| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2832229 | 68 | F | CA | 03/19/2025 |
PNC15 |
MERCK & CO. INC. |
|
Dermatitis, Erythema, Pain
Dermatitis, Erythema, Pain
|
pain and redness including subcutaneous inflammation that started 7 days after vaccin
pain and redness including subcutaneous inflammation that started 7 days after vaccin
|
||||||
| 2832230 | 11 | F | PR | 03/19/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y014510 FX3ED 9429J |
Dizziness, Hallucination, visual, Syncope; Dizziness, Hallucination, visual, Syn...
Dizziness, Hallucination, visual, Syncope; Dizziness, Hallucination, visual, Syncope; Dizziness, Hallucination, visual, Syncope
More
|
VERBALIZES SEEING COLORS, DIZZINESS AND SYNCOPE
VERBALIZES SEEING COLORS, DIZZINESS AND SYNCOPE
|
||||||
| 2832231 | 27 | F | 03/19/2025 |
FLU3 |
SANOFI PASTEUR |
UT8437AA |
Exposure during pregnancy, Incorrect dose administered, Product administered to ...
Exposure during pregnancy, Incorrect dose administered, Product administered to patient of inappropriate age
More
|
Patient, 27 years old, 32 weeks and 4 days pregnant, was given a high-dose fluzone vaccination. Pati...
Patient, 27 years old, 32 weeks and 4 days pregnant, was given a high-dose fluzone vaccination. Patient as of now states no symptoms or allergic reactions. No symptoms as of this writing.
More
|
|||||||
| 2832232 | 13 | M | 03/19/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
|
Client vaccinated at an in-school event on 3/18/2025 partnered between the local school system and l...
Client vaccinated at an in-school event on 3/18/2025 partnered between the local school system and local health department. VIIS record was checked and was incomplete as the client was from another state. The client also only consented to receive the Tdap vaccine. Client received both Tdap and MenACWY but, upon post administration review of out-of-state records 3/19/2025 given to the school prior, the client had already received MenACWY. On 3/19/2025 the parent was called and notified of the medication error. The client was assessed by the school nurse and was found to not have any adverse signs or symptoms. School nurse educated the client on self monitoring for adverse vaccine reactions.
More
|
|||||||
| 2832233 | 16 | F | MA | 03/19/2025 |
FLU3 MENB MNQ |
GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
AE2J7 B4J4B U8369BA |
Oedema peripheral, Tenderness; Oedema peripheral, Tenderness; Oedema peripheral,...
Oedema peripheral, Tenderness; Oedema peripheral, Tenderness; Oedema peripheral, Tenderness
More
|
Left arm- 3cm edema and tenderness.
Left arm- 3cm edema and tenderness.
|
||||||
| 2832234 | 50 | M | MI | 03/19/2025 |
COVID19 FLU3 PNC21 TDAP VARZOS |
MODERNA SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
8080797 TFAA2429 Y013009 9N4E7 EK225 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
|
Vaccines discussed with client, and client elected to receive Covid, Pneumococcal, Shingles, and Tda...
Vaccines discussed with client, and client elected to receive Covid, Pneumococcal, Shingles, and Tdap vaccines. RN discussed each vaccine with client, and he verbalized understanding. RN then mistakenly asked which flu shot the client would prefer between Fluzone and Flublok, and he elected to get Flublok. RN administered Flublok, Covid, Shingrix, and Tdap. Then when documenting on the Vaccine System to give client, RN noticed the mistakenly given Flu shot instead of Pneumococcal and immediately talked with client about it. He said it's totally fine, and it won't hurt him, and he still wanted the Pneumoccocal vaccine. So, RN administered the PCV-21. Client tolerated all vaccines well, and without complaint. No adverse reactions were observed or reported. RN informed her direct supervisor, MSN, RN of the situation.
More
|
||||||
| 2832235 | 70 | F | GA | 03/19/2025 |
PNC20 |
PFIZER\WYETH |
|
Pruritus, Rash, Thirst
Pruritus, Rash, Thirst
|
I woke up thirsty but i didn't drink anything because i didn't have any room temp water, t...
I woke up thirsty but i didn't drink anything because i didn't have any room temp water, then that morning when i got up around 8 o'clock i was itching on my hand. The itching went up my right forearm and i was just scratching and it was turning into a rash like thing. It just itched so bad. I did rub it with alcohol but it went to my right knee and it was itching all around my knee. I called my doctor who gave me the vaccine, and the MA called me back late that afternoon and told me to take some Benadryl. It helped stop the itching but it keeps coming back. I even came back today. It will stop one day and then it will come back. I have had to take the Benadryl for multiple days.
