| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2704537 | 75 | F | NV | 10/27/2023 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
HF9275 or WS175 hf9275 hf9275 |
Pain, Pain in extremity, Peripheral swelling, Tenderness; Arthralgia, Back pain,...
Pain, Pain in extremity, Peripheral swelling, Tenderness; Arthralgia, Back pain, Injected limb mobility decreased, Injection site pain, Neck pain; Swelling
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I noticed regular soreness. After a week I noticed that it was still hurting and there was an egg si...
I noticed regular soreness. After a week I noticed that it was still hurting and there was an egg size bump in the crux of my arm and it hurts up into the shoulder and down the entire arm. I cannot lift it without pain. The lump is soft and squishy. It does hurt if you push down into it.
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| 2844105 | M | 06/05/2025 |
COVID19 |
MODERNA |
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Immunisation reaction, Syncope
Immunisation reaction, Syncope
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I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; I had a ...
I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; This male subject of an unknown age was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine). No Medical History information was reported. On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) dosage was changed to 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) (seriousness criterion medically significant) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) outcome was unknown. For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments. ID was reported as DCP-0420-25. Regulatory Agency name was reported as mRNA-1083 Life Cycle Management Concept Evaluation. Concomitant medication use information was not provided by reporter. It was reported that there was a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine, and he just did not want to take the vaccine. He had taken two doses and did not want to take it. The reporter thought that vaccine side effects were a significant issue as well. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-786903 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live follow up received that contains no new information. On 26-May-2025: Live follow up received that contains no new information. On 27-May-2025: Live follow up received that contains significant information includes ID number was added, and narrative was updated.; Reporter's Comments: Company comment: The causality for the events was not provided by the reporter and is assessed as related to the vaccine based on close temporal association, in the absence of alternative explanation. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786903:Master case
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| 2844107 | 79 | F | IL | 06/05/2025 |
COVID19 |
MODERNA |
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Headache, Hypersomnia
Headache, Hypersomnia
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she had a headache and that she slept for a full day/couldn't think about doing much, other tha...
she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping; she had a headache and that she slept for a full day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Open heart surgery (recent heart surgery - valve repair, maze procedure, atrial abutment (Sep-1993)) in September 1993, Heart valve operation (Recent heart surgery - valve repair) in September 1993 and Cox-Maze procedure (Maze procedure) in September 1993. Previously administered products included for Product used for unknown indication: Pfizer vaccine (previous vaccine dose). Past adverse reactions to the above products included No adverse effect with Pfizer vaccine. Concurrent medical conditions included Blood pressure high (high blood pressure (normal yesterday 26-May-2025)). On 23-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In May 2025, the patient experienced HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day). The patient was treated with Paracetamol (Tylenol) in May 2025 at an unspecified dose and frequency. In May 2025, HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day) had resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient received the Spikevax (2024-2025) vaccination early on Friday of last week (23-May-2025) and had a reaction to it. She had a headache and that she slept for a full day. After receiving her dose, she was unable to think about doing much, other than sleeping. The reporter denied any severe pain. She had roughly 10 COVID vaccines, all Moderna except 1 Pfizer. She had contacted Moderna before, after receiving her first vaccine, as she experienced a really strange reaction but everything kind of settled itself. The reporter stated that it was not catastrophic, but just unusual. Patient did not recall what her reaction was. No other details provided. It was unknown if the patient experienced any additional symptoms/events. Patient's reactions were resolved with a couple of Tylenol. This case was linked to MOD-2021-049524 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2844108 | 74 | F | OH | 06/05/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA |
013M20A 013M20A 013M20A 013M20A 013M20A |
Abdominal discomfort, Angular cheilitis, Antinuclear antibody, Autoimmune disord...
Abdominal discomfort, Angular cheilitis, Antinuclear antibody, Autoimmune disorder, Chills; Ear infection, Eczema, Eye pruritus, Feeding disorder, Feeling hot; Influenza, Injection site pain, Injection site swelling, Nausea, Oral herpes; Pain, Pain in extremity, Peripheral coldness, Peripheral swelling, Pruritus; Pyrexia, Skin exfoliation, Taste disorder, Vaccination site reaction
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she does have an autoimmune disease.; skin feels like it's going to peel off/it was sun damage;...
she does have an autoimmune disease.; skin feels like it's going to peel off/it was sun damage; She got itchy spots on her skin, basically on her face and neck; It also itches around her eyes; Both corners of the mouth split, and it hurt/the left side of mouth started developing a rash that "Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face/angular cheilitis; At the injection site, her arm was sore and swollen; Right ear started to "Hurt real bad"/it was an ear infection due to the hearing aid; Pt had "Covid arm" (right arm was red, swollen, sore, and itchy)/This time including the upper arm (swollen from top of arm; it also felt hot; She also got cold sores in the corners of her mouth; mild case of the flu; aches/feeling feverish, with chills and body aches; stomach upset; Chronic eczema/Face red/hot, mouth rash(flaky, hurt, spread to face),dark red/maroon spots, stabbing/heat itches, red/itchy/painful/flaking splotches to face/neck, constant itching,burning,hurting,flaking, face blotchy/eczema in right ear/bad sunburn; could taste the medicine, it went right up to tongue; didn't eat anything; hands were like ice, was clutching "Hot hands"; PT had "Covid arm" (right arm was red, swollen, sore, and itchy); Covid arm (right arm was red, swollen, sore, and itchy)/upper arm (swollen from top of arm); feeling feverish, with chills and body aches; At the injection site, her arm was sore and swollen; chills; but nausea started by dinner time/kinda yucky; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (she does have an autoimmune disease.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 012A21A, 066F21A and 057M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dermatitis, Back pain, Weight loss and Shoulder operation (Left Shoulder surgery, Both shoulders and both wrists were operated) in 2019. Concurrent medical conditions included Hearing aid user. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (aches/feeling feverish, with chills and body aches), ABDOMINAL DISCOMFORT (stomach upset), ECZEMA (Chronic eczema/Face red/hot, mouth rash(flaky, hurt, spread to face),dark red/maroon spots, stabbing/heat itches, red/itchy/painful/flaking splotches to face/neck, constant itching, burning, hurting, flaking, face blotchy/eczema in right ear/bad sunburn), TASTE DISORDER (could taste the medicine, it went right up to tongue), FEEDING DISORDER (didn't eat anything), PERIPHERAL COLDNESS (hands were like ice, was clutching "Hot hands"), PAIN IN EXTREMITY (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)), VACCINATION SITE REACTION (Covid arm (right arm was red, swollen, sore, and itchy)/upper arm (swollen from top of arm)), PYREXIA (feeling feverish, with chills and body aches), INJECTION SITE PAIN (At the injection site, her arm was sore and swollen), CHILLS (chills) and NAUSEA (but nausea started by dinner time/kinda yucky). On 09-Mar-2021, the patient experienced FEELING HOT (it also felt hot) and PERIPHERAL SWELLING (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)/This time including the upper arm (swollen from top of arm). In March 2021, the patient experienced ORAL HERPES (She also got cold sores in the corners of her mouth) and INFLUENZA (mild case of the flu). In 2023, the patient experienced EAR INFECTION (Right ear started to "Hurt real bad"/it was an ear infection due to the hearing aid). