| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2818813 | 6 | U | OK | 12/31/2024 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y002099 Y002099 |
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; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was stored in the ...
No additional AE; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was stored in the refrigerator and administered to multiple patients. Original AE 02722046 filed on 12/13/2024. At the time of the original report (12/13/2024), patient information was n; This spontaneous report has been received from a health care professional, referring a 6-year-old patient of unknown gender. The patient's medical history, previous adverse drug reactions, drug allergy, concurrent conditions, and concomitant medication were not provided. On 10-DEC-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (strength, dose, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y002099 which has been verified to be a valid number, expiration date reported and validated as 09-JUL-2025) as a prophylaxis; which experienced a temperature excursion before administration (product storage error). However, no signs or symptoms were reported.; Sender's Comments: US-009507513-2412USA006216:
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| 2818866 | 22 | F | CA | 12/31/2024 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Exposure during pregnancy; Exposure during pregnancy, Product use issue
Exposure during pregnancy; Exposure during pregnancy, Product use issue
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medication given to pregnant
medication given to pregnant
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| 2816892 | 6 | U | OK | 12/19/2024 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y002099 |
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 adverse event; Health care professional called to report a temperature excursion on PROQUAD, the ...
No adverse event; Health care professional called to report a temperature excursion on PROQUAD, the PROQUAD was stored in the refrigerator and administered; This spontaneous report was received from an other Health Professional and refers to a 6-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications. On 09-OCT-2024, the patient was vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (strength and route of administration were not provided), that underwent a temperature excursion (TE). The reporter stated that the measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator and administered to the patient. There were no reported signs or symptoms of adverse effects. No additional adverse events This is one of several reports received from the same source.; Sender's Comments: US-009507513-2412USA005703:
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| 2816900 | 8 | U | OK | 12/19/2024 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y002099 Y002099 |
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 reported signs/symptoms of adverse effects. No additional AE/no PQC; TE on PROQUAD; This spontane...
No reported signs/symptoms of adverse effects. No additional AE/no PQC; TE on PROQUAD; This spontaneous report was received from a medical assistant referring to an 8-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 29-AUG-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (lot#: Y002099, expiration date: 09-JUL-2025; strength and dose were not provided) for prophylaxis. The administered experienced temperature excursion (TE) before (product storage error). No additional adverse events (AE) were reported (no adverse event).
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| 2813077 | 62 | F | NC | 12/02/2024 |
COVID19 RSV COVID19 RSV |
NOVAVAX PFIZER\WYETH UNKNOWN MANUFACTURER PFIZER\WYETH |
6024mf016 ln5482 6024MF016 LN5482 |
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mo...
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
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patient states she has limited range of motion in her arm and very painful
patient states she has limited range of motion in her arm and very painful
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| 1790073 | 79 | F | OH | 10/16/2021 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
Unknown |
Cerebrovascular accident; Cerebrovascular accident; Cerebrovascular accident, Va...
Cerebrovascular accident; Cerebrovascular accident; Cerebrovascular accident, Vaccination complication
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STROKE; This spontaneous report received from a patient concerned an 80 year old female. The patient...
STROKE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had always good cholesterol and was physically active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUN-2021, the patient experienced stroke and had weakness on the left side of body (left arm and left leg). The patient was recovering from the symptoms but it was slow and was still doing physical therapy and occupational therapy for the stroke. The patient attributed the stroke to the Janssen Covid-19 vaccine. The patient was in therapy at the hospital for 29 days. On 24-JUN-2021, the patient was admitted and discharged on 22-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211025160- COVID-19 VACCINE AD26.COV2.S- Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
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| 2820941 | 11 | M | WA | 01/14/2025 |
TDAP |
SANOFI PASTEUR |
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Erythema, Induration, Pain, Skin warm
Erythema, Induration, Pain, Skin warm
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Redness, pain, hard skin, hot to touch
Redness, pain, hard skin, hot to touch
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| 2820943 | 63 | F | FL | 01/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash, Rash erythematous
Rash, Rash erythematous
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Rash under breast with small red bumps and rash on partial breast
Rash under breast with small red bumps and rash on partial breast
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| 2820482 | M | WI | 01/13/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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Had the First Dose of Heplisav-B in August of 2024, But Has Not Received the Second Dose Yet; Initia...
