| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2861106 | 14 | F | IL | 09/24/2025 |
HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal distension, Arthralgia, Blister, Body temperature decreased, Erythema;...
Abdominal distension, Arthralgia, Blister, Body temperature decreased, Erythema; Heavy menstrual bleeding, Loss of personal independence in daily activities, Oligomenorrhoea, Pain in extremity, Pain of skin; Peripheral coldness, Peripheral swelling, Photosensitivity reaction, Rash, Raynaud's phenomenon; Skin discolouration, Temperature regulation disorder; Abdominal distension, Arthralgia, Blister, Body temperature decreased, Erythema; Heavy menstrual bleeding, Loss of personal independence in daily activities, Oligomenorrhoea, Pain in extremity, Pain of skin; Peripheral coldness, Peripheral swelling, Photosensitivity reaction, Rash, Raynaud's phenomenon; Skin discolouration, Temperature regulation disorder
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Raynaud's Syndrome; menstrual cycle also changed from light and sporadic to heavy with constant...
Raynaud's Syndrome; menstrual cycle also changed from light and sporadic to heavy with constant bleeding and with only a few days of relief in between; sporadic bloating of her stomach; Autoimmune Injuries; Neurologic Injuries; chronic joint pain; sun allergies; Information has been received from a lawyer referring to a female patient of unknown age (currently as an adult) regarding a case in litigation. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unknown dates, at the age of 14-year-old, the patient was vaccinated with the first dosage and the second dosage of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) Injection, both 1 dosage form total administered for preventing cervical cancer, upon recommendation of her health care provider and consent of her mother (strength, exact dose, route of administration, anatomical site, lot # and expiration date were not reported). On an unknown date, within weeks of receiving the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, the patient experienced a series of symptoms in her hands such as, coldness, pain, and swelling. The patient often experienced low body temperature and had trouble regulating her body temperature. During warm weather, her feet were painful, swollen, and red. During cold weather, her feet became painful and turned white and/or purple color. Eventually, the patient was diagnosed with Raynaud's Syndrome. Following the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine, the patient developed chronic joint pain causing difficulty with daily tasks. She also developed sun allergies, such as developing painful blisters and bumps on her hands and feet during sun exposure. The patient's menstrual cycle also changed from light and sporadic to heavy with constant bleeding and with only a few days of relief in between (Menometrorrhagia). Additionally, the patient developed sporadic bloating of her stomach (Abdominal distension) to the point she sometimes appeared seven months pregnant. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints which now included trouble regulating body temperature, coldness, pain, and swelling in hands and feet, purple and/or white hues in feet, chronic joint pain, sensitivity to sun, blisters and bumps on skin during skin exposure, abnormal menstrual periods, and heavy bloating of the abdomen. Based upon her chronic and severe post-Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, the patient has been diagnosed with various medical conditions, including but not limited to, Raynaud's Syndrome, sun allergy, chronic joint pain, and abnormal menstrual cycles. The patient contended that her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, neurologic, and menstrual injuries, including but not limited to Raynaud's Syndrome, sun allergy, chronic joint pain, and abnormal menstrual cycles, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the patient has suffered and continues to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The patient also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, the patient has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. At the reporting time, the patient had not recovered from all aforementioned events. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not applicable. The reporter considered all aforementioned events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The lawyer considered all aforementioned the events to be disabling/incapacitating.
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| 2861107 | M | 09/24/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cough, Respiratory tract congestion
Cough, Respiratory tract congestion
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very little chest congestion; little coughing; This serious case was reported by a consumer via inte...
very little chest congestion; little coughing; This serious case was reported by a consumer via interactive digital media and described the occurrence of lung congestion in a 87-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included pneumonia (had to be hospitalized twice). In SEP-2025, the patient received RSV vaccine. In SEP-2025, less than 2 weeks after receiving RSV vaccine, the patient experienced lung congestion (Verbatim: very little chest congestion) (serious criteria GSK medically significant) and cough (Verbatim: little coughing). The outcome of the lung congestion and cough were not resolved. It was unknown if the reporter considered the lung congestion and cough to be related to RSV vaccine. The company considered the lung congestion and cough to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 17-SEP-2025 This case was reported by a patient via interactive digital media. Patient received the RSV shot two weeks prior. The patient had numerous health issues, but when he became ill he only had little coughing and very little chest congestion. Patient had no sinus congestion or headaches. In previous years, the patient had suffered from pneumonia on multiple occasions, requiring hospitalization twice. Reporter believed that the RSV shot had prevented them from becoming more severely ill. This case is linked with case US2025AMR120788, reported by the same reporter.; Sender's Comments: A case of Pulmonary congestion and Cough, Less than 2 weeks after receiving RSV vaccine, in a 87-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR120788:Case for wife/same reporter
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| 2861108 | M | TX | 09/24/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Blister, Headache, Herpes zoster, Neck pain; Pain in extremity, Prur...
Arthralgia, Blister, Headache, Herpes zoster, Neck pain; Pain in extremity, Pruritus, Vaccination failure; Arthralgia, Blister, Headache, Herpes zoster, Neck pain; Pain in extremity, Pruritus, Vaccination failure
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Lack of drug effect, diagnosed with shingles on right arm, suspected vaccination failure; Shingles o...
Lack of drug effect, diagnosed with shingles on right arm, suspected vaccination failure; Shingles on right arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and relugolix (Orgovyx) for prostate cancer. Concurrent medical conditions included prostate cancer. In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Orgovyx. On 24-AUG-2025, less than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Orgovyx, the patient experienced vaccination failure (Verbatim: Lack of drug effect, diagnosed with shingles on right arm, suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on right arm). The patient was treated with valaciclovir hydrochloride (Valtrex) and thuja occidentalis (Terrasil Wart Treatment). The action taken with Orgovyx was unknown. The outcome of the vaccination failure and shingles were not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Orgovyx. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Orgovyx. Additional Information: GSK Receipt Date: 29-AUG-2025 Patient reported that in Dec-2023 he received his first dose and in Mar-2024 he was vaccinated with the second dose of Shingrix in the series. Patient reported he was diagnosed with shingles on 26-AUG-2025 on his right arm. Two days prior to diagnosis he noticed an ache in his shoulder and neck. He also noticed some water blisters on his right arm. Patient stated the pain from his right arm went up into his skull and was prescribed Valtrex for 10 days. Patient began taking Valtrex but has yet to see any effect the medication has had on the shingles at the time of the call. Patient purchased Terrasil ointment and that was helping the itching. Consumer states 2 years ago he was diagnosed with prostate cancer (exact date of diagnosis not disclosed.) States he received radiation (dates not disclosed) and up until one month ago was prescribed Orgovyx for treatment of prostate cancer. Consumer states he was prescribed ORGOVYX therapy for 18 months. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, less than 2 years after receiving Shingrix and Shingrix, in a 77-year-old male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow-up information has been sought.
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| 2861109 | F | NJ | 09/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Asthenia, Injection site pain, Myalgia, Pain in extremity, Paraesthesia
Asthenia, Injection site pain, Myalgia, Pain in extremity, Paraesthesia
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her arm hurts from the injection site, all the way down her left arm to her hand; feeling weak; arm ...
her arm hurts from the injection site, all the way down her left arm to her hand; feeling weak; arm pain; left hand is very tingly; muscle pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-AUG-2025, the patient received the 1st dose of Shingles vaccine (left deltoid). On 22-AUG-2025, 1 days after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: her arm hurts from the injection site, all the way down her left arm to her hand), feelings of weakness (Verbatim: feeling weak), pain in arm (Verbatim: arm pain), tingling of extremity (Verbatim: left hand is very tingly) and muscle pain (Verbatim: muscle pain). The outcome of the injection site pain, feelings of weakness, pain in arm, tingling of extremity and muscle pain were not resolved. It was unknown if the reporter considered the injection site pain, feelings of weakness, pain in arm, tingling of extremity and muscle pain to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, feelings of weakness, pain in arm, tingling of extremity and muscle pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-SEP-2025 The reporter stated that she had received the first dose of the shingles vaccine and experienced feelings of weakness the following day and had needed to take a nap in the afternoon. The patient reported that her left arm had continued to hurt as of day of reporting. She indicated that the pain extended from the injection site down her entire left arm to her hand, and that this had started the day after receiving the vaccine, she noted that the most intense pain was localized at the injection site Additionally, the patient reported experiencing tingling sensations in her left hand and the patient reports that it might be muscle pain. The patient stated that she had received the shingles vaccine at her local pharmacy. All information regarding these adverse events was reported as provided.