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (she does have an autoimmune disease.) (seriousness criterion medically significant), SKIN EXFOLIATION (skin feels like it's going to peel off/it was sun damage), PRURITUS (She got itchy spots on her skin, basically on her face and neck), EYE PRURITUS (It also itches around her eyes), ANGULAR CHEILITIS (Both corners of the mouth split, and it hurt/the left side of mouth started developing a rash that "Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face/angular cheilitis) and INJECTION SITE SWELLING (At the injection site, her arm was sore and swollen). The patient was treated with Cortisone in 2021 at an unspecified dose and frequency; Ruxolitinib phosphate (Opzelura) at an unspecified dose and frequency; Avena sativa fluid extract (Aveeno) at an unspecified dose and frequency; Paracetamol (Tylenol) on 10-Feb-2021 at an unspecified dose and frequency; Bismuth subsalicylate (Pepto bismol) in February 2021 at an unspecified dose and frequency; Tacrolimus at a dose of twice a day; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) at an unspecified dose and frequency and Zinc oxide (Desitin) at an unspecified dose and frequency. In February 2021, NAUSEA (but nausea started by dinner time/kinda yucky) had resolved. At the time of the report, AUTOIMMUNE DISORDER (she does have an autoimmune disease.), PAIN (aches/feeling feverish, with chills and body aches), ABDOMINAL DISCOMFORT (stomach upset), ORAL HERPES (She also got cold sores in the corners of her mouth), SKIN EXFOLIATION (skin feels like it's going to peel off/it was sun damage), PRURITUS (She got itchy spots on her skin, basically on her face and neck), FEELING HOT (it also felt hot), EYE PRURITUS (It also itches around her eyes), ECZEMA (Chronic eczema/Face red/hot, mouth rash(flaky, hurt, spread to face),dark red/maroon spots, stabbing/heat itches, red/itchy/painful/flaking splotches to face/neck, constant itching, burning, hurting, flaking, face blotchy/eczema in right ear/bad sunburn), TASTE DISORDER (could taste the medicine, it went right up to tongue), FEEDING DISORDER (didn't eat anything), PERIPHERAL COLDNESS (hands were like ice, was clutching "Hot hands"), INFLUENZA (mild case of the flu), ANGULAR CHEILITIS (Both corners of the mouth split, and it hurt/the left side of mouth started developing a rash that "Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face/angular cheilitis), EAR INFECTION (Right ear started to "Hurt real bad"/it was an ear infection due to the hearing aid), VACCINATION SITE REACTION (Covid arm (right arm was red, swollen, sore, and itchy)/upper arm (swollen from top of arm)), PYREXIA (feeling feverish, with chills and body aches), INJECTION SITE SWELLING (At the injection site, her arm was sore and swollen), INJECTION SITE PAIN (At the injection site, her arm was sore and swollen) and CHILLS (chills) had not resolved and PERIPHERAL SWELLING (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)/This time including the upper arm (swollen from top of arm) and PAIN IN EXTREMITY (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Antinuclear antibody: The result showed that she doesn't have Lupus autoimmune disease. No concomitant medications provided by the reporter. It was reported that that before covid-19 vaccination patient had a good skin condition. Patient had never pimples and acne. It was reported that after first vaccination patient experienced symptom of chills, aches, stomach upset upon arrival at home the same day and patient did not eat. Because patient experienced symptom of nausea and which was started by dinner time. Also, it was reported that patient arm was sore and swollen at the injection site (right arm was red, swollen, sore, and itchy) and the moment the nurse gave her the shot, she had a medicine taste in her mouth. She had to stay for 15 minutes at the pharmacy. The next day she felt hurt all over and she felt like she was in a car accident. She was unable to get out of bed or down the stairs. Patient felt that her hands were like ice and hot hands. Patient took treatment medication Tylenol, and she took a nap. Patient symptom continued for couple of days and patient symptom of nausea was resolved. But patient symptom of covid-arm was continued almost until the second dose was due. After 3 weeks patient was received her second shot. And after 2nd Moderna Covid-19 vaccine; patient experienced symptom that her face got red like a bad sunburn, and it also felt hot and that was lasted a couple of hours. She also got cold sores in the corners of her mouth. She never had that before. Patient started getting something weird after the first shot, had other symptoms, had more symptoms and now, the first part of this year, it really blew up. Patient never had pimple and acne and never really had anything and all of a sudden this stuff, stuff blew up in a month and My face and that were a mess. After second vaccination patient also experienced symptom of Covid arm and which was started the day after the shot, but the symptom was worse than the first time. Patient experienced symptom in the upper arm (swollen from top of arm) and symptom was lasted a couple of weeks. It was reported that patient called to dermatologist and dermatologist was prescribed treatment medication cortisone ointment for two weeks to patient. It was reported that patient symptom initially did not go away, but latter patient had no symptom. Patient had a little reaction but no worse than a mild case of the flu with no nausea. And about a week later both corners of the mouth split, and it hurt. That Spring of 2021 patient was experienced symptom of face was red, but that was not felt that hot. When patient went home, face now felt hot and looked very red. Patient experienced symptom of face got red like a bad sunburn on 09-Mar-2021. Post 1st booster dose patient left side of mouth started developing a rash and it Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face. Patient went to a new dermatologist who diagnosed it was as angular cheilitis. For patient treatment medication of tacrolimus ointment twice a day was prescribed, and patient symptom was improved. Post second booster vaccination patient experienced right ear started to hurt bad in Feb or Mar of 2023. Patient thought that it was an ear infection due to the hearing aid. Patient went to urgent care and doctor prescribed an unspecified treatment medication which did not help to patient. And patient symptom went worse. Then patient visited to an ENT and who said there was eczema in the right ear. Patient received treatment medicine which helped but her. Also, she used treatment medication of Aveeno and an unspecified treatment medication product for her hearing aid-related itching. In Jul-2024 patient noted that she had a dark red, maroonish spots to the left face. Patient took a second opinion with another dermatologist who diagnosed it as sun damage. The maroonish spots did not hurt or peel or anything to patient. After 2-3 weeks patient developed little stabbing itches, like heat itches, heat rashes, but patient did not have a rash. Then the right face she had red splotches, and which were itchy and painful and started flaking. This was worse than on the left side and this was spread to the neck for patient. Patient went back to original dermatologist who scanned for cancer and removed one spot from the face and prescribed a treatment cream which patient stopped to use. Patient ended up use of treatment medication Aquaphor to the face and Desitin to the corners of the mouth. It was reported that in 2025 patient got itchy spots on her skin, basically on her face and neck. It was also reported that when patient put on makeup, that time patient had big red swatches on her face on the left side of her face. She went to her dermatologist who told her it was sun damage. One week later, she got red swatches on the right side of her face suddenly and patient noticed that itchy spots on her neck and in her mouth. It got worse when she used facial water on her face. It was reported that patient does not have heart problems, but patient had an autoimmune disease. She received samples treatment medication of cream Opzelura to use, and it was the only cream that helped for her skin problem as it calmed her skin down and felt normal again. Now she ran out of the samples. At present patient used treatment medication of Likeerra V and Aveeno and it helped a little bit to patient, but her skin felt like it was going to peel off. It was reported that it also itched around her eyes. This case was linked to US-MODERNATX, INC.-MOD-2025-787026 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2025: Live significant follow-up received in which Patient demographic was updated (DOB), new event was added, treatment medication was added, and new reference number was added. On 29-May-2025: Live-non-significant follow-Up received in which case narrative was updated and new reference number was added.; Reporter's Comments: The medical history of Dermatitis is a confounder for skin exfoliation, pruritus, eye pruritus, eczema, and angular cheilitis events. Due to lack of biological plausibility, the causality of the events Oral herpes , Influenza, ear infection was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787026:Invalid case for multiple people
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| 2844109 | 72 | F | 06/05/2025 |
COVID19 |
MODERNA |
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Headache, Malaise
Headache, Malaise
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feeling under the weather; headaches/she stated headaches mainly; This spontaneous case was reported...
