| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2863208 | 39 | F | MD | 10/04/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Abdominal discomfort, Abdominal distension, Abdominal pain, Chest pain, Computer...
Abdominal discomfort, Abdominal distension, Abdominal pain, Chest pain, Computerised tomogram normal; Diarrhoea, Laboratory test normal
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Over 6 days, my wife had increasing adbominal distress and discomfort that worsened day by day into ...
Over 6 days, my wife had increasing adbominal distress and discomfort that worsened day by day into diarrhea, bloating, severe pain, and cramping. Was taken emergently to the ER Wednesday October 2nd when comfronted with 9/10 abdominal pain and chest pain.
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| 2863209 | 87 | F | FL | 10/04/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA4452 UT8781DA |
Decreased appetite, Fatigue, Mobility decreased, Neurological symptom, Pain in e...
Decreased appetite, Fatigue, Mobility decreased, Neurological symptom, Pain in extremity; Decreased appetite, Fatigue, Mobility decreased, Neurological symptom, Pain in extremity
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UNABLE TO MOVE LEGS. EXTEME FATIQUE. DIFFICULTY MOVING/OPENING JAW. LOSS OF APPETITE. EXTREME ARM PA...
UNABLE TO MOVE LEGS. EXTEME FATIQUE. DIFFICULTY MOVING/OPENING JAW. LOSS OF APPETITE. EXTREME ARM PAIN. CAREGIVER DESCRIBE THE SYMPTOMS AS STOKE LIKE. SYMPTOMS STARTED SAME DAY, WORST THE FIRST TWO DAYS BUT NOT GETTING ALL THAT BETTER. HAS APPOINTMENT WITH DOCTOR THIS COMING WEEK.
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| 2863210 | 60 | F | CA | 10/04/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
na0589 tfaa2501 |
Rash; Rash
Rash; Rash
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rash in arm of injections
rash in arm of injections
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| 2863212 | 35 | F | 10/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Supraventricular extrasystoles
Supraventricular extrasystoles
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Premature atrial contractions on ziopatch starting days after Pfizer COVID vaccine in 12/2020, 1/202...
Premature atrial contractions on ziopatch starting days after Pfizer COVID vaccine in 12/2020, 1/2021, 10/2025
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| 2863213 | 82 | F | CA | 10/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Micturition urgency, Urinary incontinence
Micturition urgency, Urinary incontinence
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urinary urge and leakage
urinary urge and leakage
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| 2863214 | 42 | F | CA | 10/04/2025 |
FLU3 |
SEQIRUS, INC. |
|
Pruritus, Syncope, Urticaria
Pruritus, Syncope, Urticaria
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urticaria: first happened at ~2:30am on 10/2 and I took 2 capsules of Allergra (180mg). the second t...
urticaria: first happened at ~2:30am on 10/2 and I took 2 capsules of Allergra (180mg). the second time happened at 3:30pm on 10/3 and gone after an overnight sleep. However, itchy is going on 10/2 - 10/4. Faint: happened at 4:00am on 10/4, twice.
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| 2862897 | M | CA | 10/03/2025 |
FLU3 |
SEQIRUS, INC. |
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Hypoaesthesia
Hypoaesthesia
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Participant stated that his arm felt numb after receiving the vaccination.
Participant stated that his arm felt numb after receiving the vaccination.
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| 2862898 | 20 | M | IN | 10/03/2025 |
TYP YF |
SANOFI PASTEUR SANOFI PASTEUR |
X1A261M uk218aa |
Peripheral swelling, Urticaria; Peripheral swelling, Urticaria
Peripheral swelling, Urticaria; Peripheral swelling, Urticaria
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10/01 SM got the Vaccine, 10/02 SM presented with hives on both arms. 10/03 SM presented with bilate...
10/01 SM got the Vaccine, 10/02 SM presented with hives on both arms. 10/03 SM presented with bilateral hand swelling. SM is currently being prescribed prednisone, fexofenadine, and Lasix.
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| 2862943 | F | MA | 10/03/2025 |
DTPPVHBHPB HEPA |
MSP VACCINE COMPANY MERCK & CO. INC. |
U8313AA Y014585 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE/ no PQC.; HCP reports that patients have been administered vaccines that suffered t...
