| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2850742 | 72 | F | 07/22/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
j4k4x |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Vaccine given was pediatric dose. (0.5 mL)
Vaccine given was pediatric dose. (0.5 mL)
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| 2850743 | 5 | F | MO | 07/22/2025 |
DTAP HEP IPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
3CA03C3 W038864 W1C831M Y020301 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered; Expired product administered
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Administered dose of Hep B expired at time of administration. Error caught within 15 minutes of admi...
Administered dose of Hep B expired at time of administration. Error caught within 15 minutes of administration. Parent requested no repeat administration at this time; prefers to wait 4 weeks and administer with next vaccines due. No reaction noted 45 minutes after administration.
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| 2850744 | 66 | F | TN | 07/22/2025 |
PNC21 |
MERCK & CO. INC. |
Z004302 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Vaccine ordered by PCP. Vaccine was given by me, checked vaccine administration record after, patien...
Vaccine ordered by PCP. Vaccine was given by me, checked vaccine administration record after, patient had already received vaccine in March of 2025. Extra dose was not indicated/needed at this time. Provider notified. Patient left clinic with no difficulties and did not exhibit signs of adverse reaction. Patient was called and notified of vaccination error.
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| 2850745 | 1.25 | F | IL | 07/22/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; Kinrix was ...
Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; Inappropriate schedule of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Dtap vaccine (received 3 doses of DTap vaccine on an unknown date) and IPV vaccine (received 3 doses of IPV vaccine on an unknown date). On 07-JUL-2025, the patient received Kinrix. The patient did not receive Infanrix. On 07-JUL-2025, an unknown time after receiving Kinrix, the patient had wrong vaccine administered (Verbatim: Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix), inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule 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: 09-JUL-2025 The medical assistant called to report on 07th July 2025 a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient had 3 doses of Dtap and IPV before Kinrix administration, which led to inappropriate schedule of vaccine administered. The healthcare professional mentioned that the patients were twin sisters. This case is 1 of 2 linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2025087840:Same reporter/Diffrent patient
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| 2850746 | 1.25 | F | IL | 07/22/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; b...
a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; before recommended age; Inappropriate schedule of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Dtap vaccine (received 3 doses of Dtap vaccine on an unknown date) and IPV vaccine (received 3 doses of IPV vaccine on an unknown date). On 07-JUL-2025, the patient received Kinrix. The patient did not receive Infanrix. On 07-JUL-2025, an unknown time after receiving Kinrix, the patient had wrong vaccine administered (Verbatim: a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix), inappropriate age at vaccine administration (Verbatim: before recommended age) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule 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: 09-JUL-2025 The medical assistant called to report on 07th July 2025 a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient had 3 doses of Dtap and IPV before Kinrix administration, which led to inappropriate schedule of vaccine administered. The healthcare professional mentioned that the patients were twin sisters. This case is 1 of 2 linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2025088165:Same reporter/Diffrent patient
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| 2850747 | MS | 07/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Intercepted product storage error
Intercepted product storage error
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they were planning on administering Boostrix/possible administration after temperature excursion; Th...
they were planning on administering Boostrix/possible administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 14-JUL-2025, the patient did not receive Boostrix. The patient had intercepted product storage error (Verbatim: they were planning on administering Boostrix/possible administration after temperature excursion). The outcome of the intercepted product storage error was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-JUL-2025 A nurse practitioner called in to request data about the stability of boostrix and Infanrix after an excursion, stated that they were planning on administering boostrix which led to intercepted product storage error. During the call, it was incredibly difficult to understand the conversation due to technical issues. The possible event was filed with the limited data that was able to be collected, although it was important to clarify that the dose was not administered, but being planned on being administered. The vaccine administration facility was the same as primary reporter.
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| 2850748 | 17 | M | MO | 07/22/2025 |
COVID19 FLU3 MENB |
MODERNA GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
B0005 45546 B4J4B |
Pectus excavatum, Poor quality product administered, Product temperature excursi...
Pectus excavatum, Poor quality product administered, Product temperature excursion issue; Pectus excavatum, Poor quality product administered, Product temperature excursion issue; Pectus excavatum, Poor quality product administered, Product temperature excursion issue
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Pectus excavatum; Vaccine was administered after excursion on 17-Dec-2024; Liquid vaccine was expose...
