| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2846975 | 63 | F | TX | 06/23/2025 |
CHIK |
BAVARIAN NORDIC |
LN4929 |
Erythema, Skin warm
Erythema, Skin warm
|
Left shoulder with erythema and warmth. MD prescribed cephalexin (10 day course) and cetirizine.
Left shoulder with erythema and warmth. MD prescribed cephalexin (10 day course) and cetirizine.
|
||||||
| 2846976 | 8 | M | VA | 06/23/2025 |
MNQ RAB |
SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS |
U83698A FDP00683 |
Injection site pruritus, Injection site urticaria; Injection site pruritus, Inje...
Injection site pruritus, Injection site urticaria; Injection site pruritus, Injection site urticaria
More
|
First simultaneous itching at both vaccine injection sites then Hives at both upper arm injection si...
First simultaneous itching at both vaccine injection sites then Hives at both upper arm injection sites that included the back shoulders; immediately gave 5ml of children's Benadryl repeated in 5 minutes with a second dose of 5 ml per child's weight of 59 #. No respiratory involvement. EMS called and assessed Pt. Normal Vital signs. SpO2 94%. No progression of hives. Itching resolved. EMS agreed with treatment plan and discharged Pt. to mother's choice to see PMD. Continued to observe Pt. an hour before discharge to PMD.
More
|
||||||
| 2846977 | 1.67 | CA | 06/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
20 month old that received Kinrix; Incorrect vaccine/the patient needed the Dtap/IPV immunization; T...
20 month old that received Kinrix; Incorrect vaccine/the patient needed the Dtap/IPV immunization; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-month-old patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. Co-suspect products included DTPa-IPV (DTPa-IPV) for prophylaxis. On an unknown date, the patient received Kinrix and DTPa-IPV. On an unknown date, an unknown time after receiving Kinrix and not applicable after receiving DTPa-IPV, the patient experienced inappropriate age at vaccine administration (Verbatim: 20 month old that received Kinrix) and wrong vaccine administered (Verbatim: Incorrect vaccine/the patient needed the Dtap/IPV immunization). The outcome of the inappropriate age at vaccine administration and wrong 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: 11-JUN-2025 The nurse reported that they had a 20-month-old patient that received Kinrix which led to inappropriate age at vaccine administration, and he/she was asked to follow-up if there is any concern or anything that need to be done. When asked what vaccine was supposed to receive, the nurse answered that the patient needed the Dtap/IPV immunization for the patient's age which led to wrong vaccine administered.
More
|
|||||||
| 2846978 | 67 | F | AL | 06/23/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
7MN4C |
Chills, Tremor
Chills, Tremor
|
Per RN, pt had Bexsero 3rd dose, left office, returned and about 3 hrs later to ambulatory suite an...
Per RN, pt had Bexsero 3rd dose, left office, returned and about 3 hrs later to ambulatory suite and had severe shills and shaking for approximately 45 mins.
More
|
||||||
| 2846979 | M | IN | 06/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9L944 |
Product preparation error
Product preparation error
|
Shingrix possible powder administration with another diluent than the one provided; Shingrix possibl...
Shingrix possible powder administration with another diluent than the one provided; Shingrix possible powder administration with another diluent than the one provided; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a elderly male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Shingrix possible powder administration with another diluent than the one provided) and inappropriate preparation of medication (Verbatim: Shingrix possible powder administration with another diluent than the one provided). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 13-JUN-2025 and 14-JUN-2025 Practice manager wanted to know how to proceed after finding a Shingrix box 2 with an odd number of vials only including the diluent, so she was supposing that the powder was administered to a patient using another diluent (saline water) than the one provided which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. Also, mentioned that she still needed to find out who was the patient that received it. Recommendation was given about contacting the medical information team again if she finds out the patient involved and date of administration.
More
|
|||||||
| 2846980 | 1 | M | MD | 06/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
BR2GD |
Expired product administered
Expired product administered
|
Expired dose given; This non-serious case was reported by a other health professional via call cente...
Expired dose given; 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 14-month-old male patient who received HAV (Havrix) (batch number BR2GD, expiry date 16-MAY-2025) for prophylaxis. On 13-JUN-2025, the patient received the 1st dose of Havrix. On 13-JUN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used 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: 13-JUN-2025 The healthcare professional called in to report that they accidentally administered two doses of expired Havrix to two patients which led to, expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
More
|
||||||
| 2846981 | 1 | M | MD | 06/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
BR2GD |
Expired product administered
Expired product administered
|
Expired dose given; This non-serious case was reported by a other health professional via call cente...
