| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
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| 2855932 | 21 | F | OR | 08/28/2025 |
COVID19 COVID19 HPV9 HPV9 TTOX TTOX |
MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Ras...
Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Rash; Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Rash; Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Rash
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She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic; high blood pressure; sensitiv...
She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic; high blood pressure; sensitivity to light; headaches; fatigue; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic) in a 21-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for HPV vaccine and Tetanus vaccine toxoid (Tetanus vaccine) for an unknown indication. The patient's past medical history included Raynaud's disease (Two different times, once in middle school and once in high school, the patient was diagnosed with Raynaud's Disease. Fingers were painful, difficulty opening bottles. Some days were better than others, but no comparison to how she was prior to receiving the three shots). On 13-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form, dose of HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) (unknown route) 1 dosage form and dose of Tetanus vaccine toxoid (Tetanus vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic) (seriousness criterion medically significant), HYPERTENSION (high blood pressure), PHOTOPHOBIA (sensitivity to light), HEADACHE (headaches), FATIGUE (fatigue) and RASH (rashes). At the time of the report, MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic), HYPERTENSION (high blood pressure), PHOTOPHOBIA (sensitivity to light), HEADACHE (headaches), FATIGUE (fatigue) and RASH (rashes) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient did not have any known allergies. The patient had adverse effect impacts for more than a year due to taking Gardasil 9. She received the Gardasil 9 vaccine, a Moderna vaccine shot and a Tetanus shot. Ever since receiving the shots, she had been a shell of herself. The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. She had been to numerous doctors at the clinic while in college. The patient wanted to know if it was safe to administer the Gardasil 9 along with the Covid and Tetanus shots, and asked about how to know for sure that which vaccine was causing the issues. She was trying to find out which vaccine had caused the issues. Patient had undergone bloodwork, ziopatch test for heart monitoring and Gold Standard Potts Diagnosis tests and results were not reported. Treatment medication was not reported.; Reporter's Comments: Co-suspect products HPV vaccine VLP rL1 9v, Tetanus vaccine and past medical history of Raynaud's disease are confounders for the events. The benefit -risk relationship of product is not affected by this report.
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| 2855933 | 69 | F | 08/28/2025 |
COVID19 |
MODERNA |
3031894 |
Arthralgia, COVID-19, Triple negative breast cancer
Arthralgia, COVID-19, Triple negative breast cancer
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she also got COVID around 6 months after her breast cancer surgery; after each COVID vaccine her shi...
she also got COVID around 6 months after her breast cancer surgery; after each COVID vaccine her shins and joints ache for 8-10 hours; fast growing triple negative breast cancer (40%); This spontaneous case was reported by a consumer and describes the occurrence of TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) and COVID-19 (she also got COVID around 6 months after her breast cancer surgery) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch nos. 3031894 and 204H23-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 28-Jul-2024, received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. In July 2024, the patient experienced TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (she also got COVID around 6 months after her breast cancer surgery) (seriousness criterion medically significant) and ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) and COVID-19 (she also got COVID around 6 months after her breast cancer surgery) outcome was unknown and ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. The patient was diagnosed with fast growing triple negative breast cancer (40%) in Jul-2024. It took one year and a half to become large enough to find and they found it early. They started chemo two weeks after they found it. She reported that triple negative was the deadliest form of breast cancer, so her team jumped on it and did a really good job. Over the past year she had been done with 2 rounds of chemotherapy and a full round of radiation and reported that she did not have an immune system. She was told by her cancer specialist to hurry, and she got a COVID shot for her immune system. She also got COVID around 6 months after her breast cancer surgery. Her breast cancer surgery was in Jul-2024. She reported that she was sick, but Moderna saved her life. If she hadn't had that vaccine, even if she would have Pfizer, the percentage was much lower. She blamed Moderna for saving her life. She reported that that after each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. She was 3 months out of radiation and did not have her first check-up. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-788868, MOD-2025-788869 (Patient Link).; Reporter's Comments: Concurrent medical condition Lupus syndrome is a confounder for arthralgia event. Due to lack of biological plausibility, the causality of the event Triple negative breast cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
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| 2855934 | 84 | F | OH | 08/28/2025 |
COVID19 |
MODERNA |
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Fatigue, SARS-CoV-2 test
Fatigue, SARS-CoV-2 test
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extra tired now; This spontaneous case was reported by a consumer and describes the occurrence of FA...