Pectus excavatum; Vaccine was administered after excursion on 17-Dec-2024; Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes; This spontaneous case was reported by a nurse and describes the occurrence of PECTUS EXCAVATUM (Pectus excavatum) in a 17-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Influenza vaccine inact split 3v (Flulaval) for an unknown indication and Meningococcal vaccine B (MenB) for an unknown indication. Concurrent medical conditions included Pseudostrabismus since 17-May-2014, Congenital tracheomalacia since 17-May-2014, Asthma since 09-Aug-2017 and Wheezing. Concomitant products included Salbutamol (Albuterol Hfa) from 09-Aug-2017 to an unknown date and Salbutamol sulfate (Albuterol) from 09-Aug-2017 to an unknown date for Wheezing. On 17-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form, dose of Influenza vaccine inact split 3v (Flulaval) (Intramuscular use) 1 dosage form and dose of Meningococcal vaccine B (MenB) (Intramuscular use) 1 dosage form. On 13-Dec-2024, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes). On 17-Dec-2024, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). On 15-Apr-2025, the patient experienced PECTUS EXCAVATUM (Pectus excavatum) (seriousness criterion medically significant). At the time of the report, PECTUS EXCAVATUM (Pectus excavatum) had not resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered PECTUS EXCAVATUM (Pectus excavatum) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). Another co-suspect vaccine included MenACWY vaccine which was given to patient on 17-Dec-2024 for unknown indication via intramuscular route in left deltoid and it's batch number was reported as ek7D6. Patient was not allergic to any medications, food, and other products. HCP reported multiple excursions in their refrigerator over a period ranging from 03-Dec-2024 to 11-Jun-2025. The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes respectively. On 13-Dec-2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range was reported as 16 minutes. No Moderna geriatric vaccine was stored in their refrigerator after 04-Feb-2025. No adverse events were reported in relation to the vaccination of 17-Dec-2024. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787640 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2025: Significant follow-up received in which case was upgrade from non-serious to serious, no patient identifier classification was removed, updated reporter's occupation as nurse, patient demographic was added (initial, age, gender, height, weight, race, ethnic group), other relevant history was added, suspect product vaccination information was updated (vaccination date, anatomical location), new co-suspect of Flulaval, MenB and Menacwy was added, new concomitant medication of Albuterol Hfa and Albuterol was added, new event of Pectus excavatum was added, reported event verbatim was updated, case narrative was updated.; Reporter's Comments: PECTUS EXCAVATUM was assessed as not related to SPIKEVAX 2024-2025 PFS due to nature of reported event, which is commonly assessed as congenital defect. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787640:Master case
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| 2850749 | 75 | F | TX | 07/22/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
064H21A 064H21A 064H21A 064H21A |
Alopecia, Blood thyroid stimulating hormone decreased, Blood thyroid stimulating...
Alopecia, Blood thyroid stimulating hormone decreased, Blood thyroid stimulating hormone increased, Dilated pores, Fatigue; Heart rate, Heart rate decreased, Intentional product use issue, Thyroid function test, Vaccination site discolouration; Vaccination site dryness, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth; Vision blurred
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I do believe my two Moderna booster vaccines are affecting the results of my thyroid TSH test. After...
I do believe my two Moderna booster vaccines are affecting the results of my thyroid TSH test. After the first booster, my TSH numbers increased more than double.; After my second booster, my TSH numbers fell to an extremely low number; my eyes have been very blurry; my hair is falling out. I'm losing so much of my hair" and "my eyes have been very blurry; Pulse rate low; just so tired/kind of tired; currently prescribed Synthroid 100 mcg daily but taking Synthroid 112 mcg once daily instead; my skin in that area is darker; The large red part is below the injection site. It was slightly swollen and was eight degrees hotter than the rest of my skin/the bright red part was slightly swollen and we have a temperature probe; This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin; The large red part is below the injection site. It was slightly swollen and was eight degrees hotter than the rest of my skin/the bright red part was slightly swollen and we have a temperature probe; This area was painful/physically it was just the normal kind of hurting of the arm; The large red part is below the injection site/~the second booster, I had a very bad reaction to it. Below the injection site, my arm turned bright red; This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE INCREASED (I do believe my two Moderna booster vaccines are affecting the results of my thyroid TSH test. After the first booster, my TSH numbers increased more than double.), BLOOD THYROID STIMULATING HORMONE DECREASED (After my second booster, my TSH numbers fell to an extremely low number), VISION BLURRED (my eyes have been very blurry), ALOPECIA (my hair is falling out. I'm losing so much of my hair" and "my eyes have been very blurry) and DILATED PORES (This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05FMZ1/IP and 064H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Levothyroxine sodium (Synthroid) for Thyroid disorder. The patient's past medical history included Radioactive iodine therapy in 1980. Previously administered products included for COVID-19 prophylaxis: Moderna (First dose, Lot - 008B21A) on 23-Mar-2021, Moderna (Second dose and Lot - 047B21A) on 21-Apr-2021. Past adverse reactions to the above products included No adverse effect with Moderna and Moderna. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2025, Levothyroxine sodium (Synthroid) (unknown route) dosage was changed to 150 microgram. On an unknown date, the patient started Levothyroxine sodium (Synthroid) (unknown route) 137 microgram. On an unknown date, Levothyroxine sodium (Synthroid) (unknown route) dosage was changed to 125 microgram and Levothyroxine sodium (Synthroid) (unknown route) dosage was changed to 112 microgram once a day. On 28-May-2022, the patient experienced DILATED PORES (This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin), VACCINATION SITE WARMTH (The large red part is below the injection site. It was slightly swollen and was eight degrees hotter than the rest of my skin/the bright red part was slightly swollen and we have a temperature probe), VACCINATION SITE DRYNESS (This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin), VACCINATION SITE SWELLING (The large red part is below the injection site. It was slightly swollen and was eight degrees hotter than the rest of my skin/the bright red part was slightly swollen and we have a temperature probe), VACCINATION SITE PAIN (This area was painful/physically it was just the normal kind of hurting of the arm) and VACCINATION SITE ERYTHEMA (The large red part is below the injection site/~the second booster, I had a very bad reaction to