Expired dose given; 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 19-month-old male patient who received HAV (Havrix) (batch number BR2GD, expiry date 16-MAY-2025) for prophylaxis. On 13-JUN-2025, the patient received Havrix. On 13-JUN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used 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: 13-JUN-2025 A healthcare professional called in to report that they accidentally administered 2 doses of expired Havrix to 2 patients, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025074252, reported by the same reporter for a different patient.; Sender's Comments: US-GSK-US2025074252:same reporter /different patient
More
|
||||||
| 2846982 | KY | 06/23/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Intercepted product preparation error, Product preparation error
Intercepted product preparation error, Product preparation error
|
Hiberix - Incorrect vaccine preparation/used the diluent of Priorix for the Hiberix vaccine; This no...
Hiberix - Incorrect vaccine preparation/used the diluent of Priorix for the Hiberix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted product preparation error in a patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced intercepted product preparation error (Verbatim: Hiberix - Incorrect vaccine preparation/used the diluent of Priorix for the Hiberix vaccine). The outcome of the intercepted product preparation error was not applicable. Additional Information: GSK receipt date: 13-JUN-2025 A nurse mentioned they used the diluent of Priorix for the Hiberix vaccine, and the reporter confirmed that the dose was not administered, which led to intercepted product preparation error. The reporter asked if the diluents were the same or if they were different. No further details were provided by the reporter.
More
|
||||||||
| 2846983 | 68 | F | 06/23/2025 |
RSV |
MODERNA |
3041772 |
Device issue, No adverse event
Device issue, No adverse event
|
removing the cap (where the needle is located) was also hard to remove; the vaccine's plunger w...
removing the cap (where the needle is located) was also hard to remove; the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE DIFFICULT TO USE (removing the cap (where the needle is located) was also hard to remove), DEVICE ISSUE (the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy) and NO ADVERSE EVENT (No adverse effect) in a 68-year-old female patient who received mRNA-1345 (mRESVIA) (batch no. 3041772) for Respiratory syncytial virus infection prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3041772) for Respiratory syncytial virus infection prophylaxis. No Medical History information was reported. On 17-Jun-2025, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE DIFFICULT TO USE (removing the cap (where the needle is located) was also hard to remove), DEVICE ISSUE (the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE DIFFICULT TO USE (removing the cap (where the needle is located) was also hard to remove), DEVICE ISSUE (the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1345 (mRESVIA) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were reported. HCP mentioned that they encountered a plunger error on a syringe that was administered to a patient. HCP reported that the vaccine's plunger was heavy and was very hard to push and removing the cap, where the needle was located was also hard to remove. HCP wanted a product replacement on a syringe they used to administer to a patient. HCP reported that was successfully administered to a patient. It was reported that only one syringe was used and only one patient received the vaccine. A possible occupational exposure of vaccine during administration due to plunger problem was considered. No adverse events were reported after the vaccination. No treatment medications were reported. The Device Problem Information include FDA code: 1670, IMDRF Code: A23, Device problem: Use of Device Problem. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2025: Live Follow up received that contains non-significant information and reference ID added. On 17-Jun-2025: Live Follow up received contains non-significant information and reference ID added. On 17-Jun-2025: Live Follow up received contains non-significant information and reference ID added. On 17-Jun-2025: Live follow-up received contains significant information and reporter details updated, patient details updated, new event added, narrative updated, reference ID added On 18-Jun-2025: Live Follow up received that contains non-significant information and reference ID added. On 18-Jun-2025: Live Follow-up received contains significant information and event LLT updated, Reference ID added.