extra tired now; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extra tired now) in an 84-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) on 04-Feb-2021, Moderna covid-19 vaccine (Dose 2) on 04-Mar-2021, Moderna covid-19 vaccine (Dose 3) on 29-Oct-2021, Spikevax (Dose 4) on 03-May-2022 and Spikevax XBB.1.5 (Dose 5) on 13-Oct-2023. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Spikevax and Spikevax XBB.1.5. Family history included Heart disease, unspecified (Patient had a hereditary condition which both parents also had, and they both required aortic valve replacements). Concurrent medical conditions included Cancer and Heart disease, unspecified (had hereditary condition). On 17-Sep-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extra tired now). At the time of the report, FATIGUE (extra tired now) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. No concomitant medications were reported. The patient was tested positive for Covid prior to receiving any Covid vaccine and no hospitalization was required. She was a cancer patient and was very active. She had received all Moderna Covid-19 vaccines/boosters with no problems and stated that, she had been very happy with Moderna. However, she would require a TAVAR aortic valve replacement scheduled for 16-Sep-2025. She had been requiring surgery for the last year. She was currently on bed rest in preparation for surgery and stated that, she was just extra tired now. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.
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| 2855935 | M | 08/28/2025 |
COVID19 |
MODERNA |
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Blood immunoglobulin E, Burning sensation, Histamine level, Pruritus
Blood immunoglobulin E, Burning sensation, Histamine level, Pruritus
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developed severe itching; developed burning sensations on my forearms; This spontaneous case was rep...
developed severe itching; developed burning sensations on my forearms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (developed severe itching) and BURNING SENSATION (developed burning sensations on my forearms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-May-2021, the patient experienced PRURITUS (developed severe itching) and BURNING SENSATION (developed burning sensations on my forearms). At the time of the report, PRURITUS (developed severe itching) and BURNING SENSATION (developed burning sensations on my forearms) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin E: elevated. On an unknown date, Histamine level: elevated. Concomitant medication was not reported. It was reported that patient had concern about a health issue which he experienced following his COVID-19 vaccination. Despite seeing numerous healthcare professionals, the cause of these symptoms was unclear. The symptoms had been persistent, and he had undergone various tests, which had revealed elevated IgE and histamine levels. However, a definitive diagnosis or cause had not been identified. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
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| 2855936 | F | SC | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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really hurting too. There's this like stabbing in my throat feeling and I've had it before...
really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before; really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 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 (Primary Immunization series complete), for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated, "(inaudible) really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before. I've gotten the booster every year." Later while searching for the patients account she added, "I have my Pfizer booster every year I wasn't due for it yet, I had it in at the end of Sep of last year (2024) so obviously (inaudible)." 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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| 2855937 | 84 | M | CO | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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came down with the COVID/still picked up this variant; came down with the COVID/still picked up this...
came down with the COVID/still picked up this variant; came down with the COVID/still picked up this variant; This is a spontaneous report and received from Consumer or other non HCPs, Program ID:. An 84-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "came down with the COVID/still picked up this variant". Clinical course: During an inbound call for financial assistance, the patient, (name withheld), stated, "I wish I had applied for my Part D at the start, but I'm 84, I'm not sure I can get it." When (name withheld) was asked if he had any further questions, an unknown person, who joined the call, stated, "I have a question. When I came down, I came down with the COVID first, and (name withheld) came down a day later. But I applied and I got-I got the pills for free, especially when you're sick and your brain doesn't work right anymore." After explaining the differences between the different programs offered, (name withheld) stated, "I think that-that you've helped us as much as you can, and it looks like we have to go through the government first and then go from there. But by that time, hopefully I will be over COVID." After explaining to (name withheld) that he is not eligible for the program initially, (name withheld) asked, "So, I do, or I don't?" The unknown person then answered, "You don't, but you're retired, so I don't know what they're going by because you just retired this year." Later in the call, the unknown person stated, "It's bad enough having COVID without being penalized, you know. And I must tell you that we have always kept our Pfizer vaccines up. We had our last one in Jun, but we still picked up this variant, whatever it is, and, anyway, they've always-the vaccines have always been very successful. My mother's 99, and she was living with us until a few months ago, so we were careful, but she's not with us now." At the end of the call, the unknown person stated, "Okay, I'm going to give this information to a neighbor since we have COVID and we're quarantined. So a neighbor be able to pick this up for us, I guess." 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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| 2855938 | 08/28/2025 |
MENB |
PFIZER\WYETH |
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Malaise
Malaise
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feeling sick after the first dose; This is a spontaneous report received from a Pharmacist from medi...