Had the First Dose of Heplisav-B in August of 2024, But Has Not Received the Second Dose Yet; Initial report received on 04-Dec-2024. A pharmacist reported that a 77-year-old male received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, but he has not received the second dose yet. No medical history or concomitant medications were reported. On 12-Aug-2024, the patient received dose 1 of a hepatitis B vaccine (HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). The patient has not received the second dose. The patient had no other side effects. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2820483 | F | FL | 01/13/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944920 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Received Heplisav-B on Nov 12th, She Came Back For Second Dose on Dec 6th Is it Too Early; Initial r...
Received Heplisav-B on Nov 12th, She Came Back For Second Dose on Dec 6th Is it Too Early; Initial report received on 06-Dec-2024. A nurse reported that a 26-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 12-Nov-2024 and the second dose on 06-Dec-2024. No medical history or concomitant medications were reported. On 12-Nov-2024, the patient received dose 1 of a hepatitis B vaccine, HEPLISAV-B (lot number 944920, expiration date 04-Dec-2026, and NDC number 43528-003-01) intramuscularly (site not reported). On 06-Dec-2024, 24 days after receiving the first dose, the patient received dose 2 of HEPLISAV-B (lot number 944920, expiration date 04-Dec-2026, and NDC number 43528-003-01) intramuscularly (site not reported). The patient received her second injection less than one month after the first. No adverse reactions were reported. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2820484 | U | 01/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Dysgeusia
Dysgeusia
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Patient had bitter taste in mouth; This non-serious case was reported by a consumer via call center ...
Patient had bitter taste in mouth; This non-serious case was reported by a consumer via call center representative and described the occurrence of taste bitter in a 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 taste bitter (Verbatim: Patient had bitter taste in mouth). The outcome of the taste bitter was not reported. It was unknown if the reporter considered the taste bitter to be related to Shingrix. It was unknown if the company considered the taste bitter to be related to Shingrix. Additional Information: GSK Receipt Date: 18-DEC-2024 The reporter reported that patient had bitter taste in mouth after administration of Shingrix vaccine.
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| 2820485 | U | 01/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash, Rash pruritic
Rash, Rash pruritic
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Rash over side which itched a lot; This non-serious case was reported by a consumer via patient supp...
Rash over side which itched a lot; This non-serious case was reported by a consumer via patient support programs and described the occurrence of itchy rash in a 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 itchy rash (Verbatim: Rash over side which itched a lot). The outcome of the itchy rash was not reported. It was unknown if the reporter considered the itchy rash to be related to Shingrix. It was unknown if the company considered the itchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 18-DEC-2024 The reporter reported that patient had rash over side which itched a lot after administration of Shingrix vaccine.
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| 2820486 | U | 01/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Balance disorder
Balance disorder
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permanently have lost my balance; This non-serious case was reported by a consumer via interactive d...
permanently have lost my balance; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of loss of balance in a 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 loss of balance (Verbatim: permanently have lost my balance). The outcome of the loss of balance was not resolved. It was unknown if the reporter considered the loss of balance to be related to Shingrix. It was unknown if the company considered the loss of balance to be related to Shingrix. Additional Information: GSK receipt date: 04-JAN-2025 and 07-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that beware the Shingles vaccine (Shingrix), had terrible reaction. He/she had a violent reaction plus permanently had lost balance.