More
|
|||||||
| 2846985 | F | 06/23/2025 |
PNC20 |
PFIZER\WYETH |
LP4947 |
Injection site cellulitis, Injection site reaction, Rash erythematous
Injection site cellulitis, Injection site reaction, Rash erythematous
|
red rash at site of injection/likely celulitis; red rash at site of injection/likely celulitis; This...
red rash at site of injection/likely celulitis; red rash at site of injection/likely celulitis; This is a spontaneous report received from a Physician. A 67-year-old female patient (not pregnant) received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 12Jun2025 as dose number unknown, single (Lot number: LP4947) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Hypersensitivity"; Bactrim, reaction(s): "Hypersensitivity"; Tetracycline, reaction(s): "Hypersensitivity". The following information was reported: VACCINATION SITE CELLULITIS (non-serious), VACCINATION SITE RASH (non-serious) all with onset 13Jun2025, outcome "unknown" and all described as "red rash at site of injection/likely celulitis". Therapeutic measures were taken as a result of vaccination site cellulitis, vaccination site rash. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The patient taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event included antibiotic. Causality for "red rash at site of injection/likely celulitis" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
More
|
||||||||
| 2846986 | 30 | F | FL | 06/23/2025 |
RSV |
PFIZER\WYETH |
|
Chills, Diarrhoea, Nausea, Pain, Vomiting
Chills, Diarrhoea, Nausea, Pain, Vomiting
|
Severe vomiting; diarrhoea; Nausea; Chills; Body ache; This is a spontaneous report received from a ...
Severe vomiting; diarrhoea; Nausea; Chills; Body ache; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Jun2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025), described as "Body ache"; CHILLS (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025); NAUSEA (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025); VOMITING (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025), described as "Severe vomiting"; DIARRHOEA (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025). The patient was hospitalized for vomiting, diarrhoea, nausea, chills, pain (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of vomiting, diarrhoea, nausea, chills, pain. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
More
|
โ | |||||
| 2846987 | 06/23/2025 |
PNC20 |
PFIZER\WYETH |
|
Parotitis
Parotitis
|
parotitis/My parotid gland on the left-hand side is swollen; This is a spontaneous report received f...
parotitis/My parotid gland on the left-hand side is swollen; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROTITIS (non-serious) with onset 20Jun2025, outcome "unknown", described as "parotitis/My parotid gland on the left-hand side is swollen". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||||
| 2846988 | F | 06/23/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Neurodermatitis
Neurodermatitis
|
prurigo nodularis developed after the covid vaccine; This is a spontaneous report received from a Co...
prurigo nodularis developed after the covid vaccine; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA153013 (Sanofi). A 62-year-old 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; dupilumab (DUPIXENT), since 12Dec2022 (Lot number: 4F595A, Expiration Date: 30Nov2026) at 300 mg (300 mg qow), subcutaneous for dermatitis atopic. The patient's relevant medical history included: "atopic dermatitis" (ongoing). Concomitant medication(s) included: CALCIPOTRIENE; SULFACETAMIDE SODIUM AND SULFUR [SULFACETAMIDE SODIUM;SULFUR]; NALTREXONE HCL. The following information was reported: NEURODERMATITIS (non-serious), outcome "unknown", described as "prurigo nodularis developed after the covid vaccine". The action taken for dupilumab was unknown. Additional information: It was reported patient said that when she was taking dupixent she formed abscesses more than once and the medication was not working. Patient had been started on nemluvio therapy. patient stated prurigo nodularis developed after the covid vaccine. no other details were provided'. An unknown (nemluvio therapy) corrective treatment was received for abscess and not reported for neurodermatitis." Batch/lot number is not provided, and it cannot be obtained. BNT162B2 OMICRON (KP.2) is under agreement with BIONTECH SE.
More
|
||||||||
| 2846989 | 0.33 | M | FL | 06/23/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
K1098A |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
PENTACEL was administered without the ActHib portion with no reported adverse event; Initial informa...
PENTACEL was administered without the ActHib portion with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who received diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without the ACT-HIB portion 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); and Rotavirus vaccine live oral 1v (Rotarix) as both for Immunisation. On 16-Jun-2025, the patient received 0.5 ml of diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with strength- standard (expiry date- 30-SEP-2025 and lot K1098A) once via unknown route in unknown administration site for Immunization, without the ACT-HIB portion with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, Caller inquiring if the DTaP-IPV portion would be valid and then if the Act-Hib portion could be administered separately. 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.
More
|
||||||
| 2846990 | 12 | M | NV | 06/23/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
medical assistants accidentally administered daptacel to a 12-year-old patient with no reported adve...
medical assistants accidentally administered daptacel to a 12-year-old patient with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who was accidentally administered with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] by medical assistant to a 12-year-old 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 HPV vaccine and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) both for Immunisation. On 20-Jun-2025, the patient received 0.5mL of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA55C1, expiry date 31-Aug-2026, strength standard and frequency once) via intramuscular route in the left deltoid for Immunisation and was accidentally administered to a 12-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, they wanted to know if they need to revaccinate and what they should look out for. 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.