feeling sick after the first dose; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received meningococcal group b Rlp2086 (TRUMENBA), in Mar2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2024, outcome "unknown", described as "feeling sick after the first dose". Additional information: The pharmacist reported that I have a patient that requires the Trumenba two dose series. Patient initially received first dose March of 2024 but reported feeling sick after the first dose so did not follow-up for 2nd dose 6 months later. Patient is now interested in completing the series. Does the patient need to restart the series or can they just receive one more dose?. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
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| 2855939 | 08/28/2025 |
PNC20 |
PFIZER\WYETH |
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Drug ineffective, Pneumonia
Drug ineffective, Pneumonia
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has been continuing to get pneumonia; has been continuing to get pneumonia; This is a spontaneous re...
has been continuing to get pneumonia; has been continuing to get pneumonia; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "has been continuing to get pneumonia". Clinical course: Reporter like to know what is the level of efficacy of Prevnar 20 in preventing recurrent pneumonia (ex: he has a patient that had pneumonia, received Prevnar 20, and has been continuing to get pneumonia). Provider was asking if we had any information on the following questions: what is the rate of incidence of illness in the 9 serotypes found in PCV21 and not found in Prevnar 20. Wants to know that rate of incidence of illness in the serotypes found in Prevnar 20 vs. serotypes in PCV 21. He also would like to know what is the level of efficacy of Prevnar 20 in preventing recurrent pneumonia (ex: he has a patient that had pneumonia, received Prevnar 20, and has been continuing to get pneumonia). Provider was asking if we had any information on the following questions: what is the rate of incidence of illness in the 9 serotypes found in PCV21 and not found in Prevnar 20. Wants to know that rate of incidence of illness in the serotypes found in Prevnar 20 vs. serotypes in PCV 21. 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: The efficacy of a product varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product pneumococcal 20-val conj vac to the reported event 'has been continuing to get pneumonia' cannot be ruled out.
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| 2855940 | F | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident
Cerebrovascular accident
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stroke; This is a spontaneous report received from a Consumer or other non HCP. A female patient re...
stroke; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alzheimer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Premarin, reaction(s): "Stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". 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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| 2855941 | M | 08/28/2025 |
PNC20 |
PFIZER\WYETH |
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Pain in extremity
Pain in extremity
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pain in arm after vaccination; This is a spontaneous report received from a Consumer or other non HC...
pain in arm after vaccination; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm after vaccination". It was unknown if therapeutic measures were taken as a result of pain in extremity. Additional information: Patient reported pain in arm after vaccination. It was unknown if the patient received any other vaccines on the same date as the suspected vaccine. It was unknown if the patient received any other vaccines within 4 weeks prior to the suspected vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. The reporter classified the event as non-serious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2855942 | F | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Drug ineffective, Suspected COVID-19
Drug ineffective, Suspected COVID-19
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there is a chance that I could have had covid, I had a kind of fluish period of time; there is a cha...
there is a chance that I could have had covid, I had a kind of fluish period of time; there is a chance that I could have had covid, I had a kind of fluish period of time; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "there is a chance that I could have had covid, I had a kind of fluish period of time". Clinical course: per caller she was thinking that she need another booster, and that they could give her a titer blood test to see if she still had immunity against a covid virus. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2855943 | M | NY | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Metastasis
Metastasis
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metastasis of prostate cancer.; This is a spontaneous report received from a Physician from a sales ...
metastasis of prostate cancer.; This is a spontaneous report received from a Physician from a sales representative. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Metastatic Prostate Cancer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; manufacturer unknown), for Covid-19 immunisation. The following information was reported: METASTASIS (life threatening, medically significant), 1 month after the suspect product(s) administration, outcome "recovering", described as "metastasis of prostate cancer.". Therapeutic measures were taken as a result of metastasis. Clinical course: Dr. reported about a month after he received his 3rd Pfizer Covid vaccine, he had metastasis of prostate cancer. Dr. considered the event resulted in life threatening illness (immediate risk of death from the event). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event metastasis and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available. 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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| 2855944 | F | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills
Chills
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had some chills and other side effects; This is a spontaneous report received from a Consumer or oth...
