| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
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| 2848221 | 60 | F | PA | 07/02/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LK6650 LK6650 |
Influenza, Injection site erythema, Injection site mass, Injection site pain, In...
Influenza, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site swelling
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lump on injection site and very itchy; lump on injection site and very itchy; injection site redness...
lump on injection site and very itchy; lump on injection site and very itchy; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; flu symptoms; pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 at 11:00 as dose 1, single (Lot number: LK6650) at the age of 60 years, in left arm for immunisation. The patient did not receive any other vaccines on the same date as the vaccine(s) for which the reporter is reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which the reporter is reporting. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SIMVASTATIN. The following information was reported: INFLUENZA (non-serious) with onset 25Jun2025, outcome "recovering", described as "flu symptoms"; VACCINATION SITE PAIN (non-serious) with onset 25Jun2025, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 26Jun2025, outcome "recovering" and all described as "injection site redness and site swelling that spread on the arm including pain"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Jun2025, outcome "recovering" and all described as "lump on injection site and very itchy". Therapeutic measures were not taken as a result of influenza, vaccination site pain, vaccination site erythema, vaccination site swelling, pain in extremity, erythema, peripheral swelling, vaccination site mass, vaccination site pruritus. Additional information: On 25Jun2025 (day 2), the patient had flu symptoms and pain at the injection site. By 26Jun2025 (day 3), injection site redness and site swelling that spread on the arm including pain. By 27Jun2025 (day 4), all before and lump on injection site and very itchy.
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| 2848222 | 59 | F | TX | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LN4929 |
Injection site erythema
Injection site erythema
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Red ring around area vaccine was given.
Red ring around area vaccine was given.
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| 2848223 | M | TX | 07/02/2025 |
COVID19 FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
LM2222 |
Neuralgia, Periarthritis; Neuralgia, Periarthritis
Neuralgia, Periarthritis; Neuralgia, Periarthritis
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frozen shoulder/ Lost mobility in his right arm/ could not lift it all the way above his head; it ju...
frozen shoulder/ Lost mobility in his right arm/ could not lift it all the way above his head; it just did not stop hurting/ nerve pain; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old male patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 27Aug2024 as dose number unknown, single (Lot number: LM2222, Expiration Date: 24Mar2025), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 27Aug2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Immunisation; Covid shots (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PERIARTHRITIS (non-serious) with onset Sep2024, outcome "not recovered", described as "frozen shoulder/ Lost mobility in his right arm/ could not lift it all the way above his head"; NEURALGIA (non-serious) with onset Sep2024, outcome "not recovered", described as "it just did not stop hurting/ nerve pain". The event "it just did not stop hurting/ nerve pain" required physician office visit. Therapeutic measures were taken as a result of periarthritis, neuralgia. Additional Information: The pharmacist gave the COVID shot straight in to the right arm of his wife, with him, he took an angle. It was like, he avoided the deltoid muscle. The patient had got frozen shoulder after two weeks, after receiving the shot. He had been to therapy and that was finished and they cannot help him anymore. He was just doing exercises but he had lost mobility in his right arm. After he received the COVID shot, within two week afterwards he started having problems with his right arm and did not know what was affecting and he could not lift it straight up and within 2 weeks time, he could not lift it all the way above his head. He can just lift it up to the side, he cannot lift it away from him, it was limited mobility. When he gave him the shot for the COVID, it was hurting. It was not so bad. He had to go to the hospital but it just did not stop hurting. He eventually had to see his general practitioner and she put him on Gabapentin to offset the nerve pain that the shot had given him and he was still taking it. The patient had shots given for years; flu and the COVID shot.
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| 2848224 | 69 | F | TX | 07/02/2025 |
COVID19 |
PFIZER\BIONTECH |
EP6955 |
Pain in extremity
Pain in extremity
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Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous ...
Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old female patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot #: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Pain in arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered", described as "Sore Arm/my arm might have been sore for a day or so and then it wasn't".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132661 same patient/suspect/events; different dose;US-PFIZER INC-PV202500077806 same patient/suspect/events; different dose;US-PFIZER INC-202500132660 same patient/suspect/events; different dose;
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| 2848225 | 70 | F | TX | 07/02/2025 |
COVID19 |
PFIZER\BIONTECH |
FF8841 |
Pain in extremity
Pain in extremity
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Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous ...
Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot #: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Pain in arm"; BNT162b2 (Dose 2, single, Lot #: EP6955), administration date: 21Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Pain in arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered", described as "Sore Arm/my arm might have been sore for a day or so and then it wasn't".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132661 same patient/suspect/events; different dose.;US-PFIZER INC-202500132659 same patient/suspect/events; different dose.;US-PFIZER INC-PV202500077806 same patient/suspect/events; different dose.;
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| 2848227 | F | 07/02/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Aphonia, Asthma, Autoimmune disorder, Cataract, Chills; Confusional state, Cough...
Aphonia, Asthma, Autoimmune disorder, Cataract, Chills; Confusional state, Cough, Dysphonia, Dyspnoea exertional, Migraine; Nausea, Panic attack, Pyrexia, Sensitivity to weather change
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cataract; Patient's autoimmune system has never been correct; asthmatic flare up; cough; panic ...
cataract; Patient's autoimmune system has never been correct; asthmatic flare up; cough; panic attack; confusion; loses her voice; weather changes will affect her voice; voice is noted to be hoarse and raspy; shortness of breath upon exertion; migraine; nausea; fever (pyrexia); chills; PROGRAM NAME NOT AVAILABLE This is a solicited report received from a Consumer or other non HCP from License Party, Program ID: NOT AVAILABLE. Other Case identifier(s): 2021SA054848 (BioNTech SE). A 65-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 15Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 05Aug2019) at 600 mg 1x/day and second regimen since 19Aug2019) at 300 mg (300 mg, every other week (maintenance dose)), all subcutaneous for dermatitis atopic, asthma. The patient's relevant medical history included: "loses her speech" (unspecified if ongoing); "body becomes numb" (unspecified if ongoing); "mimic a stroke" (unspecified if ongoing); "Aphasia" (unspecified if ongoing); "Hypoaesthesia" (unspecified if ongoing); "migraine" (ongoing), notes: since her 40s.; "post-traumatic stress disorder not dementia," (unspecified if ongoing); "allergic asthma" (ongoing); "Forgetfulness" (unspecified if ongoing); "hospital", start date: Feb2021 (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE; SYMBICORT; PREDNISONE. The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "fever (pyrexia)"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown"; MIGRAINE (non-serious) with onset 11May2022, outcome "recovering"; CATARACT (hospitalization, medically significant) with onset 01May2025, outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "Patient's autoimmune system has never been correct"; ASTHMA (non-serious), outcome "not recovered", described as "asthmatic flare up"; COUGH (non-serious), outcome "not recovered"; PANIC ATTACK (non-serious), outcome "not recovered"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; DYSPNOEA EXERTIONAL (non-serious), outcome "not recovered", described as "shortness of breath upon exertion"; APHONIA (non-serious), outcome "unknown", described as "loses her voice"; SENSITIVITY TO WEATHER CHANGE (non-serious), outcome "unknown", described as "weather changes will affect her voice"; DYSPHONIA (non-serious), outcome "recovering", described as "voice is noted to be hoarse and raspy". The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of cataract. The reporter's assessment of the causal relationship of "cataract", "patient's autoimmune system has never been correct", "asthmatic flare up", "cough", "panic attack", "confusion", "fever (pyrexia)", "chills", "shortness of breath upon exertion", "nausea", "loses her voice", "weather changes will affect her voice", "voice is noted to be hoarse and raspy" and "migraine" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: The patient's past medical history included sometimes loses her speech and her body becomes numb and that they could mimic a stroke, Aphasia and Hypoaesthesia. At the time of the event, the patient had ongoing very bad migraine since her 40s. describes her migraine episodes as being debilitating, had post-traumatic stress disorder not dementia, allergic asthma and forgetfulness. Concomitant medications included budesonide, formoterol fumarate (Symbicort), prednisone. On 05Aug2019, the patient took Dupixent (Dupilumab) (strength:150mg/ml) at a dose of 600 mg(milligram) 1x/day, followed by since 19Aug2019 with maintenance dose of 300 mg QOW (every