it. Below the injection site, my arm turned bright red). In 2025, the patient experienced VACCINATION SITE DISCOLOURATION (my skin in that area is darker). On an unknown date, the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (I do believe my two Moderna booster vaccines are affecting the results of my thyroid TSH test. After the first booster, my TSH numbers increased more than double.), BLOOD THYROID STIMULATING HORMONE DECREASED (After my second booster, my TSH numbers fell to an extremely low number), VISION BLURRED (my eyes have been very blurry), ALOPECIA (my hair is falling out. I'm losing so much of my hair" and "my eyes have been very blurry), HEART RATE DECREASED (Pulse rate low), FATIGUE (just so tired/kind of tired) and INTENTIONAL PRODUCT USE ISSUE (currently prescribed Synthroid 100 mcg daily but taking Synthroid 112 mcg once daily instead). At the time of the report, BLOOD THYROID STIMULATING HORMONE INCREASED (I do believe my two Moderna booster vaccines are affecting the results of my thyroid TSH test. After the first booster, my TSH numbers increased more than double.), BLOOD THYROID STIMULATING HORMONE DECREASED (After my second booster, my TSH numbers fell to an extremely low number), DILATED PORES (This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin), VACCINATION SITE DISCOLOURATION (my skin in that area is darker), VACCINATION SITE PAIN (This area was painful/physically it was just the normal kind of hurting of the arm), VACCINATION SITE ERYTHEMA (The large red part is below the injection site/~the second booster, I had a very bad reaction to it. Below the injection site, my arm turned bright red), FATIGUE (just so tired/kind of tired) and INTENTIONAL PRODUCT USE ISSUE (currently prescribed Synthroid 100 mcg daily but taking Synthroid 112 mcg once daily instead) outcome was unknown, VISION BLURRED (my eyes have been very blurry), ALOPECIA (my hair is falling out. I'm losing so much of my hair" and "my eyes have been very blurry), HEART RATE DECREASED (Pulse rate low) and VACCINATION SITE DRYNESS (This area was painful and my skin became dry plus my pores were enlarged/It was a very weird reaction. the area that was very red, it just dried out my skin and it enlarged the pores of my skin) had not resolved and VACCINATION SITE WARMTH (The large red part is below the injection site. It was slightly swollen and was eight degrees hotter than the rest of my skin/the bright red part was slightly swollen and we have a temperature probe) and VACCINATION SITE SWELLING (The large red part is below the injection site. It was slightly swollen and was eight degrees hotter than the rest of my skin/the bright red part was slightly swollen and we have a temperature probe) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: now is my pulse rate is getting to be much lower than it should be low pulse rate went all the way down below normal.. On an unknown date, Thyroid function test: abnormal and TSH number "shot way up went more than double the number of normal. They went way up into the high area.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that everything went well with the first two shots. It was reported that after second booster, patient had a very bad reaction. Below the injection site, the arm turned bright red and the bright red part was slightly swollen and that red part was 8 degrees hotter than the rest of the skin it lasted, and it started fading a little bit after a week and then it gradually started fading. Patient had problems with her thyroid tests. Patient had radioactive iodine from the thyroid in 1980 and was perfectly fine until had the first booster. The spot was visible the area on my arm where it affected my arm. After first COVID booster shot, physically it was just the normal kind of hurting of the arm, kind of tired, so not any big deal but patient's TSH number shot way up it went more than double the number of normal and with the second one, TSH number went all the way down below normal. Patient was prescribed Synthroid 100 mcg daily but taking Synthroid 112 mcg once daily instead. It was reported that the problem was that endocrinologist kept lowering the thyroid amount and patient was having so many symptoms, not getting enough thyroid medication and endocrinologist lowered it again on 09-Jul-2025 and was having terrible symptoms for not getting enough of the thyroid. It was unknown if the patient experienced any additional symptoms/events. Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2025: Live follow-up received. Medical history and new events added. Suspect details were updated.
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| 2850750 | 59 | F | FL | 07/22/2025 |
PNC20 |
PFIZER\WYETH |
LN4929 |
Injection site cellulitis
Injection site cellulitis
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Cellulitis on their arms where they had to administer; This is a spontaneous report received from a ...
Cellulitis on their arms where they had to administer; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jul2025 as dose number unknown, single (Lot number: LN4929, Expiration Date: 31Jul2026) at the age of 59 years intramuscular, in arm for immunisation, Device Lot Number: LN4929, Device Expiration Date: 31Jul2026. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset Jul2025, outcome "unknown", described as "Cellulitis on their arms where they had to administer". The event "cellulitis on their arms where they had to administer" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (30Jun2025) unknown result, notes: 2 days before the vaccine was given. Therapeutic measures were taken as a result of vaccination site cellulitis. Causality for "cellulitis on their arms where they had to administer" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Clinical course: This was in regard to an adverse reaction that two patients had when they were vaccinated with Prevnar 20. What happened was the patients when they were vaccinated, they experience with what caller described as Cellulitis on their arms where they had to administer. The patients came back with an adverse reaction in their arm, they had what the caller describe as cellulitis on their arm. The reaction was severe enough, there were two people that were vaccinated with those Prevnar 20, they had to be administered antibiotic and or steroid treatment to prevent the infection on their arm. This was an adverse reaction because of the vaccine, the customer or rather caller would like to report that to know how to proceed with those patients. The reporter was a medical assistant at the doctor's office where the vaccine was administered. Site of administration was reported as Left right. Concomitant products, other medication and lab works: The patient was taking medication on a daily basis, and she did get blood work done 2 days before the vaccine was given. No further details about the medication. There was a treatment. After it was administrated, the vaccine she was seen 7 days letter. They prescribed Prednisone, a steroid medication. The indication was provided as pneumonia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500144744 Same reporter/vaccine/event, different patients;
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| 2850751 | M | IN | 07/22/2025 |
PNC13 |
PFIZER\WYETH |
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Death, Leukaemia, Transfusion
Death, Leukaemia, Transfusion
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leukemia; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old ma...
