 year old male patient received an expired does of RECOMBIVAX HB 0.5ml, lot...
No symptoms reported.; 47 year old male patient received an expired does of RECOMBIVAX HB 0.5ml, lot X026485; HCP called to report an AE for RECOMBIVAX HB. Caller reported that a 47 year old male patient received an expired does of RECOMBIVAX HB today, 5/29/2025. Caller reported that dose expired 5/11/2025. Potency of the dose was supported by the Post; This spontaneous report was received from a Pharmacist and refers to a 47-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 29-May-2025, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) Injection (lot #X026485, expiration date: 11-May-2025) 0.5 mL administered by Unknown route as prophylaxis. Potency of the dose was supported by the Post Expiry Memo. No symptoms reported. No additional AE/PQC.
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| 2843538 | F | CA | 06/02/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945665 |
Joint swelling, Peripheral swelling
Joint swelling, Peripheral swelling
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Swollen Joints; Swollen Feet; Swollen Fingers; Initial report received on 06-May-2025. A consumer...
Swollen Joints; Swollen Feet; Swollen Fingers; Initial report received on 06-May-2025. A consumer reported that she, a female (age, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced swollen feet, fingers, and joints. Medical history included psoriatic arthritis. No concomitant medications were reported at the time of vaccination. On 26-Apr-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot # 945665, expiration date, NDC #, route, and site not available). On an unknown date, a few days after receiving HEPLISAV-B, she experienced swelling in the feet, fingers, and joints. No additional information was reported. Company Comment: he company assessed the events as non-serious.; Sender's Comments: he company assessed the events as non-serious.
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| 2843539 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Antinuclear antibody positive
Antinuclear antibody positive
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nowi have a positive ANA/serious reaction to their vaccine; This serious case was reported by a cons...
nowi have a positive ANA/serious reaction to their vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of antinuclear antibody positive 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 antinuclear antibody positive (Verbatim: nowi have a positive ANA/serious reaction to their vaccine) (serious criteria other: serious as per reporter). The outcome of the antinuclear antibody positive was not resolved. It was unknown if the reporter considered the antinuclear antibody positive to be related to Shingles vaccine. The company considered the antinuclear antibody positive to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The patient had a serious reaction to their vaccine and when the patient tried to report it their web site was so encrypted that the patient could report it and no one ever called him/her. Now the patient had a positive ANA and won't ever take another vaccine and said but you can make your own decisions.; Sender's Comments: Antinuclear antibody positive is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2843540 | 0.5 | F | 06/02/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5h95b |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Kinrix was administered to a 6months old patient; This non-serious case was reported by a other heal...
Kinrix was administered to a 6months old patient; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5h95b, expiry date 16-FEB-2026) for prophylaxis. On 05-MAY-2025, the patient received the 1st dose of Kinrix (right thigh). On 05-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 6months old patient). The outcome of the inappropriate age at vaccine administration 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: 05-MAY-2025 Other Health Professional reported that Kinrix was administered to a 6months old patient , which led to Inappropriate age at vaccine administration.
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| 2843541 | 06/02/2025 |
COVID19 VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Skin disorder, Vaccination failure; Herpes zoster, Skin disorder,...
Herpes zoster, Skin disorder, Vaccination failure; Herpes zoster, Skin disorder, Vaccination failure
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Suspected vaccination failure; Suspected shingles; Kinds of skin problems; This serious case was rep...
Suspected vaccination failure; Suspected shingles; Kinds of skin problems; 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 COVID-19 vaccine for prophylaxis. 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Suspected shingles) and skin disorder (Verbatim: Kinds of skin problems). The outcome of the vaccination failure was not reported and the outcome of the shingles and skin disorder were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin disorder 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 skin disorder to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. Patient reported that vaccine was as bad as the Covid vaccine, patient's doctor made them get it before Covid and then when they got the Covid vaccines they thought they were going to die. Patient had all the symptoms of shingles? At the time of reporting patient had all kinds of skin problems. Also indicated that too many vaccines. It was unknown if reporter considered the COVID vaccine to be related to shingles and skin problems. 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 Shingrix.