had some chills and other side effects; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "had some chills and other side effects". Additional information: Patient heard yesterday on social media information from an anti-vaccine cardiologist (couldn't remember his name) that all covid vaccine were being cancelled and taken off the market. Patient was very upset, frustrated by this administration making decisions that effect millions of people. You don't announce things by social media. Patient was so angry that these people who have no medical or science background are making these decision. Patient had mostly the Moderna vaccine and had headaches, chills and felt kinda crummy but it was nothing comparted to if got covid. Patient got her first Pfizer covid vaccine in July and had some chills and other side effects. She did not want toprovide any more information as she did not want to give any information that anyone could use against the vaccine. Patient was very grateful for the vaccines and has never gotten covid and Patient would be traumatized if the vaccines were taken away. Patient had fewer side effects than she did with the Moderna vaccine. Patient did not want to speak with safety or give her name or age just that she is an adult (> 18 years) female.
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| 2855945 | CO | 08/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I came down with the COVID; I came down with the COVID; This is a spontaneous report and received fr...
I came down with the COVID; I came down with the COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 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: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "I came down with the COVID". Therapeutic measures were taken as a result of covid-19. 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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| 2855946 | CT | 08/28/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK232AB |
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event, Underdose
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inappropriate use due to patient not receiving a full dose with no reported adverse event; Initial i...
inappropriate use due to patient not receiving a full dose with no reported adverse event; Initial information received on 22-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who did not receive full dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient did not receive a full dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK232AB, expiry date 31-Aug-2026, strength not reported) via unknown route in unknown administration site for Immunisation, with no reported adverse event (incorrect dose administered) (latency same day). Reportedly, nurse stated that they had patient that was administered with Pentacel but the patient moved and was not able to get the full dose. Nurse was not sure of if the patient was able to get at least half the dose but the needle punctured the patient's skin. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2855947 | 20 | F | CO | 08/28/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
47KS7 47KS7 |
Injected limb mobility decreased, Injection site pain, Injection site reaction, ...
Injected limb mobility decreased, Injection site pain, Injection site reaction, Myalgia, Pain; Pyrexia, Rash, Rash papular
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Fever x 1 day within 24 hours of administration. Fine papular rash of face and chest x 2 days after ...
Fever x 1 day within 24 hours of administration. Fine papular rash of face and chest x 2 days after vaccine. Left upper arm pain and limited ROM of shoulder x 1 week after vaccine administration. Seen in office on 8/19 for this concern. Patient concerned for possible bursitis. Limited ROM secondary to pain (limited lateral extension of left arm past 90 degrees, limited internal and external rotation due to pain. No swelling or redness on exam. Pain to palpation of deltoid. Treated with NSAIDs and prednisone taper 20mg BID x 5 days and 20mg daily x 5 days. Pain resolved within 48 hours of treatment. No ongoing concerns.
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| 2855948 | 2 | F | NC | 08/28/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
hep A |
Unevaluable event
Unevaluable event
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My supervisor spoke with Communical disease nurse about what steps to take, spoke with mother of ch...
My supervisor spoke with Communical disease nurse about what steps to take, spoke with mother of child and she was fine with the event that took place.
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| 2855950 | 31 | M | NC | 08/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
045AZ1A 0Z6BZ1A |
Arthralgia, Blood test normal, Rheumatoid factor negative; Arthralgia, Blood tes...
Arthralgia, Blood test normal, Rheumatoid factor negative; Arthralgia, Blood test normal, Rheumatoid factor negative
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Joint pain in hands that never fully went away. Within 1-2 weeks of the vaccine my hands suddenly fe...
Joint pain in hands that never fully went away. Within 1-2 weeks of the vaccine my hands suddenly felt like I was 80 years old, it gradually got better but it never went away. The same thing happened after boosters. It's been 4 1/2 years and hands still hurt.
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| 2855951 | 5 | M | MD | 08/28/2025 |
MMRV |
MERCK & CO. INC. |
Y018154 |
Extra dose administered
Extra dose administered
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Member received a third dose of MMR. Reported to doctor of the day. No further treatment or actions ...
Member received a third dose of MMR. Reported to doctor of the day. No further treatment or actions required other than to notify member's parent of extra dose given. Member's mother given information and verbalized understanding of event.
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| 2855952 | 14 | M | SD | 08/28/2025 |
IPV MMR MNQ |
SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR |
w1b511, x026404 u8574aa |
Disorientation, Immediate post-injection reaction, Loss of consciousness; Disori...