No additional AE/ no PQC.; HCP reports that patients have been administered vaccines that suffered temperature excursions. After running an assessment its been found that the vaccines have a supported outcome (02793998). Dates of administration and patient demographics are unk; This spontaneous invalid report was received from an Other health professional and refers to patients of unknown ages and genders. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates, the patients started therapy with Hepatitis A Vaccine, Inactivated (VAQTA), Injection, dose not provided (lot #Y014585, expiration date: 01-Feb-2026) as prophylaxis. On an unknown dates, the patients started therapy with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, (VAXELIS), Injection (lot #U8313AA, expiration date: 30-Sep-2027) dose 0.5 ml, as prophylaxis. The vaccines that suffered temperature excursions (temperature 9.38C, for 10 minutes, previous temperature excursion was 1 Hour, 52 Minutes; Temp: 11.33C]. No adverse event was reported. This is an invalid report due to lack of multiple patients identifiers. Follow-up information was received from a clinic volunteer in the form of a questionnaire, on 30-Sep-2025. The patient was a 12-month-old female (at the time of vaccination). It was reported that there were no adverse reactions. There was a temperature excursion which was revolved and the vaccine given was viable. The reporter provided details only for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, (VAXELIS) with new information: route of administration was intramuscular and date of administration was 18-Apr-2025. There was no mention of Hepatitis A Vaccine, Inactivated (VAQTA) (which was conservatively left in the case). This is now a valid case.; Reporter's Comments: Keywords : ; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02794007-02793990 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZFCzGYAX|30092025230036|1922 , Central date : 2025-10-01 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2279933 , MNSC case number : 02794007 , MNSC interaction number : 02793990 , Integration log UniqueID : 500UW00000ZFCzGYAX|30092025230036|1922 , Service cloud CaseID : 500UW00000ZFCzGYAX
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| 2862944 | MA | 10/03/2025 |
HPV9 |
MERCK & CO. INC. |
y018297 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE/No PQC; a PFS of GARDASIL 9 that was activated on 9/19/2025 was not discarded as re...
No additional AE/No PQC; a PFS of GARDASIL 9 that was activated on 9/19/2025 was not discarded as recommended by end of day on 9/19/2025, and was inadvertently administered to a 9yr old on 9/22/2025.; This spontaneous report was received from a nurse and refers to a 9-year-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 19-Sep-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled syringe was activated, but was not discarded as recommended by the end of day. On 22-Sep-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled was inadvertently administered, at a dose of 0.5 mL (lot #y018297, expiration date: 13-Feb-2027) for prophylaxis (Product use issue). No adverse effects were reported.
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| 2862945 | CA | 10/03/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site pain
Injection site pain
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painful injection with GARDASIL 9; This spontaneous report has been received from a pharmacist, rega...
painful injection with GARDASIL 9; This spontaneous report has been received from a pharmacist, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 25-SEP-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) as prophylaxis (dose, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not reported). On 25-SEP-2025, the patient experienced painful injection (pain). The outcome of the event was not provvided. The causal relationship between the event and suspect vaccine was not provided. This case was determined to be non-valid due to the lack of patient's identifiers.
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| 2862946 | CA | 10/03/2025 |
HPV9 |
MERCK & CO. INC. |
Y018297 |
No adverse event, Product storage error
No adverse event, Product storage error
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Medical Assistant noted that there was no symptomatic events reported; medical assistant regarding T...
Medical Assistant noted that there was no symptomatic events reported; medical assistant regarding T/E only GARDASIL-9 was administered.; This spontaneous report was received from medical assistant 01-Oct-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that other vaccines experienced this temperature excursion: pneumococcal 15v conj vaccine (crm197) (VAXNEUVANC), hepatitis a vaccine, inactivated (VAQTA), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), but the vaccines were no administered and the only vaccine administered was Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9). On 30-Sep-2025, the patient was vaccinated with a temperature excursion of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9) prefilled syringe (lot #Y018297, expiration date: 13-Feb-2027) (dose, dose number and route of administration was not reported) for Prophylaxis (Product storage error). Operator of device was reported as a health care professional. The administered dose of the vaccine experienced a temperature excursion 46.2 degrees Fahrenheit for 30 Minutes, no previous temperature excursion reported.