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| 2843542 | NY | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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second dose was given 1 year later from the first dose; This non-serious case was reported by a cons...
second dose was given 1 year later from the first dose; 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 patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was given 1 year later from the first dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 28-MAY-2025 The reporter reported that someone had received only one dose of Shingrix and had forgotten to take the second dose within the recommended 2 to 6 month window, but instead received the second dose one year after the first. The reporter had a question if they need to restart the two-dose series. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2843543 | 06/02/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Nerve injury; Nerve injury
Nerve injury; Nerve injury
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nerves are permanently damaged; This non-serious case was reported by a consumer via interactive dig...
nerves are permanently damaged; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage 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 nerve damage (Verbatim: nerves are permanently damaged). The outcome of the nerve damage was not reported. It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the nerve damage to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The patient took both of those and no relief. He/she assuming nerves were permanently damaged and he/she would have to live with this the rest of life. The patient even had steroid injections and no relief from that either.
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| 2843544 | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Bone pain, Myalgia
Bone pain, Myalgia
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For 3 days after my muscles and bone's ached; For 3 days after my muscles and bone's ached...
For 3 days after my muscles and bone's ached; For 3 days after my muscles and bone's ached; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. In MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, 3 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: For 3 days after my muscles and bone's ached) and bone pain (Verbatim: For 3 days after my muscles and bone's ached). The outcome of the muscle pain and bone pain were not reported. It was unknown if the reporter considered the muscle pain and bone pain to be related to Shingrix. It was unknown if the company considered the muscle pain and bone pain to be related to Shingrix. Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. Three weeks ago patient received the 1st of two Shingrix shots with the second due in 6 months. The patient know a few friends that suffered for months after getting shingles, they encouraged to get the shots . For 3 days after my muscles and bone's ached but that was unusual and the patient understood . The patient was glad for started with the shots.
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| 2843545 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failure; 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. 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) and shingles (Verbatim: 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 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: 27-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the shot in the last two years and still got shingles. 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 time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2843546 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; 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. 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) and shingles (Verbatim: 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 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: 27-MAY-2025 This case was reported by a patient via interactive digital media. The reporter stated that bad stuff happened. Patient got his/her shots, it helped, but it had already worked and still , he/she had it. 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2843547 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; i got the shot and i still got shingles many times with it.; This ser...
Suspected vaccination failure; i got the shot and i still got shingles many times with it.; 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) and shingles (Verbatim: i got the shot and i still got shingles many times with it.). 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: 28-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles many times with it. The shingles was very tricky and the shot only last five years do your research before doing the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2843548 | M | TN | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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not feeling well after dose 1 of the vaccine; feeling rough after dose 1 of the vaccine; This non-se...
not feeling well after dose 1 of the vaccine; feeling rough after dose 1 of the vaccine; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well after dose 1 of the vaccine) and feeling abnormal (Verbatim: feeling rough after dose 1 of the vaccine). The outcome of the feeling unwell and feeling abnormal were not reported. It was unknown if the reporter considered the feeling unwell and feeling abnormal to be related to Shingrix. It was unknown if the company considered the feeling unwell and feeling abnormal to be related to Shingrix. Additional Information: GSK receipt date: 29-MAY-2025 The patient was approximately 59 year old. The physician reported that he had taken first dose of Shingrix and experienced not feeling well and feeling rough. Despite this, he returned and completed the second dose. He had not described specific symptoms, and he had not stated how long the symptoms had lasted.
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| 2843549 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Muscular weakness
Muscular weakness
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having muscle weakness; This non-serious case was reported by a consumer via interactive digital med...
having muscle weakness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle weakness 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 muscle weakness (Verbatim: having muscle weakness). The outcome of the muscle weakness was not resolved. It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine. It was unknown if the company considered the muscle weakness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via interactive digital media. Patient was having muscle weakness and asked if that's was side effect.