feeling under the weather; headaches/she stated headaches mainly; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly). At the time of the report, MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient got weaker reaction. She had headaches mainly and felt under the weather. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787139 (E2B Linked Report). This case was linked to MOD-2021-030965 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 29-May-2025: Live Follow up contains significant information received: event verbatim updated for headaches, Outcome of event feeling under the weather updated to recovered from unknown and reference added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787139:Mother case
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| 2844110 | M | 06/05/2025 |
COVID19 |
MODERNA |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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had covid once in august 2022; This spontaneous case was reported by a consumer and describes the oc...
had covid once in august 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid once in august 2022) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. In August 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In August 2022, the patient experienced COVID-19 (had covid once in august 2022). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. In 2022, COVID-19 (had covid once in august 2022) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) tested negative twice. The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown. No concomitant medication was reported. The patient was scheduled to receive the Spikevax 24-25 vaccine; however, due to its expiration, he decided against taking it. He was advised to wait until the fall season for the new vaccine, as the previous version was no longer available. He had already received 7 doses and contracted COVID-19 once in August 2022. He mentioned that when he had COVID-19, it was on a Monday, and after visiting the doctor, he was prescribed a pill. Five days later, he recovered and tested negative twice. He reported experiencing no side effects, as he took Tylenol. Reporter causality was not reported. Reporter did not allow further contact
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| 2844113 | 22 | F | TX | 06/05/2025 |
COVID19 |
PFIZER\BIONTECH |
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Epilepsy, Investigation, Palpitations, Seizure
Epilepsy, Investigation, Palpitations, Seizure
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seizures; epilepsy; heart palpitations; This is a spontaneous report received from a Consumer or oth...
seizures; epilepsy; heart palpitations; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 22-year-old female patient received BNT162b2 (BNT162B2), on 12Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Dose 1, single), administration date: 2021, for COVID-19 immunization. The following information was reported: EPILEPSY (hospitalization, medically significant) with onset Feb2022, outcome "unknown"; PALPITATIONS (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "heart palpitations"; SEIZURE (hospitalization, medically significant) with onset Feb2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "seizures". Reporter stated that her daughter received her first dose of the Pfizer Covid-19 vaccine at the end of 2021 and second dose in Dec2021. In Feb2022 (started 2 months after receiving the second dose of the Pfizer Covid-19 vaccine), her daughter started experiencing heart palpitations, seizures, and epilepsy. The patient has these seizures at least two to three times a week that sometimes it really got to where she has hospitalized for like a week. She has been intubated probably 20 times. This did not start until after she got that second Pfizer shot for the COVID. She has been tested for epilepsy, she had all kind of tests running on her and then to several different specialists and all the test always come back negative, everything comes back fine/normal. Testing was performed and several EEDS, "ton of them were done,"were performed, however they are "not detecting brain magnetism through the EED." Reporter was asking if there is some time of testing that can be performed to see if the vaccine is causing her daughter's epilepsy and if there is anything they can do to control her daughter's seizures. Patient takes Lacosamide (twice a day) and Briviact (Brivaracetam) 20 mg (as reported), both for Epilepsy. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2844125 | KY | 06/05/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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patients are hard to get back for their second dose; This non-serious case was reported by a physici...
patients are hard to get back for their second dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st dose of vaccine on an unknown date). On an unknown date, the patients did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: patients are hard to get back for their second dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-JUN-2025 The field representative reported the question from a pediatrician who wanted to know what the efficacy after just one dose was of Bexsero. She was asking this because multiple patients were hard to get back for their second dose and she was just curious about what efficacy would give just one dose. This AE (adverse event) was filed as potential since the reporter stated that the pediatrician said that it was hard to get back the patients to complete their schedules. So, more than one patient could be involved. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to an incomplete course of vaccination.
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| 2844126 | 06/05/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Immunisation reaction, Pain, Pyrexia; Immunisation reaction, Pain, Pyrexia
Immunisation reaction, Pain, Pyrexia; Immunisation reaction, Pain, Pyrexia
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serious adverse effects; I usually take it on the weekend because I know I'm going to be sick a...
serious adverse effects; I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc; I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc; This subject of an unknown age and gender was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of IMMUNISATION REACTION (serious adverse effects). The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced IMMUNISATION REACTION (serious adverse effects) (seriousness criterion medically significant), PAIN (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc) and PYREXIA (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc). At the time of the report, IMMUNISATION REACTION (serious adverse effects), PAIN (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc) and PYREXIA (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc) outcome was unknown. The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) and Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Unknown) was unknown. For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments. DCP-ID: DCP-0420-25 DCP name: mRNA-1083 Life Cycle Management Concept Evaluation No concomitant medications provided by the reporter. It was reported that subject did have serious adverse effects. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-786904, US-MODERNATX, INC.-MOD-2025-786905, US-MODERNATX, INC.-MOD-2025-786906, US-MODERNATX, INC.-MOD-2025-786907, US-MODERNATX, INC.-MOD-2025-787115, US-MODERNATX, INC.-MOD-2025-787116, US-MODERNATX, INC.-MOD-2025-787117 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live non-significant information follow-up received in which new reporter details were added. On 26-May-2025: Live follow-up received in which follow-up information included no new information. On 27-May-2025: Live follow up received that contains significant information includes added DCP number and narrative was updated.; Reporter's Comments: The causality of the event Immunisation reaction, Pain and Pyrexia was assessed conservatively as related, due to the unknown temporal association and limited information provided. Further information is requested. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786904:Unspecified number of peoples US-MODERNATX, INC.-MOD-2025-786906:Female patient US-MODERNATX, INC.-MOD-2025-786905:Female patient US-MODERNATX, INC.-MOD-2025-786907:Male patient US-MODERNATX, INC.-MOD-2025-787116:Female patient US-MODERNATX, INC.-MOD-2025-787117:Unknown patient US-MODERNATX, INC.-MOD-2025-787115:Unknown patient
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| 2844127 | 29 | M | PA | 06/05/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
33036BD 33036BD |
Balance disorder, Blood test, Dizziness, Drug intolerance, Headache; Hemiparesis...