leukemia; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: LEUKAEMIA (death, hospitalization, medically significant), 1 month after the suspect product(s) administration, outcome "fatal", described as "leukemia". The patient underwent the following laboratory tests and procedures: complete physical: was fine. Therapeutic measures were taken as a result of leukaemia. The patient date of death was unknown. Reported cause of death: "leukemia". It was not reported if an autopsy was performed. Clinical course: The wife informed that the doctor asked if the patient wanted the Prevnar 13 shot and he said yes he would take it and it threw him into leukemia. In 2015, her husband took Prevnar 13, and it killed him. The patient got leukemia about a month later after the shot. Her husband had been to the hospital and he had a complete physical and was fine. She was just told he was in great shape. They told him that he could get transfusions, and he did for about a month and then they told him after a while it wouldn't do any good and he would have not very long to live so he wanted to quit, and he did quit and was dead within 3 months of the shot. The cause of death was leukemia. The wife wanted to know what the company will do about it. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Reported Cause(s) of Death: leukemia
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| 2850752 | 55 | F | NJ | 07/22/2025 |
PNC20 |
PFIZER\WYETH |
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Pyrexia
Pyrexia
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persistent fever; This is a spontaneous report received from a Consumer or other non HCP. A 55-year...
persistent fever; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Jul2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SHINGRIX taken for immunisation, in Jun2025 as dose number unknown, single. The following information was reported: PYREXIA (non-serious) with onset 19Jul2025, outcome "not recovered", described as "persistent fever". Therapeutic measures were not taken as a result of pyrexia. Additional Information: No known allergy. The patient did not received any other vaccine on the same date as the vaccines. The patient was taking other medications within 2 weeks of event starting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2850753 | F | TX | 07/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Lymphadenitis
Lymphadenitis
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lymph nodes remained inflamed for weeks after the vaccine; This is a spontaneous report received fro...
lymph nodes remained inflamed for weeks after the vaccine; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENITIS (non-serious), outcome "recovered", described as "lymph nodes remained inflamed for weeks after the vaccine". It was unknown if therapeutic measures were taken as a result of lymphadenitis. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2850754 | M | OH | 07/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Seizure
Seizure
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seizures; This is a spontaneous report received from a Consumer or other non HCP. A male patient re...
seizures; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 2021, 1 week after the suspect product(s) administration, outcome "unknown", described as "seizures". Clinical course: the patient took the "2021 vaccine" for work, and the week after, he ended up with seizures. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2850760 | F | TX | 07/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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they gave me the COVID; they gave me the COVID; This is a spontaneous report received from a Consume...
they gave me the COVID; they gave me the COVID; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they gave me the COVID". The event "they gave me the covid" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient stated, "They made her call from (redacted) to get her prescription for Paxlovid, after asking if her physician had prescribed Paxlovid, patient advised, "The emergency room last night." Later advised, "Her daughter-in-law is the one who got sick first, and they took her to the physical therapy, and it was funny because she didn't feel no symptoms at all. Not even when they went with them last night to the ER because her son and the baby got sick, and it's funny they gave her the COVID, and that's when it turns out suppose she have a fever she didn't even feel it, and she had high blood pressure real high. Today she has been feeling it. Her nose because she couldn't, she was congested, guess she was not congested, she was breathing. and everything. Now, yeah." Later, (Withheld) stated, "I had taken the Pfizer COVID shot before." After confirming that she had taken the Pfizer vaccination in the past, patient stated, "Yes" how well it worked out for her, (Withheld) stated, "Well, it didn't, you know, cause what, 2,3 years, I guess, when it first started, we're already getting it right now. I didn't got it back then." (Withheld) also advised, "Back then, I had that COVID Vaccine, I didn't have the COVID, I was okay. It helped me big time." After confirming if the patient had taken Paxlovid in the past, (Withheld) advised, "No, I didn't have no COVID at all, I was safe I had got the Pfizer vaccine, both of them, and I didn't got sick." Towards the end of the call, (Withheld) advised, "I was just no, I guess I'm ask the pharmacy because they got me on Ozempic and Humira to take."