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| 2843550 | M | 06/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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Autism spectrum disorder, Maternal exposure during pregnancy
Autism spectrum disorder, Maternal exposure during pregnancy
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took 4-5 shots while she was pregnant; Autism; This is a spontaneous report received from a Consumer...
took 4-5 shots while she was pregnant; Autism; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient was exposed to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), transplacental, administration details for the mother: not provided as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "took 4-5 shots while she was pregnant"; AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "Autism". Clinical flare reaction: Caller stated she (Patient's mother) was trying to learn about Autism and the screening and how to get him (patient) help/resources. Where could she get help to learn about Autism? Caller stated she was told that she might have it but was never screened and her Mom had a learning disability as well and there was a communication barrier with the Doctor. Patient's mother asking if she was still a participant in the Covid 19 Vaccine study? Caller stated she was trying to get in contact with them and also to see if they were studying the babies of the pregnant women who received the shots? Caller states she took 4-5 shots while she was pregnant with her son and he was showing signs of Autism. Caller stated her mom his Guardian and told her that she needs to sign over her rights as his parent to get him screened for autism. Caller stated her objective was not to report because she did not knew how to represent herself legally, for now she was just trying to get him services and if he had cognitive issues, get him the medical professionals to get screened and get care. Caller stated she was a willing volunteer, they didn't trick her. She stated she was just trying to get her son to get the services he needs. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109463 Mom case;
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| 2843551 | F | 06/02/2025 |
RSV |
PFIZER\WYETH |
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Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
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experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced ...
experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced swelling, warmness, itching and noticed a red circle at the injection site; This is a spontaneous report received from a Pharmacist from medical information team. A 78-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "experienced swelling, warmness, itching and noticed a red circle at the injection site". Additional information : Patient experienced Swelling, warmness, itching and noticed a red circle at the injection site were started at day 4 or 5 after getting the vaccine. The patient would like to know if it was normal. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2843552 | M | MD | 06/02/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood bilirubin, Blood folate, Blood thyroid stimulating hormone, Full blood cou...
Blood bilirubin, Blood folate, Blood thyroid stimulating hormone, Full blood count, HIV test; Investigation, Metabolic function test, Psychotic disorder, Syphilis test, Toxicologic test; Vitamin B12
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Protracted Psychiatric Complications Including Psychosis; The initial case was missing the following...
Protracted Psychiatric Complications Including Psychosis; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 28May2025, this case now contains all required information to be considered valid. This is a literature report for the following literature source(s). This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Case report: The patient is a 54-year-old man with no prior psychiatric history, well-functioning with a stable job as supervisor at a large landscaping company. He was married with children and had an excellent relationship with family. He drank alcohol infrequently and did not use any other substances. He has a family history of depression in both his parents. He began to experience symptoms of intense anxiety and paranoia in 2021, 4 days after receiving his second Pfizer BioNTech COVID-19 vaccination. He developed severe insomnia and was fearful that police were pursuing him despite nothing to suggest this was a realistic concern. He did not have COVID-19 when his psychiatric symptoms first started and did not have any medical problems aside from asthma. The patient was first hospitalized 2 weeks after these symptoms began at one of the psychiatric facilities in the area. The documents obtained from that facility indicated his complete blood count, complete PROTRACTED metabolic panel, B12, folate, and thyroid-stimulating hormone were within normal reference ranges except for a mildly elevated total bilirubin. HIV, RPR, and Lyme disease IgG/IgM were negative. Urine toxicology screening did not detect any substances. He was recommended to get a brain magnetic resonance imaging during that hospitalization, but he declined due to fears he would be taken to the police instead. He was discharged from the facility with partial improvement of the