Balance disorder, Blood test, Dizziness, Drug intolerance, Headache; Hemiparesis, Intracranial venous sinus stenosis, Magnetic resonance imaging, Tinnitus, Transverse sinus thrombosis
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MRI results revealing transverse sinus stenosis; transverse sinus stenosis with the transverse throm...
MRI results revealing transverse sinus stenosis; transverse sinus stenosis with the transverse thrombosis/Thrombotic events; lot left sided weakness; Unilateral tinnitus; Dizziness; Intolerance; stability balance issues; unilateral headaches; This is a spontaneous report received from a Physician from medical information team, Program ID. A 29-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2022 at 17:45 as dose 3 (booster), 0.3 ml single (Lot number: 33036BD, Expiration Date: 30Jun2022) at the age of 29 years intramuscular, in left deltoid 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. The following information was reported: DIZZINESS (non-serious) with onset Jan2022, outcome "unknown"; DRUG INTOLERANCE (non-serious) with onset Jan2022, outcome "unknown", described as "Intolerance"; INTRACRANIAL VENOUS SINUS STENOSIS (medically significant) with onset Jan2022, outcome "unknown", described as "MRI results revealing transverse sinus stenosis"; TINNITUS (non-serious) with onset Jan2022, outcome "not recovered", described as "Unilateral tinnitus"; HEMIPARESIS (medically significant) with onset Jan2022, outcome "unknown", described as "lot left sided weakness"; BALANCE DISORDER (non-serious) with onset Jan2022, outcome "unknown", described as "stability balance issues"; TRANSVERSE SINUS THROMBOSIS (medically significant) with onset Jan2022, outcome "unknown", described as "transverse sinus stenosis with the transverse thrombosis/Thrombotic events"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "unilateral headaches". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Magnetic resonance imaging: transverse sinus stenosis. Clinical course: Caller is a dentist writing a clinical case study about his experience following administration of the Pfizer COVID-19 vaccine in 19Jan2022. He states that he experienced multiple adverse events and would like information regarding the ingredients and formulation of the 2022 COVID-19 vaccine including the amount of vaccine so he may formally describe this information in his case presentation. In particular, caller alleges a possible defect with lot 33036BD booster dose with expiration date of 30Jun2022 stating that it was from the back of the shelf. He states that based on reports he has read, there are some other adverse events associated with certain lots. Caller lists the following which have persisted since 2022 and experienced right after receiving the dose: MRI results revealing transverse sinus stenosis, thrombotic events, unilateral tinnitus, dizziness, intolerance. Regarding the adverse events consumer stated, "One of them was transverse sinus stenosis with the transverse thrombosis. Transverse sinus stenosis and thrombosis of the left dural venous sinus in the oppositional area. This is called unilateral tinnitus, stability balance issues, unilateral headaches and lot left sided weakness, but the main thing is the tinnitus, continuous ringing in the left side, pretty much all day and night from last three years." Concomitant products, other medical conditions and lab work: Consumer stated, "No, blood work within two weeks. Consistence and persistence and 20Jan2022, present in three years. I do not think it is some underlying condition or blood work. I think, it was this product and in my professional medical opinion confirmed by MRI doctor". Treatment: Consumer stated, "For transverse sinus stenosis, I want you to put a 'stenosis' no I did not get anything done. I did not want to get an offered and procedure done no. I did not get anything done, but they wanted to take a further CT scan, and I did not do that either. I do not think, it is good practice from how far that had in that area, is too much radiation in my opinion. So, no treatment for yet and it might get worst you know."; Sender's Comments: As there is limited information in the case provided, the causal association between the events intracranial venous sinus stenosis, transverse sinus thrombosis, and hemiparesis; and the suspect drug BNT162B2 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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| 2844128 | M | CA | 06/05/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Biopsy, Blood calcium, Blood calcium increased, Blood disorder, Blood test; Body...
Biopsy, Blood calcium, Blood calcium increased, Blood disorder, Blood test; Body height, Investigation, Lymphadenopathy, Positron emission tomogram
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had very high levels, very big lymph nodes, all over body; did not have right balance in blood; he h...
had very high levels, very big lymph nodes, all over body; did not have right balance in blood; he had little higher calcium than he should; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 79-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fall" (unspecified if ongoing), notes: They did all sorts tests; "cholesterol" (ongoing); "blood pressure" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); LOSARTAN taken for blood pressure measurement (ongoing). The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "had very high levels, very big lymph nodes, all over body"; BLOOD DISORDER (non-serious), outcome "unknown", described as "did not have right balance in blood"; BLOOD CALCIUM INCREASED (non-serious), outcome "unknown", described as "he had little higher calcium than he should". The events "had very high levels, very big lymph nodes, all over body" and "he had little higher calcium than he should" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results; Blood calcium: little higher; Blood test: Unknown results; Body height: 6, notes: feet. When he was in air force; test: Unknown results, notes: did all sorts tests; Positron emission tomogram: Unknown results, notes: twice for lymph nodes. They are not cancerous; Unknown results, notes: year later, they had reduced in size but, still there. Therapeutic measures were taken as a result of blood calcium increased. Clinical course: For the last couple of years, 2 or 3 years, doctors sent him on wild goose chase. One doctor said he did not have right balance in blood, and particular vitamin. They maybe considered cancer, he did not have cancer. Brought him to pulmonologist, found out, he had enlarged lymph nodes. Had PET scan, twice for lymph nodes. They are not cancerous, they have no idea why he has them. Patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. No treatment was received for the adverse event/incident. Hair loss, enlarged lymph nodes, caught Covid. Patient was not allergic to any previous vaccination, medications, food or other products. Only started to come down with sinus issue that was minor. There are no any other diagnos; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
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| 2844129 | 52 | M | NJ | 06/05/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Computerised tomogram head, Gait disturbance, Haemorrhagic stroke, Headache, Hem...
Computerised tomogram head, Gait disturbance, Haemorrhagic stroke, Headache, Hemiplegia; Impaired driving ability, Impaired quality of life, Investigation
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Hemorrhagic stroke; unconscious; Left side was paralyzed; Can't walk his dog; could not walk; w...