other week) via subcutaneous route (with an unknown form, batch number and expiry date) for atopic Dermatitis, Asthma via prefilled syringe. On 15Apr2021, the patient started taking covid-19 vaccine (with an unknown formulation, strength, dosage, route, frequency, batch number, and expiry date) for COVID-19 immunization. On an unknown date in Feb2021 patient was in the hospital and that she was not called to schedule (hospitalization), latency: (1 year 5 months approximately) following the first dose intake of dupilumab. On an unknown date in Apr2021 the patient developed fever (pyrexia), chills, and nausea, latency(1 year 7 months approximately) following the first dose intake of dupilumab. The patient was in bed for 3 days due to fever, chills, and nausea. Patient reported having an asthmatic flare up (asthma) and stated that every year around this time her cough gets worse (cough) (onset date and latency: unknown) following the first dose intake of dupilumab due to the weather and seasons changing. On an unknown date, patient had a panic attack (panic attack) (unknown latency) right after she took Dupixent she noticed she was more confused. On an unknown date, confusion was much worse (confusional state) (condition aggravated) (unknown latency) following the first dose intake of dupilumab. Upon follow-up it was stating that Dupixent keeps the consumer stable. However, the consumer loses her voice slightly close to the time where she would take her next injection (aphonia) (unknown latency and onset) following the first dose intake of dupilumab. On an unknown date, patient's voice is noted to be hoarse and raspy(dysphonia) (unknown latency) and states that he weather changes will affect her voice ( sensitivity to weather change) (unknown latency) following the first dose intake of dupilumab. It was reported on follow-up "is having migraine headaches since yesterday; she does states that she has a history of migraines that had been intermittent since before starting Dupixent; patient's voice is noted to be hoarse and raspy; states that he weather changes would affect her voice; that was her case today and was a common thing with Asthma; In inquiring about what device she uses, she does say that she uses syringe, but she did mention previously at one point that she tried the auto-injecting pen, and at which point, she was saying that it was difficult to control the device more than the syringe offers better control than the pen; Currently the patient was using syringe and was planning to proceeding over with the prefilled syringe; She had attempted a pen previously, and didn't like how it was functional to her; said that the syringe was easier for her to control; so there's some lack of control with the pen versus the prefilled syringe. Patient's last dose was taken on 15Apr2022". On 11May2022, latency: 2 years 9 months 6 days, patient stated she has had a severe migraine. On an unknown date, the patient took Dupilumab Solution for injection (strength: 300 mg) at a dose of 300 mg QOW subcutaneous for Dermatitis atopic and Asthma. Patient reported that she was recently in the hospital. On 01May2025, she recently had cataract surgery (cataract) (latency: 5 years 8 months 27) (unknown batch number and expiry date). She informed that she had really bad attacks. She expressed being harsh with her voice.Information regarding batch number and expiration date corresponding to the one at the time of event occurrence was requested. No lab data was provided. Action taken: Unknown for cataract and o action taken for all the other events with pre-filled syringe and no action taken for cataract and unknown for all the other event with pre-filled pen. Corrective: cataract surgery for the event cataract and not reported for all the other events. Outcome: Not recovered/not resolved for the events panic attack, confusional state, autoimmune disorder, aphonia, condition aggravated and dyspnoea exertional), recovering for migraine, Dysphonia, cataract and unknown for rest of the events. Reporter causality: Unassessable for hospitalization and not related for events pyrexia, chills, nausea, asthma, cough, migraine and not reported for rest all events Company causality: Not reportable for all the events. Seriousness Criteria: Medically significant for the event autoimmune disorder, cataract and hospitalized for the event (hospitalization), cataract. 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. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on known disease pathophysiology, and limited information available, the events are assessed as not related to COVID-19 Vaccine, and more likely due to underlying medical conditions.