symptoms. The discharge diagnoses by the facility were major depressive disorder with psychotic features and generalized anxiety disorder. The discharge medications were risperidone 2 mg nightly, buspirone 15 mg twice a day, and lithium 900 mg nightly (lithium level of 0.86). Upon discharge, he was referred to our facility for outpatient follow-up in our partial hospital program. In the following 2 years, he experienced fluctuations in the symptoms and did not have a sustained return to his premorbid level of functioning. While outpatient, he developed kidney stones, so his lithium was switched to carbamazepine. This was also discontinued once he developed a rash. His risperidone was switched to quetiapine multiple antidepressant trials including fluvoxamine, escitalopram, and venlafaxine, none of which were helpful. Lorazepam was added without any significant benefit. He ended up being psychiatrically hospitalized at our facility 3 additional times. He attempted suicide by overdosing on his medications and another time by trying to hang himself. Given his age, atypical presentation, and presence of symptoms. Neurology involved approximately 7months after the onset of the symptoms. Lumbar puncture was notable for an elevated protein of 147 mg/dL and a corrected white blood cell count of 6 cells/uL. Multiple sclerosis profile, ENC2 panel, and Alzheimer's panel were normal. Repeat lumbar puncture 4 months later was completely normal without any abnormalities. Anti-thyroid peroxidase was elevated at 89 IU/mL and anti-La (SS-B) elevated at 2.3 antibody index. Routine electroencephalogram (EEG) was normal. Brain magnetic resonance imaging with and without contrast only showed minimal scattered subcortical and periventricular white matter T2/ FLAIR hyperintensities, which was likely due to chronic small vessel ischemia. Computed tomography scans of the chest, abdomen, and pelvis and scrotal ultrasound did not show evidence of malignancies. The patient's last psychiatric hospitalization at our facility was approximately 22 months after the initial onset of his symptoms of anxiety and paranoia. Symptoms at the time of this hospitalization included severely depressed mood, decreased concentration, psychomotor retardation, and catatonia evidenced by decreased oral intake, marked ambivalence, selective mutism, mannerisms, and negativism. Laboratory results were only notable for slightly elevated alanine transaminase to 60 units/L, which later resolved. Once on the inpatient unit, he was titrated on lorazepam to 4 mg 3 times daily. His sertraline was increased to 100 mg twice a day. He was continued on quetiapine 100 mg nightly for psychosis. Propranolol 20mg twice a day was added for restlessness but eventually was discontinued due to dizziness and lack of efficacy. Symptoms were refractory to medications, so he was ultimately started on ECT about a month after the admission. He received 11 bifrontal ECT treatments during his hospital stay. His score on the Montgomery-Asberg Depression Rating Scale improved from 39 out of 60 at pre- ECT to 18 out of 60 after 11 ECT treatments. He tolerated the ECT treatments well. He was discharged from the hospital two months after his admission. He received 7 additional bifrontal ECT treatments as an outpatient over the course of 3 months. At the time of his last session, he scored 10 out of 60 on the Montgomery-Asberg Depression Rating Scale. As of 10 months after the last ECT session, he had been tapered off his quetiapine and was undergoing a slow taper of his lorazepam. He remained in full remission without any relapse of symptoms and had returned to premorbid level of function. The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 28May2025, this case now contains all required information to be considered valid. This is a literature report for the following literature source(s). This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Case report: The patient is a 54-year-old man with no prior psychiatric history, well-functioning with a stable job as supervisor at a large landscaping company. He was married with children and had an excellent relationship with family. He drank alcohol infrequently and did not use any other substances. He has a family history of depression in both his parents. He began to experience symptoms of intense anxiety and paranoia in 2021, 4 days after receiving his second Pfizer BioNTech COVID-19 vaccination. He developed severe insomnia and was fearful that police were pursuing him despite nothing to suggest this was a realistic concern. He did not have COVID-19 when his psychiatric symptoms first started and did not have any medical problems aside from asthma. The patient was first hospitalized 2 weeks after these symptoms began at one of the psychiatric facilities in the area. The documents obtained from that facility indicated his complete blood count, complete PROTRACTED metabolic panel, B12, folate, and thyroid-stimulating hormone were within normal reference ranges except for a mildly elevated total bilirubin. HIV, RPR, and Lyme disease IgG/IgM were negative. Urine toxicology screening did not detect any substances. He was recommended to get a brain magnetic resonance imaging during that hospitalization, but he declined due to fears he would be taken to the police instead. He was discharged from the facility with partial improvement of the symptoms. The discharge diagnoses by the facility