Hemorrhagic stroke; unconscious; Left side was paralyzed; Can't walk his dog; could not walk; walk with ASO and cane; Can't drive car; Can't do anything; Headache; This is a spontaneous report received from a consumer. A 52-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Never smoked" (unspecified if ongoing); "Never drank" (unspecified if ongoing); "Man who ran" (unspecified if ongoing); "Vegetarian" (unspecified if ongoing); "Healthy man" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered"; HAEMORRHAGIC STROKE (hospitalization, life threatening, medically significant) with onset 27Feb2022, outcome "unknown", described as "Hemorrhagic stroke; unconscious"; HEMIPLEGIA (hospitalization, life threatening, medically significant) with onset 27Feb2022, outcome "not recovered", described as "Left side was paralyzed"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "Can't walk his dog; could not walk; walk with ASO and cane"; IMPAIRED DRIVING ABILITY (non-serious), outcome "unknown", described as "Can't drive car"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "Can't do anything". The patient was hospitalized for haemorrhagic stroke, hemiplegia (start date: 27Feb2022, discharge date: 28Mar2022, hospitalization duration: 30 day(s)). The events "hemorrhagic stroke; unconscious", "left side was paralyzed", "headache", "can't walk his dog; could not walk; walk with aso and cane", "can't drive car" and "can't do anything" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (2022) Brain filled with blood; Testing: (2022) Unknown results. Therapeutic measures were taken as a result of haemorrhagic stroke, hemiplegia, gait disturbance, impaired driving ability, impaired quality of life. The patient was not allergic to any previous vaccination, medications, food, or other products. Patient never smoked, never drank, nothing. The patient had no other conditions or products. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient had the 2 vaccines, first and second then, had booster shot that came out shortly after. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine or on the same date as the Pfizer vaccine. The patient's wife does not know why she never just called to Pfizer but filed report with government. This is regarding Pfizer booster vaccine, first COVID booster given on 17Dec2021. The facility where vaccine was administered was at a local hospital. On 17Dec2021, the patient immediately came home from having that booster shot, he did not feel good. The patient had severe headache immediately, right after he got that booster, had headache for weeks. He had severe headache immediately, right after he got that booster. The headaches started immediately, thought maybe he had COVID or sinus infection, knew something was not right. Had testing done. Went to physician, went to ENT, he did not have sinus infection, did not have COVID. Patient had some massive thing that almost killed him, brewing in his head. On 27Feb2022, the patient suffered severe hemorrhagic stroke from COVID-19 vaccine booster. The patient had no symptoms and, all of a sudden, had stroke. He was sitting in golf cart, 27Feb2022, all of a sudden, left side was paralyzed. The patient knew what was happening, got himself to trauma center (hospital). If he didn't know signs of stroke, would have been dead on the golf course. Patient was on ventilator and trach for 30 days. He was admitted to hospital for 30 days from 27Feb2022, he was unconscious, into ICU unit, released 28Mar2022. Then, he went to an inpatient rehab center for around 60 days until May2022 (around 18May2022 to 20May2022). The patient did not come home from 27Feb2022 until end of May2022. When patient came home, he started outpatient rehabilitation, 3 days a week, from the day he came home, until Dec2022. Patient has speech therapy, occupational therapy, physical therapy. They said he was having inpatient therapy at outpatient facility. Every other day, besides going to therapy, was seeing so many doctors, neurologists, so many people, eye doctors (physicians and ENT). Patient still in therapy today, 3 years later, still has 2 therapists, goes to therapy twice a week. 3 years later, had many ASO braces made. When released from inpatient therapy, could not walk still. They released him on stretcher, never told them about any ASO braces. The whole experience, just does not even know. Patient was in wheelchair for many months, probably until beginning of Mar2023, when he got his first ASO brace. Patient still paralyzed now, walk with ASO and cane, for 3 years. Patient was healthy man his entire life. As treatment, after stroke, they put him on what they usually give people in ICU. Has entire list at home. Patient still on medication. They could write a book, the amount of paperwork, scans, and everything she has. No stone has been unturned. Has everything documented and printed out. Patient has had 5000 tests since 2022. As far as brain scans, brain filled with blood from booster shot, has scans of that. 3 years later, patient still has never been 100%, left side paralyzed still. Patient still in therapy twice a week, spent number of dollars, has seen so many medical professionals. Per patient's wife, there must be something that Pfizer has to do, something for the people they nearly killed or whose lives they changed, including the patient whose life will never be the same. Their kids' lives will bever be the same. If the patient was not smart enough to get himself help within 8 minutes, the wife would be a widow today, because of the COVID-19 booster. Their life turned upside down. Patient was a man who ran, was vegetarian. Now, can't walk his dog, can't drive car, can't do anything. Per patient's wife, the people who developed this should rot in prison. The government signed their lives away when this got job mandated, to receive the booster and, if anything happens, can't do anything if anyone might die. Per patient's wife, it is a well-known fact that the Pfizer vaccine has killed people, has changed their life, paralyzed people. Pfizer must do something; the whole entire thing is a hoax. They came out with this, does not even know what vaccine. Knows many people that have had side effects, patient was the most severe. Knows people who have died, unfortunately. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2844130 | 61 | M | ME | 06/05/2025 |
RSV |
PFIZER\WYETH |
HMO168 |
Dyspnoea, Gait inability
Dyspnoea, Gait inability
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difficulty breathing/more trouble breathing; could not walk; This is a spontaneous report received f...
difficulty breathing/more trouble breathing; could not walk; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Jun2024 at 15:00 as dose 1, single (Lot number: HMO168) at the age of 61 years for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOVATO. The following information was reported: GAIT INABILITY (life threatening) with onset 14Jun2024 at 07:00, outcome "recovering", described as "could not walk"; DYSPNOEA (life threatening) with onset 14Jun2024 at 07:00, outcome "recovering", described as "difficulty breathing/more trouble breathing". The events "difficulty breathing/more trouble breathing" and "could not walk" required emergency room visit. Therapeutic measures were not taken as a result of dyspnoea, gait inability.
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| 2844139 | 71 | F | GA | 06/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Headache, Hypoaesthesia, Nausea
Headache, Hypoaesthesia, Nausea
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Nausea and headache since day of immunization. Headache described as "needle being poked into h...
Nausea and headache since day of immunization. Headache described as "needle being poked into her eye". New onset numbness in left arm last night or this morning (6/5). Seems to be resolving as of 6pm this evening. Has not sought treatment for any of the above complaints.
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| 2844140 | 1 | M | OR | 06/05/2025 |
MMR |
MERCK & CO. INC. |
X028353 |
Injection site discharge
Injection site discharge
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Family notified office about 1.5 hours after visit that a yellow, mostly clear fluid with some areas...
Family notified office about 1.5 hours after visit that a yellow, mostly clear fluid with some areas of congealed consistency, leaked out of the injection site of the right thigh after they got home. It streamed down to his knee, an estimated .5mL of fluid. Pt was dancing at the baby gate when the fluid came out. It did not bother him. He is happy and acting normally. This was the site of the MMR injection. The MMR vaccine is yellow fluid
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| 2844141 | 52 | F | TX | 06/05/2025 |
PNC21 TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
y013009 u8353aa |
Pruritus, Rash erythematous, Rash papular, Skin warm, Swelling; Pruritus, Rash e...
Pruritus, Rash erythematous, Rash papular, Skin warm, Swelling; Pruritus, Rash erythematous, Rash papular, Skin warm, Swelling
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Reports red raised bumps, itching, swelling and warm to the touch. No fever. Symptoms started 3 day...
Reports red raised bumps, itching, swelling and warm to the touch. No fever. Symptoms started 3 days after the vaccines were administered. Pt was prescribed ibuprofen and triamcinolone cream by physician.
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| 2844142 | 19 | F | NY | 06/05/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MD3414 MD3414 |
Asthenia, Blood glucose normal, Crying, Immediate post-injection reaction, Malai...