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| 2861110 | F | PA | 09/24/2025 |
RSV VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
255T2 UNK UNK |
Herpes zoster, Product administered to patient of inappropriate age, Vaccination...
Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure; Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure; Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
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Vaccination failure; Shingles; Patient is less than 60; This serious case was reported by a consumer...
Vaccination failure; Shingles; Patient is less than 60; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 59-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis. On 27-AUG-2025, the patient received the 1st dose of Arexvy (left arm). In NOV-2019, the patient received the 2nd dose of Shingrix. In AUG-2019, the patient received the 1st dose of Shingrix. On 27-AUG-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient is less than 60). On 05-SEP-2025, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with valaciclovir hydrochloride (Valacyclovir Hcl). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the shingles to be related to Arexvy, Shingrix and Shingrix. It was unknown if the reporter considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Arexvy, Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-SEP-2025 It was reported that Shingles appeared just over a week after the patient received the RSV vaccination, which could have been coincidental. The patient mentioned that this timing might have been a coincidence, as the RSV vaccine was administered and, just over a week later, a Shingles outbreak occurred. The patient had previously received the Shingrix vaccine (first dose in August 2019; second dose in November 2019), which had definitely reduced the severity of the Shingles outbreak. However, the patient was unsure if the RSV vaccination had triggered the event and thought it was worth reporting.; Sender's Comments: A case of Vaccination failure, 9 days after receiving 1st dose of Arexvy and 2nd dose of Shingrix, in a 59-year-old female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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| 2861111 | F | 09/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache, Hypoaesthesia, Vertigo
Headache, Hypoaesthesia, Vertigo
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Severe vertigo; Numbness of hands and fingers; Severe headache; This non-serious case was reported b...
Severe vertigo; Numbness of hands and fingers; Severe headache; This non-serious case was reported by a consumer and described the occurrence of vertigo in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included migraine and vertigo. Concurrent medical conditions included arthritis (of the spine with bone spurs thereon) and anxiety. Concomitant products included escitalopram. On 03-SEP-2025, the patient received Shingrix. On 05-SEP-2025, 2 days after receiving Shingrix, the patient experienced vertigo (Verbatim: Severe vertigo), numbness in hand (Verbatim: Numbness of hands and fingers) and headache (Verbatim: Severe headache). On 06-SEP-2025, the outcome of the vertigo and headache were resolved (duration 1 day) and the outcome of the numbness in hand was resolved. It was unknown if the reporter considered the vertigo, numbness in hand and headache to be related to Shingrix. It was unknown if the company considered the vertigo, numbness in hand and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 08-SEP-2025 The patient had severe vertigo, numbness of hands and fingers and severe headache.
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| 2861112 | 37 | F | GA | 09/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
3D72S |
Expired product administered
Expired product administered
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she administered an expired Priorix to a patient today.; This non-serious case was reported by a pha...
she administered an expired Priorix to a patient today.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 37-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. On 08-SEP-2025, the patient received Priorix. On 08-SEP-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: she administered an expired Priorix to a patient today.). 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.
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| 2861114 | 1 | M | CA | 09/24/2025 |
HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
LY35X U029794 U039948 |
Anaphylactic reaction, Anaphylaxis treatment, Cough, Cyanosis, Vomiting; Anaphyl...
Anaphylactic reaction, Anaphylaxis treatment, Cough, Cyanosis, Vomiting; Anaphylactic reaction, Anaphylaxis treatment, Cough, Cyanosis, Vomiting; Anaphylactic reaction, Anaphylaxis treatment, Cough, Cyanosis, Vomiting
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anaphylactic reaction; throwing up; coughing; Lips turned blue; This serious case was reported by a ...
anaphylactic reaction; throwing up; coughing; Lips turned blue; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 12-month-old male patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis. Co-suspect products included MMR (MMR vaccine) (batch number U029794) for prophylaxis and Varicella zoster vaccine (Varicella vaccine) (batch number U039948) for prophylaxis. Concurrent medical conditions included meat allergy and food allergy (patient has multiple food allergies). On 22-AUG-2022, the patient received Havrix 720, MMR vaccine and Varicella vaccine. On 22-AUG-2022, 20 min after receiving Havrix 720, MMR vaccine and Varicella vaccine, the patient experienced anaphylactic reaction (Verbatim: anaphylactic reaction) (serious criteria GSK medically significant), vomiting (Verbatim: throwing up), cough (Verbatim: coughing) and lip discoloration (Verbatim: Lips turned blue). The patient was treated with epinephrine. The outcome of the anaphylactic reaction, vomiting, cough and lip discoloration were resolved. It was unknown if the reporter considered the anaphylactic reaction, vomiting, cough and lip discoloration to be related to Havrix 720, MMR vaccine and Varicella vaccine. The company considered the anaphylactic reaction to be unrelated to Havrix 720 and MMR vaccine. It was unknown if the company considered the vomiting, cough and lip discoloration to be related to Havrix 720, MMR vaccine and Varicella vaccine. It was unknown if the company considered the anaphylactic reaction to be related to Varicella vaccine. Additional Information: GSK receipt date: 18-SEP-2025 The mother of a male patient reported that her son, who was 1 year old at the time of the adverse event, experienced an anaphylactic reaction after receiving his first dose of Havrix on 22-AUG-2022. The vaccine was administered into an unknown leg, along with the MMR vaccine and the Varicella vaccine which were given in unknown legs during the same visit. All three vaccines were routine pediatric immunizations. Less than 20 minutes after receiving these vaccines, the patient developed an anaphylactic reaction. He began vomiting, coughing, and his lips turned blue. The pediatrician administered epinephrine, and the patient was transported to the emergency room by ambulance. There was no overnight hospital stay. Following the administration of epinephrine, the patient recovered. The mother reported that the patient, now 4 years old, was under the care of an allergist. Allergy testing revealed that the patient was allergic to pork. In addition to the pork allergy, the patient has multiple food allergies, though no further details were provided. The patient received his second dose of Havrix on 20-MAR-2023 with lot number 9R5LC, Expiry date as November 2024, and no adverse events were reported following the administration of this dose. No additional information regarding these events was provided; Sender's Comments: A case of Dermatitis bullous and Pruritus, 20 min after receiving Shingrix in a 12-month-old male patient. Causal relation is indeterminate considering two vaccines given concomitantly and concurrent meat and food allergy.
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| 2861115 | 09/24/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Arthropod bite, Blister, Pain, Pruritus, Scab; Skin warm
Arthropod bite, Blister, Pain, Pruritus, Scab; Skin warm
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Pain/sore; flea bites; itchy; blistered; Scab; burn when i touch; This non-serious case was reported...
Pain/sore; flea bites; itchy; blistered; Scab; burn when i touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: Pain/sore), flea bite (Verbatim: flea bites), pruritus (Verbatim: itchy), blister (Verbatim: blistered), scab (Verbatim: Scab) and feeling hot (Verbatim: burn when i touch). The outcome of the pain, flea bite, pruritus, blister, scab and feeling hot were not reported. It was unknown if the reporter considered the pain, flea bite, pruritus, blister, scab and feeling hot to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain, flea bite, pruritus, blister, scab and feeling hot to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 27-AUG-2025 The patient received Herpes zoster vaccine and started having pain in the side and then started to get these whelps that patient thought were flea bites and they started forming looking hoes with a scab and a couple of them were blistered up the very itchy and they were very sore and they burn if touch them what could it be.