were major depressive disorder with psychotic features and generalized anxiety disorder. The discharge medications were risperidone 2 mg nightly, buspirone 15 mg twice a day, and lithium 900 mg nightly (lithium level of 0.86). Upon discharge, he was referred to our facility for outpatient follow-up in our partial hospital program. In the following 2 years, he experienced fluctuations in the symptoms and did not have a sustained return to his premorbid level of functioning. While outpatient, he developed kidney stones, so his lithium was switched to carbamazepine. This was also discontinued once he developed a rash. His risperidone was switched to quetiapine multiple antidepressant trials including fluvoxamine, escitalopram, and venlafaxine, none of which were helpful. Lorazepam was added without any significant benefit. He ended up being psychiatrically hospitalized at our facility 3 additional times. He attempted suicide by overdosing on his medications and another time by trying to hang himself. Given his age, atypical presentation, and presence of symptoms. Neurology involved approximately 7months after the onset of the symptoms. Lumbar puncture was notable for an elevated protein of 147 mg/dL and a corrected white blood cell count of 6 cells/uL. Multiple sclerosis profile, ENC2 panel, and Alzheimer's panel were normal. Repeat lumbar puncture 4 months later was completely normal without any abnormalities. Anti-thyroid peroxidase was elevated at 89 IU/mL and anti-La (SS-B) elevated at 2.3 antibody index. Routine electroencephalogram (EEG) was normal. Brain magnetic resonance imaging with and without contrast only showed minimal scattered subcortical and periventricular white matter T2/ FLAIR hyperintensities, which was likely due to chronic small vessel ischemia. Computed tomography scans of the chest, abdomen, and pelvis and scrotal ultrasound did not show evidence of malignancies. The patient's last psychiatric hospitalization at our facility was approximately 22 months after the initial onset of his symptoms of anxiety and paranoia. Symptoms at the time of this hospitalization included severely depressed mood, decreased concentration, psychomotor retardation, and catatonia evidenced by decreased oral intake, marked ambivalence, selective mutism, mannerisms, and negativism. Laboratory results were only notable for slightly elevated alanine transaminase to 60 units/L, which later resolved. Once on the inpatient unit, he was titrated on lorazepam to 4 mg 3 times daily. His sertraline was increased to 100 mg twice a day. He was continued on quetiapine 100 mg nightly for psychosis. Propranolol 20mg twice a day was added for restlessness but eventually was discontinued due to dizziness and lack of efficacy. Symptoms were refractory to medications, so he was ultimately started on ECT about a month after the admission. He received 11 bifrontal ECT treatments during his hospital stay. His score on the Montgomery-Asberg Depression Rating Scale improved from 39 out of 60 at pre- ECT to 18 out of 60 after 11 ECT treatments. He tolerated the ECT treatments well. He was discharged from the hospital two months after his admission. He received 7 additional bifrontal ECT treatments as an outpatient over the course of 3 months. At the time of his last session, he scored 10 out of 60 on the Montgomery-Asberg Depression Rating Scale. As of 10 months after the last ECT session, he had been tapered off his quetiapine and was undergoing a slow taper of his lorazepam. He remained in full remission without any relapse of symptoms and had returned to premorbid level of function.; Sender's Comments: Based on the temporal relationship, the association between the event "Protracted Psychiatric Complications Including Psychosis" with BNT162B2 NOS can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): SG-PFIZER INC-PV202500064750 Master article; Secondary article;
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| 2843553 | 70 | F | NC | 06/02/2025 |
FLU3 |
SEQIRUS, INC. |
388461 |
Pain in extremity
Pain in extremity
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severe pain in right arm, many doctor and PT visits, surgery on rotator cuff
severe pain in right arm, many doctor and PT visits, surgery on rotator cuff
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| 2843554 | 57 | M | MD | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
unknown |
Injection site erythema, Injection site pruritus, Injection site reaction, Injec...
Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Pyrexia
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fever for 1 day; injection site reaction for 3 days (red, hot, mild itchiness)
fever for 1 day; injection site reaction for 3 days (red, hot, mild itchiness)
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| 2843555 | 20 | F | NY | 06/02/2025 |
HPV9 |
MERCK & CO. INC. |
W028573 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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event: after receiving the third vaccine (on 5/22/25), it was discovered that the second vaccine re...
event: after receiving the third vaccine (on 5/22/25), it was discovered that the second vaccine received on 1/22/25 (above) had expired on 1/06/2025. patient was contacted and advised to receive additional hpv vaccine to complete series on or after aug 14 (12 weeks after vaccine given 5/22/25). no symptoms or signs experienced by patient.