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| 2850761 | ME | 07/22/2025 |
RAB |
SANOFI PASTEUR |
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Incomplete course of vaccination
Incomplete course of vaccination
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patient looking to finish her imovax pre-exposure course. however, her first and only dose was on 6/...
patient looking to finish her imovax pre-exposure course. however, her first and only dose was on 6/13/2023 with no reported adverse event.; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender who looked to finish her i Rabies (Hdc) Vaccine [Imovax Rabies] pre-exposure course. however, her first and only dose was on 6/13/2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Jun-2023, the patient received an unknown dose (dose 1) of suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and patient was looking to finish her imovax pre-exposure course. however, her first and only dose was on 6/13/2023 with no reported ae (routine immunisation schedule not administered). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, they wanted to know what was recommended that the patient still received one dose to complete of her series, or did she need two doses 7 days apart to be considered fully vaccinated. 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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| 2850762 | 5 | F | TN | 07/22/2025 |
DTAP |
SANOFI PASTEUR |
2CA77C1 |
Expired product administered
Expired product administered
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patient was administered with the expired dose of daptacel with no reported ae; Initial information ...
patient was administered with the expired dose of daptacel with no reported ae; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old female patient who received an expired dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jul-2025, the patient received an expired 0.5ml (dose 5) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, (once) Suspension for injection, lot 2CA77C1, Strength : Standard and expiry date 30-Apr-2025 via intramuscular route in the left vastus lateralis for Immunization, with no reported adverse event (expired product administered) (Latency Same day). Reportedly, Licensed practical nurse went through their inventory and verified that only 1 patient was administered with the expired dose of Daptacel. Treatment: No, no other immunizations. 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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| 2850763 | 72 | F | GA | 07/22/2025 |
PNC20 |
PFIZER\WYETH |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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PATIENT RECEIVED A 2ND DOSE OF PREVNAR 20 ON 7/21/25. PATIENT SHOULD HAVE ONLY GOTTEN ONE DOSE, WHIC...
PATIENT RECEIVED A 2ND DOSE OF PREVNAR 20 ON 7/21/25. PATIENT SHOULD HAVE ONLY GOTTEN ONE DOSE, WHICH THEY GOT ON 6/9/22. PATIENT HAS NOT HAD ANY TYPE OF REACTION YET AND IS STILL FEELING GOOD AFTER I SPOKE TO HER.
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| 2850764 | 88 | F | MA | 07/22/2025 |
PNC20 |
PFIZER\WYETH |
LN4930 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Redness & swelling at site & extending down left upper arm wrapping around to under side, on...
Redness & swelling at site & extending down left upper arm wrapping around to under side, onset was 1-2 days after vaccine and came to facility seeking treatment on 7/22/2025, Was given course of antibiotics, & monitor sx to ensure resolution, or seek further care if not resolving or if worsening
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| 2850765 | 63 | F | NJ | 07/22/2025 |
PNC20 |
PFIZER\WYETH |
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Arthralgia, Mobility decreased, Paraesthesia
Arthralgia, Mobility decreased, Paraesthesia
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Extreme pain in left shoulder joint, impaired mobility (unable to raise arm), tingling in fingers of...
Extreme pain in left shoulder joint, impaired mobility (unable to raise arm), tingling in fingers of left hand
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| 2850778 | 28 | F | KY | 07/22/2025 |
MENB |
PFIZER\WYETH |
GP8617 |
Incorrect dose administered
Incorrect dose administered
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INCORRECT DOSING SCHEDULE
INCORRECT DOSING SCHEDULE
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| 2850779 | 0.33 | M | CA | 07/22/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Kinrix given to 4 month old instead of Pediarix. Considered off label. should be given 4-6yrs
Kinrix given to 4 month old instead of Pediarix. Considered off label. should be given 4-6yrs
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| 2850780 | 55 | F | LA | 07/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FC3182 FC3182 |
Asthenia, Asthma, Brain fog, Dyspnoea, Fatigue; Immediate post-injection reactio...
Asthenia, Asthma, Brain fog, Dyspnoea, Fatigue; Immediate post-injection reaction, Memory impairment, Palpitations, Pharyngitis streptococcal
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Second dose October, 2021. Immediate effects, winded, weakness, fatigue. Strip throat and Asthma. He...
Second dose October, 2021. Immediate effects, winded, weakness, fatigue. Strip throat and Asthma. Heart palpitations, brain fog, forgetfulness.
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| 2850781 | 4 | F | NM | 07/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Pyrexia, Rash, Streptococcus test negative
Pyrexia, Rash, Streptococcus test negative
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Ring shaped rash on arms and legs, low grade fever
Ring shaped rash on arms and legs, low grade fever
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| 2850782 | 65 | M | PR | 07/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
A5T73 |
Pruritus, Pustule, Tenderness, Tissue rupture
Pruritus, Pustule, Tenderness, Tissue rupture
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Pustules in different parts of the body (foot, torso, back, face, leg) that start with a small bubbl...
Pustules in different parts of the body (foot, torso, back, face, leg) that start with a small bubble and then breaks resulting in itching, and open sore that stings to the touch.
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| 2850783 | 57 | F | 07/22/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
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Day after injection patients arm became swollen and red, painful and hot to the touch. This was fr...
Day after injection patients arm became swollen and red, painful and hot to the touch. This was from just below shoulder to about 2 inches above elbow. Day 2 and 3 also had high fever (103.) Pt used Tylenol and fever seems better. When Patient came in today, arm was not swollen but still quite red and warm. Although patient seems to be getting better, they are still very concerned. Patient will continue Tylenol and ice pack as needed as it continues to resolve itself.
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| 2850784 | 79 | M | AZ | 07/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9jt4s |
Injury associated with device
Injury associated with device
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While administering the vaccination the technician hiccuped causing his body and arm to jerk back. ...