Disorientation, Immediate post-injection reaction, Loss of consciousness; Disorientation, Immediate post-injection reaction, Loss of consciousness; Disorientation, Immediate post-injection reaction, Loss of consciousness
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child passed out immediately after injection of 3rd vaccine. noted that child looked at vaccine whil...
child passed out immediately after injection of 3rd vaccine. noted that child looked at vaccine while being given, even after being told multiple times to look the other way, immediately after he slumped forward in chair and was noted to have fainted. was lowered to the ground by nurse and his lower legs were placed on nearby chair. within 1 minute he was conscious again, though disorientated. nurse and patients mother provided comfort and reminded him where he was and what happened. after approximately 5 minutes he was assisted to a sitting position on the floor and "scooted" over to a nearby desk that he could lean on while sitting, where he remained for the rest of the family's appointment (approximately 40 minutes). after that time he was assisted to stand, he denies dizziness, nausea, weakness or any other symptoms at that time and left the office with his family with no help. nurse checked back with mom later that day, approximately 5 hours after incident and she reported Jayden was feeling well and had no other symptoms at that time.
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| 2855953 | 51 | F | NC | 08/28/2025 |
PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
LN4930 LN4930 LN4930 |
Headache, Hypertension, Influenza virus test negative, Injection site cellulitis...
Headache, Hypertension, Influenza virus test negative, Injection site cellulitis, Injection site erythema; Injection site pain, Injection site swelling, Pain in extremity, Pruritus, Pyrexia; SARS-CoV-2 test negative, Streptococcus test negative, Viral infection
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Patient received a Prevnar 20 vaccine on 8/19/25 from Pharmacy. She stated that throughout the day ...
Patient received a Prevnar 20 vaccine on 8/19/25 from Pharmacy. She stated that throughout the day and the next day she started to developed a fever, headaches, high blood pressure and pain in her arm. She was rushed to Hospital via EMS on 8/20/25 and was discharged the same day. While at the ED a flu, strep and covid testing was completed and they all resulted negative. She was discharged with a diagnosis of Viral Syndrome. Patient then contacted our facility on 8/25/25 stating that she is still having a lot of pain in her arm where the vaccine was administered and that its red and swollen and painful to the touch in addition to itching to her chest and left leg. Patient was treated at urgent care for cellulitis of the left upper arm with a Kenalog and ketorolac injection, a 10 day course of Amoxicillin, Ibuprofen for pain and a LUE US was ordered to rule out Thrombophlebitis and DVT. A follow-up call was conducted by this writer and patient reports feeling a lot better, the pain has decreased and the redness is slowly going away.
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| 2855954 | 58 | M | GA | 08/28/2025 |
PNC21 |
MERCK & CO. INC. |
Z006076 |
Computerised tomogram, Malaise, Pain in extremity, Peripheral swelling, X-ray li...
Computerised tomogram, Malaise, Pain in extremity, Peripheral swelling, X-ray limb
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pain in arm with swelling and malaise for 1 month
pain in arm with swelling and malaise for 1 month
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| 2855955 | 85 | F | OH | 08/28/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
U8764BB LN4932 |
Swelling face; Swelling face
Swelling face; Swelling face
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Patient reported being given Prevnar 20 Syringe and Fluzone HD Trivalent 2025-26 PFS around 3:30 pm ...
Patient reported being given Prevnar 20 Syringe and Fluzone HD Trivalent 2025-26 PFS around 3:30 pm on 8/27/25. Around 4:30 pm on 8/27/25, patient noticed left side of face swollen. Her friend noticed this as well and commented about the facial swelling to the patient. Patient reported taking Lisinopril 20mg in the evening after the facial swelling had already started. Patient stated she went straight to bed after taking Lisinopril 20mg so she is uncertain if that medication affected any of the swelling. Patient did not take anything for the facial swelling. The patient did not call her doctor to report the facial swelling. Patient reports today on 8/28/25 that the swelling is gone. I notified her physician and the store pharmacist on 8/28/25.
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| 2855956 | 1 | M | NC | 08/28/2025 |
HEPA HIBV MMRV PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
L4EA4 Y020467 Y016874 LK6653 Z005456 |
Extra dose administered, Rash; Extra dose administered, Rash; Extra dose adminis...
Extra dose administered, Rash; Extra dose administered, Rash; Extra dose administered, Rash; Extra dose administered, Rash; Extra dose administered, Rash
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Whole body rash started a few days after vaccination where patient received double dose of varicella...