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| 2861116 | 09/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Adverse reaction, Antibody test positive, Incomplete course of vaccination
Adverse reaction, Antibody test positive, Incomplete course of vaccination
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skipped 2nd dose; This non-serious case was reported by a consumer via interactive digital media and...
skipped 2nd 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 did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient had incomplete course of vaccination (Verbatim: skipped 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-SEP-2025 The patient reported that got Shingrix vaccine about three years ago and had really strong reaction, side effects, so before got second dose, asked to the doctor to did a titer (also spelled titer) antibody blood test, and he said the 1st did the job and antibody levels were good, so skipped 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
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| 2861117 | F | 09/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Neuralgia, Vaccination failure
Herpes zoster, Neuralgia, Vaccination failure
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I've also been vaccinated for the shingles after the fact; I still have flare ups; The nerve pa...
I've also been vaccinated for the shingles after the fact; I still have flare ups; The nerve pain is still lingering; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: I've also been vaccinated for the shingles after the fact) (serious criteria GSK medically significant), shingles (Verbatim: I still have flare ups) and nerve pain (Verbatim: The nerve pain is still lingering). The outcome of the vaccination failure was not reported and the outcome of the shingles and nerve pain were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and nerve pain to be related to Shingrix. Additional Information: GSK Receipt Date: 10-SEP-2025 and 11-SEP-2025 This case was reported by a patient via interactive digital media. Consumer reported that it's been over 8 years for and still had flare ups. The reporter mentioned she had also been vaccinated for the shingles after the fact. The nerve pain was still lingering. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2861118 | 09/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Malaise, Vaccination failure
Herpes zoster, Malaise, Vaccination failure
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Suspected vaccination failure; Had Shingles 3 years ago; This serious case was reported by a consume...
Suspected vaccination failure; Had Shingles 3 years ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had Shingles 3 years ago). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 years ago, have so many places on the back. The patient had never been so sick and thought were going to die, it was a horrible experience. The patient prays for anyone who gets it and the patient took the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2861119 | 09/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; It gave me the worst case of shingles; This serious case was reporte...
Suspected vaccination failure; It gave me the worst case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It gave me the worst case of shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 15-SEP-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got last vaccine, and the first in forty years was the shingles vaccine. It gave them the worst case of shingles 3 doctors said they had ever seen. No more poison was going in his/her blood again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2861120 | 09/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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Then got shingles; This non-serious case was reported by a consumer via interactive digital media an...
Then got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Then got shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-SEP-2025 This case was reported by a patient via interactive digital media. The patient had the shot and the doctor said needed another shot so another shot, so the patient did and then got shingles a few weeks later. Pretty rough going. The patient said that same as the rest of the vaccines. Put it into the body and what did they expect.
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| 2861121 | MD | 09/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Therapy non-responder
Therapy non-responder
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No immunity after series; This non-serious case was reported by a other health professional via call...
No immunity after series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient received Shingrix. After receiving Shingrix, the patient experienced therapy non-responder (Verbatim: No immunity after series). The outcome of the therapy non-responder was not applicable.
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| 2861122 | 2 | M | GA | 09/24/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMAB056A |
Expired product administered
Expired product administered
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Expired dose administered; This non-serious case was reported by a other health professional via cal...
Expired dose administered; 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 2-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB056A, expiry date 21-AUG-2025) for prophylaxis. On 03-SEP-2025, the patient received Menveo. On 03-SEP-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 03-SEP-2025 The patient received a vaccine that was expired it was the Menveo 2-vial presentation. The reporter consented to follow up.
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| 2861123 | 0.33 | M | VA | 09/24/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MB599 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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inadvertent administration of Havrix to a 4-month-old patient; This non-serious case was reported by...
inadvertent administration of Havrix to a 4-month-old patient; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received HAV (Havrix) (batch number MB599, expiry date 25-JAN-2027) for prophylaxis. On 04-SEP-2025, the patient received the 1st dose of Havrix. On 04-SEP-2025, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of Havrix to a 4-month-old patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-SEP-2025 The physician informed about the inadvertent administration of Havrix to a 4-month-old patient. The reporter consented to follow up.
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| 2861124 | 55 | F | OH | 09/24/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4GR2B |
Device connection issue, Incorrect dose administered
Device connection issue, Incorrect dose administered
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vaccine was leaking where needle is screwed to the syringe; pharmaceutical product complaint; Incomp...
vaccine was leaking where needle is screwed to the syringe; pharmaceutical product complaint; Incomplete dose due to prefilled syringe leakage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 55-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4GR2B, expiry date 30-JUN-2026) for prophylaxis. This case was associated with a product complaint. On 10-SEP-2025, the patient received FluLaval 2024-2025 season. On 10-SEP-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incomplete dose administered (Verbatim: Incomplete dose due to prefilled syringe leakage). On an unknown date, the patient experienced syringe leak (Verbatim: vaccine was leaking where needle is screwed to the syringe) and pharmaceutical product complaint (Verbatim: pharmaceutical product complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe leak to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak to be related to FluLaval 2024-2025 season and Flulaval 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: 10-SEP-2025 Reporter stated that during Prefilled Syringe FluLaval administration to a patient, they noticed vaccine was leaking where needle was screwed to the syringe.
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| 2861125 | SC | 09/24/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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got COVID after getting vaccinated; This spontaneous case was reported by an other health care profe...
got COVID after getting vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got COVID after getting vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID after getting vaccinated). At the time of the report, COVID-19 (got COVID after getting vaccinated) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Reporter stated that the patient got COVID after getting vaccinated and mentioned it was not as bad as the flu. No treatment information was provided. This case contains information for the 1 of 2 patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-789337 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2022: Upon internal review on 23-Sep-2025, significant correction was performed to update the case type as valid from invalid and added No patient identifiers classification.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-789337:Patient 2 of 2
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| 2861126 | 77 | M | 09/24/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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COVID-19, Weight decreased; COVID-19, Weight decreased
COVID-19, Weight decreased; COVID-19, Weight decreased
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Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Co...
Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Comirnaty) for an unknown indication. The patient's past medical history included COVID-19 in May 2021, Sleep apnea and Open heart surgery. Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine. Concurrent medical conditions included Prediabetes, Immunocompromised and Congestive heart failure. Concomitant products included Tirzepatide (Zepbound) for an unknown indication. On 27-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On an unknown date, the patient received dose of Tozinameran (Comirnaty) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: Loss 80 pound. He was immuno and was at risk, congestive heart failure, and old. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Concomitant products were nothing related to Covid, he was taking drugs for heart, took a handful of drugs for heart. Medical conditions were prediabetic, cardiologist was told to take Zepbound, he lost 80 pounds, prediabetes disappeared, sleep apnea gotten better. The patient had first time Covid was in May-2021. It was the Pfizer COVID vaccines he had prior to having Covid in May-2021. Second time had Covid was probably in 2023, about May-2023 or Jun-2023, was after had Moderna COVID vaccine, then had Pfizer COVID vaccine subsequently. He had a total of two or three of the Pfizer COVID-19 vaccine and one dose of Moderna COVID-19 vaccine. No AE required a visit to the emergency room and not required visit to a physician's office. No antipyretic products were used around the date of vaccination. No treatment medication was reported.