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| 2820487 | 75 | M | NJ | 01/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site induration, Myalgia, Tenderness
Injection site induration, Myalgia, Tenderness
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stiffness at the injection site; bad muscle ache; sensitive to touch on certain parts of his body wh...
stiffness at the injection site; bad muscle ache; sensitive to touch on certain parts of his body which was painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles many years ago). On 20-NOV-2024, the patient received the 1st dose of Shingrix. In NOV-2024, less than 2 weeks after receiving Shingrix, the patient experienced injection site induration (Verbatim: stiffness at the injection site), muscle pain (Verbatim: bad muscle ache) and tenderness (Verbatim: sensitive to touch on certain parts of his body which was painful). The outcome of the injection site induration and muscle pain were resolved and the outcome of the tenderness was not resolved. It was unknown if the reporter considered the injection site induration, muscle pain and tenderness to be related to Shingrix. It was unknown if the company considered the injection site induration, muscle pain and tenderness to be related to Shingrix. Additional Information: GSK receipt date: 12-DEC-2024 The reporter was the spouse of a male patient. The reporter reported that the patient experienced sensitivity in his muscles after the 1st dose of Shingrix Vaccine. It was unknown in which arm the vaccine was administered. The lot and expiry date were unknown. The reporter stated that the vaccine was provided at a local pharmacy on November 20th, 2024. The reporter stated that the patient was sensitive to touch on certain parts of his body, and it was painful. Reporter states that the patient initially reported normal stiffness at the injection site, and a bad muscle ache. The patient reported to the caller that he had shingles many years ago and it feels like the same sensitivity pain. The reporter stated It had been 5 weeks since it started, and the sensitivity pain continued. The reporter stated even the sheets bother him. This case had been link with US2024156990, reported by the same reporter.; Sender's Comments: US-GSK-US2024156990:same reporter
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| 2820488 | 74 | F | NJ | 01/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site induration, Myalgia
Injection site induration, Myalgia
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stiffness at the injection site; a bad muscle ache; This non-serious case was reported by a consumer...
stiffness at the injection site; a bad muscle ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20-NOV-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 20-NOV-2024, less than a day after receiving Shingrix, the patient experienced injection site induration (Verbatim: stiffness at the injection site) and muscle pain (Verbatim: a bad muscle ache). The outcome of the injection site induration and muscle pain were resolved. It was unknown if the reporter considered the injection site induration and muscle pain to be related to Shingrix. It was unknown if the company considered the injection site induration and muscle pain to be related to Shingrix. Additional Information: GSK Receipt Date: 12-DEC-2024 The reporter reported that she was a 74 year old female patient. The patient reported on December 12th, 2024, that she received the 1st dose of Shingrix vaccine at a local pharmacy. The patient was administered the vaccine in the right arm. The lot and expiry date were unknown. Reporter stated that she initially had stiffness at the injection site and a bad muscle ache. Patient reported that her symptoms just lasted a few days and had resolved. No additional event was reported.; Sender's Comments: US-GSK-US2024156989:same reporter
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| 2820489 | M | AZ | 01/13/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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He received the first shot 37 days ago/ Twinrix's 2nd late dose; This non-serious case was repo...
He received the first shot 37 days ago/ Twinrix's 2nd late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received 37 days ago). On 05-NOV-2024, the patient received the 2nd dose of Twinrix. On 05-NOV-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: He received the first shot 37 days ago/ Twinrix's 2nd late dose). The outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-DEC-2024 Pharmacist questioned could we mix Havrix and Twinrix if so, what was the schedule. If someone got Twinrix first how long should you wait to get the Havrix. He received the first shot 37 days ago. Out of precaution an AE for Interchange of vaccines was filed but Havrix was not administered. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
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| 2820490 | 10 | F | NY | 01/13/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
4799G |
Product storage error
Product storage error
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product storage error and administration/one patient received Boostrix after it was exposed to 48.3 ...