More
|
||||||
| 2846991 | 33 | M | MI | 06/23/2025 |
TD TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U7927AA |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
|
patient was supposed to receive adacel, but they received tenivac with no reported adverse event; In...
patient was supposed to receive adacel, but they received tenivac with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 33 years old male who was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], but they received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 20-JUN-2025 the patient was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine, but they received 0.5 of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength, frequency once with lot U7927AA and expiry date 13-Oct-2025 via intramuscular route in the left deltoid for Immunization with no reported adverse event (wrong product administered) (latency same day). Reportedly, The pharmacist explains that the patient's wife is giving birth soon, which is why he needs pertussis coverage. When he was vaccinated, he was expecting pertussis coverage. However, he was erroneously given tenivac; he did not receive adacel. 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.
More
|
||||||
| 2846992 | 55 | F | MO | 06/23/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
|
Redness and swelling that has progressively gotten worse since the 21st of June...area is warm, red ...
Redness and swelling that has progressively gotten worse since the 21st of June...area is warm, red and swollen at an area of 3.5 " x 2.75"
More
|
||||||
| 2846993 | 66 | F | MI | 06/23/2025 |
TDAP |
SANOFI PASTEUR |
|
Muscle spasms
Muscle spasms
|
Lower leg cramping for 2 days.
Lower leg cramping for 2 days.
|
||||||
| 2847001 | 25 | F | CA | 06/23/2025 |
COVID19 HPV9 |
PFIZER\BIONTECH MERCK & CO. INC. |
me6072 z005469 |
Fall, Hypoacusis, Peripheral coldness, Thirst, Tunnel vision; Fall, Hypoacusis, ...
Fall, Hypoacusis, Peripheral coldness, Thirst, Tunnel vision; Fall, Hypoacusis, Peripheral coldness, Thirst, Tunnel vision
More
|
After giving pt the 2 vaccines, we asked the pt to stay for 15 minutes for observations. A few minut...
After giving pt the 2 vaccines, we asked the pt to stay for 15 minutes for observations. A few minutes later, heard mom calling out pt's name. Stepped out to see pt (sitting on chair) slowly falling to her left side. Mom was able to catch pt before she hit her head on the floor. So pt never hit her head. Pt was pale, and her hands were cold to the touch. Pt did not have any breathing issues, or anything other extreme symptoms. We asked pt and mom if they needed us to call 911, but they said not needed. Per mom, while talking to pt, pt asked for water, and then her eyes become unfocused and she started to fall sideway, while sitting. Per pt, she said she was feeling anxious/emotional prior to getting vaccines, as she always feel anxious prior to getting any vaccines. Pt stated that she felt thirsty, had tunnel vision, and muffled hearing. Upon being pulled up from the floor, pt said she felt like she was asleep, and that she was waking from her sleep. She knew she was at the pharmacy, and felt embarrassed for what had happened. She kept saying sorry. Upon feeling more alert after a couple of minutes, pt asked for water, and we went and got pt a bottle of cold water. Again, pt refused 911 call. We asked pt and mom to remain in pharmacy area for at least 30 minutes to make sure everything is ok. we checked on pt multiple time and pt was feeling much better, more alert, and had colors back, and hands not as clammy. After 30 minutes, pt and mom left the pharmacy on their own, since pt said she felt better.
More
|
||||||
| 2847002 | 77 | F | CA | 06/23/2025 |
COVID19 |
MODERNA |
3046734 |
Eye movement disorder, Mental status changes
Eye movement disorder, Mental status changes
|
Change in condition related to altered mental status and abnormal vital signs. On 6/22/2025 @ 1749, ...
Change in condition related to altered mental status and abnormal vital signs. On 6/22/2025 @ 1749, resident noted with BP 136/86, Pulse 102, Temperature 98.6, Oxygen saturation 73% on Room Air, BS 124 mg/dl. Resident noted to have eyes rolling to back of head, unable to hold arms up during assessment, only responded to pain stimulation (Sternal rub), Resident transferred to Hospital for further evaluation.