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| 2843556 | 1.08 | F | NC | 06/02/2025 |
HEPA MMR MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
H3N97 Y014391 Y019173 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse events noted immediately after the administration and for the duration of the patient app...
No adverse events noted immediately after the administration and for the duration of the patient appointment visit.
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| 2843557 | 76 | M | 06/02/2025 |
MNQ |
SANOFI PASTEUR |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient was administered the 2nd MenQuadfi dose too early. 1st MenQuadfi dose was administered on 4/...
Patient was administered the 2nd MenQuadfi dose too early. 1st MenQuadfi dose was administered on 4/2/2025 and 2nd dose was due on 5/28/2025 however, the 2nd dose was administered on 5/16 which was too early
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| 2843558 | 32 | F | MA | 06/02/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
943888 |
Unevaluable event
Unevaluable event
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HEPLISAV-BGiven at Step Step 1 of 2 Brand HEPLISAV-B Components Hepatitis B vaccine (recombinant), C...
HEPLISAV-BGiven at Step Step 1 of 2 Brand HEPLISAV-B Components Hepatitis B vaccine (recombinant), CpG adjuvanted Route IM Location deltoid Side L Lot No Given at Step Step 1 of 2 Brand HEPLISAV-B Components Hepatitis B vaccine (recombinant), CpG adjuvanted Route IM Location deltoid Side L Lot No 943888 Order details signed on 04/18/25 Order details signed on 04/18/25
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| 2843559 | 0.5 | F | MI | 06/02/2025 |
DTAPIPVHIB DTAPIPVHIB HEP HEP PNC20 PNC20 RV5 RV5 |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
UK307AB UK307AB 7NX57 7NX57 LN4929 LN4929 2091232 2091232 |
Hyperhidrosis, Injection site reaction, Pain in extremity, Pyrexia, Rash; Skin w...
Hyperhidrosis, Injection site reaction, Pain in extremity, Pyrexia, Rash; Skin warm; Hyperhidrosis, Injection site reaction, Pain in extremity, Pyrexia, Rash; Skin warm; Hyperhidrosis, Injection site reaction, Pain in extremity, Pyrexia, Rash; Skin warm; Hyperhidrosis, Injection site reaction, Pain in extremity, Pyrexia, Rash; Skin warm
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injection site reaction, rash and fever, swelling, warmth and pain both lower extremities
injection site reaction, rash and fever, swelling, warmth and pain both lower extremities
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| 2843560 | 12 | F | VT | 06/02/2025 |
HPV9 HPV9 MNQ MNQ TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
Y013407 Y013407 U8375AA U8375AA 3CA30C1 3CA30C1 |
Cold sweat, Head injury, Hyperhidrosis, Hypotension, Pallor; Syncope; Cold sweat...
Cold sweat, Head injury, Hyperhidrosis, Hypotension, Pallor; Syncope; Cold sweat, Head injury, Hyperhidrosis, Hypotension, Pallor; Syncope; Cold sweat, Head injury, Hyperhidrosis, Hypotension, Pallor; Syncope
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Pt fainted 3 minutes after receiving, 3 vaccines. She was pale, clammy and sweaty, BP slightly low, ...
Pt fainted 3 minutes after receiving, 3 vaccines. She was pale, clammy and sweaty, BP slightly low, pulse in 90's. She did hit her head when fainting, no open wound or concussion though. It took her 35 minutes to recover and be discharged. Provider did assess pt.
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| 2843561 | 63 | F | TX | 06/02/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Erythema, Feeling hot, Inflammation
Erythema, Feeling hot, Inflammation
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Redness and inflammation, hot to the touch, two inches wide and 3 inches long. Lasted 3-4 days.
Redness and inflammation, hot to the touch, two inches wide and 3 inches long. Lasted 3-4 days.
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| 2843562 | 61 | M | KY | 06/02/2025 |
PNC21 |
MERCK & CO. INC. |
NDC: 00006-4347 |
Back pain, Dyspnoea, Headache, Injection site reaction, Nausea
Back pain, Dyspnoea, Headache, Injection site reaction, Nausea
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following day, red sore injection site, headaches, back soreness, did not feel like I could take a f...
following day, red sore injection site, headaches, back soreness, did not feel like I could take a full breath, nausea. Day 2, sore injection site, back soreness, still not a full breath.