product storage error and administration/one patient received Boostrix after it was exposed to 48.3 degree F for 144 hours and also 31.2 degree F for 144 hours; 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 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4799G, expiry date 16-NOV-2026) for prophylaxis. On 09-DEC-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: product storage error and administration/one patient received Boostrix after it was exposed to 48.3 degree F for 144 hours and also 31.2 degree F for 144 hours). The outcome of the incorrect storage of drug was unknown. 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: 17-DEC-2024 The patient received Boostrix after it was exposed to 48.3 degree F for 144 hours and also 31.2 degree F for 144 hours, which led to incorrect storage of vaccine.; Reporter's Comments: degree
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| 2820491 | F | OH | 01/13/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
344J3 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Twinrix - Late second dose; This non-serious case was reported by a pharmacist via call center repre...
Twinrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received HAB (Twinrix) (batch number 344J3, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 28th May 2024, batch number:344J3 and expiry date:12-SEP-2026). On 21-DEC-2024, the patient received the 2nd dose of Twinrix. On 21-DEC-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix - Late second dose). The outcome of the drug dose administration interval too long was unknown. 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: 23-DEC-2024 Pharmacist mentioned that a patient received the first dose of Twinrix on 28th May 2024 and second dose was given on 21st December 2024. The reporter asked how to proceed in this situation. The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
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| 2820492 | M | OH | 01/13/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Product storage error
Product storage error
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received a dose of Menveo 2 vial following a temperature excursion.; This non-serious case was repor...
received a dose of Menveo 2 vial following a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of product storage error in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced product storage error (Verbatim: received a dose of Menveo 2 vial following a temperature excursion.). The outcome of the product storage error was unknown. Additional Information: GSK Receipt Date: 23-DEC-2024 A practice manager called to report that they administered a dose of Menveo 2 vial that had a temperature excursion to a boy born in 2008, which led to incorrect storage of vaccine. Upon callback the healthcare professional mentioned that the Menveo vaccine was exposed to 51.3-degree F for 3 hours with no prior excursions. The reporter consented to follow up.
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| 2820493 | 20 | M | VA | 01/13/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
2R4GG |
Product preparation issue
Product preparation issue
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instead of reconstituting the vaccine, the HCP gave only the diluent portion; instead of reconstitut...
instead of reconstituting the vaccine, the HCP gave only the diluent portion; instead of reconstituting the vaccine, the HCP gave only the diluent portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old male patient who received Hib (Hiberix) (batch number 2R4GG, expiry date 17-MAR-2026) for prophylaxis. On 16-DEC-2024, the patient received Hiberix. On 16-DEC-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: instead of reconstituting the vaccine, the HCP gave only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: instead of reconstituting the vaccine, the HCP gave only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt Date: 24-DEC-2024 Practice Manager stated for Hiberix, instead of reconstituting the vaccine, the healthcare professional gave only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2820494 | U | OH | 01/13/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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Boostrix stored at 1) 31.9F x 46 hours and 2) 51F x 3 hours; This non-serious case was reported by a...
Boostrix stored at 1) 31.9F x 46 hours and 2) 51F x 3 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On 15-NOV-2024, an unknown time after receiving Boostrix, the patient experienced product storage error (Verbatim: Boostrix stored at 1) 31.9F x 46 hours and 2) 51F x 3 hours). The outcome of the product storage error was unknown. 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: 26-DEC-2024 The reporter requested stability data for Boostrix stored at 1) 31.9F x 46 hours and 2) 51F x 3 hours, which led to incorrect storage of vaccine. No prior excursions were reported. Boostrix had been administered to several patients, patient demographics were unknown at time of call. The reporter thought excursion occurred around 15th November 2024. The reporter consented to follow up.
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| 2820495 | F | OR | 01/13/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
X3M3D |
Incorrect route of product administration
Incorrect route of product administration
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vaccine it was given IM instead of Subcue; This non-serious case was reported by a pharmacist via ca...
vaccine it was given IM instead of Subcue; 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 adult female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: vaccine it was given IM instead of Subcue). The outcome of the subcutaneous injection formulation administered by other route was unknown. 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: 26-DEC-2024 The reporter called to report the following that he/she had a patient that received the Priorix, the MMR vaccine it was given IM instead of Subcutaneous, did the patient need to be revaccination Subcutaneous route or be the IM be sufficient, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up.