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| 2848228 | M | 07/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebral haemorrhage, Dizziness, Platelet count, Platelet count decreased
Cerebral haemorrhage, Dizziness, Platelet count, Platelet count decreased
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intensive care unit in February due to a brain bleed, caused by low platelet count; intensive care u...
intensive care unit in February due to a brain bleed, caused by low platelet count; intensive care unit in February due to a brain bleed, caused by low platelet count; sent to emergency room for dizziness; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA072402 (Sanofi), AE-019819 (BioNTech). Initial information received on 28Feb2024 regarding an unsolicited valid non-serious case received from patient via specialty pharmacy. The case was updated to serious on 02Jun2025. This case involved a 68-year-old male patient who had been admitted to the intensive care unit in February due to a brain bleed caused by a low platelet count while being treated with dupilumab [Dupixent]delivered via dupilumab single dose prefilled pen and the COVID-19 vaccine. Every couple of injections he has some of the liquid trickle back out of his leg with no reported adverse event directly linked to accidental exposure to product and exposure via skin contact. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Terbinafine and Tirzepatide (Mounjaro). On 16Mar2021, the patient started taking dupilumab Solution for injection (strength-300mg/2ml) at a dosage of 300 mg with frequency of QOW (Every Other Week) via subcutaneous route for Atopic dermatitis. On an unknown date, the patient started taking covid-19 vaccine (with an unknown dosage, strength, frequency and route) for an unknown indication. Reportedly, the patient stated that every couple of injections, some of the liquid had trickled back out of his leg(accidental exposure to product)(exposure via skin contact)(onset date; latency-unknown). He mentioned that he did not have much fatty tissue and experienced difficulty with injections in his abdomen. No additional pertinent information was provided. (Batch number: Lot 3F278A, Expiry date: 31Jul2025). Upon follow up information received, the patient stated that his last dose of DUPIXENT was in Jan2025. He was admitted to the intensive care unit in February due to a brain bleed(cerebral haemorrhage), which was attributed to a low platelet count(platelet count decreased)(onset date-Feb2025)(latency-approximately 3 years 11 months). The patient's doctors believed that DUPIXENT may have contributed to the low platelet levels. He reported that his platelet count had consistently been at the low end of normal or slightly below normal (around 200). The patient was sent to the emergency room for dizziness(Dizziness)(onset date Feb2025)(latency-approximately 3 years 11 months), where he was diagnosed with a brain bleed and received platelet infusions. At the time of reporting, he was no longer taking DUPIXENT, following the advice of his doctors. He had been on DUPIXENT for four years and believed that his platelet levels began to decline after receiving COVID-19 vaccines, although it was unclear whether the two were related. No additional details were provided (batch number- 4F517A; expiration date- 31Aug2026) Action taken- drug withdrawn for Platelet count decreased, Cerebral haemorrhage and Dizziness; not applicable for other events. Corrective treatment- platelet infusions for Platelet count decreased and Cerebral haemorrhage; not reported for other events Outcome- Not Recovered / Not Resolved for Cerebral haemorrhage (its symptoms). Seriousness Criteria-medically significant and Hospitalized for Cerebral haemorrhage(its symptoms). 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. Additional information was received on 02Jun2025 from the patient. Based on this information, the case initially considered as non-serious was upgraded to serious. New event- Cerebral haemorrhage(Platelet count decreased and Dizziness as symptom) were added. Clinical course updated. Text amended accordingly. Sanofi Company Comment on 05-Jun-2025: This case involved a 68-year-old male patient who was admitted to the intensive care unit in February due to a brain bleed caused by a low platelet count while being treated with dupilumab [Dupixent]delivered via dupilumab single dose prefilled pen. Causal relationship of the suspect drugs cannot be denied however limited information provided regarding this case preclude comprehensive assessment of this case. Case would be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medication. Batch/lot number is not provided, and it cannot be obtained. Comirnaty is under agreement with BIONTECH SE.
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| 2848229 | 69 | F | TX | 07/02/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6202 |
Pain in extremity
Pain in extremity
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Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous ...
Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered", described as "Sore Arm/my arm might have been sore for a day or so and then it wasn't".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132661 same patient/suspect/events; different dose;US-PFIZER INC-202500132659 same patient/suspect/events; different dose;US-PFIZER INC-202500132660 same patient/suspect/events; different dose;US-PFIZER INC-202500130444 same patient/drug, different AE/dose;
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| 2848230 | 68 | F | OH | 07/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Vaccination failure
COVID-19, Vaccination failure
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I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP. ...