More
|
||||||
| 2832236 | 1.5 | F | OR | 03/19/2025 |
COVID19 COVID19 HEPA HEPA |
MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. |
3044186 3044186 Y012054 Y012054 |
Chills, Crying, Cyanosis, Fatigue, Feeling cold; Hypotonia, Irritability, Pyrexi...
Chills, Crying, Cyanosis, Fatigue, Feeling cold; Hypotonia, Irritability, Pyrexia, Screaming, Somnolence; Chills, Crying, Cyanosis, Fatigue, Feeling cold; Hypotonia, Irritability, Pyrexia, Screaming, Somnolence
More
|
Patient had a weird reaction this evening, about 5 hours after vaccines today. This was post-bath t...
Patient had a weird reaction this evening, about 5 hours after vaccines today. This was post-bath time and very alarming & out of character: Floppy body/inability or unwillingness to stand herself up or hold anything. Goosebumps, shivering, screaming/crying, purple lips/mouth/skin and feeling cold to the touch. It was resolved after about 10 minutes. She?s exhausted, whiny, feverish, and sleepless. She was awake until about 4:30am.
More
|
||||||
| 2832237 | 76 | F | VA | 03/19/2025 |
COVID19 COVID19 FLU3 FLU3 PNC20 PNC20 RSV RSV COVID19 COVID19 FLU3 FLU3 PNC20 PNC20 RSV RSV |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LM2210 LM2210 U8532AA U8532AA LC1281 LC1281 AE435 AE435 LM2210 LM2210 U8532AA U8532AA LC1281 LC1281 AE435 AE435 |
Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; H...
Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness; Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia; Hypoaesthesia, Muscular weakness
More
|
pt reports all 4 vaccines given in right arm, but vaccine reporting system shows discrepancies, pts ...
pt reports all 4 vaccines given in right arm, but vaccine reporting system shows discrepancies, pts daughter states all vaccines given in right arm(4 vaccines), unknown type of RSV vaccine per Vaccine reporting system, pt notes continued pain, numbness and tingling in 4th and 5th fingers with right hand weakness, pt is right hand dominant and now hard to write
More
|
✓ | |||||
| 2832238 | M | 03/19/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
COVID-19, Delirium, Haematochezia, Haemoptysis, Post-acute COVID-19 syndrome; Ra...
COVID-19, Delirium, Haematochezia, Haemoptysis, Post-acute COVID-19 syndrome; Rash
More
|
it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fati...
it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance; he feels delirious sometimes, like he can't get words out.; He's got blood in his stool also; He's got a cough, and when he coughs blood comes up; He's got skin rashes/rashes in his face; his brother also got covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance), DELIRIUM (he feels delirious sometimes, like he can't get words out.) and HAEMATOCHEZIA (He's got blood in his stool also) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance) (seriousness criterion hospitalization), DELIRIUM (he feels delirious sometimes, like he can't get words out.) (seriousness criterion medically significant), HAEMATOCHEZIA (He's got blood in his stool also) (seriousness criterion medically significant), HAEMOPTYSIS (He's got a cough, and when he coughs blood comes up), RASH (He's got skin rashes/rashes in his face) and COVID-19 (his brother also got covid). At the time of the report, POST-ACUTE COVID-19 SYNDROME (it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance), DELIRIUM (he feels delirious sometimes, like he can't get words out.), HAEMATOCHEZIA (He's got blood in his stool also), HAEMOPTYSIS (He's got a cough, and when he coughs blood comes up) and RASH (He's got skin rashes/rashes in his face) had not resolved and COVID-19 (his brother also got covid) outcome was unknown. No concomitant medications were reported. It was reported that the reporter does not know and not sure if his brother received Moderna or Pfizer or another brand of COVID-19 vaccine. Reporter also confirmed that his brother experienced an adverse reaction after receiving a covid-19 vaccine. It has been 4 years now. Reporter does not know the lot number of the vaccine and when he got the vaccine. Reporter does not remember all the side effects his brother experienced and stated he will look at post-covid vaccine symptoms to jog his memory. Reporter knows one of them is definitely brain fog and reporter does not know when this brain fog started, but this had been going on for almost 4 years now. In the four years brother also experienced sleep disturbance and he always tell that he can't sleep, it's keeping brother up, he was taking loads of pills and everything, he's went to loads of doctors and psychiatrists and he's been in the hyperbaric chamber, and he's been in hospitals. He said he felt delirious sometimes, like he can't get words out. He used to speak fluently, and he was able to run 6 miles a day, but he can't do any of that. He lost his job because of his symptoms, it was reported that he can't work anymore, and he has not been working for like 4 years now. He definitely had fatigue, muscle and joint pain, and loss of stamina. He's got skin rashes. If he eats certain foods like 90% of the foods out on the market, he gets rashes in his face. He's got a cough and when he coughs blood comes up and he's got blood in his stool also. And reporter guessed it's now called long covid. Reporter confirmed his brother also got covid. He had the vaccine, and he got the covid. Reporter believed his brother's symptoms started after the vaccine. No treatment medications were reported. Company comment: The company causality for the events of COVID-19 and Post-acute COVID-19 syndrome is not applicable. Regarding the event of Rash, as it was stated that the patient got rash on his face after eating certain foods, the causality is assessed as not related to the suspect product, as temporal relationship is more suggestive to food intake. Regarding the remaining events, as start date was not provided, the causality is assessed as related. The benefit-risk relationship of the product is not affected by this report.