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| 2820496 | M | CA | 01/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
G9987 |
Product preparation issue
Product preparation issue
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Administration of liquid portion only; Administration of liquid portion only; This non-serious case ...
Administration of liquid portion only; Administration of liquid portion only; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number G9987, expiry date 26-OCT-2026) for prophylaxis. On 12-DEC-2024, the patient received Shingrix. On 12-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Administration of liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 26-DEC-2024 Office manager called to report that a patient received the liquid portion only of shingles vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2820497 | 19 | F | MT | 01/13/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Engerix-B - Adult dose to an adolescent patient; Engerix-B - Adult dose to an adolescent patient.; T...
Engerix-B - Adult dose to an adolescent patient; Engerix-B - Adult dose to an adolescent patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis. On 26-DEC-2024, the patient received Engerix B adult. On 26-DEC-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engerix-B - Adult dose to an adolescent patient) and overdose (Verbatim: Engerix-B - Adult dose to an adolescent patient.). The outcome of the adult product administered to child and overdose were unknown. 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: 26-DEC-2024 A registered nurse reported the administration of the adult dose of Engerix-B to a 19 year-old patient, which led to adult product administered to child and overdose. The nurse asked for recommendations on this situation. The reporter could not provide patient initials nor data about the dose given (lot number, expiration date). The reporter consented to follow up.
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| 2820505 | F | 01/13/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; She has had them twice since she took shot; This serious case was rep...
Suspected vaccination failure; She has had them twice since she took shot; 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. 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: She has had them twice since she took shot). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. 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: 01-JAN-2024 This case was reported by a consumer via interactive digital media Reporter reported that the patient (sister-in-law) never had shingles so she got shot to be safe. She has had them twice since she took shot and had them on the day of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2820507 | U | 01/13/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got the shingles the next year; This serious case was reported by a c...
Suspected vaccination failure; got the shingles the next year; 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: got the shingles the next year). 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: 06-JAN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she got the vaccine and got the shingles the next year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2820508 | M | NE | 01/13/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9R2D7 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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received a dose of Infanrix instead of a dose of Boostrix; received a dose of Infanrix instead of a ...
received a dose of Infanrix instead of a dose of Boostrix; received a dose of Infanrix instead of a dose of Boostrix; 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 80-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Infanrix and Boostrix. On an unknown date, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Infanrix instead of a dose of Boostrix) and inappropriate age at vaccine administration (Verbatim: received a dose of Infanrix instead of a dose of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. 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: 16-DEC-2024 The immunization coordinator called to report that they accidentally administered a dose of Infanrix to an adult patient instead of a dose of Boostrix which led to, wrong vaccine administered and inappropriate age at vaccine administration. The reporter had a question did the patient needs an additional dose of Infanrix or was it ok to administer a dose of Boostrix now. The reporter asked did the patient needs to wait to receive another dose.
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| 2820583 | 3 | F | OH | 01/13/2025 |
FLU3 |
SEQIRUS, INC. |
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Condition aggravated, Dyspnoea
Condition aggravated, Dyspnoea
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Patient developed a "gasping" noise. She will be talking then all of a sudden make a gaspi...
Patient developed a "gasping" noise. She will be talking then all of a sudden make a gasping noise. I would like to note that this started last year, the exact time it started is unknown. It wasn't until July last year that we finally had her seen as it got progressively worse. Patient's grandparents said it was going on longer than what both myself and my wife noticed. We ended up having her adnoids removed, and it went away and there have been "0" incidents until she got the flu shot. Since then it is back and worse than it was ever last year. It started the same day in the evening that the flu shot was administered. Wife notitied the DR office when she was in there with her other child this came back.