I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COMIRNATY (primary immunisation series complete), for COVID-19 immunisation: the patient took the vaccine since it's been available, and every 6 months, and it's always been Pfizer. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "I have COVID". Therapeutic measures were taken as a result of vaccination failure, COVID-19: the patient was prescribed PAXLOVID the morning of this report. The patient specified that she had got symptoms pretty major- not major but quite a few symptoms. The patient took the Pfizer COVID vaccine a month prior to this report, and she had been up to date like every 6 months, and she did not understand why she was so sick. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2848238 | 20 | M | NY | 07/02/2025 |
MMR |
MERCK & CO. INC. |
X024177 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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inadvertently administered expired MMR-II on 06/16/2025; No additional AE/PQC.; This spontaneous rep...
inadvertently administered expired MMR-II on 06/16/2025; No additional AE/PQC.; This spontaneous report was received from a nurse practitioner and refers to a 20-year-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 16-Jun-2025, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot #X024177, expiration date: 11-Jun-2025) 0.5 mL /dose, as prophylaxis. No symptoms reported. No additional AE details reported.
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| 2848239 | 62 | F | NC | 07/02/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0151 EW0151 |
Illness, Knee arthroplasty, Pain, Pyrexia, Vertigo; Weight
Illness, Knee arthroplasty, Pain, Pyrexia, Vertigo; Weight
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fever; sick; aches, pains; Vertigo She had an 8 hour episode and had to go the ER; knee replacement ...
fever; sick; aches, pains; Vertigo She had an 8 hour episode and had to go the ER; knee replacement surgery in Jan; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 66-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0151) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "Blood pressure high" (ongoing); "Weight loss" (ongoing). Concomitant medication(s) included: ZEPBOUND taken for weight decreased (ongoing); NEVIBOLOL DCI taken for hypertension (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: BNT162b2 (Dose 1, lot number: ER2613; in left arm, below shoulder, few inches below elbow), administration date: 17Mar2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "knee replacement surgery in Jan", "fever", "sick", "aches, pains". The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 21Jan2025, outcome "unknown", described as "knee replacement surgery in Jan"; VERTIGO (non-serious) with onset 07Mar2025, outcome "unknown", described as "Vertigo She had an 8 hour episode and had to go the ER"; PYREXIA (non-serious), outcome "recovered", described as "fever"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown", described as "aches, pains". The events "vertigo she had an 8 hour episode and had to go the er" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: loss. Therapeutic measures were taken as a result of knee arthroplasty. Clinical course: A patient on the line reporting on Comirnaty vaccine. She said recently received booster vaccine on 28Jun2025 and every time in the past she has gotten a fever in a few hours, but this time did not. She stated she had in past aches, pain, and fever so was surprised to not experience that this time. She also mentioned she had a knee replacement in Jan. She wondering if her vaccine is effective. She also clarified every time got the vaccine, she also gets the fever and aches within 10 hours or so and it would always last for a day or less, but this time did not. She has received both the Moderna and Pfizer vaccines, and this is the first time this did not happen. While capturing details she clarified at up until Jun2025 out of the 8 covid vaccines received only 2, the first two were manufactured by Pfizer. The rest were Moderna. Then this 9th one she just received was her 9th Covid Vaccine, and 3rd Pfizer vaccine manufactured by Pfizer.
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| 2848240 | 42 | F | KY | 07/02/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Exposure during pregnancy, No adverse event, Pregnancy test urine positive
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Drug exposure during pregnancy with no reported adverse event; Initial information received on 25-Ap...
Drug exposure during pregnancy with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 42 years old female patient who was exposed to vaccine influenza vaccine in context of drug exposure during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date is 01-Jul-2025. The patient's past medical history included Cholelithiasis, Cholelithiasis in AUG-2023, Caesarean section in AUG-2023, Cholecystectomy and Last menstrual period determination on 21-AUG-2024. The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy. Concomitant medications included Drospirenone (SLYND) for Contraception. On 21-Aug-2024, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and had drug exposure during pregnancy with no reported adverse event (exposure during pregnancy). Relevant laboratory test results included: Pregnancy test urine - On 05-Sep-2024: Negative; on 12-Sep-2024: Negative; on 02-Oct-2024: Negative; on 27-Mar-2025: Positive Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2848241 | 70 | M | MT | 07/02/2025 |
FLU3 |
SANOFI PASTEUR |
U8524DA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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patient was administered with expired FLUZONE HD, with no reported adverse evet; Initial information...