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| 2862947 | M | NJ | 10/03/2025 |
HPV9 |
MERCK & CO. INC. |
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Syncope
Syncope
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a patient fainted during the 15 minute observation period after receiving a GARDASIL 9 dose.; This s...
a patient fainted during the 15 minute observation period after receiving a GARDASIL 9 dose.; This spontaneous report was received from a physician and refers to a 14-year-old male patient. The patient's concurrent conditions included dehydration and was fasting. His medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter. On an unspecified date, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (strength, dose number, route of administration, site of administration, lot #, and expiration date were not provided) given as prophylaxis. Later, during the 15-minute observation period, the patient fainted (Syncope). The patient went to vaccination dehydrated and fasting. At the reporting time, the outcome of the event, as well as, if patient sought medical attention, if treatment was given for the adverse event or if laboratory diagnostics or studies were performed, were unknown. The causal relationship between the event of syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) was not reported. Upon internal review, the event of syncope was determined to be medically significant. Batch/Lot number is being requested and will be submitted if received.
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| 2862948 | 2 | F | TX | 10/03/2025 |
HPV9 |
MERCK & CO. INC. |
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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 other AE; Inadvertent administration of GARDASIL 9 to a 2 year old girl; This spontaneous report ...
No other AE; Inadvertent administration of GARDASIL 9 to a 2 year old girl; This spontaneous report was received from a medical assistant, concerning a 2-year-old female (reported as girl) patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 02-Oct-2025, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (route of administration, anatomical location, lot #, and expiration date were not reported) administered as prophylaxis (Product administered to patient of inappropriate age). The medical assistant would not provide further patient information and refused to provide the lot and expiration date or any other information regarding the product. No other adverse event (AE) nor PQC were reported. Lot # is being requested and will be submitted if received.
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| 2862949 | F | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Deafness unilateral
Deafness unilateral
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Lost my hearing in my Left ear; This serious case was reported by a consumer via interactive digital...
Lost my hearing in my Left ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced hearing loss (Verbatim: Lost my hearing in my Left ear) (serious criteria disability and GSK medically significant). The outcome of the hearing loss was not resolved. The reporter considered the hearing loss to be related to Shingrix. The company considered the hearing loss to be unrelated to Shingrix. Additional Information: GSK receipt date: 26-SEP-2025 This case was reported by a patient via interactive digital media. Consumer reported that took first shingles shots and the next day lost hearing in left ear. The reporter mentioned no more took shots now and had to get hearing AIDS.; Sender's Comments: A case of Deafness, 1 day after receiving 1st dose of Shingrix, in a female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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| 2862952 | F | 10/03/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
7SS27 |
Wrong product administered
Wrong product administered
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was given wrong vaccine without side effects; This non-serious case was reported by other health pro...
was given wrong vaccine without side effects; This non-serious case was reported by other health professional and described the occurrence of wrong vaccine administered in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 7SS27, expiry date 31-OCT-2026) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. Concomitant products included ethinylestradiol;norgestimate (Ortho Tri-Cyclen). On 28-AUG-2025, the patient received Menveo (intramuscular). The patient did not receive Bexsero. On 28-AUG-2025, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: was given wrong vaccine without side effects). The outcome of the wrong vaccine administered 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: 04-SEP-2025 A patient was administered the wrong vaccine Menveo instead of Bexsero, but the patient did not experience any symptoms. No treatment was required, as no symptoms were reported. It was reported that patient had administered ortho tri cyclene for birth control.