More
|
✓ | |||||||
| 2832239 | 72 | M | NY | 03/19/2025 |
COVID19 |
MODERNA |
|
Irritability, Sleep deficit, Tinnitus
Irritability, Sleep deficit, Tinnitus
|
he is losing sleep; has become very irritable with his family and coworkers; Ringing in ears; This s...
he is losing sleep; has become very irritable with his family and coworkers; Ringing in ears; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DEFICIT (he is losing sleep), IRRITABILITY (has become very irritable with his family and coworkers) and TINNITUS (Ringing in ears) in a 72-year-old male 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 SLEEP DEFICIT (he is losing sleep), IRRITABILITY (has become very irritable with his family and coworkers) and TINNITUS (Ringing in ears). At the time of the report, SLEEP DEFICIT (he is losing sleep), IRRITABILITY (has become very irritable with his family and coworkers) and TINNITUS (Ringing in ears) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The customer works 60 hours a week in security to make ends meet for his family. The customer stated that for the past 4 months, as he tried to get some sleep, he kept hearing a whooshing sound in his ears, kind of like a steady wind sound or ringing, he was losing sleep, had become very irritable with his family and coworkers, and will have to go for costly treatments very soon. The customer stated that before he contacted his attorneys, he wanted to contact Moderna directly and ask for some sort of settlement, somewhere in the neighborhood of $75,000.00 or an amount of their choosing. The customer stated that going through an attorney will cost much more and will cost more legal time, that's why he wanted to contact office directly. The customer requested to consider his plea and contact him for some sort of settlement very soon. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-783378 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2025: Live follow up received in which no new information was added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783378:Same reporter/different patient (Other people)
More
|
||||||
| 2832240 | 81 | F | TX | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Feeling hot, Pruritus, Urticaria
Feeling hot, Pruritus, Urticaria
|
full blown hives on trunk, waist up to bottom of breasts, whole front sides and back all the way aro...
full blown hives on trunk, waist up to bottom of breasts, whole front sides and back all the way around; hot spots, and it itches; hot spots, and it itches; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: has had ulcerative colitis for 32 years and was is in remission for the past 2 to 3 years.; "blood pressure" (ongoing), notes: Been on low dose Lisinopril (started probably 3 or 4 years ago) and on amlodipine currently.; "started itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg", start date: Jul2024 (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal, stop date: Dec2024; AMLODIPINE taken for blood pressure abnormal, start date: 27Dec2024 (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Lot: EN5318), administration date: 29Jan2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, single), administration date: 26Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (booster), single), administration date: 01Oct2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), single, Lot number: FM9992), administration date: 17May2022, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 5 (Booster), single, lot number: GJ2524), administration date: 09Sep2022, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 6 (Booster, single),), administration date: 20May2023, when the patient was 79-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (Dose 1, single,, Lot number: HG4629), administration date: 22Sep2023, when the patient was 80-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (Dose 2, single), administration date: 22Mar2024, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Sep2024, outcome "not recovered", described as "full blown hives on trunk, waist up to bottom of breasts, whole front sides and back all the way around"; FEELING HOT (non-serious) with onset Sep2024, outcome "unknown", PRURITUS (non-serious) with onset Sep2024, outcome "not recovered" and all described as "hot spots, and it itches". Therapeutic measures were taken as a result of urticaria, feeling hot, pruritus. Additional information: Patient has had a total of 9 shots of the Pfizer COVID vaccination starting 29Jan2021 and the last one was 06Sep2024. Had no symptoms, none of the shots gave her any symptoms. Patient's theory, why calling about this, is that sometime in July2024 started itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg. Was scratching, scratching in July, but continued, didn't go away. Was not drawing blood at that time from scratching. Didn't think of it, didn't connect to COVID shot in her head. Hives: Start date: On 06Sep2024, got the 9th shot, that was Comirnaty also, that was her last shot. Within 3 to 4 days had full blown hives on her trunk, waist up to bottom of breasts, whole front sides and back all the way around, and that's when really started scratching. Went to MD in September, MD sent her to dermatologist, saw dermatologist twice, couldn't help her, sent her to immunologist, quit that immunologist because wanted to give her allergy shots for a year, once a week, and her share would have been $12,000. Patient has been to two immunologists. Patient had never been to allergic to anything she knows of, didn't go back to first immunologist. Patient got, found another immunologist, and she was on antihistamines. Patient was going to immunologist. HCP in formal fields was MD and was the first one that looked at her and sent to dermatologist, but MD did not know that much about it. Hives: Stop date, outcome: Doesn't look the same, has now what patient would call hot spots, and it itches, and patient scratches, ends up with small scabs, has small scabs all over in scalp, back, torso, itches on butt cheeks, hips, especially the outer leg area, been moving, increasing, increasing, so now has from knee down to ankle, arms also, but not real bad. Arms are probably, of the extremities, the least worrisome. Batch/lot number is not provided, and it cannot be obtained.