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| 2820584 | 38 | F | MI | 01/13/2025 |
HEPA |
MERCK & CO. INC. |
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Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Incorrect does was given to pt. Pt was contacted to receive correct dose. No adverse reactions.
Incorrect does was given to pt. Pt was contacted to receive correct dose. No adverse reactions.
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| 2820585 | 72 | F | VA | 01/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5H777 |
Injection site erythema, Product administered at inappropriate site
Injection site erythema, Product administered at inappropriate site
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My injection was high up on the left arm. About 3 inches down from the injection site is a red area...
My injection was high up on the left arm. About 3 inches down from the injection site is a red area about 2 x 2 inches. It doesn't hurt, is not itchy or hot. It seems to be going away today.
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| 2820586 | 14 | F | PA | 01/13/2025 |
COVID19 |
MODERNA |
B0002 |
Expired product administered
Expired product administered
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Vaccine given after beyond use date
Vaccine given after beyond use date
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| 2820587 | 16 | F | KS | 01/13/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
EN939 M23G5 |
Product storage error; Product storage error
Product storage error; Product storage error
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Vaccine deemed not stable due to temperature excursion
Vaccine deemed not stable due to temperature excursion
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| 2820588 | 25 | F | FL | 01/13/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0169 EW0169 EW0169 30155BA 30155BA 30155BA |
Anaemia, Blood prolactin, Blood testosterone, Fatigue, Full blood count; Heavy m...
Anaemia, Blood prolactin, Blood testosterone, Fatigue, Full blood count; Heavy menstrual bleeding, Increased tendency to bruise, Intermenstrual bleeding, Metabolic function test, Oligomenorrhoea; Peripheral coldness, Serum ferritin decreased, Thyroid function test; Anaemia, Blood prolactin, Blood testosterone, Fatigue, Full blood count; Heavy menstrual bleeding, Increased tendency to bruise, Intermenstrual bleeding, Metabolic function test, Oligomenorrhoea; Peripheral coldness, Serum ferritin decreased, Thyroid function test
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Started bleeding marginally about two days after the first vaccine dose, despite just completing men...
Started bleeding marginally about two days after the first vaccine dose, despite just completing menstrual cycle about a week prior. Menstrual cycles had been regular for about a year at that point. The bleeding then continued for 9-10 months straight, some days heavier than others. I followed up with my endocrinologist and everything, could not be found to be related to any standing medical conditions or anything else. Since then I now suffer Chronic anemia, with low ferritin levels. I never had anemia or low ferritin levels any time prior to that. I still have to take iron daily or else the levels drop and cause severe fatigue and other problems. I bruise very easily and my hands and feet are almost always ice cold now. Due to this I actually was unable to donate bone marrow to a cancer kid after being identified as a match about a year ago.
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| 2820589 | 18 | F | PA | 01/13/2025 |
COVID19 |
MODERNA |
B0002 |
Expired product administered
Expired product administered
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Vaccine adminstered after beyond use date
Vaccine adminstered after beyond use date
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| 2820590 | 3 | M | NE | 01/13/2025 |
HEPA HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
C24b9 C24b9 |
Febrile convulsion, Influenza A virus test negative, Influenza B virus test nega...
Febrile convulsion, Influenza A virus test negative, Influenza B virus test negative, Postictal state, Pyrexia; Respiratory viral panel, Streptococcus test negative
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Per Dr.'s note. Patient appears to have had a febrile seizure very early this morning with a po...
Per Dr.'s note. Patient appears to have had a febrile seizure very early this morning with a post ictal state. He was transported by paramedics to ER where he was noted to have a high fever. He had negative strep, influenza, RSV and COVID testing per mother. Respiratory viral panel is pending. He is doing well now. Mother is continuing tylenol every 4 hours. He is allergic to ibuprofen. Recommended to call the EMS for any seizure lasting more than 5 minutes. If he has a third febrile seizure or a seizure without fever, would obtain EEG. There is no FMH of seizures in mother, but she is adopted and has incomplete family history knowledge. If he has negative respiratory viral panel at ER, would report this incident to VAERS as he had second hepatitis A vaccine less than two days prior to his seizure activity.