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| 2862953 | F | VA | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Dry skin, Injection site erythema, Injection site warmth, Skin warm
Dry skin, Injection site erythema, Injection site warmth, Skin warm
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she had a red injection site that was hot; she had a red injection site that was hot; Hot dry skin; ...
she had a red injection site that was hot; she had a red injection site that was hot; Hot dry skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site erythema (For tolerance to first dose refer case US2025AMR115960). On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she had a red injection site that was hot), injection site warmth (Verbatim: she had a red injection site that was hot) and hot dry skin (Verbatim: Hot dry skin). Rechallenge with Shingrix was positive. The outcome of the injection site erythema, injection site warmth and hot dry skin were resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and hot dry skin to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site warmth and hot dry skin to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR115960 Additional Information: GSK Receipt Date: 05-Sep-2025 The patient reported that six or seven years ago she received the Shingrix series. In 2018, the patient had all the reported events.; Sender's Comments: US-GSK-US2025AMR115960:same reporter
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| 2862954 | 59 | M | NY | 10/03/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Extra dose administered
Extra dose administered
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the HCP mentioned that it was not a 4-month period, it was a 5-month period; This non-serious case w...
the HCP mentioned that it was not a 4-month period, it was a 5-month period; 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 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9JT4S) for prophylaxis. Previously administered products included Boostrix (received 1st dose of boostrix on 2 APR 2025, batch number XN575). On 04-SEP-2025, the patient received the 2nd dose of Boostrix. On 04-SEP-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: the HCP mentioned that it was not a 4-month period, it was a 5-month period). The outcome of the extra dose administered 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-SEP-2025 During the call, the reporter mentioned that it was not a 4-month period, it was a 5-month period. The vaccine administration facility was the same as primary reporter.
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| 2862955 | 67 | M | FL | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site vesicles
Injection site vesicles
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blister at the injection site; This non-serious case was reported by a pharmacist via call center re...
blister at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date). On 12-SEP-2025, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 14-SEP-2025, 2 days after receiving Shingrix, the patient experienced injection site blisters (Verbatim: blister at the injection site). The outcome of the injection site blisters was not resolved. It was unknown if the reporter considered the injection site blisters to be related to Shingrix. It was unknown if the company considered the injection site blisters to be related to Shingrix. Additional Information: GSK Receipt Date: 15-SEP-2025 The pharmacist reported that the patient had received the Shingrix vaccine and had noticed a blister at the injection site, which was described as a shiny bubble, half the size of a dime (0.67 millimeter). The batch number was not provided and a request for this information has been made.
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| 2862956 | F | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Muscular weakness
Muscular weakness
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she is experiencing muscle weakness now; This non-serious case was reported by a consumer via call c...
she is experiencing muscle weakness now; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle weakness (Verbatim: she is experiencing muscle weakness now). The outcome of the muscle weakness was not resolved. It was unknown if the reporter considered the muscle weakness to be related to Shingrix. It was unknown if the company considered the muscle weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 25-SEP-2025 The patient reported that she received Shingrix vaccine over a year ago. The patient states she was experiencing muscle weakness now.
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| 2862958 | 10/03/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failu...
Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure; Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure; Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure
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Suspected Vaccination Failure; shingles nearly 3 weeks ago, and it was all over my body, but primari...
Suspected Vaccination Failure; shingles nearly 3 weeks ago, and it was all over my body, but primarily my eye; shingles nearly 3 weeks ago, and it was all over my body, but primarily my ear; shingles nearly 3 weeks ago, and it was all over my body, but primarily my face, neck and chest.; 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 Varicella zoster vaccine for prophylaxis and Varicella zoster vaccine for prophylaxis. The patient's past medical history included chickenpox (had twice as a youngster). On an unknown date, the patient received Shingles vaccine, the 2nd dose of Varicella zoster vaccine and the 1st dose of Varicella zoster vaccine. In SEP-2025, an unknown time after receiving Shingles vaccine, Varicella zoster vaccine and Varicella zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles nearly 3 weeks ago, and it was all over my body, but primarily my eye) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles nearly 3 weeks ago, and it was all over my body, but primarily my ear) (serious criteria GSK medically significant) and shingles (Verbatim: shingles nearly 3 weeks ago, and it was all over my body, but primarily my face, neck and chest.). The outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingles vaccine, Varicella zoster vaccine and Varicella zoster vaccine. The company considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be unrelated to Shingles vaccine. It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Varicella zoster vaccine and Varicella zoster vaccine. Additional Information: GSK Receipt Date: 24-SEP-2025 This case was reported by a patient via interactive digital media. Th patient also received the 2 original shingles vaccines plus the newest vaccine and got shingles nearly 3 weeks ago, and it was all over his/her body, but primarily my face, eyes, ears, neck and chest. The patient said that people also need to hear the other side of the argument and said yes and the shingles are terrible. The individuals should get inoculated against shingles. However, the patient was an individual who had chickenpox twice as a youngster, The patient said that trust me, if you are an individual who was living under any type of stress, there's a high likelihood that you will contract shingles, especially if you're over 50-years old. Furthermore, you can get them over and over again and people need to be aware of that fact. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, Ophthalmic herpes zoster and Herpes zoster oticus, on an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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| 2862959 | 10/03/2025 |
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 adult patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included herpes virus infection (had in the 70s due to unprotected sex, for decades then it was settled down), stress (herpes came back when the patient was stressed) and feels awful. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster 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 was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 23-SEP-2025 This was reported by the patient via (Open field AE monitoring) interactive digital media. The patient experienced shingles for the first time ever and they were horrible. Patient got prescribed for additional medications. However, several days into the treatment, there were no changes. 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. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in an adult patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2862960 | F | 10/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash, Rash morbilliform
Rash, Rash morbilliform
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measles-like /spreading right forearm and left arm and on chest; This non-serious case was reported ...