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| 2843563 | 17 | M | PA | 06/02/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
DD72H U8558BA |
Limb mass, Pain in extremity, Pruritus, Skin warm; Limb mass, Pain in extremity,...
Limb mass, Pain in extremity, Pruritus, Skin warm; Limb mass, Pain in extremity, Pruritus, Skin warm
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Per patient and mother, On Thursday, left arm was more sore. On Friday morning, Left arm was sore, h...
Per patient and mother, On Thursday, left arm was more sore. On Friday morning, Left arm was sore, hot to the touch, itchy, with small lump. Per provider assessment: 2-3 cm erythematous, raised, itchy, not circular at anterior of bicep head, not over deltoid, not fluctuant, no induration. Advised cool compresses and Benadryl as needed.
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| 2843564 | 12 | M | IA | 06/02/2025 |
MNQ MNQ MNQ TDAP TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8493AA U8493AA U8493AA 9YB4G 9YB4G 9YB4G |
Agitation, Dizziness, Dyskinesia, Eye pain, Gait disturbance; Headache, Hypoaest...
Agitation, Dizziness, Dyskinesia, Eye pain, Gait disturbance; Headache, Hypoaesthesia, Nausea, Neck pain, Pain in jaw; Tic, Tremor, Vision blurred; Agitation, Dizziness, Dyskinesia, Eye pain, Gait disturbance; Headache, Hypoaesthesia, Nausea, Neck pain, Pain in jaw; Tic, Tremor, Vision blurred
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Mom got a call from the school nurse on Wednesday, April 30th at 11am stating her son was having a h...
Mom got a call from the school nurse on Wednesday, April 30th at 11am stating her son was having a hard time walking, he was dizzy, nauseous, had a headache and vision was blurry. He has a hx of migraines, so Mom thought it was that. He then started complaining that he had severe neck pain, eye pain, jaw pain and numbness in fingers and told her that he felt like he ?was being stabbed in the brain?. Mom took him to their PCP, and they recommended he go to hospital. When they got to hospital, Mom said the doctor thought this was a side effect of his ADHD med, Adderall, but Mom said he had been on the med for over a year. She told them about the vaccines he had gotten on Monday, April 28th and they said he had just probably developed a tic and that tics can develop at any time. By this time, her son had become agitated, had the shakes and uncontrolled jaw movement. He did not have a fever. They sent them home and told her to give him Benedryl, Advil and take Guaifenesin at bedtime. No CT scan or MRI were done. Mom asked about Myasthenia Gravis and the doctor told her that he did not have this. I did reach out to Mom on May 6th, to see how her son was doing, and she said the involuntary jaw movement lasted until Saturday, May 3rd but everything is now back to normal.
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| 2843565 | 11 | M | MO | 06/02/2025 |
HPV9 |
MERCK & CO. INC. |
Y008119 |
Dizziness, Fall
Dizziness, Fall
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after receiving vaccine and waiting in the clinic, patient was light headed upon exiting and fell in...
after receiving vaccine and waiting in the clinic, patient was light headed upon exiting and fell into the wall. He did not lose consciousness
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| 2843566 | 11 | F | TX | 06/02/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
x024650 v8375AB u7999aa |
Throat tightness; Throat tightness; Throat tightness
Throat tightness; Throat tightness; Throat tightness
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Client stated that she felt like her throat was closing post injections for just a "second.&quo...
Client stated that she felt like her throat was closing post injections for just a "second.". Client was monitored for 15 minutes with no distress noted before being released with no labored respirations. Mother stated that the child was a "Drama Queen."
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| 2843567 | 18 | M | VA | 06/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
55N34 |
Injected limb mobility decreased
Injected limb mobility decreased
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Patient reports since the injection his left arm has been feeling like he has no mobility and is hav...
Patient reports since the injection his left arm has been feeling like he has no mobility and is having trouble using his arm. Patient prefers to defer second dose of vaccine
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