More
|
||||||
| 2847003 | 68 | F | FL | 06/23/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
p2443 |
Pruritus, Urticaria
Pruritus, Urticaria
|
Patient got severe hives and itching
Patient got severe hives and itching
|
||||||
| 2847004 | 70 | F | GA | 06/23/2025 |
PNC20 |
PFIZER\WYETH |
LJ5283 |
Extra dose administered
Extra dose administered
|
Patient received a 2nd dose of Prevnar 20 on accident. First dose was 4/24/2024 in a different state...
Patient received a 2nd dose of Prevnar 20 on accident. First dose was 4/24/2024 in a different state.
More
|
||||||
| 2847005 | 0.17 | F | MI | 06/23/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
V7788AA |
Vomiting projectile
Vomiting projectile
|
Projectile vomited for the first time in her life about 5-6 hours after vaccine
Projectile vomited for the first time in her life about 5-6 hours after vaccine
|
||||||
| 2847006 | 4 | F | NE | 06/23/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
7745R Y013576 |
Injection site urticaria; Injection site urticaria
Injection site urticaria; Injection site urticaria
|
Hives around the vaccine site.
Hives around the vaccine site.
|
||||||
| 2847007 | 74 | F | CO | 06/23/2025 |
COVID19 |
MODERNA |
3046714 |
Pruritus, Rash, Swelling
Pruritus, Rash, Swelling
|
patient presented to the pharmacy 6/18/2025 at 4PM with large raised bump, raised and hot to touch, ...
patient presented to the pharmacy 6/18/2025 at 4PM with large raised bump, raised and hot to touch, approximately softball size. reported it at coming on next day after vaccination 6/17/2025 and itchy. Reported taking benadryl and applying ice.
More
|
||||||
| 2847008 | 52 | F | MT | 06/23/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y011819 Y011819 Y011819 |
Asthenia, Chills, Fatigue, Injection site pain, Myalgia; Nausea, Oedema peripher...
Asthenia, Chills, Fatigue, Injection site pain, Myalgia; Nausea, Oedema peripheral, Pain, Pruritus, Pyrexia; Urticaria
More
|
103.9 temp x 3 days, fever, chills, nausea, severe muscle aches, shooting pain in right arm to finge...
103.9 temp x 3 days, fever, chills, nausea, severe muscle aches, shooting pain in right arm to finger tips on day 2, weakness, fatigue, severe arm pain at injection site for 2 days. On day 6, deep red welts and edema appeared on arm, spreading, itching.
More
|
||||||
| 2847009 | 55 | M | FL | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
kr75k |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Patient previously received the Boostrix on 8/17/24, so this is a duplicated vaccine. The vaccine o...
Patient previously received the Boostrix on 8/17/24, so this is a duplicated vaccine. The vaccine on 8/17/24 was not reported to FL shots, so the pharmacist was unaware that it was previously given last year.
More
|
||||||
| 2847016 | 0.33 | M | CA | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
EB499 |
Dizziness, Presyncope
Dizziness, Presyncope
|
Patient felt dizzy and nearly fainted after receiving the vaccine. Pt's father and Health Profe...
Patient felt dizzy and nearly fainted after receiving the vaccine. Pt's father and Health Professional moved pt from immunization area to another chair. When pt was asked how he felt, pt responded feeling lightheaded, dizzy, about to faint. Pharmacy offered to call 911, but pt's father declined. After sitting on chair for approximately 10 minutes and drinking water, pt reported dizziness was gone, responded no other side effects, he able to walk normally. Pt's father stated afterwards he was likely too nervous getting vaccine.
More
|
||||||
| 2846802 | 25 | M | CO | 06/22/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
30145BA 30145BA EW0196 EW0196 |
COVID-19, Dizziness, Fatigue, Heart rate increased, Laboratory test; Palpitation...
COVID-19, Dizziness, Fatigue, Heart rate increased, Laboratory test; Palpitations, Syncope; COVID-19, Dizziness, Fatigue, Heart rate increased, Laboratory test; Palpitations, Syncope
More
|
Dizziness/faint, racing heart, fatigue, got covid 2 days after the event.