measles-like /spreading right forearm and left arm and on chest; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of measles-like rash in a female patient who received MMR (Priorix) for prophylaxis. On 12-SEP-2025, the patient received Priorix. On 16-SEP-2025, 4 days after receiving Priorix, the patient experienced measles-like rash (Verbatim: measles-like /spreading right forearm and left arm and on chest). The outcome of the measles-like rash was not resolved. It was unknown if the reporter considered the measles-like rash to be related to Priorix and Priorix Pre-Filled Syringe Device. It was unknown if the company considered the measles-like rash to be related to Priorix and Priorix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-SEP-2025 and 25-SEP-2025 The pharmacist self-reported this case for herself. The patient had received the Priorix vaccine last Friday. Starting on Tuesday, and definitely by Wednesday morning, the patient woke up with what seemed like a measles-like rash as described in the package insert. The patient mentioned that it kept spreading, it was mostly on the right under forearm but had spread to the forearm and was climbing up and it had also appeared on the left arm and slightly on the chest, and it kept getting worse.
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| 2862961 | 10/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Rash, Vaccination failure
Herpes zoster, Rash, Vaccination failure
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Suspected vaccination failure; Still got shingles but it was on my butt; This serious case was repor...
Suspected vaccination failure; Still got shingles but it was on my butt; 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: Still got shingles but it was on my butt). 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: 25-SEP-2025 This case was reported by a patient via interactive digital media. Patient stated that several of neighbors had shingles and patient knew they suffered greatly so patient went and got the Shingles vaccine as soon as possible. Patient still got shingles but it was on his/her butt. As the rash was dried up patient showed it to primary care and physician told patient that was shingles and it looked like it was really painful. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a? possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2862962 | F | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles at the age of 53 years old). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 27-SEP-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she had received the vaccine afterwards but now have shingles again just one shingle. The patient stated that one could get shingles again, and that it was a current condition which could recur. The batch number was not provided, and we are unable to contact the reporter. 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: A case of Vaccination failure, an unknown time after receiving Shingrix, in a 57-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2862963 | M | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; still got shingles the pain is under bearable; This serious case was ...
Suspected vaccination failure; still got shingles the pain is under bearable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles the pain is under bearable). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 27-SEP-2025 This case was reported by a patient via interactive digital media. The patient got a Shingles shot (Shingrix) and still got shingles the pain was under bearable. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a adult male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2862964 | F | 10/03/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; had two shingles vaccines and she got shingles anyway; This serious c...
Suspected vaccination failure; had two shingles vaccines and she got shingles anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shingles vaccines and she got shingles anyway). 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 26-SEP-2025 This case was reported by the friend of the patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving 1st and 2nd dose of Shingles vaccine, in a female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2862966 | 26 | F | GA | 10/03/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
H4K3S |
Exposure during pregnancy, Extra dose administered, Wrong product administered; ...
Exposure during pregnancy, Extra dose administered, Wrong product administered; Exposure during pregnancy, Extra dose administered, Wrong product administered
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Boostrix first dose administration during pregnancy; received two shots of Boostrix (2 months apart)...