Whole body rash started a few days after vaccination where patient received double dose of varicella.
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| 2855957 | 0.17 | M | MO | 08/28/2025 |
UNK |
UNKNOWN MANUFACTURER |
U8383AB |
Extra dose administered, No adverse event, Wrong product administered
Extra dose administered, No adverse event, Wrong product administered
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Patient received Pentacel and Rotavirus that day. Patient received Quadracel that day as well inste...
Patient received Pentacel and Rotavirus that day. Patient received Quadracel that day as well instead of receiving Vaxneuvance (PCV 15) that day. So pt was double dosed with Dtap & IPV essentially. No side effects reported to the office. Parents did return with patient on 8/20 to receive PCV15 and did not report any adverse reactions. We did want to report the error
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| 2855958 | 67 | F | 08/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523j |
Arthralgia, Neck pain, Pain in jaw
Arthralgia, Neck pain, Pain in jaw
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patient felt pain up her shoulder, neck and jaw
patient felt pain up her shoulder, neck and jaw
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| 2855959 | 12 | F | MI | 08/28/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
K7JY3 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Given Bexsero when should have been given Menveo, no side effects
Given Bexsero when should have been given Menveo, no side effects
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| 2855960 | 5 | M | TX | 08/28/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site pain, Injection site pruritus
Injection site erythema, Injection site pain, Injection site pruritus
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Redness, itching, soreness around injection site, started two days after administration per parent.
Redness, itching, soreness around injection site, started two days after administration per parent.
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| 2855961 | 4 | M | CA | 08/28/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Crying, Injection site erythema, Injection site swelling, Injection site vesicle...
Crying, Injection site erythema, Injection site swelling, Injection site vesicles, Pain
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Patient received Kinrix for his 5th Dtap and 4th IPV. His mother took him to the ER on 08/23/2025 du...
Patient received Kinrix for his 5th Dtap and 4th IPV. His mother took him to the ER on 08/23/2025 due to his right thigh being red, swollen and having a small area that was blistered with complaints of pain and crying. ER doctor gave 25mg Benadryl and 365.5mg ibuprofen and prescribed Benadryl 25mg PO BID PRN at discharge. ER doctor stated there were no signs of cellulitis or infection and to follow up with PCP. Patient presented to clinic with mother on 08/27/2025 for follow up as directed. No swelling, redness or blistering at visit. Patient per provider was back to baseline.
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| 2855962 | 11 | F | MI | 08/28/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
JF7DM |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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none
none
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| 2855963 | 48 | F | NC | 08/28/2025 |
FLU3 |
SANOFI PASTEUR |
u8790aa |
Dyspnoea, Palpitations, Paraesthesia, Paraesthesia oral
Dyspnoea, Palpitations, Paraesthesia, Paraesthesia oral
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Heart racing, difficulty breathing, tingling in lips and limbs - pt took benadryl and went to ER; st...
Heart racing, difficulty breathing, tingling in lips and limbs - pt took benadryl and went to ER; still experiencing some tingling today 8/28/25
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| 2855964 | 3 | M | WA | 08/28/2025 |
TDAP |
SANOFI PASTEUR |
U8274AA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient does not meet minimum age requirement for vaccine.
Patient does not meet minimum age requirement for vaccine.
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| 2855965 | 77 | F | SC | 08/28/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y011819 Y011819 |
Bone pain, Injection site erythema, Injection site induration, Injection site in...
Bone pain, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain; Injection site warmth
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Patient noted that vaccine was painful at the time of administration. Shortly after administration, ...
Patient noted that vaccine was painful at the time of administration. Shortly after administration, the injection site was red and hard to the touch. It got worse overnight and she developed a hard, red, inflamed area about 4 inches long underneath her deltoid to just above her elbow that wrapped the entire circumference of her arm. She reported that it was hot, red and hard to the touch. She also noted "bone pain" that extended from the top of her arm, into her elbow and down to her fingertips. The injection site pain dissipated, but the pain underneath her deltoid and in her bones worsened. She has full range of motion in her shoulder muscle, but has aching internally in her arm
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| 2855966 | 6 | M | OH | 08/28/2025 |
DTAPIPV HEP HEPA MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
42Y93 4D333 DN273 Y014306 |
Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperacti...
Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder; Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder; Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder; Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder
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Since the shots he started acting out, yelling kicking, throwing things, threatening people, hitting...