patient was administered with expired FLUZONE HD, with no reported adverse evet; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old male patient who was administered with expired Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] 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 Elasomeran (COVID-19 vaccine Moderna),Hepatitis A Vaccine Inact, Hepatitis B Vaccine Rhbsag (Yeast) (Twinrix) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunisation. On 01-Jul-2025, the patient received 0.5 ml expired dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8524DA,expiry date:30-Jun-2025,frequency:once,strength:high via intramuscular route in the right deltoid for immunisation with no reported adverse event (expired product administered) (latency:same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
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| 2848242 | 2 | M | IA | 07/02/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK019AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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inadvertently administered a dose of Pentacel one day after it expired with no adverse event; patien...
inadvertently administered a dose of Pentacel one day after it expired with no adverse event; patient of 24 moths 9 days old received Pentaxim with no adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months 9 days old male patient who was inadvertently administered a dose of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] one day after it expired with no adverse even. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A vaccine for Immunisation. On 01-Jul-2025, the patient of 24 months 9 days old received 0.5 ml of dose 4 of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- unknown, expiry date- 30-Jun-2026 and lot UK019AA) via intramuscular route in the right thigh for Immunization one day after it expired with no adverse event (expired product administered) (product administered to patient of inappropriate age) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2848243 | 1.5 | F | CA | 07/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
A3X2K |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848244 | 63 | F | CA | 07/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Autoimmune disorder, Biopsy, Lichen planus
Autoimmune disorder, Biopsy, Lichen planus
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Lichen Planus -- autoimmune
Lichen Planus -- autoimmune
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✓ | |||||
| 2848245 | 4 | M | CA | 07/02/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848246 | 1.83 | F | CA | 07/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
A3X2K |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848247 | 68 | F | CA | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LN4930 |
Injection site cellulitis
Injection site cellulitis
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Patient was seen at ER for cellulitis of the injection site.
Patient was seen at ER for cellulitis of the injection site.
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| 2848260 | 74 | M | CA | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LN4930 |
Joint swelling
Joint swelling
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Swelling of the left elbow
Swelling of the left elbow
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| 2848261 | 4 | F | CA | 07/02/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
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| 2848262 | 57 | M | CA | 07/02/2025 |
PNC20 PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
LN4930 LN4930 LN4930 LN4930 |
Pain in extremity; Arthralgia, Cellulitis, Injection site pain; Pain in extremit...
Pain in extremity; Arthralgia, Cellulitis, Injection site pain; Pain in extremity; Arthralgia, Cellulitis, Injection site pain
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Left Arm Pain
Left Arm Pain
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| 2848263 | 12 | M | CA | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
Yoo7197 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
More
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| 2848264 | 54 | F | NC | 07/02/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
L5529 LP1780 |
Cellulitis, Injection site irritation, Injection site rash; Cellulitis, Injectio...
Cellulitis, Injection site irritation, Injection site rash; Cellulitis, Injection site irritation, Injection site rash
More
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Patient received Boostrix and Shingrix (dose one of two) on April 18, 2025 at approximately 4pm. Pa...
Patient received Boostrix and Shingrix (dose one of two) on April 18, 2025 at approximately 4pm. Patient developed rash and irritation in the injection site area five days later on April 23, 2025. She sought care from her provider on April 25, 2025 and was diagnosed with cellulitis and received antibiotics.
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| 2848265 | 2 | M | CA | 07/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
A3X2K |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
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| 2848266 | 2 | M | 07/02/2025 |
HEPA MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
|
Rash; Rash
Rash; Rash
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Patient developed rash on face and arms post vaccination.
Patient developed rash on face and arms post vaccination.
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| 2848267 | 26 | F | AZ | 07/02/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944920 |
Chills, Fatigue, Muscle spasms, Paraesthesia, Pyrexia
Chills, Fatigue, Muscle spasms, Paraesthesia, Pyrexia
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TINGLING ON HANDS, FATIGUE, FEVER, CHILLS, MUSCLE SPASMS ON ARMS (FOR ABOUT 2 WEEKS)
TINGLING ON HANDS, FATIGUE, FEVER, CHILLS, MUSCLE SPASMS ON ARMS (FOR ABOUT 2 WEEKS)
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| 2848268 | 4 | M | CA | 07/02/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848269 | 1.25 | F | CA | 07/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
A3X2K |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848270 | 56 | F | CA | 07/02/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4929 LN4929 |
Erythema, Hypersensitivity, Pruritus, Rash, Skin warm; Tenderness
Erythema, Hypersensitivity, Pruritus, Rash, Skin warm; Tenderness
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Local allergic reaction Erythematous, warm, tender rash. No systemic symptoms. Claritin recommended...