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| 2820592 | 0.17 | F | ME | 01/13/2025 |
DTPPVHBHPB FLU3 PNC15 RV1 |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
U7907AA A555J Y005351 32PF3 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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10 Week old patient was administered an influenza vaccine, which are not indicated to give until 6 m...
10 Week old patient was administered an influenza vaccine, which are not indicated to give until 6 months of age.
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| 2820593 | 1.33 | F | KS | 01/13/2025 |
DTAP FLU3 HEPA HIBV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
TX77L J245K Y011643 X022982 |
Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error
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Vaccine deemed not stable due to temperature excursion
Vaccine deemed not stable due to temperature excursion
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| 2820594 | 60 | M | OK | 01/13/2025 |
TDAP |
SANOFI PASTEUR |
U7624AA |
Expired product administered
Expired product administered
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Vaccine was expired when administered. Expiration date was 12/6/2024.
Vaccine was expired when administered. Expiration date was 12/6/2024.
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| 2820595 | 90 | F | IA | 01/13/2025 |
TDAP |
SANOFI PASTEUR |
U8264AA |
Cough, Injection site bruising, Injection site erythema, Injection site swelling...
Cough, Injection site bruising, Injection site erythema, Injection site swelling, Vomiting
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emesis following coughing with breakfast the next morning, bruising redness, and swelling noted at s...
emesis following coughing with breakfast the next morning, bruising redness, and swelling noted at site of administration. no respiratory distress
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| 2820596 | 62 | M | OH | 01/13/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
060H21A 060H21A |
Computerised tomogram head, Dizziness, Ear discomfort, Echocardiogram, Syncope; ...
Computerised tomogram head, Dizziness, Ear discomfort, Echocardiogram, Syncope; Tilt table test, Ultrasound Doppler
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light headed, ears full, sincope, dizziness
light headed, ears full, sincope, dizziness
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| 2820597 | 0.33 | M | MI | 01/13/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
T343J |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient has not shown any signs of adverse reactions to the vaccination.
Patient has not shown any signs of adverse reactions to the vaccination.
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| 2820598 | 75 | F | NY | 01/13/2025 |
FLU3 |
SEQIRUS, INC. |
388482 |
Joint range of motion decreased, Pain in extremity
Joint range of motion decreased, Pain in extremity
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PT REPORTS SORE ARM AND LIMITED RANGE OF MOTION CONTINUING FOR 2 MONTHS NOW. PT USING PHYSICAL THERA...
PT REPORTS SORE ARM AND LIMITED RANGE OF MOTION CONTINUING FOR 2 MONTHS NOW. PT USING PHYSICAL THERAPY AND IT IS GETTING BETTER.
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| 2820599 | 1.5 | M | MD | 01/13/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5H773 |
Diarrhoea, Vaccination site rash
Diarrhoea, Vaccination site rash
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Rash occurred at vaccine site area ( Left thigh). vaccine was given 01/07/2025. Father reported rash...
Rash occurred at vaccine site area ( Left thigh). vaccine was given 01/07/2025. Father reported rash same day that improved over three days. Child was seen in office on 01-10-2025 for the rash and Diarrhea concern.
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| 2820600 | 62 | F | FL | 01/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered
Extra dose administered
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Records stated patient received first Arexvy vaccine on 10/21/23. Patient then received another vacc...
Records stated patient received first Arexvy vaccine on 10/21/23. Patient then received another vaccine on 1/13/25. When I spoke to the patient, she stated she is unaware that she got the Arexvy back in 2023 and thought it was a pneumonia vaccine, however records states otherwise.
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| 2820601 | 17 | M | SC | 01/13/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H DD72H |
Cold sweat, Dizziness, Hyperhidrosis, Malaise, Pain; Pruritus, Pyrexia, Streptoc...