Since the shots he started acting out, yelling kicking, throwing things, threatening people, hitting people. He did not act like this before the shots. Since then the diaognosed him with ADHD and adjustment disorder but I dont believe them. I believe my son has been injured by this round of shots.
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| 2855967 | 12 | M | WA | 08/28/2025 |
HEPA HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
42DM9 Y012864 U8508AA U8252AA |
Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive...
Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli; Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli; Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli; Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli
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After receiving the fourth vaccine (meningococcal) patient appeared to have a vasovagal response (he...
After receiving the fourth vaccine (meningococcal) patient appeared to have a vasovagal response (head nodding, unresponsive) for 5-10 seconds.
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| 2855968 | 0.5 | M | OH | 08/28/2025 |
DTPPVHBHPB PNC20 RV1 |
MSP VACCINE COMPANY PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
U7969AA LX2498 |
Injection site reaction, Rash macular; Injection site reaction, Rash macular; In...
Injection site reaction, Rash macular; Injection site reaction, Rash macular; Injection site reaction, Rash macular
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MSP Vaccine Company Vaxelis in left thigh, Prevnar 20 in right thigh and rotavirus (Rotatix) oral.Ab...
MSP Vaccine Company Vaxelis in left thigh, Prevnar 20 in right thigh and rotavirus (Rotatix) oral.About one hour later, developed a lacey and blotchy bilateral lower leg rash. No urticaria, respiratory or GI symptoms. Has remained stable, happy and began to fade by the time seen virtually 5 hours later.
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| 2855969 | 57 | F | TN | 08/28/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EN5318 EN5318 EN5318 |
Arthralgia, Asthenia, Dysstasia, Fatigue, Hypoaesthesia; Laboratory test, Magnet...
Arthralgia, Asthenia, Dysstasia, Fatigue, Hypoaesthesia; Laboratory test, Magnetic resonance imaging, Muscular weakness, Myelitis transverse, Pain in extremity; Plasmapheresis, Wheelchair user
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pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She w...
pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She was very weak. At work she had a sharp pain that went from her hip and went down her right leg. She immediately sat down. She had to called the ambulance because she couldn't stand up. She was taken to Hospital ER. She couldn't feel it when they lifted her right leg. She was admitted and was there for over 2 weeks. She was diagnosed with Transverse myelitis that affected both legs and lower part of her body. She is currently wheelchair bound and disabled. Had to go to (withheld name) rehab after being discharged. She is currently being treated by a neurologist Dr. at the MS clinic.
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| 2855970 | 66 | F | FL | 08/28/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8794BA UT8794BA |
Dizziness, Fatigue, Feeling cold, Muscular weakness, Pyrexia; Vomiting
Dizziness, Fatigue, Feeling cold, Muscular weakness, Pyrexia; Vomiting
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I got the injection around noon, and i came home and i sat down with my dog and a cup of coffee and ...
I got the injection around noon, and i came home and i sat down with my dog and a cup of coffee and then all of the sudden i was freezing and i couldn't get warm. Then i got tired, fever, throwing up, dizzy. My legs are very weak.
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| 2855971 | 50 | F | AZ | 08/28/2025 |
FLU3 HEP PNC21 VARZOS |
SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
U8790AA 945664 Z003579 945664 |
Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site...
Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site erythema, Pruritus, Pyrexia
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Patient came back 2 days later after 4 vaccines. Right arm had redness from muscle area down arm to...
Patient came back 2 days later after 4 vaccines. Right arm had redness from muscle area down arm to just above elbow, had itching around arm and chest. Said they had fever, light headedness. Pt wanted to make sure they could take something will take Tylenol or ibuprofen, antihistamine for the itching, ice the area and follow up with PCP if needed
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| 2855972 | 18 | M | UT | 08/28/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00720 |
Bell's palsy, Facial paralysis
Bell's palsy, Facial paralysis
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Pt woke up day after vaccination with left sided facial paralysis. No other neurologic symptoms. H...
Pt woke up day after vaccination with left sided facial paralysis. No other neurologic symptoms. He was treated for Bell's Palsy with prednisone and Valacyclovir by another health professional
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| 2855973 | 76 | M | OH | 08/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
AE435 |
Injection site pain, Limb discomfort
Injection site pain, Limb discomfort
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patient notified pharmacy on 8/28/25 that he has had soreness and pain he described as "a needl...
patient notified pharmacy on 8/28/25 that he has had soreness and pain he described as "a needle stuck in my arm" ever since receiving the vaccine on 8/21/25 - he stated he has full range of motion and no redness, bruising, or feeling of warmth at the injection site.