Dizziness/faint, racing heart, fatigue, got covid 2 days after the event.
|
โ | โ | ||||
| 2846803 | 75 | M | TN | 06/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EJ1686 EL3246 |
Cardiac arrest, Death; Cardiac arrest, Death
Cardiac arrest, Death; Cardiac arrest, Death
|
Death due to Cardiac arrest
Death due to Cardiac arrest
|
โ | |||||
| 2846804 | 58 | F | TN | 06/22/2025 |
MMR |
MERCK & CO. INC. |
|
Condition aggravated, Vertigo
Condition aggravated, Vertigo
|
Symptoms of vertigo after getting the booster shot. Not sure it was related to the vaccine since I?v...
Symptoms of vertigo after getting the booster shot. Not sure it was related to the vaccine since I?ve had vertigo before and it can recur I think.!
More
|
||||||
| 2846805 | 06/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
missed the 6 month window for second dose; This non-serious case was reported by a consumer via inte...
missed the 6 month window for second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included shingles vaccine (received 1st dose of vaccine on an unknown date). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: missed the 6 month window for second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. It had been 8 months since he/she had received his/her first shingles vaccine; he/she had missed the 6-month window for the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
More
|
|||||||||
| 2846806 | 1 | F | AR | 06/22/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
GG39D |
Expired product administered
Expired product administered
|
Infanrix expired (less than 30 days) dose administration; This non-serious case was reported by a nu...
Infanrix expired (less than 30 days) dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-month-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 05-JUN-2025) for prophylaxis. On 12-JUN-2025, the patient received the 4th dose of Infanrix. On 12-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix expired (less than 30 days) dose administration). The outcome of the expired vaccine used 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: 13-JUN-2025 A Licensed Practical Nurse wanted to know how to proceed after administering an expired dose of Infanrix on 12th June 2025 to a patient, which led to Expired vaccine used. It was intended to be the fourth dose in the immunization schedule.
More
|
||||||
| 2846807 | 33 | SC | 06/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Off label use
Off label use
|
Intentional Off Label Prescription by HCP: Imovax prescribed with off labe ldiagnosis Bitten by dog,...
Intentional Off Label Prescription by HCP: Imovax prescribed with off labe ldiagnosis Bitten by dog, initial encounter, with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 33-year-old and unknown gender patient who was intentionally prescribed with IPV (VERO) [Imovax] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a intentional prescription of 1ml dose of suspect IPV (VERO) Suspension for injection, frequency-4 times (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for bitten by dog, initial encounter (Animal bite) with no reported adverse event (off label use). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable.
More
|
|||||||
| 2846808 | 41 | F | GA | 06/22/2025 |
TDAP |
SANOFI PASTEUR |
4CA04C1 |
Contusion, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Contusion, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
|
My arm began to experience pain, swelling from shoulder to wrist, hives, itching, & bruising. Th...
My arm began to experience pain, swelling from shoulder to wrist, hives, itching, & bruising. The pain started short after the injection, however, I didn?t realize my arm was in hives until around 4 or 5 hours because the itching wouldn?t stop. I took an antihistamine of Claritin, hydrocortisone ointment, I applied aloe, cold cloth thru out the day. Today is 6/22/25 and my arm still has a bruise, slight pain on the bruise, & minor swelling. It?s much better, but not 100%.
More
|
||||||
| 2846809 | 13 | F | SD | 06/22/2025 |
HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Agitation, Amnesia, Computerised tomogram head normal, Delusion, Dizziness; Dysa...
Agitation, Amnesia, Computerised tomogram head normal, Delusion, Dizziness; Dysarthria, Headache, Hypersomnia, Hypoaesthesia, Irritability; Mental impairment, Nausea, Somnolence, Vision blurred, Vomiting
More
|
My daughter had numbness go down her riight ring finger, then middle, then index and thumb. She fel...
My daughter had numbness go down her riight ring finger, then middle, then index and thumb. She felt like she had an explosion on the right side of her head. The headache intensified until she felt nauseous. Then she had trouble visually focusing , she repeatedly stated she couldn't think, asked what happened, had short-term memory loss. I took her to the ER. She had a CT scan done to her head which revealed no skull fractures or issues with any veins. As she was in the ER she became increasingly agitated and irritable. She started slurring her speech. She had trouble staying awake. She was given Tylenol and Zofran and sent home with me. She vomited 5 times after she got home. She called her face a foot, her glasses contacts, her shoes she called glasses. Eventually she fell asleep. (the doctor said it was ok to let her sleep). She slept for 17 hours. Woke up with headache and dizziness. She has had a headache ever since and today is 6/22/25.