Boostrix first dose administration during pregnancy; received two shots of Boostrix (2 months apart) when she was supposed to receive a Human Papillomavirus shot; Boostrix extra dose administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4K3S, expiry date 30-OCT-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and HPV vaccine VLP rL1 2v (baculovirus) (Human papillomavirus (types 16, 18) vaccine, adsorbed) for prophylaxis. On 05-SEP-2025, the patient received the 2nd dose of Boostrix. In JUL-2025, the patient received the 1st dose of Boostrix. The patient did not receive Human papillomavirus (types 16, 18) vaccine, adsorbed. On 05-SEP-2025, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received two shots of Boostrix (2 months apart) when she was supposed to receive a Human Papillomavirus shot) and extra dose administered (Verbatim: Boostrix extra dose administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Boostrix first dose administration during pregnancy). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and extra dose administered were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Exposure (Human papillomavirus (types 16, 18) vaccine, adsorbed): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing 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-SEP-2025 The reporter asked for safety data after a patient experienced adverse events (medication error events). The vaccine administration facility was the same as primary reporter. The batch number was not provided upon follow- up with the reporter.
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| 2862967 | F | FL | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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A patient received the 1st dose of Shingrix in 2019 and never completed the series; This non-serious...
A patient received the 1st dose of Shingrix in 2019 and never completed the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose in 2019 from batch number 3P25J with expiry date 21-SEP-2021). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: A patient received the 1st dose of Shingrix in 2019 and never completed the series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-SEP-2025 The pharmacist wanted to know did the patient needs a whole new schedule of Shingrix. This case was linked with US2025AMR118879, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR118879:same reporter / different patient
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| 2862968 | 64 | F | MA | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3E27G |
Product preparation issue
Product preparation issue
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Shingrix adjuvant alone administration; Shingrix adjuvant alone administration; This non-serious cas...
Shingrix adjuvant alone administration; Shingrix adjuvant alone administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3E27G, expiry date 28-APR-2027) for prophylaxis. On 22-SEP-2025, the patient received Shingrix. On 22-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant alone administration) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant alone administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 22-SEP-2025 A Registered nurse enquired about the procedure to follow after the administration of adjuvant alone of Shingrix to a patient.
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| 2862969 | 53 | M | WA | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3E27G |
Product preparation issue
Product preparation issue
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Administration of adjuvant only; Administered mixed vaccine on same say as invalid dose.; This non-s...
Administration of adjuvant only; Administered mixed vaccine on same say as invalid dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 3E27G, expiry date 28-APR-2027) for prophylaxis. On 24-SEP-2025, the patient received the 1st dose of Shingrix. On 24-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Administration of adjuvant only) and inappropriate preparation of medication (Verbatim: Administered mixed vaccine on same say as invalid dose.). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 24-SEP-2025 The nurse reported that the medical assistant inadvertently just gave the liquid portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, They administered it she also went and administered a mixed vaccine on top of that.
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| 2862970 | 32 | F | MD | 10/03/2025 |
RSV |
PFIZER\WYETH |
MM9159 |
Exposure during pregnancy, Extra dose administered
Exposure during pregnancy, Extra dose administered
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Patient received two separate doses of Abrysvo during this pregnancy. First done was administered in...
Patient received two separate doses of Abrysvo during this pregnancy. First done was administered in her L deltoid on 9/12/2025 and the second was administered in her L deltoid on 9/19/2025. The patient was 34.0 weeks pregnant at time of second dose. She is currently 36.0 weeks pregnant. Weight at time of second dose was 226.8 lbs. Estimated date of delivery is 10/31/25.
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| 2862971 | 89 | F | IL | 10/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4TY55 |
Extra dose administered
Extra dose administered
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Patient was given, unbeknownst to her, Abresvo on 11-05-2024 at another facility...I verified admini...
Patient was given, unbeknownst to her, Abresvo on 11-05-2024 at another facility...I verified administration with staff
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| 2862973 | 29 | F | KY | 10/03/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7FY52 7FY52 |
Bell's palsy, Eyelid function disorder, Facial paralysis, Fatigue, Headache...