While administering the vaccination the technician hiccuped causing his body and arm to jerk back. He didn't feel anything hit is hand but noticed later there was blood so the needle had scraped his finger.
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| 2850785 | 61 | F | MA | 07/22/2025 |
COVID19 |
MODERNA |
807956 |
Audiogram abnormal, Deafness neurosensory, Tinnitus
Audiogram abnormal, Deafness neurosensory, Tinnitus
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Tinnitus. Symptoms began one hour and 20 minutes after the vaccine and has continued since then. I...
Tinnitus. Symptoms began one hour and 20 minutes after the vaccine and has continued since then. I mentioned it to my PCP at my annual exam and she recommended that I make an appointment with an Ear/Nose/Throat specialist for testing. The ENT doctor recommended that I file a report of my symptoms.
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| 2850786 | 71 | F | AL | 07/22/2025 |
HEP PNC20 |
DYNAVAX TECHNOLOGIES CORPORATION PFIZER\WYETH |
946063 ln4927 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient had already received prevnar20 vaccination on 07/13/2022 at different facility. Vaccination ...
Patient had already received prevnar20 vaccination on 07/13/2022 at different facility. Vaccination was not reported to state data base and patient did not recall having it previously.
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| 2850811 | 10 | M | CA | 07/22/2025 |
HPV9 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z002903 9JT4S |
Eye movement disorder, Hunger, Pallor; Eye movement disorder, Hunger, Pallor
Eye movement disorder, Hunger, Pallor; Eye movement disorder, Hunger, Pallor
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Pt was going to receive 2 vaccines Tdap Booster and HPV # 2 to complete series. Pt was a bit nervous...
Pt was going to receive 2 vaccines Tdap Booster and HPV # 2 to complete series. Pt was a bit nervous and requested both vaccines to be administered on Left arm, while he held his mother's hand with his right hand. Tdap was the first vaccine administered on Left Arm. Pt tolerated well and was surprised how well he did. I had asked pt to tell me about what he had done for summer break to allow him to distract himself from the next vaccine. HPV # 2 was administered on Left Arm. Both vaccines were completed by 0933. Pt was surprised how well he tolerated both vaccines. I was informing MOC that pt would need to wait 15 minutes after the vaccine to rule out any adverse reaction. Shortly after mentioning post vaccine instructions. At 0934 MOC noticed pt looking pale and eye rolling up. Pt leaned towards me and and MOC to notify any nursing staff in our nursing station. I also verbally called a code Blue in rrom 3, while exam room door was open. 0934 Dr entered the exam room and assisted in laying pt on the exam table. Vitals were obtained at 0934. Pt was responsive and still a little out of it, but was able to answer all questions to provider. MOC was informed by provider that pt was ok, but would recommend to wait the 15 minutes. Apple juice was offered to pt. 0936 Pt was alert, skin color was back to normal and was conversing. Vitals were obtained at 0937. Pt was very cooperative with vitals. Vitals were obtained at 0941. Pt communicated was feeling better and hungry. Pt was discharged at 0953
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| 2850441 | F | CA | 07/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
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Hot at injection site; Injection site redness; This non-serious case was reported by a consumer via ...
Hot at injection site; Injection site redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In JUL-2025, less than a week after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Hot at injection site) and injection site erythema (Verbatim: Injection site redness). The outcome of the injection site warmth and injection site erythema were not resolved. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site warmth and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JUL-2025 The patient received her first dose of Shingrix in her right arm on 08 JUL 2025. Consumer reports the injection site was hot and red. No further information was provided/obtained.
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| 2850442 | 07/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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sick; This non-serious case was reported by a consumer via interactive digital media and described t...
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUL-2025 This case was reported by the patient via interactive digital media. The patient got both shots. Made him/her sick as a dog could get in bed.
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| 2850443 | 07/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Rash
Rash
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rash on my face; This non-serious case was reported by a consumer via interactive digital media and ...
rash on my face; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash (Verbatim: rash on my face). The outcome of the rash was resolving. It was unknown if the reporter considered the rash to be related to Shingles vaccine. It was unknown if the company considered the rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-JUL-2025 This case was reported by a patient via interactive digital media. The patient had a rash on his/her face and hoped it's not that patient was putting on medication cream and thought that was helping and got the vaccine about 3 years ago
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| 2850444 | 3 | OK | 07/21/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
4T93R |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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adult dose(Harvix) to a pediatric patient; adult dose(Harvix) to a pediatric patient; Upon review tw...
adult dose(Harvix) to a pediatric patient; adult dose(Harvix) to a pediatric patient; Upon review two other doses were also given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-year-old patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 23-MAY-2025, the patient received Havrix 1440 adult. On 23-MAY-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: adult dose(Harvix) to a pediatric patient), adult product administered to child (Verbatim: adult dose(Harvix) to a pediatric patient) and extra dose administered (Verbatim: Upon review two other doses were also given). The outcome of the overdose, adult product administered to child and extra dose 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: 07-JUL-2025 The reporter reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old)and upon review two other doses were also given, which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not. Any side effects need to advise the parents of as well. This case was 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025085083:Same reporter/Diffrent patient US-GSK-US2025087636:Same reporter/Diffrent patient
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| 2850445 | 1 | OK | 07/21/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
4T93R |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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adult dose(Harvix) to a pediatric patient (19 Month Old); adult dose(Harvix) to a pediatric patient ...