More
|
โ | |||||
| 2846810 | 39 | M | GA | 06/22/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
301358A 301358A 301358A FF2588 FF2588 FF2588 |
Blood creatinine, Cardiac disorder, Cardiac stress test, Cardiomyopathy, Compute...
Blood creatinine, Cardiac disorder, Cardiac stress test, Cardiomyopathy, Computerised tomogram heart; Echocardiogram, Ejection fraction decreased, Electrocardiogram, Fatigue, Haematocrit; Magnetic resonance imaging heart, Pain in extremity, Scan with contrast; Blood creatinine, Cardiac disorder, Cardiac stress test, Cardiomyopathy, Computerised tomogram heart; Echocardiogram, Ejection fraction decreased, Electrocardiogram, Fatigue, Haematocrit; Magnetic resonance imaging heart, Pain in extremity, Scan with contrast
More
|
Initially, sore arm, fatigue, no major illness detected. Within 3 months, I developed a heart condit...
Initially, sore arm, fatigue, no major illness detected. Within 3 months, I developed a heart condition. I assumed it would go away or get better. Combine that with my career (Pilot), I can't have medical tests that will show adversely against my medical. I didn't test anything until March 2024 when I was diagnosed with cardiomyopathy, low ejection fraction.
More
|
โ | โ | ||||
| 2846811 | 64 | F | GA | 06/22/2025 |
HEP PNC21 |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. |
946062 Z002626 |
Injection site erythema, Injection site pruritus; Injection site erythema, Injec...
Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus
More
|
Redness and itching at injection site
Redness and itching at injection site
|
||||||
| 2846812 | 68 | F | FL | 06/22/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered
Extra dose administered
|
duplicate
duplicate
|
||||||
| 2846825 | 71 | F | CA | 06/22/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
041L20A 041L20A 041L20A 044A21A 044A21A 044A21A |
Chromosomal analysis, Computerised tomogram head, Flow cytometry, Full blood cou...
Chromosomal analysis, Computerised tomogram head, Flow cytometry, Full blood count, Headache; Immediate post-injection reaction, Laboratory test, Mantle cell lymphoma, Mobility decreased, Next-generation sequencing; Positron emission tomogram, Tinnitus; Chromosomal analysis, Computerised tomogram head, Flow cytometry, Full blood count, Headache; Immediate post-injection reaction, Laboratory test, Mantle cell lymphoma, Mobility decreased, Next-generation sequencing; Positron emission tomogram, Tinnitus
More
|
Bedridden x2 days, headache, tinnitus, Mantel Cell Lymphoma. Headache began immediately after, tinn...
Bedridden x2 days, headache, tinnitus, Mantel Cell Lymphoma. Headache began immediately after, tinnitus soon after, Mantel Cell Lymphoma diagnosis 1/2025
More
|
โ | โ | ||||
| 2846832 | 36 | F | MD | 06/22/2025 |
IPV YF |
SANOFI PASTEUR SANOFI PASTEUR |
|
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling; Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
More
|
Rash/swelling/tenderness/itching @ site of yellow fever injection 4.5 x 5.5 cm area of erythema.
Rash/swelling/tenderness/itching @ site of yellow fever injection 4.5 x 5.5 cm area of erythema.
|
||||||
| 2846778 | OH | 06/21/2025 |
HPV9 |
MERCK & CO. INC. |
X019196 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being a...
Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being administered the expired dose of GARDASIL 9. No additional AE; expired administration of a dose of GARDASIL 9; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 16-JUN-2025, the patient was inadvertently vaccinated with an expired vaccine of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, 0.5 mL, Two or Three dose series, administered as prophylaxis (lot number X019196 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 25-APR-2025; dose, formulation, anatomical site of injection, and route of administration were not reported) (Expired product administered). Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being administered the expired dose of the vaccine (No adverse event). No additional information provided.
More
|
||||||||
| 2846783 | 84 | F | FL | 06/21/2025 |
COVID19 |
NOVAVAX |
|
Fatigue, Muscle spasms, Pyrexia
Fatigue, Muscle spasms, Pyrexia
|
Extreme fatigue, fever severe leg cramps for one hour in evening
Extreme fatigue, fever severe leg cramps for one hour in evening
|
||||||
| 2846784 | 53 | F | CA | 06/21/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Arthralgia, Dizziness, Gait disturbance, Injection site pain, Lethargy; Musculos...