Asthenia, Blood glucose normal, Crying, Immediate post-injection reaction, Malaise; Nervousness, Ocular hyperaemia, Pallor, Paraesthesia
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PATIENT FELT WEAK 5-7 MINUTES AFTER ADMINISTRATION. SHE WAS SITTING DOWN AT THE MOMENT AS PER PHARM...
PATIENT FELT WEAK 5-7 MINUTES AFTER ADMINISTRATION. SHE WAS SITTING DOWN AT THE MOMENT AS PER PHARMACIST ADVISED ORIGINALLY . SHE COMPLAINED RIGHT AFTER VACCINE THAT SHE FELT NERVOUS. THEN AFTER 7 MINUTES APPROXIMATELY SHE SAID SHE DOES NOT FEEL GOOD . PHARMACIST CAME OVER, PATIENT LOOKED PALE, CLOSED HER EYES. HER BLOOD PRESSURE WAS CHECKED AND IT WAS 80/50. SHE WAS GIVEN WATER, SALTY FOOD, COLD CLOTH ON THE CHEST AND FOREHEAD. IN A FEW MINUTES SHE START COMPLAINING ABOUT TINGLING ON HANDS, SPOTTY REDNESS AROUND EYE AREAMAY BE FROM CRYING. WE CALLED EMT. BY THE TIME EMT ARRIVED PATIENT WAS FEELING BETTER, HER BLOOD PRESURE AND BLOOD SUGAR WERE OK. VITALS CAME BACK TO NORMAL. SHE WAS ADVISED TO SIT FOR A WHILE AND THEN CAN GO HOME. NO COMPLAINTS AFTER THIS. PATIENT LEFT AROUND 6:30PM.
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| 2844143 | 2 | M | SD | 06/05/2025 |
COVID19 |
PFIZER\BIONTECH |
LN6739 |
Expired product administered, Irritability
Expired product administered, Irritability
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Pfizer Covid vaccine with beyond use date of 5/29/25 was given on 6/4/25. Patient's mother repo...
Pfizer Covid vaccine with beyond use date of 5/29/25 was given on 6/4/25. Patient's mother reports patient fussier than usual today (6/5/25) after receiving the Covid vaccine, Hepatitis A vaccine, and DTaP vaccines on 6/4/25.
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| 2844144 | 42 | M | FL | 06/05/2025 |
ANTH ANTH TYP TYP UNK UNK |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Chest X-ray, Chest pain, Chills, Cough, Electrocardiogram; Laboratory test, Odyn...
Chest X-ray, Chest pain, Chills, Cough, Electrocardiogram; Laboratory test, Odynophagia, Pyrexia, Throat tightness; Chest X-ray, Chest pain, Chills, Cough, Electrocardiogram; Laboratory test, Odynophagia, Pyrexia, Throat tightness; Chest X-ray, Chest pain, Chills, Cough, Electrocardiogram; Laboratory test, Odynophagia, Pyrexia, Throat tightness
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Symptoms 1st 24hrs: Cold chills, fever, tight throat. Symptoms within 36hrs: Chest pain, painful to...
Symptoms 1st 24hrs: Cold chills, fever, tight throat. Symptoms within 36hrs: Chest pain, painful to swallow, throat worsen, dry cough-no constipation (no signs of it being a common cold). Symptoms after a week continue as hard dry cough, chest pain, fever is gone, cold chills and fever come and go.
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| 2844145 | 4 | M | OH | 06/05/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
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Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased; Contusi...
Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased; Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased
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Two weeks after vaccinations, child started getting bruising all over his legs along with body wide ...
Two weeks after vaccinations, child started getting bruising all over his legs along with body wide petechia.
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| 2844146 | 56 | M | CA | 06/05/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4mg3e |
No adverse event
No adverse event
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This is not an adverse event issue. pharmacist forgot to mix the antigen powder with the provided ...
This is not an adverse event issue. pharmacist forgot to mix the antigen powder with the provided prefilled syringe with sterile water. pt was only injected with the sterile water ONLY. no side effects were reported. pt was called to come back to revaccinate
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| 2844148 | 12 | F | GA | 06/05/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y012508 EK7DG DY3K7 |
Injection site erythema, Injection site swelling, Injection site warmth, Rash; I...
Injection site erythema, Injection site swelling, Injection site warmth, Rash; Injection site erythema, Injection site swelling, Injection site warmth, Rash; Injection site erythema, Injection site swelling, Injection site warmth, Rash
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Patient came to office with rash on L arm that extended underneath the arm as well. The area where v...
Patient came to office with rash on L arm that extended underneath the arm as well. The area where vaccine was given was red, swollen and warm to the touch. Dr. recommended that the patient not have any more HPV vaccinations.
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| 2844149 | 16 | M | WA | 06/05/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945655 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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N/A
N/A
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| 2843760 | 68 | F | 06/04/2025 |
COVID19 |
MODERNA |
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Nasopharyngitis
Nasopharyngitis
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had the lightest cold symptoms with Delta; This spontaneous case was reported by a consumer and desc...
had the lightest cold symptoms with Delta; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had the lightest cold symptoms with Delta) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Pneumonia. Concurrent medical conditions included Asthmatic. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (had the lightest cold symptoms with Delta). At the time of the report, NASOPHARYNGITIS (had the lightest cold symptoms with Delta) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient was fit athletic. She was asthmatic that easily gets pneumonia from just the common cold. Vaccines helped her greatly not had that reaction. When her dog had surgery, and brought Delta into her home, she lost her 2 cats but had the lightest cold symptoms with Delta that she especially had ever had. She had bird flu and wild flocks, so she was looking forward to receiving that vaccine. HCP recommended to get the mRna Covid-19 vaccine several times. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787090 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787090:For male patient
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| 2843761 | 22 | CA | 06/04/2025 |
RAB |
SANOFI PASTEUR |
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Injection site rash
Injection site rash
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developed rashes around the injection site after the second dose,described the rash to be circular; ...
developed rashes around the injection site after the second dose,described the rash to be circular; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 22 years old and unknown gender patient who had developed rashes around the injection site after the second dose,described the rash to be circular after receiving rabies (HDC) vaccine [Imovax rabies]. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 23-May-2025, the patient received Dose 2 of 1 ml of suspect rabies (HDC) vaccine Powder and solvent for suspension for injection of strength standard and frequency once (Unknown lot and expiry date) via intramuscular route in the left arm for Immunisation. Information on the batch number was requested corresponding to the one at time of event occurrence. On 23-May-2025 the patient developed rashes around the injection site after the second dose, described the rash to be circular (vaccination site rash) (Latency same day). Reportedly, reporter reported that a patient developed rashes around the injection site after the second dose but eventually disappeared. the patient was not given any treatment. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved in May 2025 for the event.