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| 2861127 | F | 09/24/2025 |
COVID19 |
MODERNA |
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Fatigue, Hyperhidrosis, Pain in extremity
Fatigue, Hyperhidrosis, Pain in extremity
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sweats; sore arms; fatigue; This spontaneous case was reported by a consumer and describes the occur...
sweats; sore arms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma. In March 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue) had resolved. No concomitant medications were provided. The patient had always received her vaccine, either Moderna or Pfizer, mostly Moderna. She got her first shot back in 2021 and had been getting vaccinated every six months. Patient considered herself a loyal customer. It was reported that patient's last vaccine was in Mar-2025, and she was due for another. She had COVID once and did not want to contract it again. Patient had experienced side effects like fatigue, sweats, and sore arms except vomiting for at least 3 to 4 days. She was now considering whether she needed to get the mNEXSPIKE vaccine because she was down in her bed, seriously. Although she hated to get the mNEXSPIKE vaccine, she knew it was important, but the information worried her. She had experienced major side effects with every vaccine since 2021 and had side effects real bad. It was reported that her healthcare provider advised her to get the vaccine because she had asthma. She was wondering if there were now two vaccines, one for those under 65 and another for those over 65 and asked about the differences and in dosages. The patient had received the information on the dosage of each new vaccine, but patient was unsure which one to get. It was reported that she tends to get sick with either vaccine. The patient was advised to speak with her healthcare provider for lessen her symptoms if her symptoms were so bad and also for further information. She mentioned that her doctor had not been helpful. She had not yet scheduled her vaccine and wanted to ensure she had nothing important to do when she gets it, especially since they were moving, and she did not want to get it during the move because it was pretty tough and rough on her. she was down for four days. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to MOD-2025-789476 (Patient Link).
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| 2861128 | F | 09/24/2025 |
COVID19 |
MODERNA |
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Fatigue, Hyperhidrosis, Pain in extremity
Fatigue, Hyperhidrosis, Pain in extremity
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sweats; sore arms; fatigue; This spontaneous case was reported by a consumer and describes the occur...
sweats; sore arms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were provided. The patient had always received her vaccine, either Moderna or Pfizer, mostly Moderna. She got her first shot back in 2021 and had been getting vaccinated every six months. Patient considered herself a loyal customer. It was reported that patient's last vaccine was in Mar-2025, and she was due for another. She had COVID once and did not want to contract it again. Patient had experienced side effects like fatigue, sweats, and sore arms except vomiting for at least 3 to 4 days. She was now considering whether she needed to get the mNEXSPIKE vaccine because she was down in her bed, seriously. Although she hated to get the mNEXSPIKE vaccine, she knew it was important, but the information worried her. She had experienced major side effects with every vaccine since 2021 and had side effects real bad. It was reported that her healthcare provider advised her to get the vaccine because she had asthma. She was wondering if there were now two vaccines, one for those under 65 and another for those over 65 and asked about the differences and in dosages. The patient had received the information on the dosage of each new vaccine, but patient was unsure which one to get. It was reported that she tends to get sick with either vaccine. The patient was advised to speak with her healthcare provider for lessen her symptoms if her symptoms were so bad and also for further information. She mentioned that her doctor had not been helpful. She had not yet scheduled her vaccine and wanted to ensure she had nothing important to do when she gets it, especially since they were moving, and she did not want to get it during the move because it was pretty tough and rough on her. she was down for four days. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to MOD-2025-789476 (Patient Link).
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| 2861129 | 80 | M | CA | 09/24/2025 |
FLU3 FLU3 UNK UNK |
SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abdominal discomfort, Chills, Condition aggravated, Hypertension, Injection site...
Abdominal discomfort, Chills, Condition aggravated, Hypertension, Injection site pain; Malaise, Pain, Pain in extremity, Pyrexia, Tremor; Abdominal discomfort, Chills, Condition aggravated, Hypertension, Injection site pain; Malaise, Pain, Pain in extremity, Pyrexia, Tremor
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he didn't feel well; high blood pressure; chills; I went to move my arm and it felt like somebo...
he didn't feel well; high blood pressure; chills; I went to move my arm and it felt like somebody was stabbing me with a knife. It was extremely painful." & "My arm was still a little sore, but by Sunday I was perfectly fine.; fever/later a fever of 101.9/he had fever of 101.6'F; pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible; I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop; His stomach was upset; His heart rate wasn't too bad, it was 92 something; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible), TREMOR (I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop), HEART RATE INCREASED (His heart rate wasn't too bad, it was 92 something), ABDOMINAL DISCOMFORT (His stomach was upset) and MALAISE (he didn't feel well) in an 80-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Fluzone) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 1) on 29-Jan-2021, Pfizer COVID-19 vaccine (Dose 2) on 17-Feb-2021, Pfizer COVID-19 vaccine (Dose 3) on 25-Sep-2021, Pfizer COVID-19 vaccine (Dose 4) on 22-Apr-2022 and Pfizer COVID-19 vaccine (Dose 5) on 09-Sep-2022; for COVID-19 prophylaxis: Spikevax XBB.1.5 (Dose 6) on 04-Oct-2023, Spikevax XBB.1.5 (Dose 7) on 22-Mar-2024, SPIKEVAX 2024-2025 (KP.2) (SPIKEVAX 2024-2025 (KP.2) Dose 8) on 30-Aug-2024 and SPIKEVAX 2024-2025 (KP.2) (SPIKEVAX 2024-2025 (KP.2) Dose 9) on 02-Mar-2025. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, SPIKEVAX 2024-2025 (KP.2), SPIKEVAX 2024-2025 (KP.2), Spikevax XBB.1.5 and Spikevax XBB.1.5. Concurrent medical conditions included Blood pressure high since 2013, Arrhythmia since 2013 and Abnormal breathing since 2013. On 12-Sep-2025, the patient received dose of Influenza vaccine (Fluzone) (Intramuscular use) 1 dosage form. On 12-Sep-2025 at 1:00 PM, the patient received tenth dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 12-Sep-2025, the patient experienced VACCINATION SITE PAIN (pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible), TREMOR (I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop), ABDOMINAL DISCOMFORT (His stomach was upset), HYPERTENSION (high blood pressure), CHILLS (chills), PAIN IN EXTREMITY (I went to move my arm and it felt like somebody was stabbing me with a knife. It was extremely painful." & "My arm was still a little sore, but by Sunday I was perfectly fine.) and PYREXIA (fever/later a fever of 101.9/he had fever of 101.6'F). On 13-Sep-2025, the patient experienced MALAISE (he didn't feel well). In September 2025, the patient experienced HEART RATE INCREASED (His heart rate wasn't too bad, it was 92 something). The patient was treated with Paracetamol (Tylenol) on 12-Sep-2025 at an unspecified dose and frequency and Codeine phosphate (Codeine) on 12-Sep-2025 at an unspecified dose and frequency. On 14-Sep-2025, PAIN IN EXTREMITY (I went to move my arm and it felt like somebody was stabbing me with a knife. It was extremely painful." & "My arm was still a little sore, but by Sunday I was perfectly fine.) had resolved. At the time of the report, VACCINATION SITE PAIN (pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible) was resolving, TREMOR (I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop), HEART RATE INCREASED (His heart rate wasn't too bad, it was 92 something), ABDOMINAL DISCOMFORT (His stomach was upset), CHILLS (chills) and PYREXIA (fever/later a fever of 101.9/he had fever of 101.6'F) had resolved and MALAISE (he didn't feel well) and HYPERTENSION (high blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2025, Body temperature: 101.6'F. On 13-Sep-2025, Body temperature: 97.9'F. In September 2025, Heart rate: 92. Concomitant medications were not reported. It was reported that patient never had a problem. It was reported that patient had sore arm for an hour up to the next day and described it as terrible. It was reported that by 9 o'clock, he had fever of 101.6'F. He took 2 Tylenol probably, at 8:30pm It was reported that patient called the doctor and got the nurse service, explained everything to a registered nurse and was advised to take Tylenol which he confirmed to the nurse that he already did. Patient was then advised by the nurse that patient should visit into the emergency room immediately because of the health history. Patient refused the advice of the nurse and stated that If it got worse will get an ambulance. At 10 PM and then another (both meds) on Saturday 4 AM. On the second take, the pain was stopped enough for patient to go to sleep for a few minutes or an hour or so. And then when he woke up, he took another one - Tylenol and Codeine. MOP then managed to sleep through the night off and on. Patient's his arm, even on Saturday, his arm really hurt. By sunday it was pretty much ok, and patient was better. But, all day Saturday, patient didn't feel well. The patient did not experience any additional symptoms/events. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2025: Live follow-up received is significant. DOB was added, gender was added, suspect product was updated, new events were added, reference number was added. On 17-Sep-2025: Live follow up received is non-significant. Reference number was added.