Arthralgia, Dizziness, Gait disturbance, Injection site pain, Lethargy; Musculoskeletal chest pain, Myalgia, Nausea, Pain, Pyrexia; Rash, Sensitive skin
More
|
0 hours: injection site pain, soreness; <12 hours muscle ache, joint pain, overall body ache, fee...
0 hours: injection site pain, soreness; <12 hours muscle ache, joint pain, overall body ache, feeling of sensitive skin (i.e. skin hurts to touch); <24 hours feverish, increased overall body aches and pains, lethargy, pain lower right rib. Began 1g (2*500mg) acetaminophen Q6 hours for symptoms; <48 hours dizziness, nausea, unsteady gait, overall body pain and muscle aches (discontinue acetaminophen); >48 hours painful rash posterior to injection site on right arm, pruritis (very itchy), >72 hours pain lower right rib persists (constant, not off and on) especially if taking deep breath, pruritis on and below injection site including red rash area, placed topical salonpas patch on area to prevent scratching.
More
|
||||||
| 2846785 | 63 | F | NM | 06/21/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Erythema, Induration, Muscle swelling, Skin warm
Erythema, Induration, Muscle swelling, Skin warm
|
Pt complained of swollen deltoid, hot to touch, hard swelling. Red "finger" marks.
Pt complained of swollen deltoid, hot to touch, hard swelling. Red "finger" marks.
|
||||||
| 2846786 | 60 | F | CA | 06/21/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
|
Cellulitis, Chills, Erythema, Feeling hot, Pain in extremity; Peripheral swellin...
Cellulitis, Chills, Erythema, Feeling hot, Pain in extremity; Peripheral swelling
More
|
Chills redness of arm swelling of arm - arm pain- arm felt warm - redness spread everyday further do...
Chills redness of arm swelling of arm - arm pain- arm felt warm - redness spread everyday further down to elbow and spread side ways surrounding the arm - continue to spread for about 5-6 days. On 6 days seek medical attention and was given Cephalexin 500mg q6h - was told for cellulitis - symptoms - subsided - finishing the 7 day course of antibiotics right now -
More
|
||||||
| 2846787 | 59 | F | AZ | 06/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Dizziness, Lip swelling, Nausea, Syncope
Dizziness, Lip swelling, Nausea, Syncope
|
The patient received her 2nd dose of Shingrix vaccine on 6/19/2025. Patient reported that 36 hours a...
The patient received her 2nd dose of Shingrix vaccine on 6/19/2025. Patient reported that 36 hours after she received the vaccination, in the early am on 6/21/2025, she woke up with a swelling upper lip, nausea, and syncope. She called the pharmacy at 10:15 am 6/21/2025 and reported her reactions with still a swollen upper lip and feeling like she was going to "black out" when she stands up. I recommended going to the emergency room, she was accompanied by her daughter at the time of the call.
More
|
||||||
| 2846788 | 51 | F | GA | 06/21/2025 |
PNC21 |
MERCK & CO. INC. |
z002626 |
Injection site erythema, Injection site reaction, Injection site warmth
Injection site erythema, Injection site reaction, Injection site warmth
|
injection site reaction with redness swelling and heat. advised to use topical benedryl
injection site reaction with redness swelling and heat. advised to use topical benedryl
|
||||||
| 2846789 | 57 | F | GA | 06/21/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
z002626 3j2s2 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
More
|
injection site reaction redness, swelling, heat on arm - recommended benedryl cream
injection site reaction redness, swelling, heat on arm - recommended benedryl cream
|
||||||
| 2846790 | 79 | F | NY | 06/21/2025 |
RSV |
PFIZER\WYETH |
|
Cough, Dyspnoea, Rhinorrhoea
Cough, Dyspnoea, Rhinorrhoea
|
cough and runny nose from the outset.....nothing helped. On March 24, 2025. I awoke UNABLE TO BREAT...
cough and runny nose from the outset.....nothing helped. On March 24, 2025. I awoke UNABLE TO BREATHE. Managed to call EMS and was rushed to the hospital, in which was a patient for an entire week. When I was discharged, I came home with inhalers, nose drops AND OXYGEN!!!! Never been on oxygen in my life!!! Now I'm stuck with it!!!
More
|
โ | โ |