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| 2843774 | 40 | F | KY | 06/04/2025 |
PNC20 |
PFIZER\WYETH |
|
Chest X-ray, Pneumonia
Chest X-ray, Pneumonia
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Pneumonia
Pneumonia
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| 2843775 | 21 | F | 06/04/2025 |
ANTH HEPA JEV1 UNK |
EMERGENT BIOSOLUTIONS GLAXOSMITHKLINE BIOLOGICALS INTERCELL AG UNKNOWN MANUFACTURER |
300215A JEV23J01E HR4RB |
Exposure during pregnancy, Pregnancy test urine positive; Exposure during pregna...
Exposure during pregnancy, Pregnancy test urine positive; Exposure during pregnancy, Pregnancy test urine positive; Exposure during pregnancy, Pregnancy test urine positive; Exposure during pregnancy, Pregnancy test urine positive
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21 yo service member presented to immunization for vaccines. Prior to her getting vaccines, Name, DO...
21 yo service member presented to immunization for vaccines. Prior to her getting vaccines, Name, DOB, Allergies, any negative reactions, pregnancy status now or in the near future were all verified by one of the corpsman. Patient answered Negative to all pre screener questions above. Post vaccination, Patient returned to immunization department requesting for pregnancy test due to uncertainly of her pregnancy status. Pregnancy test ordered and the result indicated positive for pregnancy. Pnt reported that her LMP was around 15APR2025 and she was not sure if she was pregnant or not. PCM CDR was reported and informed of patient, EDD: 20JAN2026
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| 2843777 | 0.5 | F | NJ | 06/04/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK023AA |
Expired product administered
Expired product administered
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Pentacel was given past the expiration date with no reported adeverse event; Initial information rec...
Pentacel was given past the expiration date with no reported adeverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who was given Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] past the expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-May-2025, the patient received 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK023AA, expiry date 30-APR-2025; strength not reported) for Immunization and was given past the expiration date with no reported adverse event (expired product administered) (latency same day). Reportedly, caller reported that the Pentacel was given to 3 different patients past the expiration date. The first injection occurred on 03-May-2025, the second on 12-May-2025 and the last injection was on 14-May-2025. 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.; Sender's Comments: US-SA-2025SA146684: US-SA-2025SA142769:
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| 2843778 | 1.25 | M | IN | 06/04/2025 |
TDAP |
SANOFI PASTEUR |
U8252AA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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ADACEL was administered to a 15-month-6 days-old with no reported adverse event; Initial information...
ADACEL was administered to a 15-month-6 days-old with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months 6 days old male patient who received Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine for Immunisation. On 22-May-2025, The patient received 0.5ml dose (Once) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength standard, lot U8252AA and expiry date 31-May-2026 via unknown route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2843779 | 31 | M | WA | 06/04/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2410 |
Expired product administered
Expired product administered
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patient was administered with an expired FLUBLOK today, with no reported adverse event; Initial info...
patient was administered with an expired FLUBLOK today, with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 31 years old male patient who was administered with an expired influenza trivalent recombinant vaccine [flublok] today, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jun-2025, the patient received a dose of 0.5 ml of expired suspect influenza trivalent recombinant vaccine, Solution for injection (lot TFAA2410 and expiry date 30-May-2025) (strength: standard and frequency: once) via intramuscular route in the left deltoid for immunization today with no reported adverse event (expired product administered) (Latency : same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2843832 | F | DE | 06/04/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Arthralgia, Decreased appetite, Fatigue, Peripheral swelling, Pyrexia; Rash
Arthralgia, Decreased appetite, Fatigue, Peripheral swelling, Pyrexia; Rash
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shoulder pain; arm swelling; fever of 104 degrees; fatigue; no appetite; rash; This spontaneous repo...
shoulder pain; arm swelling; fever of 104 degrees; fatigue; no appetite; rash; This spontaneous report was received from a 69-year-old female patient who was referring to herself. Her concurrent conditions included allergy to ciprofloxacin (CIPRO) and streptomycin sulfate (SEPTIN). The patient's medical history and concomitant therapies were not provided. On 02-MAY-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On the same day, she experienced shoulder pain, arm swelling, fever of 104 degrees (no exact units provided), fatigue, no appetite and a rash. On 09-MAY-2025, the patient recovered from the events. It was also reported that the fever lasted for 3 days (inconsistent information). Causality assessment was not provided. Lot # is being requested and will be submitted if received.
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| 2843833 | F | OH | 06/04/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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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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a 37 year old female patient received her first dose of the GARDASIL 9 vaccine on 11/28/2023. The pa...
a 37 year old female patient received her first dose of the GARDASIL 9 vaccine on 11/28/2023. The patient received her second dose of the GARDASIL 9 vaccine on 05/28/2025; No additional AE; Information has been received from Business Partner/CRO on 28-May-2025. This spontaneous report was received from a/an Pharmacist and refers to a(n) 37-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Nov-2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9),, dose number 1, (first dose), administered by Unknown route (lot # and expiration date were not reported). On 28-May-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9),, dose number 2, (second dose), administered by Unknown route (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), for the treatment of prophylaxis. On an unknown date, the patient experienced a 37 year old female patient received her first dose of the GARDASIL 9 vaccine on 11/28/2023. The patient received her second dose of the GARDASIL 9 vaccine on 05/28/2025. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of a 37 year old female patient received her first dose of the GARDASIL 9 vaccine on 11/28/2023. The patient received her second dose of the GARDASIL 9 vaccine on 05/28/2025 and No additional AE was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.
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| 2843835 | PA | 06/04/2025 |
HEP |
MERCK & CO. INC. |
X024136 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No additional AE; an adult has been administered the child dose of RECOMBIVAX HB; This spontaneous r...
No additional AE; an adult has been administered the child dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant and referred to an adult 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 05-MAY-2025, the adult patient was vaccinated with child dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) Injection (strength: 5 microgram/0.5 ml, lot # X024136, expiration date: 21-MAY-2026; dose, route and anatomical site were unknown) for prophylaxis (underdose). No additional adverse event (no adverse event). The outcome of the events was unknown.
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| 2843837 | 06/04/2025 |
COVID19 COVID19 FLUN3 FLUN3 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. |
6024mf013 6024mf013 WF2582 WF2582 |
Body temperature, Dizziness, Dyspnoea, Feeling abnormal, Headache; Nausea, Pyrex...