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| 2861130 | 64 | F | 09/24/2025 |
COVID19 |
MODERNA |
3052030 |
Eye pain, Sudden visual loss, Vision blurred
Eye pain, Sudden visual loss, Vision blurred
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sudden vision loss and blurry in the distance; eye pain; This spontaneous case was reported by a pha...
sudden vision loss and blurry in the distance; eye pain; This spontaneous case was reported by a pharmacist and describes the occurrence of SUDDEN VISUAL LOSS (sudden vision loss and blurry in the distance) in a 64-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No medical history provided. Concomitant products included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for an unknown indication. On 09-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 11-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced SUDDEN VISUAL LOSS (sudden vision loss and blurry in the distance) (seriousness criterion medically significant). In September 2025, the patient experienced EYE PAIN (eye pain). At the time of the report, SUDDEN VISUAL LOSS (sudden vision loss and blurry in the distance) and EYE PAIN (eye pain) had not resolved. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. Patient had received MMR vaccine week prior to mNEXSPIKE. The patient received the vaccine on 09-Sep-2025 and on 11-Sep-2025, patient had sudden vision loss. Patient woke up at 3 am and read the side effects and had not noticed that before (the vision loss symptom) when she read the sheet. Her biggest question right then was whether her symptoms were temporary or permanent. She could not read or type. Patient went to the eye doctor on 12-Sep-2025 at 8 o'clock and had been using eyeglasses that were like a reader 2.25 and it jumped to a 4.75 recommendation in layman's terms. Her eye doctor said that she had never seen such vision loss so fast. It was reported that things were blurry, and she had eye pain and that it was sudden vision loss and blurry in the distance. It was also hard to read street signs, and it was really debilitating. Patient could not read the tablets to verify the tablets and pills and could not read prescriptions. She was in the middle of getting strong eyeglasses but if that ended up being temporary or went away in a few days, she did not want to order glasses. No specific treatment drugs were reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2861131 | 29 | F | NY | 09/24/2025 |
COVID19 |
MODERNA |
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Dizziness, Fall, Nausea, Syncope
Dizziness, Fall, Nausea, Syncope
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Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from ...
Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.) in a 29-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced SYNCOPE (Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that the patient thought she had fainted 10-15 minutes after administration. The patient had fallen down part of elevator but did not remember how. After recovering from the fall, the patient had felt dizzy and nauseous. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2861132 | 83 | M | 09/24/2025 |
COVID19 |
MODERNA |
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Blood immunoglobulin A, Immunoglobulins, Non-Hodgkin's lymphoma
Blood immunoglobulin A, Immunoglobulins, Non-Hodgkin's lymphoma
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Recurrent Non-Hodgkin lymphoma in the L3 region of the spine; This spontaneous case was reported by ...
Recurrent Non-Hodgkin lymphoma in the L3 region of the spine; This spontaneous case was reported by a consumer and describes the occurrence of NON-HODGKIN'S LYMPHOMA (Recurrent Non-Hodgkin lymphoma in the L3 region of the spine) in an 83-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Non-Hodgkin's lymphoma (Patient reported a diagnosis of non-Hodgkin's lymphoma back in 2005.) since 2005. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, the patient experienced NON-HODGKIN'S LYMPHOMA (Recurrent Non-Hodgkin lymphoma in the L3 region of the spine) (seriousness criterion medically significant). The patient was treated with Radiotherapy (radiation) for Non-Hodgkin's lymphoma. At the time of the report, NON-HODGKIN'S LYMPHOMA (Recurrent Non-Hodgkin lymphoma in the L3 region of the spine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin A: subclinical IgA levels. On an unknown date, Immunoglobulins: all other immunoglobulin levels remain normal. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that patient received many Moderna COVID-19 vaccines and specifically mentioned receiving a shot in 2023, prior to the recurrence of non-Hodgkin lymphoma in the L3 region of the spine, which was treated with radiation in 2023. It was reported that the patient was being immunocompromised, though not severely, as a result of cancer treatment. This had led to subclinical IgA levels, while all other immunoglobulin levels remained normal. No specific treatment medications were reported.; Reporter's Comments: Medical history of Non-Hodgkin๏ฟฝs lymphoma remains as a risk factor for the event. The benefit-risk relationship of product is not affected by this report.
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| 2861133 | F | 09/24/2025 |
COVID19 |
MODERNA |
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Fatigue, Hyperhidrosis, Pain in extremity
Fatigue, Hyperhidrosis, Pain in extremity
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sweats; sore arms; fatigue; This spontaneous case was reported by a consumer and describes the occur...
sweats; sore arms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arms) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medications were provided. The patient had always received her vaccine, either Moderna or Pfizer, mostly Moderna. She got her first shot back in 2021 and had been getting vaccinated every six months. Patient considered herself a loyal customer. It was reported that patient's last vaccine was in Mar-2025, and she was due for another. She had COVID once and did not want to contract it again. Patient had experienced side effects like fatigue, sweats, and sore arms except vomiting for at least 3 to 4 days. She was now considering whether she needed to get the mNEXSPIKE vaccine because she was down in her bed, seriously. Although she hated to get the mNEXSPIKE vaccine, she knew it was important, but the information worried her. She had experienced major side effects with every vaccine since 2021 and had side effects real bad. It was reported that her healthcare provider advised her to get the vaccine because she had asthma. She was wondering if there were now two vaccines, one for those under 65 and another for those over 65 and asked about the differences and in dosages. The patient had received the information on the dosage of each new vaccine, but patient was unsure which one to get. It was reported that she tends to get sick with either vaccine. The patient was advised to speak with her healthcare provider for lessen her symptoms if her symptoms were so bad and also for further information. She mentioned that her doctor had not been helpful. She had not yet scheduled her vaccine and wanted to ensure she had nothing important to do when she gets it, especially since they were moving, and she did not want to get it during the move because it was pretty tough and rough on her. she was down for four days. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789490 (E2B Linked Report). This case was linked to MOD-2025-789481, MOD-2025-789483 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789490:Husband case
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| 2861134 | 73 | F | RI | 09/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Headache, Pain
Headache, Pain
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Headache and Body Ache; Headache and Body Ache; This spontaneous case was reported by a consumer and...
Headache and Body Ache; Headache and Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Headache and Body Ache) and HEADACHE (Headache and Body Ache) in a 73-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 16-Sep-2025, the patient experienced PAIN (Headache and Body Ache) and HEADACHE (Headache and Body Ache). On 17-Sep-2025, PAIN (Headache and Body Ache) and HEADACHE (Headache and Body Ache) had resolved. No concomitant medications were reported. The patient had no medical history, concomitant diseases or risk factor. There were no lab data/results available. No treatment medications were reported.
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| 2861135 | 24 | F | 09/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
3052030 |
Injection site discharge, Underdose
Injection site discharge, Underdose
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administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after ...
administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn; administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) and INCORRECT DOSE ADMINISTERED (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) in a 24-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma and Arthritis. Concomitant products included Influenza vaccine (Flu) for an unknown indication. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, the patient experienced VACCINATION SITE DISCHARGE (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) and INCORRECT DOSE ADMINISTERED (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn). At the time of the report, VACCINATION SITE DISCHARGE (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) and INCORRECT DOSE ADMINISTERED (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. It was reported that the Flu shot was administered at the same time after the mNEXSPIKE was administered. HCP had reported that a colleague had administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn. HCP confirmed through the colleague who administered that the plunger was fully depressed during the administration. HCP confirmed that his colleague did not notice anything different with what he normally does during the process of administration. HCP guessed would be perhaps that they did not use the appropriate size needle. HCP confirmed they have used a gauge 25 luer-style needle by 1-inch. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.