adult dose(Harvix) to a pediatric patient (19 Month Old); adult dose(Harvix) to a pediatric patient (19 Month Old); upon review two other doses were also given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-month-old patient who received HAV (Havrix 1440) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 23-MAY-2025, the patient received Havrix 1440. On 23-MAY-2025, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: adult dose(Harvix) to a pediatric patient (19 Month Old)), adult product administered to child (Verbatim: adult dose(Harvix) to a pediatric patient (19 Month Old)) and extra dose administered (Verbatim: upon review two other doses were also given). The outcome of the overdose, adult product administered to child and extra dose 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: 07-JUL-2025 The reporter reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old)and upon review two other doses were also given, which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not. Any side effects need to advise the parents of as well. This case was 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025087634:Same reporter/Diffrent patient US-GSK-US2025085083:Same reporter/Diffrent patient
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| 2850446 | 16 | F | NV | 07/21/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
E4A39 |
Expired product administered
Expired product administered
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administration of an Expired vaccine - Menveo; This non-serious case was reported by a other health ...
administration of an Expired vaccine - Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 08-JUL-2025, the patient received the 1st dose of Menveo. On 08-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administration of an Expired vaccine - Menveo). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt date: 09-JUL-2025 A Medical Assistant called to report the administration of an expired vaccine, Menveo (1 vial) to a patient, which led to expired vaccine used. She called to get some guidance in case the dose should be repeated. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2850447 | 65 | F | 07/21/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
49M2F |
Incorrect route of product administration
Incorrect route of product administration
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administered a dose of Priorix in intramuscular route; This non-serious case was reported by a pharm...
administered a dose of Priorix in intramuscular route; 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 65-year-old female patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis. On 10-JUL-2025, the patient received the 2nd dose of Priorix (intramuscular). On 10-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administered a dose of Priorix in intramuscular route). 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: 10-JUL-2025 On 10th July 2025, a pharmacist called to inform that earlier that day, he had administered a dose of Priorix in intramuscular route which led to subcutaneous injection formulation administered by other route. No further details were provided.
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| 2850448 | F | FL | 07/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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A patient received a tetanus vaccine (Boostrix) 5 months apart; This non-serious case was reported b...
A patient received a tetanus vaccine (Boostrix) 5 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Boostrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: A patient received a tetanus vaccine (Boostrix) 5 months apart). 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: 10-JUL-2025 On 10th July 2025 a pharmacist called to ask for a patient who received a tetanus vaccine (Boostrix) 5 months apart which led to extra dose administration, and wanted to know if was there anything that they need to do?
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| 2850449 | F | WI | 07/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
ZF9T5 |
Product storage error
Product storage error
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Boostrix exposed to -5๏ฟฝF; This non-serious case was reported by a other health professional via ca...
Boostrix exposed to -5๏ฟฝF; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number ZF9T5, expiry date 08-AUG-2026) for prophylaxis. On 09-JUL-2025, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix exposed to -5๏ฟฝF). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 10-JUL-2025 A nurse called to report that one dose of the Boostrix vaccine that was exposed to minus 5-degree Fahrenheit because of a temperature excursion was administered to a patient, which led to incorrect storage of drug. Follow-up agreed via email.
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| 2850450 | 0.5 | M | MD | 07/21/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
7745R |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Underage administration (6 month old patient); This non-serious case was reported by a other health ...
Underage administration (6 month old patient); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis. On 10-JUL-2025, the patient received Kinrix. On 10-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration (6 month 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: 10-JUL-2025 The Certified Medical Assistant called asking for recommendations/advise since a six month old patient was given a Kinrix vaccine at the time of reporting, which led to inappropriate age at vaccine administration. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
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| 2850451 | F | FL | 07/21/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call cente...
Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose of vaccine in May 2018) and Twinrix (received 2nd dose of vaccine in June 2018). On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-JUL-2025 The pharmacist had called to report that a patient had been administered two doses of Twinrix back in May and June of Twenty-eighteen. It was unclear whether the vaccination series needed to be restarted, as no specific vaccination dates or vaccine details had been obtained during the call. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
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| 2850452 | F | NC | 07/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Received a first dose in September 2023 and 2nd dose in October 2023; This non-serious case was repo...
Received a first dose in September 2023 and 2nd dose in October 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). In OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received a first dose in September 2023 and 2nd dose in October 2023). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 The pharmacist reported that a patient received a first dose of the Shingrix vaccine and received the second dose a little bit early in October 2023. She wanted to know if that was a problem and asked if she needs to get another dose or what was the advice if somebody received the second dose of Shingrix too early. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
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| 2850453 | F | GA | 07/21/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
3275B |
Expired product administered
Expired product administered
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received an expired dose of Menveo (1 vial); This non-serious case was reported by a other health pr...
received an expired dose of Menveo (1 vial); This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 3275B, expiry date 30-JUN-2025) for prophylaxis. On 16-JUL-2025, the patient received Menveo. On 16-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received an expired dose of Menveo (1 vial)). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported the administration of an expired dose of Menveo (1 vial) to a patient, which led to expired vaccine used The reporter asked would the patient need to be revaccinated and was there a time frame window to receive again the dose.
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| 2850454 | 1.5 | M | 07/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK303AB |
No adverse event, Product storage error
No adverse event, Product storage error
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Temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. Therefriger...
Temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. Therefrigerator went too cold and did not alarm. Vaccines were given from the refrigerator with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this US-SA-2025SA181088 [Master case]. This case involves a 18 months old male patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] in which temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. The refrigerator went too cold and did not alarm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jun-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK303AB, expiry date: 31-Aug-2026, frequency:once, via intramuscular route in unknown administration site for prophylactic vaccination (immunisation) in which temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. therefrigerator went too cold and did not alarm. vaccines were given from the refrigerator with no reported adverse event (poor quality product administered) (latency:same day). Reportedly,no adverse event occurred.Sanofi was contacted by clinic who advised to revaccinate. 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-2025SA181088:master case
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| 2850456 | ME | 07/21/2025 |
TDAP |
SANOFI PASTEUR |
U8232AA |
No adverse event, Product storage error
No adverse event, Product storage error
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patient were given ADACEL after the excursions with no reported adverse event; Initial information r...
patient were given ADACEL after the excursions with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who were given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] after the excursions with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received Unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection of standard strength (Unknown expiry date) with lot U8232AA via unknown route in unknown administration site for Immunization after the excursions with no reported adverse event (poor quality product administered) (Latency same day) Reportedly, The previous report stated the vaccines were not administered after the excursions that deemed them no longer suitable for use, but after investigating further she found that 3 patients were given adacel after the excursions 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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| 2850457 | 3 | F | UT | 07/21/2025 |
DTAP DTAPIPV |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
U8209CB |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
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Inappropriate use due to administration of a QUADRACEL dose to a 3 years old patient, intended to gr...
Inappropriate use due to administration of a QUADRACEL dose to a 3 years old patient, intended to grab the Dtap vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to patient with no adverse event; Inappropriate use due to administration of a QUADRACEL dose to a 3 years old patient, intended to grab the Dtap vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to patient with no adverse event; Initial information received on 16-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old female patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (vero)], reporter intended to grab the diphtheria, tetanus and acellular pertussis vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to the patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine CONJ (TET TOX) (ACTHIB); varicella zoster vaccine (varicella vaccine) and hepatitis A vaccine (hepatitis A), all for Immunisation. On 11-Jul-2025, the patient received 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine Solution for injection of standard strength, frequency once with lot U8209CB and expiry date 31-May-2026 via intramuscular route in unknown administration site for Immunization, reporter intended to grab the diphtheria, tetanus and acellular pertussis vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to the patient with no reported adverse event (product administered to patient of inappropriate age) (Wrong product administered) (Latency same day). Reportedly, reporter stated that the patient is new to them. 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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| 2850461 | 54 | F | CA | 07/21/2025 |
PNC21 |
MERCK & CO. INC. |
Z006076 |
Erythema, Pain in extremity, Pyrexia, Rash papular, Rash pruritic
Erythema, Pain in extremity, Pyrexia, Rash papular, Rash pruritic
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PATIENT EXPERIENCED FEVER AND SORE ARM FEW HOURS AFTER VACCINATION. ON 7/20 NOTICED WIDESPREAD (FRO...
PATIENT EXPERIENCED FEVER AND SORE ARM FEW HOURS AFTER VACCINATION. ON 7/20 NOTICED WIDESPREAD (FROM SHOULDER TO MORE THAN HALF WAY DOWN TO ELBOW) RED, RAISED RASH WITH SOME ITCHINESS. PATIENT NOT SURE IF SHE GOT IT BEFORE TODAY BUT ONLY NOTICED IT TODAY. ON AND OFF FEVER AND PAIN MANAGED BY TYLENOL. MADE APPOINTMENT TO SEE DR BUT NOT UNTIL AUGUST.
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| 2850462 | 57 | F | TX | 07/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Migraine with aura
Migraine with aura
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Migraine with aura
Migraine with aura
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| 2850466 | 07/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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she got shingles a few days after getting vaccine; This non-serious case was reported by a consumer ...
she got shingles a few days after getting vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: she got shingles a few days after getting vaccine). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 15-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her friend had been a nurse for 25 years and she got shingles a few days after receiving that vaccine. She said she would never take another vaccine as long as she lived, even if it meant losing her job.
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| 2850467 | 0.25 | F | PA | 07/21/2025 |
HIBV |
SANOFI PASTEUR |
UK113AB |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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administered ACTHIB with diluent from another vaccine, perhaps sterile water from MMR (with no repor...
administered ACTHIB with diluent from another vaccine, perhaps sterile water from MMR (with no reported adverse event); administered ACTHIB with diluent from another vaccine, perhaps sterile water from MMR (with no reported adverse event); Initial information received on 16-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 months old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] with diluent from another vaccine, perhaps sterile water from MMR with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 13-Jun-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine with diluent from another vaccine, perhaps sterile water from mmr (formulation: Powder and solvent for solution for injection) (lot UK113AB) (strength and expiry date not reported) via unknown route in the left thigh with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day) 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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| 2850538 | 50 | F | MI | 07/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93n4j |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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The powdered Shingrix was mixed with a sterile diluent (sterile water) instead of the liquid vial th...
The powdered Shingrix was mixed with a sterile diluent (sterile water) instead of the liquid vial that came in the box. Patient has had no adverse reaction.
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