Bell's palsy, Eyelid function disorder, Facial paralysis, Fatigue, Headache; Injection site swelling, Muscle twitching, Myalgia, Pyrexia
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Friday September 12, 2025, after the vaccine I experienced swelling on the injection site, muscle ac...
Friday September 12, 2025, after the vaccine I experienced swelling on the injection site, muscle aches, Saturday September 13,2025 I had muscle aches, fever, severe headache, fatigue, Sunday September 14, 2025, same symptoms, muscle aches, fever, severe headache, fatigue. Following dates September 15,16,17,18 facial twitching, severe headaches. September 19, 2025, left side of face paralyzed, unable to close left eye, severe headache.
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| 2862974 | 39 | F | AR | 10/03/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2L353 |
Dyspnoea, Ocular hyperaemia
Dyspnoea, Ocular hyperaemia
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Reports SOB and "blood shot eyes" couple hours after vaccine administration. Patient went ...
Reports SOB and "blood shot eyes" couple hours after vaccine administration. Patient went to the ER and was given benadryl, side effects were resolved shortly after.
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| 2862975 | 51 | F | OH | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
594G2 |
Pain
Pain
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8/20/25 Began having intermittent burning type nerve pain in right outer thigh area. Symptoms last a...
8/20/25 Began having intermittent burning type nerve pain in right outer thigh area. Symptoms last a few seconds. Nothing exacerbates, nothing alleviates the pain. Has been occurring everyday since vaccination.
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| 2862976 | 75 | F | KY | 10/03/2025 |
FLU3 |
SANOFI PASTEUR |
U8855BA |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Injection site reaction (redness, swelling) down left arm, lasting 7 days
Injection site reaction (redness, swelling) down left arm, lasting 7 days
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| 2862977 | 24 | M | NC | 10/03/2025 |
FLU3 TYP YF |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
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Injection site reaction, Rash erythematous; Injection site reaction, Rash erythe...
Injection site reaction, Rash erythematous; Injection site reaction, Rash erythematous; Injection site reaction, Rash erythematous
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patient displayed red rash on vaccine site for yellow fever. no fever, no puritis . patient symptoms...
patient displayed red rash on vaccine site for yellow fever. no fever, no puritis . patient symptoms documented.
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| 2862978 | 78 | M | NY | 10/03/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
|
Chills, Cough, Pain, Rash pruritic, Rhinorrhoea; Chills, Cough, Pain, Rash pruri...
Chills, Cough, Pain, Rash pruritic, Rhinorrhoea; Chills, Cough, Pain, Rash pruritic, Rhinorrhoea
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chills, body aches, itchy rash left side ear to hip, runny nose, cough
chills, body aches, itchy rash left side ear to hip, runny nose, cough
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| 2862980 | 65 | F | SC | 10/03/2025 |
COVID19 |
MODERNA |
3052583 |
Erythema, Mass, Pain, Swelling
Erythema, Mass, Pain, Swelling
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swelling, redness, and painful lump; about the size of 2 quarters (if put next to each other). Pt go...
swelling, redness, and painful lump; about the size of 2 quarters (if put next to each other). Pt going to follow up with md
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| 2862981 | 62 | F | 10/03/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2NG23 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Patient received flu vaccine via IV injection at 09:27. Patient monitored closely. Asymptomatic at t...
Patient received flu vaccine via IV injection at 09:27. Patient monitored closely. Asymptomatic at time of injection. VSS.
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| 2862982 | 81 | F | NJ | 10/03/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Headache
Headache
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Pt said she ended up getting heavy headaches back to back nights after that first one went to er.
Pt said she ended up getting heavy headaches back to back nights after that first one went to er.
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| 2862983 | 18 | F | FL | 10/03/2025 |
MENB MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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Abdominal discomfort, Chills, Diarrhoea, Dizziness, Dyspnoea; Electrocardiogram,...
Abdominal discomfort, Chills, Diarrhoea, Dizziness, Dyspnoea; Electrocardiogram, Fatigue, Haemoglobin decreased, Loss of personal independence in daily activities, Pain in extremity; X-ray
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Employee was the medical assistant, another girl whose name we did not get administered the vaccine ...