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| 2861136 | 66 | F | WA | 09/24/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
80777-0400-60 80777-0400-60 |
Chills, Fall, Gait disturbance, Gait inability, Mobility decreased; Neuralgia, U...
Chills, Fall, Gait disturbance, Gait inability, Mobility decreased; Neuralgia, Underdose, Urinary incontinence
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Total loss of bladder control (2.5 days); Severe nerve pain upper and lower body along with intense ...
Total loss of bladder control (2.5 days); Severe nerve pain upper and lower body along with intense chills; Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling; Severe nerve pain upper and lower body along with intense chills; received 0.2 microgram dose; Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling; Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Total loss of bladder control (2.5 days)), NEURALGIA (Severe nerve pain upper and lower body along with intense chills), MOVEMENT DISORDER (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), GAIT DISTURBANCE (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling) and FALL (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling) in a 66-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777-0400-60) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 microgram. In September 2025, the patient experienced MOVEMENT DISORDER (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling) and GAIT DISTURBANCE (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling). On 16-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced URINARY INCONTINENCE (Total loss of bladder control (2.5 days)), NEURALGIA (Severe nerve pain upper and lower body along with intense chills), FALL (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), CHILLS (Severe nerve pain upper and lower body along with intense chills) and UNDERDOSE (received 0.2 microgram dose). At the time of the report, URINARY INCONTINENCE (Total loss of bladder control (2.5 days)), NEURALGIA (Severe nerve pain upper and lower body along with intense chills), MOVEMENT DISORDER (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), GAIT DISTURBANCE (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), FALL (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), CHILLS (Severe nerve pain upper and lower body along with intense chills) and UNDERDOSE (received 0.2 microgram dose) was resolving. Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
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| 2861137 | F | OH | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Dizziness, Headache
Asthenia, Dizziness, Headache
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I felt dizzy, weak; Blinding headache; Headache was so strong and across my temple; Pounding headach...
I felt dizzy, weak; Blinding headache; Headache was so strong and across my temple; Pounding headache; I felt dizzy, weak; This is a spontaneous report received from a Consumer or other non HCP. An 87-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. The following information was reported: HEADACHE (non-serious) with onset 14Mar2024, outcome "unknown", described as "Blinding headache; Headache was so strong and across my temple; Pounding headache"; DIZZINESS (non-serious) with onset 14Mar2024, outcome "unknown", ASTHENIA (non-serious), outcome "unknown" and all described as "I felt dizzy, weak". 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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| 2861138 | F | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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terribly sick; This is a spontaneous report received from a Consumer or other non HCP from medical i...
terribly sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), administration date: Nov2024, for COVID-19 immunization, reaction(s): "IgM number really goes up", "nose bleeds/bleeding disorder", "nose bleeds", "She has some kind of unknown bleeding disorder". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "terribly sick". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2861139 | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Wheezing
Wheezing
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More wheezing from my chest; This is a spontaneous report received from a Consumer or other non HCP,...
More wheezing from my chest; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHEEZING (non-serious), outcome "unknown", described as "More wheezing from my chest". Additional information: The patient could hear more wheezing from chest since the patient had the covid shot. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2861140 | F | CT | 09/24/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Aura, Vaccination site pain; Aura, Vaccination site pain
Aura, Vaccination site pain; Aura, Vaccination site pain
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Experienced brief (visual) aura immediately following vaccination, for 5 min or less; Moderate arm p...
Experienced brief (visual) aura immediately following vaccination, for 5 min or less; Moderate arm pain in the arm where the Comirnaty and flu shot were administered; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 at 17:00 as dose number unknown, single (upper right arm) (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 19Sep2025 as dose number unknown, single (flu shot) for immunisation. The patient's relevant medical history included: "Yes but the only relevant one is migraines that sometimes have aura" (ongoing), notes: I did not have a migraine, headache, or nausea post vaccination, only the aura. The patient's concomitant medications were not reported. Vaccination history included: shingrix (DOSE NUMBER UNKNOWN, SINGLE), administration date: 05Sep2025, for Immunization; Tdap (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Typhoid (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), administration date: Jan2021, for COVID-19 immunization; Influenza (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Shingrix (DOSE NUMBER UNKNOWN, SINGLE), for Immunization. The following information was reported: AURA (non-serious) with onset 19Sep2025, outcome "recovering", described as "Experienced brief (visual) aura immediately following vaccination, for 5 min or less"; VACCINATION SITE PAIN (non-serious) with onset 19Sep2025, outcome "not recovered", described as "Moderate arm pain in the arm where the Comirnaty and flu shot were administered". Therapeutic measures were not taken as a result of aura. Additional information: The patient was taking other medications within 2 weeks of the event starting. The patient experienced brief (visual) aura immediately following vaccination, for 5 minutes or less. This has never happened before with Comirnaty (have had every recommended dose since Jan2021), or other vaccinations like influenza, shingrix, TdaP, typhoid, etc. Additionally, the patient had moderate arm pain in the arm where the Comirnaty and flu shot were administered, that has not yet resolved though patient expected it to resolve within 72 hours or so of the vaccination. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2861142 | F | MO | 09/24/2025 |
PNC20 PNC20 PNC20 PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
MA2523 MA2523 MA2523 MA2523 MA2523 MA2523 |
Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase, Blood al...
Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase, Blood albumin normal, Blood alkaline phosphatase normal; Blood bilirubin, Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal; Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone decreased, Blood triglycerides normal, Blood urea normal; Carbon dioxide normal, Glomerular filtration rate normal, Glycosylated haemoglobin, High density lipoprotein normal, Liver disorder; Low density lipoprotein normal, Non-high-density lipoprotein cholesterol, Pain in extremity, Protein total normal, Sleep disorder; Total cholesterol/HDL ratio normal
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pain in left upper arm post vaccine, pain in left upper arm kept awake, since then it's been &#...
pain in left upper arm post vaccine, pain in left upper arm kept awake, since then it's been 'zero' to 'four' pain during the day with increased pain at night, moderately interfered with sleep; The only problem with it, there was a liver issue; Pain in left upper arm post vaccine; Pain in left upper arm kept awake; Increased pain at night; This is a spontaneous report received from a Nurse from medical information team. A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5ml single (Lot number: MA2523, Expiration Date: 30Sep2026) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; PROVERA. The following information was reported: SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious), outcome "unknown", described as "pain in left upper arm post vaccine, pain in left upper arm kept awake, since then it's been 'zero' to 'four' pain during the day with increased pain at night, moderately interfered with sleep"; LIVER DISORDER (non-serious), outcome "unknown", described as "The only problem with it, there was a liver issue"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Pain in left upper arm post vaccine; Pain in left upper arm kept awake; Increased pain at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sleep disorder due to general medical condition, insomnia type, liver disorder, vaccination site pain. Additional information: It was reported that, ongoing pain in left upper arm post vaccine, pain in left upper arm kept awake, since then it's been 'zero' to 'four' pain during the day with increased pain at night, moderately interfered with sleep. The first patient was just having pain in the arm, and the other was having a little bit more going on but that was reported from a September 8th administration and a September 5th administration with the same lot." Reporter stated, They had thyroid. It sated that, TSH 0.95. She had a lipid panel, HDL-56, Triglycerides-124, LDL-121.2. Other results on that test: Non-HDL Cholesterol-146, the cholesterol HDL ratio-3.6, hemoglobin A1C-5.5. The CMP or comprehensive metabolic profile there was a lot on here. Sodium-144, potassioun-4.5, Chloride-107, Carbon dioxide- 28, Anion gap-9, Calsium-9.6, Glucose-85, Protein-7.1, Albumin-4.3, Alkaline Phosphatase-62. For the liver provided that, the ALT, the ALT was going to be 48, the AST was going to be 28, Bilirubin total 0.4, BUN-14, Creatinine-0.85, GFR-81, CBC is the next one. Everything was good on that did they need those results? CBC was normal because there was a lot on there. Everything was good on the CBC. The only problem with it, there was a liver issue. Treatment: Reporter stated, "This one I just told them about was sent over an antibiotic, Keflex."