Body temperature, Dizziness, Dyspnoea, Feeling abnormal, Headache; Nausea, Pyrexia, SARS-CoV-2 test; Body temperature, Dizziness, Dyspnoea, Feeling abnormal, Headache; Nausea, Pyrexia, SARS-CoV-2 test
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a bit faint; headache; fever; nausea; Started feeling bad that evening; Shortness of breath; A spont...
a bit faint; headache; fever; nausea; Started feeling bad that evening; Shortness of breath; A spontaneous report has been received from a consumer. The report concerns a female adolescent patient (age 15 years). No medical history was reported. No concomitant products were reported. The patient received Covid-19 Vaccine (batch number(s) 6024mf013), via intramuscular use for covid-19 immunization on 11-OCT-2024. The patient received 1 dose(s). The patient started treatment with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) (batch number(s) WF2582) UNK, Nasal use, on 11-OCT-2024. On 11-OCT-2024, the patient experienced a bit faint (preferred term: Dizziness),fever (preferred term: Pyrexia),headache (preferred term: Headache),nausea (preferred term: Nausea),shortness of breath (preferred term: Dyspnoea),started feeling bad that evening (preferred term: Feeling abnormal). At the time of reporting, the event a bit faint, fever, headache, nausea, shortness of breath and started feeling bad that evening was improving. The events were considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): a bit faint, fever, headache, nausea, shortness of breath and started feeling bad that evening. The reporter considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): a bit faint, fever, headache, nausea, shortness of breath and started feeling bad that evening. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): a bit faint, fever, headache, nausea, shortness of breath and started feeling bad that evening. Laboratory values are available. ERROR F_ADDITIONAL_DEVICE_INFORMATION: ORA-01422: exact fetch returns more than requested number of rows
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| 2843838 | 33 | F | CT | 06/04/2025 |
COVID19 |
MODERNA |
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Abortion spontaneous, Exposure during pregnancy
Abortion spontaneous, Exposure during pregnancy
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Miscarried 5 week pregnancy hours after injection.
Miscarried 5 week pregnancy hours after injection.
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| 2843839 | 72 | M | MA | 06/04/2025 |
PNC20 |
PFIZER\WYETH |
LX4484 |
Injection site erythema, Injection site warmth, Pain in extremity, Peripheral sw...
Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling, Swelling face
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Pt presented to office the day after his injection and was experiencing significant pain with mild s...
Pt presented to office the day after his injection and was experiencing significant pain with mild swelling in his L hand (pt has arthritis in same location of hand), mild swelling to R cheek and mild redness/warmth at injection site. Seen by MD who dx with allergic rxn to vaccine (Pneumo vaccine entered as new allergy in medical record) and was prescribed 10 days of Prednisone 40mg daily. Pt had received 2 previous pneumococcal vaccines w/o issue: PPV 23 in October 2019 and PCV 13 in July 2021
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| 2843840 | 26 | M | 06/04/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Angina pectoris, Attention deficit hyperactivity disorder, Brain fog, Condition ...
Angina pectoris, Attention deficit hyperactivity disorder, Brain fog, Condition aggravated, Dizziness; Dyspnoea, Irritable bowel syndrome, Liver injury, Pruritus
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Whole body itching, yearly blood test indicating liver damage after vaccination, (no other reason fo...
Whole body itching, yearly blood test indicating liver damage after vaccination, (no other reason for damage), severe ibs, severe symptoms of adhd. extreme brain fog, dizziness, heart pains, extreme shortness of breath,
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| 2843841 | 76 | F | IN | 06/04/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3043157 3043157 |
Blister, Injection site erythema, Injection site pain, Injection site swelling, ...
Blister, Injection site erythema, Injection site pain, Injection site swelling, Rash; Rash erythematous
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Rash/blisters on Right leg, neck, and chest-Severe, Additional Details: Patient states she awoke at 3am with a terrible stiff arm that she could not bend. She took 4 ibuprofen and about an hour later is was more tolerable, but then later on her right leg rashes and blisters appears, then appeared on her chest and neck also. The leg rash went away within about a week, but the other rashes on her chest/neck took 6 weeks or more to resolve.
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| 2843842 | 44 | F | AL | 06/04/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945662 945662 |
Dizziness, Fatigue, Injection site pain, Lethargy, Malaise; Pyrexia
Dizziness, Fatigue, Injection site pain, Lethargy, Malaise; Pyrexia
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Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / ...
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Additional Details: asked patient for another shot at drive through said previous shots made her very sick and that never happens and wont get any more shots., Other Vaccines: VaccineTypeBrand: gardasil; Manufacturer: merk; LotNumber: y013469; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: boostrix; Manufacturer: glaxcosmith; LotNumber: p63rp; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2843844 | 73 | F | FL | 06/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
9sb34 |
Injection site rash, Injection site swelling, Injection site warmth, Rash erythe...
Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
More
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details:...
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: developed a red hot rash 2 days after injection..2 inches in diameter..self-resolved
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| 2843845 | 80 | M | TN | 06/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
x5t42 |
Asthenia, Chest discomfort, Chest pain, Dizziness
Asthenia, Chest discomfort, Chest pain, Dizziness
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Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemi...
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: weak-Mild
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| 2843846 | 67 | F | FL | 06/04/2025 |
COVID19 |
MODERNA |
8080748 |
Pyrexia
Pyrexia
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Systemic: Fever-Medium
Systemic: Fever-Medium
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| 2843847 | 66 | F | FL | 06/04/2025 |
COVID19 |
MODERNA |
AU3832B |
Pyrexia
Pyrexia
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Systemic: Fever-Medium
Systemic: Fever-Medium
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| 2843848 | 65 | F | FL | 06/04/2025 |
COVID19 |
MODERNA |
AS7146B |
Pyrexia
Pyrexia
|
Systemic: Fever-Medium
Systemic: Fever-Medium
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| 2843849 | 76 | F | MI | 06/04/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
TS525 TS525 |
Chills, Flushing, Headache, Hyperhidrosis, Injection site pruritus; Pruritus, Py...
Chills, Flushing, Headache, Hyperhidrosis, Injection site pruritus; Pruritus, Pyrexia, Rash
More
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M...
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: Symptoms did not get worse, patient taking benadryl to combat rash near elbow and face ( itchy eyes), Other Vaccines: VaccineTypeBrand: TDAP boostrix; Manufacturer: glaxosmithkline; LotNumber: PG3RP; Route: IM; BodySite: Left deltoid; Dose: ; VaxDate: UNKNOWN
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| 2843850 | 65 | M | CA | 06/04/2025 |
COVID19 |
MODERNA |
3042914 |
Fatigue, Headache, Lethargy
Fatigue, Headache, Lethargy
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Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
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| 2843851 | 57 | M | CA | 06/04/2025 |
COVID19 |
MODERNA |
3042914 |
Fatigue, Headache, Lethargy
Fatigue, Headache, Lethargy
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Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
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| 2843852 | 76 | M | FL | 06/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ts525 |
Injection site pain, Product administered at inappropriate site
Injection site pain, Product administered at inappropriate site
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Site: Pain at Injection Site-Severe, Additional Details: Patient says the shot was administered too ...
Site: Pain at Injection Site-Severe, Additional Details: Patient says the shot was administered too high on the shoulder but did not go to doctor or er to have examined. He said the severe pain in his shoulder kept him from daily activities for 3 days.
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| 2843853 | 85 | F | CA | 06/04/2025 |
COVID19 |
MODERNA |
8079588 |
Depressed mood, Injection site pain
Depressed mood, Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: Caregiver reports that patient experienced in...
Site: Pain at Injection Site-Mild, Additional Details: Caregiver reports that patient experienced injection sit soreness for about 5-6 days after receiving the vaccine. The pain started the day after the vaccine was administered. She also seemed to feel down for 3-4 days after the vaccine
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| 2843854 | 70 | F | OH | 06/04/2025 |
COVID19 |
MODERNA |
1 |
Pyrexia
Pyrexia
|
Systemic: Fever-Mild
Systemic: Fever-Mild
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