Local allergic reaction Erythematous, warm, tender rash. No systemic symptoms. Claritin recommended over Allegra. Prednisone prescribed to prevent delayed reaction. - Prescribe Claritin 10 mg once daily in the morning. - Advise Benadryl every six hours if itching persists. - Prescribe topical steroid cream twice daily. - Prescribe Pepcid every evening until rash resolves. - Prescribe prednisone, two tablets daily for five days, with food in the morning. - Advise ice application to reduce inflammation. - Suggest baking soda paste or Aveeno oatmeal bath for relief.
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| 2848271 | 0.67 | M | CA | 07/02/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
4L544 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848272 | 59 | F | FL | 07/02/2025 |
COVID19 |
MODERNA |
|
Lichen planopilaris, Pruritus, Scalp biopsy, Skin exfoliation
Lichen planopilaris, Pruritus, Scalp biopsy, Skin exfoliation
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Shortly after the vaccine (March 24, 2021) I noted scalp issues including itching; shedding; etc. I...
Shortly after the vaccine (March 24, 2021) I noted scalp issues including itching; shedding; etc. I scheduled an appointment with a dermatologist for June 1, 2021. (I had to wait several weeks to obtain an appointment.) The dermatologist diagnosed lichen planopilaris (an auto-immune disease resulting in permanent hair loss). I have been in treatment for over fours years including doxycycline, clobetasol, kenalog steroid injections, plaquenil, cell crept, myfortic.
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✓ | |||||
| 2848273 | 1.08 | M | CA | 07/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
A3X2K |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848274 | 0.58 | M | CA | 07/02/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
4L544 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848275 | 12 | M | CA | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
Yoo7197 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
More
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| 2848276 | 0.58 | F | CA | 07/02/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
4L544 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848277 | 0.58 | F | CA | 07/02/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
4L544 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848278 | 16 | M | CA | 07/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99G34 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
More
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| 2848279 | 0.33 | M | CA | 07/02/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
4L544 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
More
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| 2848280 | 11 | M | CA | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
Yoo7197 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
More
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| 2848281 | 69 | F | FL | 07/02/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946063 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received 2nd dosage of Heplisav-B 26 days after her first dosage. ACIP Guidelines state that...
Patient received 2nd dosage of Heplisav-B 26 days after her first dosage. ACIP Guidelines state that patients should receive 2nd dosage of Heplisav-B at least 28 days after 1st dosage.
More
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| 2848282 | 11 | M | CA | 07/02/2025 |
HPV9 MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
Yoo7197 XL223 |
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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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
More
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| 2848284 | 60 | F | CA | 07/02/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Dry skin, Increased tendency to bruise, Joint swelling, Lymphadenopa...
Arthralgia, Dry skin, Increased tendency to bruise, Joint swelling, Lymphadenopathy; Musculoskeletal stiffness, Nausea, Neck pain, Pain, Pruritus; Pyrexia, Skin exfoliation
More
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Day 1: immediate itching, sandpaper skin reaction. Day 2 morning: Left arm stiffnesss, all over join...
Day 1: immediate itching, sandpaper skin reaction. Day 2 morning: Left arm stiffnesss, all over joint pain, especially left thumb. Day 2 afternoon: Nausea Day 2 evening: fever, shooting pain in joints, neck pain, nausea Day 3: Lymph node above left collar bone swollen and visibly protruding, joint pain, skin on hand very flaky. Day 4: swollen joints in hands, easy bruising. Ongoing approx one month: joint pain
More
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| 2848285 | 12 | M | CA | 07/02/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
|
Chills, Cough, Headache, Lethargy, Pain in extremity; Pyrexia
Chills, Cough, Headache, Lethargy, Pain in extremity; Pyrexia
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Fever, cough, sore arm, headache, lethargic, chills
Fever, cough, sore arm, headache, lethargic, chills
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| 2848286 | 60 | F | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Pruritus, Swelling
Pruritus, Swelling
|
Patient reported itching and swelling 3 days after receiving vaccine
Patient reported itching and swelling 3 days after receiving vaccine
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| 2848299 | 89 | M | OK | 07/02/2025 |
COVID19 |
MODERNA |
3046731 |
Cerebrovascular accident, Musculoskeletal disorder, Posture abnormal, Urinary tr...