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| 2861143 | M | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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he got 4 shot of covid vaccine but still got; he got 4 shot of covid vaccine but still got; This is ...
he got 4 shot of covid vaccine but still got; he got 4 shot of covid vaccine but still got; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he got 4 shot of covid vaccine but still got". Clinical course: Caller said he got 4 shot of covid vaccine but still got Covid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2861144 | NY | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Neuropathy peripheral
Neuropathy peripheral
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peripheral neuropathy; This is a spontaneous report received from a Consumer or other non HCP. A 62...
peripheral neuropathy; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheral neuropathy". Clinical course: the patient was convinced that Pfizer vaccine caused her/his peripheral neuropathy. Pfizer ruined her/his whole life at the age of sixty two. Just when she/he was ready to retire. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2861145 | 09/24/2025 |
FLUX |
UNKNOWN MANUFACTURER |
No batch number |
Drug ineffective, Influenza
Drug ineffective, Influenza
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Flu; Flu; Lack of efficacy; This spontaneous case, initially received on 16-Sep-2025, was reported b...
Flu; Flu; Lack of efficacy; This spontaneous case, initially received on 16-Sep-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported, Dose regimen: not reported, Route of administration: unknown, Lot number: No batch number available, and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Flu (Medically Significant, outcome: Unknown), Flu (Medically Significant, outcome: Unknown), Lack of efficacy (Medically Significant, outcome: Unknown). Case was upgraded to serious upon company assessment of the reported event's (Flu and Lack of efficacy) clinical significance. When the patient taught, the flu shot was highly recommended, so the patient received it twice, and both times the patient got the flu. When the patient did not get the vaccine, the patient never got the flu. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The primary reporter assessed the event as non-serious with causality was reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, the events influenza and drug ineffective are considered related for reporting purposes. Of note, there is limited information on temporality, age, medical history, suspect indication, lab test for flu and vaccine details to perform in depth analysis. A lack of effect can generally not be excluded for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
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| 2861146 | F | 09/24/2025 |
COVID19 FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number |
Decreased immune responsiveness, Malaise, Pneumonia; Decreased immune responsive...
Decreased immune responsiveness, Malaise, Pneumonia; Decreased immune responsiveness, Malaise, Pneumonia
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Bronchopneumonia; Immune defenses are lowered; still unwell; This spontaneous case, initially receiv...
Bronchopneumonia; Immune defenses are lowered; still unwell; This spontaneous case, initially received on 16-Sep-2025, was reported by a non-health professional and concerns a female patient of unknown age. Relevant History and concomitant medication were not reported. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication Not reported, Dose regimen: not reported, Anatomical Location: not reported, Route of administration: Unknown, Lot number: No batch number available and unable to obtain due to no follow-up consent provided. Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine), Indication: Not reported. Dose regimen: not reported, Anatomical Location: not reported, Route of administration: not reported, Lot number: No batch number available and unable to obtain due to no follow-up consent provided. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Bronchopneumonia (Medically Significant, outcome: Not recovered / Not resolved), Immune defenses are lowered (outcome: Not recovered / Not resolved), On an unknown date, the patient experienced still unwell (outcome: Not recovered / Not resolved). Case was upgraded to serious upon company assessment of the reported event's (Bronchopneumonia) clinical significance. With the vaccine, the immune defences were lowered. To a friend of reporter, after the Covid serum and then the flu vaccine, bronchopneumonia and after six weeks she was still unwell. The reporter had urged others to stop ruining people. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter assessed the event Bronchopneumonia as non-serious and the causality assessment reported as unknown. The reporter did not provide a seriousness or causality assessment for event Immune defenses are lowered, still unwell .; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For the events bronchopneumonia, decreased immune responsiveness there is insufficient information about precise event latency, clinical course, type/organism identified, diagnostic reports, treatment taken, medical history to perform a more in-depth analysis. Malaise is likely attributed to bronchopneumonia. Co-suspect Covid19 vaccination is a confounding factor.
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| 2861189 | IN | 09/24/2025 |
MMR MMRV |
UNKNOWN MANUFACTURER MERCK & CO. INC. |
Y015834 Y013575 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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No additional AE; Product Lot number issue; was given on 8/13/2025; an adult patient received PROQUA...
No additional AE; Product Lot number issue; was given on 8/13/2025; an adult patient received PROQUAD; This spontaneous report was received from a pharmacist and refers to a 33-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013575, expiration date: 03-Feb-2026) 1 dosage form with sterile diluent (Hollister-Stier STERILE DILUENT) (Product administered to patient of inappropriate age). On 13-Aug-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) with sterile diluent (Hollister-Stier STERILE DILUENT), (lot #Y015834 (invalid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) but valid for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)), product lot issue), expiration date: 20-Sep-2026) 1 dosage form (Expiration Date was also reported as 02-SEP-2026) (Inappropriate schedule of product administration). All were of prophylaxis. No additional events (no adverse event).
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| 2861190 | NV | 09/24/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Employee Received First Dose of HEPLISAV-B, But are Anywhere From 2-8 Months Late In Receiving the S...
Employee Received First Dose of HEPLISAV-B, But are Anywhere From 2-8 Months Late In Receiving the Second Dose; Initial report received on 28-Aug-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is late in receiving the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 28-Aug-2025, after receiving HEPLISAV-B, the reporter noted that the patient, who is an employee, was 2-8 months late in receiving their second dose of HEPLISAV-B. No side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861191 | NE | 09/24/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Computerised tomogram head normal, Computerised tomogram spine normal, Hypoaesth...
Computerised tomogram head normal, Computerised tomogram spine normal, Hypoaesthesia
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Numbness On Left Side Of Body Experienced After Heplisav-B Injection; Initial report received on 05-...
Numbness On Left Side Of Body Experienced After Heplisav-B Injection; Initial report received on 05-Sep-2025. A consumer reported that she, a 36-year-old female, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced numbness to the left side of the body. The patient had received the hepatitis B vaccine series previously, but was not sure which she had. No concomitant medications were reported. On 11-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, and not reported)] intramuscularly in the left deltoid. The patient had started a new job and received the series because her hepatitis B titer was low. On 12-Aug-2025, 1 day after being vaccinated with HEPLISAV-B, the patient experienced numbness in the left elbow and arm extending down to the torso, then down to the left leg. It progressed to numbness of the entire left side of her body, from the top of her head down to her toes. The patient reported that the numbness in her hand comes and goes, while the rest of her arm remains numb. She stated there is a decrease in sensation but no tingling. She went to the Emergency Room (ER) to rule out a stroke. The patient underwent a CT scan of the head and cervical spine without contrast, which did not show any acute findings or changes. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861192 | 09/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Formication
Formication
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sense of things crawling under skin for about a year after being vaccinated; This non-serious case w...
sense of things crawling under skin for about a year after being vaccinated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin discomfort (Verbatim: sense of things crawling under skin for about a year after being vaccinated). The outcome of the skin discomfort was resolved. It was unknown if the reporter considered the skin discomfort to be related to Shingles vaccine. It was unknown if the company considered the skin discomfort to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-SEP-2025 This case was reported by a patient via interactive digital media. The patient must have a bad batch of shot, for it produced the sense of things crawling under skin for about a year after being vaccinated against it. The patient resisted it but finally agreed a strong application of Prednisone and that turned the corned for patient. Never would ever take any vaccine ever, after that experience.