Employee was the medical assistant, another girl whose name we did not get administered the vaccine via intramuscular left arm around 4:45/5pm on 9/29. Was supposed to administer the MCV4 Booster but inadvertently administered meningococcal B Patient Started having dizziness, difficulty breathing, fatigue, L arm pain down to left leg at starting at 8am on 9/30 throughout the day. Later on at work that same day around 7pm she stated that she almost fainted twice, had chills, was disoriented and had some difficulty breathing while at work. I took her to the ER around 9:30pm. They drew blood, did an EKG, X-rays and provided IV fluids. She was diagnosed with an adverse reaction to the vaccine received , discharged to home around 11:30 and was told to follow up with her PCP. She did end up missing school or 2 days due to diarrhea, upset stomach and continued dizziness.
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| 2862984 | M | AZ | 10/03/2025 |
RSV |
PFIZER\WYETH |
MM9148 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Pt. was given Abrysvo when he was supposed to get Beyfortus. No adverse reactions noted. Poison c...
Pt. was given Abrysvo when he was supposed to get Beyfortus. No adverse reactions noted. Poison control was notified and pt. watched for an hour, and all vital signs remained stable.
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| 2862985 | 45 | F | OH | 10/03/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0161 EW0161 |
Conversion disorder, Dizziness, Headache, Hypertension, Ischaemic stroke; Loss o...
Conversion disorder, Dizziness, Headache, Hypertension, Ischaemic stroke; Loss of consciousness, Neuropathy peripheral, Seizure
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4 days later became light headed and passed out at work, was taken to hospital via ambulance with ex...
4 days later became light headed and passed out at work, was taken to hospital via ambulance with extreme high blood pressure and headaches. Released with diagnosis of high blood pressure and headaches as root cause. never had either one prior to.
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| 2862986 | 71 | M | ID | 10/03/2025 |
PNC21 |
MERCK & CO. INC. |
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Burning sensation, Pruritus, Pyrexia, Rash, Urticaria
Burning sensation, Pruritus, Pyrexia, Rash, Urticaria
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Hives, rash, itch, burning, fever
Hives, rash, itch, burning, fever
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| 2862987 | 77 | M | 10/03/2025 |
FLU3 |
SEQIRUS, INC. |
407248 |
Extra dose administered
Extra dose administered
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Vaccine given per provider order during record system Downtime. Patient made aware of receiving flu ...
Vaccine given per provider order during record system Downtime. Patient made aware of receiving flu vaccine and made no comment or statement that he had already gotten one. Once record system came back hours later, was documenting vaccine in chart and saw patient had already gotten flu vaccine in August 2025.
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| 2862988 | 8 | M | NM | 10/03/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Pain
Pain
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1 dose of Comirnaty prefilled covid-19 vaccine 0.3mL given to 8 year old male. No symptoms or treatm...
1 dose of Comirnaty prefilled covid-19 vaccine 0.3mL given to 8 year old male. No symptoms or treatment required. Localized soreness reported.
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| 2862990 | 7 | F | AR | 10/03/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2L353 |
Injected limb mobility decreased, Injection site erythema, Injection site indura...
Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
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Left arm injection site red, swollen, hard and warm to the touch. area affected measured 4 inches b...
Left arm injection site red, swollen, hard and warm to the touch. area affected measured 4 inches by 3 inches and covered most of the upper arm. The upper arm felt tight and stiff. Mother had applied benadryl cream and ice pack. Had appointment to see PCP.
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| 2862992 | 17 | M | AL | 10/03/2025 |
FLU3 MENB MNQ |
SEQIRUS, INC. PFIZER\WYETH SANOFI PASTEUR |
406989 HP9988 U8573AA |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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12 - 24 hours after vaccine, patient develop pain, redness, swelling and warmth at injection site on...
12 - 24 hours after vaccine, patient develop pain, redness, swelling and warmth at injection site on L deltoid. Reaction spread to a greatest dimension of 15 cm x 7 cm. Advised NSAIDs PRN, cold compresses. Given history of immunoglobulin deficiency, size of reaction, warmth, treated with Keflex for possible cellulitis on 10/3/25.
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