Cold sweat, Dizziness, Hyperhidrosis, Malaise, Pain; Pruritus, Pyrexia, Streptococcus test positive
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Patient receive vaccine at 10:46am. At 12:30 started to feel poorly at school - felt feverish and ac...
Patient receive vaccine at 10:46am. At 12:30 started to feel poorly at school - felt feverish and achy and like he was going to pass out. Patient curled up in fetal position and sweaty/clammy - EMS called. Low grade fever in ED. After getting fluids in ED, felt much better. Zpac rx for + Strep on ED test (had been rx'ed amox previous week). Went to bed - woke up overnight - with all over itching - esp wrists and hands. Took 2 benadryl. No difficulty breathing. Epi pen at home for tree nut allergy.
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| 2820602 | 88 | F | AL | 01/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient came in and received second dose of Arexvy after getting one in 2/2024. No issues reported b...
Patient came in and received second dose of Arexvy after getting one in 2/2024. No issues reported but only one dose per lifetime is recommended at this time.
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| 2820603 | 65 | M | FL | 01/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received Arexvy Vaccine twice (11/20/2023 and 01/07/2025). The patient came to our pharmacy ...
Patient received Arexvy Vaccine twice (11/20/2023 and 01/07/2025). The patient came to our pharmacy requesting to receive the vaccine we administered and were later notified patient had already received it at store. We notified the patient who stated he experienced no side effects from the vaccine.
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| 2820604 | 16 | F | NE | 01/13/2025 |
COVID19 |
PFIZER\BIONTECH |
Fa7485 |
Blood test abnormal, Fatigue, Oligomenorrhoea, Pain, Von Willebrand's disea...
Blood test abnormal, Fatigue, Oligomenorrhoea, Pain, Von Willebrand's disease
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Developed fatigue, body aches. 2 days after started menstrual bleeding that wouldn't stop. Cons...
Developed fatigue, body aches. 2 days after started menstrual bleeding that wouldn't stop. Consequencely, diagnosed with Von Willebrand disease without any previous chlidhood or family history. Bled for 9 months before any semblance of control. Lifelong management required.
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| 2820605 | 47 | F | OH | 01/13/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8523BA U8523BA |
Discomfort, Impaired driving ability, Inflammation, Injected limb mobility decre...
Discomfort, Impaired driving ability, Inflammation, Injected limb mobility decreased, Mobility decreased; Musculoskeletal pain, Neck pain, Pain, Pain in extremity
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Pt states within the first hour after the vaccine she had unusual pain in the left arm and then it m...
Pt states within the first hour after the vaccine she had unusual pain in the left arm and then it moved into the left shoulder blade. By the end of the day, she could not lift her arm. The pain was 10 out of 10. The pain was mainly in the left shoulder blade and not in the arm itself. She found it very uncomfortable to sit. The pain escalated to the neck area. Then she lost movement to her head. She could not turn her head to the left or right and it hurt to move her head forward. Her mobiltity was restricted. She contacted her physician and he revoked her driving privalges. She had to work from home because she had trouble sitting or moving and couldnt drive. She had an appt with her PCP and was told her to use heating pad, pain relief patches and biofreeze gel. She had to alernate tylenol and ibuprofen around the clock for a total of 2 weeks. Her mobiltity was restricted for at least 2 weeks but she was in pain and had limited mobility for about 4 weeks. Her doctor told her she had inflammation from the vaccine. She is not sure its from the vaccine ingredients or where it was or how it was injected. She still has some pain that comes and goes from time to time.
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| 2820606 | 11 | F | KS | 01/13/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
X014788 M23G5 HA9CH |
Product storage error; Product storage error; Product storage error
Product storage error; Product storage error; Product storage error
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Vaccine deemed not stable due to temperature excursion
Vaccine deemed not stable due to temperature excursion
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