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| 2861193 | F | 09/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster
Herpes zoster
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Shingles; This non-serious case was reported by a consumer via interactive digital media and describ...
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 This case was reported by a patient via interactive digital media. The patient's doctor convinced her to receive a Shingles vaccination (Shingrix) after she informed him that she had never had chickenpox. About a week later, the patient mentioned she developed shingles. She advised others not to take the vaccine if they have never had chickenpox.
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| 2861194 | 72 | M | TX | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Angina pectoris, Cardiac disorder, Chest discomfort, Chills, Palpitations
Angina pectoris, Cardiac disorder, Chest discomfort, Chills, Palpitations
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Really bad pain in my heart; heart issue/his heart started to hurt; still feel a tens of tightening ...
Really bad pain in my heart; heart issue/his heart started to hurt; still feel a tens of tightening of the chest; Palpitation; chills; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing). Concomitant medication(s) included: PRAVASTATIN oral taken for blood cholesterol increased (ongoing). The following information was reported: CHILLS (non-serious) with onset 17Sep2025, outcome "unknown"; PALPITATIONS (non-serious) with onset 20Sep2025, outcome "unknown", described as "Palpitation"; ANGINA PECTORIS (medically significant) with onset 20Sep2025, outcome "unknown", described as "Really bad pain in my heart"; CARDIAC DISORDER (medically significant) with onset 20Sep2025, outcome "unknown", described as "heart issue/his heart started to hurt"; CHEST DISCOMFORT (non-serious) with onset 20Sep2025, outcome "unknown", described as "still feel a tens of tightening of the chest". Therapeutic measures were taken as a result of chills. Clinical course: The consumer reported receiving the most recent dose of the Comirnaty (Pfizer COVID-19) vaccine on Tuesday, 16Sep2025. He experienced chills the following day, which subsided after taking Advil. On Saturday, 20Sep2025, he experienced significant chest pain and subsequently consulted his primary care physician on Monday and a physician assistant at a cardiology clinic on Tuesday. Both assessments reportedly found no acute cardiac issues. The consumer described ongoing heart discomfort since the event and expressed concern about the nature and duration of symptoms, noting they are impacting his daily life. He mentioned previous fatigue with earlier Pfizer vaccines but stated that this current reaction is unlike any past experience. The consumer reported taking 10 mg of Pravastatin orally once daily for high cholesterol, ongoing for approximately three years. He has been self-treating the current symptoms with over-the-counter Advil since Monday night, though exact dosage is unknown. Product details such as vaccine lot number and expiration date were not available. Vaccine was administered at a retail pharmacy. No vaccine card was available, but the consumer mentioned having a vaccine record. The call was transferred to Pfizer Medical Information for further assistance. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2861195 | 0.25 | M | NY | 09/24/2025 |
PNC20 |
PFIZER\WYETH |
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Skin discolouration, Unresponsive to stimuli
Skin discolouration, Unresponsive to stimuli
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became unresponsive for 1-3 minutes; turned dusky; This is a spontaneous report received from a Phys...
became unresponsive for 1-3 minutes; turned dusky; This is a spontaneous report received from a Physician from Medical information team. A 3-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 3 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UNRESPONSIVE TO STIMULI (hospitalization, medically significant) with onset 14Sep2025, outcome "unknown", described as "became unresponsive for 1-3 minutes"; SKIN DISCOLOURATION (medically significant) with onset 14Sep2025, outcome "recovered" (14Sep2025), described as "turned dusky". The patient was hospitalized for unresponsive to stimuli (start date: Sep2025). The patient underwent the following laboratory tests and procedures: Body height: (04Aug2025) 23.5, notes: inches. Additional information: Caller wasn't there, would say medically significant from the story caller got from patient's mother. Clarified patient was taken to hospital, doesn't think anything was done, not given antibiotics or anything, was seen in emergency room and admitted overnight. Confirmed was admitted into the hospital, therefore seriousness selected in formal field as hospitalization. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events unresponsive to stimuli and skin discoloration based on the known safety profile and temporal association. However there is not enough information to make a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
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| 2861196 | 41 | F | VA | 09/24/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
025J20-2A 025J20-2A 022M20A 022M20A |
Abortion spontaneous, Chills, Fatigue, Headache, Pain; Palpitations, Pyrexia; Ab...
Abortion spontaneous, Chills, Fatigue, Headache, Pain; Palpitations, Pyrexia; Abortion spontaneous, Chills, Fatigue, Headache, Pain; Palpitations, Pyrexia
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Headache, fever, body aches, chills, fatigue lasting over a week. Heart palpitations. Miscarriage se...
Headache, fever, body aches, chills, fatigue lasting over a week. Heart palpitations. Miscarriage several months later.
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| 2861197 | 57 | F | NV | 09/24/2025 |
TDAP |
SANOFI PASTEUR |
4CA04C1 |
Pruritus
Pruritus
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Patient reported on the late morning of 9/24/2025 that she was experiencing slight itching "all...
Patient reported on the late morning of 9/24/2025 that she was experiencing slight itching "all over" her body. She stated that she took a Benadryl and it subsided. At around 2:00 pm, she reported again that the itching was more severe. She denies any redness or swelling at the injection site nor shortness of breath or dizziness. She reports that she does not remember eating anything she might have been allergic to, but did state, "Maybe it's the water here?" This Employee Health nurse advised patient to complete a medical evaluation at Urgent Care as soon as possible. A Workman's Comp form was given to her as well as instructions on completing an Adverse Incident Report in database.
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| 2861198 | 14 | M | ID | 09/24/2025 |
MNQ |
SANOFI PASTEUR |
P-U7853BB |
Product substitution error
Product substitution error
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Private immunization given instead of State
Private immunization given instead of State
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| 2861199 | 8 | F | FL | 09/24/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8770NA UT8770NA |
Culture urine negative, Gaze palsy, Loss of consciousness, Respiratory pathogen ...
Culture urine negative, Gaze palsy, Loss of consciousness, Respiratory pathogen panel, Seizure; Staring, Unresponsive to stimuli, White blood cell count increased
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CHILD GOT ANNUAL FLU VACCINE ON 9/13/25 DURING ANNUAL WELL VISIT AT PEDIATRICIAN. ON 9/15/25 CHILD H...
CHILD GOT ANNUAL FLU VACCINE ON 9/13/25 DURING ANNUAL WELL VISIT AT PEDIATRICIAN. ON 9/15/25 CHILD HAD A SEIZURE AT SCHOOL WHILE IN THE BATHROOM . CHILD WAS NONRESPONSIVE TO NAME, HAD A LOSS OF CONSCIOUSNESS, BLANK STARE AND EYE DEVIATION. EMERGENCY MEDICATION VALTOCO 10 MG GIVEN BY SCHOOL NURSE AND PARENTS WERE CONTACTED AT 9:12 AM EST BY SCHOOL PERSONNEL. CHILD TRANSPORTED TO ER. NO KNOWN RESPIRATORY PATHOGENS WERE FOUND PER SWAB TESTING HOWEVER CHILD'S WHITE BLOOD CELL COUNT WAS ELEVATED. CHILDS VITALS WERE STABLE BUT AFTER SEIZURE SHE SLEPT FOR HOURS AND DID NOT REGAIN STRENGTH UNTIL GIVEN TYLENOL AND REST. CHILD WAS DEEMED HEALTHY BY PEDIATRICIAN DURING WELL VISIT ON 9/13/25. PARENTS ADVISED ER ATTENDING PHYSICIAN THAT CHILD HAD FLU VACCINE ON THAT SAME DATE AND BELIEVE FLU VACCINE AN ACTIVE VIRUS CAUSED CHILD'S SEIZURE.
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