Cerebrovascular accident, Musculoskeletal disorder, Posture abnormal, Urinary tract infection
More
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Per Nurses documentation on 6/11/25 patient could not sit up straight on the side of the bed, R arm ...
Per Nurses documentation on 6/11/25 patient could not sit up straight on the side of the bed, R arm limp loss of control of R arm, R foot curled in. Resident sent to Medical Center where he was admitted and dx'd with CVA & UTI. He was hospitalized until 6/17/25 then he was discharged back to the retirement center.
More
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✓ | |||||
| 2847914 | 07/01/2025 |
PNC21 |
MERCK & CO. INC. |
|
Arthralgia, Chills, Fatigue, Myalgia, Tenderness
Arthralgia, Chills, Fatigue, Myalgia, Tenderness
|
Last night (and today) I experienced several of the reactions listed on the information sheet, inclu...
Last night (and today) I experienced several of the reactions listed on the information sheet, including: Chills; Muscle Ache; Tenderness; Joint pain; Tiredness; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine for prophylaxis (dose, lot #, expiration date, route of administration and anatomical site of injection were not reported). On 26-Jun-2025 (reported as last night and today), the patient experienced muscle ache (myalgia), tenderness, joint pain (arthralgia), chills and tiredness (fatigue). At the reporting time, the outcome of all the events was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.
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| 2847915 | TN | 07/01/2025 |
TDAP |
SANOFI PASTEUR |
|
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
unsuitable product administered with no reported adverse event; Initial information received on 26-J...
unsuitable product administered with no reported adverse event; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was exposed to temperature excursion for 48 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication: No other vaccines On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site which was exposed to temperature excursion for 48 hours with no reported adverse event (poor quality product administered). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, Nurse stated that she was not sure for the temperature during excursion. There was no human error in this excursion and extended stability data covers this excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
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| 2847923 | 78 | M | FL | 07/01/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Injection site erythema, Injection site pain, Pain
Injection site erythema, Injection site pain, Pain
|
pain at injection site; redness at the injection site; has pain when moving the arm; This non-seriou...
pain at injection site; redness at the injection site; has pain when moving the arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. On 13-JUN-2025, the patient received Twinrix (intramuscular use, left arm) 1 ml. In JUN-2025, an unknown time after receiving Twinrix, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at the injection site) and pain in arm (Verbatim: has pain when moving the arm). The outcome of the injection site pain, injection site erythema and pain in arm were not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and pain in arm to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site erythema and pain in arm to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 20-JUN-2025 The reporter was a healthcare professional. She reported on June 20th 2025 an adverse event for Twinrix vaccine. She reported that a male patient received a Twinrix vaccine at their pharmacy on June 13th, 2025. The vaccine was administered in the left arm. The patient contacted the pharmacy twice and reported an adverse event of pain at the injection site, (pain). The patient reported he had pain when moving the arm (painful when moving). The patient reported to healthcare professional that the redness at the injection site and stated it was the size of a dime. The healthcare professional reported that after a week the patient was still experienced these events and have not improved. No additional medical history or medications information were provided.
More
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| 2847924 | F | OR | 07/01/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
The patient did not receive the shot; This non-serious case was reported by a pharmacist via call ce...
The patient did not receive the shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (first dose on 31st March 2025, batch number 3X937, expiry date 31st December 2025). On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: The patient did not receive the shot). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 20-JUN-2025 A pharmacist called to informed of a patient that had missed the second dose of Engerix-B. She informed that the patient had the first dose in March 2025 and according to schedule the second one was supposed to be in April 2025. The patient did not receive the shot and went to the pharmacy until June 2025. The pharmacist wanted to know how to proceed in order to complete the doses of the vaccine schedule. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
More
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