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| 2855974 | 9 | M | PA | 08/28/2025 |
TDAP |
SANOFI PASTEUR |
|
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Pt was given Adacel at the of 9. Per Provider who saw him 8/2025, When reviewing his vaccinations, I...
Pt was given Adacel at the of 9. Per Provider who saw him 8/2025, When reviewing his vaccinations, I found he was incorrectly given Tdap at age 9 in 2023. Per package insert, Adacel is not indicated until age 10. I did order another Tdap at time of physical as it is recommended to have Tdap at proper age.
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| 2855975 | 4 | M | MI | 08/28/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
42y93 y011484 y011018 |
Injection site reaction; Injection site reaction; Injection site reaction
Injection site reaction; Injection site reaction; Injection site reaction
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possible site reaction,
possible site reaction,
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| 2855976 | 4 | M | GA | 08/28/2025 |
HPV9 |
MERCK & CO. INC. |
Z004534 |
Wrong product administered
Wrong product administered
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Administration Error-Incorrect vaccine given, HPV administered instead of HepA
Administration Error-Incorrect vaccine given, HPV administered instead of HepA
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| 2855977 | 76 | F | OK | 08/28/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
z003579 z003579 |
Diarrhoea, Erythema, Headache, Injection site pain, Injection site swelling; Pai...
Diarrhoea, Erythema, Headache, Injection site pain, Injection site swelling; Pain in extremity, Skin warm, Somnolence
More
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Patient had a really sore arm following the vaccination, swelling and pain at the injection site tha...
Patient had a really sore arm following the vaccination, swelling and pain at the injection site that traveled from her shoulder down to her elbow. She also experienced drowsiness, headache, diarrhea, and red skin. The arm was red and hot to the touch for 3 days. Her doctor recommended she try benadryl and she also applied ice to the swelling. patient is feeling better after the 3 days following vaccination.
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| 2855978 | 61 | M | TX | 08/28/2025 |
PNC21 |
MERCK & CO. INC. |
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Chills, Feeling cold, Headache, Pain in extremity, Speech disorder
Chills, Feeling cold, Headache, Pain in extremity, Speech disorder
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I received Capvaxive 21. I had previously received Pneumovax 23 on 06/30/2002. I received the inject...
I received Capvaxive 21. I had previously received Pneumovax 23 on 06/30/2002. I received the injection at about 7:30 am and only had a sore arm for most of the day. At about 9:30 pm, I started feeling a dull headache, and wondered if it might be low blood sugar. I drank about two mouthfuls of cold chocolate milk and had a sudden, very strong wave of chills run through my entire body, and was immediately freezing, shivering, and having trouble speaking. I had to sleep under heavy covers using a heating pad that night, and was very cold every time I woke up during the night. By the next morning, the chills were gone and I was left with only a sore arm again. I've never had an adverse reaction to a vaccination before, including flu, shingles, covid, cholera, hepatitis A, hepatitis B, MMR, meningococcal, Tdap, typhoid, and yellow fever.
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| 2855979 | 11 | M | TX | 08/28/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8169AB U8274AA |
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
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Patient developed itching of right arm with swelling and redness.
Patient developed itching of right arm with swelling and redness.
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| 2855980 | 7 | F | VA | 08/28/2025 |
PNC20 |
PFIZER\WYETH |
LP4947 |
Erythema, Inflammation
Erythema, Inflammation
|
ERYTHEMA AND INFLAMMATION
ERYTHEMA AND INFLAMMATION
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| 2855981 | 10 | M | CA | 08/28/2025 |
COVID19 |
MODERNA |
3046979 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Vaccine administration error. Patient was given moderna covid vaccine 12yrs and older instead of the...
Vaccine administration error. Patient was given moderna covid vaccine 12yrs and older instead of the 6 months- 11 years old. Provider was notified and stated that there is no adverse reaction and that it is still FDA approved. Parent was notified and was explained that the child will be okay.
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| 2855982 | 1 | F | LA | 08/28/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z009474 Z003766 |
Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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PROQUAD WAS GIVEN AT THE SAME TIME AS VARICELLA. IT WAS ONLY SUPPOSED TO BE MMR AND VARICELLA (SEPER...
PROQUAD WAS GIVEN AT THE SAME TIME AS VARICELLA. IT WAS ONLY SUPPOSED TO BE MMR AND VARICELLA (SEPERATE)
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