More
|
||||||
| 2832241 | F | FL | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
|
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received fr...
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a consumer, Program ID. An 83-year-old (age range was 82 to 85 years) female patient received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2024, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2024) Positive; (Jul2024) Positive. This case is for the child's (reporter) mother. The patient's child tested positive for COVID-19 and was staying at the parents' and all three of them have tested positive. They did two tests each and the patient just went to a gathering with three of her sisters and they all got that the patient was feeling really bad the previous night. So, the patient's child tested the patient that morning (14Jul2024), and the child and husband, all three of them have it. Now the patient and her husband, they're 82 and 85 and the child doesn't want to have to take them to get re-tested, but all three of them were positive. The child guessed the reason why they haven't gotten it like extremely bad (they were pretty sick), but the service was like a week ago, and guessed it's probably been hanging on to it. But just recently, the patient started to feel really bad on 13Jul2024, and luckily, they all have been taking Pfizer vaccine even up until the last available one. And they've all taken them and so the child was wondering. The patient and her husband have doctors, and the child will call them and asked if they could call in a prescription for the patient and her husband. Both the patient and her husband take quite a few medications. With the patient's age, the child was concerned too and guessed that it's best that they got it now because they've been vaccinated. They've been taking the Pfizer Vaccination from day one, and then they were all up to date. The child thinks the last time they got vaccinated was maybe 3 or 4 months ago (2024), they got the final most recent one. They were all vaccinated up, child guessed on the third or the fourth kind, the new when Pfizer kept coming out with the next one for the next strain, they would go and get it so that's obviously what's helped them to be functioning. The child was told that an aunt and her husband went into nirmatrelvir/ritonavir (PAXLOVID) and so the child trying to figure out what to do for him/herself, the patient, and patient's husband to get them on it as quickly as possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500058181 Same reporter, product, and event; different patient;US-PFIZER INC-PV202500031906 Same reporter, product, and event; different patient;
More
|
|||||||
| 2832242 | 80 | F | TX | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Incorrect dose administered, Pruritus
Incorrect dose administered, Pruritus
|
second dose of Comirnaty 23/24; itching on outer thighs up to the hip, hip down to about 3/4 of the ...
second dose of Comirnaty 23/24; itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: Has had ulcerative colitis for 32 years, is in remission for the past 2 to 3 years.; "Blood pressure" (ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal, stop date: Dec2024. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: EN5318), administration date: 29Jan2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 26Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 01Oct2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM9992), administration date: 17May2022, when the patient was 78-year-old, for Covid-19 immunization; comirnaty bivalente ba.4/ba.5 (DOSE 5 (BOOSTER), SINGLE; lot number: GJ2524), administration date: 09Sep2022, when the patient was 79-year-old, for Covid-19 immunization; comirnaty bivalente ba.4/ba.5 (DOSE 6 (BOOSTER), SINGLE; (Pfizer Bivalent)), administration date: 20May2023, when the patient was 79-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (DOSE 7 (BOOSTER), SINGLE; Lot number: HG4629 (Pfizer Comirnaty 23/24)), administration date: 22Sep2023, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Jul2024, outcome "not recovered", described as "itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "second dose of Comirnaty 23/24". Additional information: Calling about the Pfizer COVID vaccination. Caller has had a total of 9 shots of the Pfizer COVID vaccination starting 29Jan2021 and the last one was 06Sep2024. Got it every time became available, because of age was encouraged to take the shot. Has had experience of hives. Cannot prove, not sure, was the COVID vaccination, but the 8th shot was the Comirnaty. The first were Bivalent, thinks all of them up to the 6th shot, and then first Comirnaty was 22Sep2023, which was caller's 7th shot, that was the first Comirnaty caller had. 8th shot was also Comirnaty, well it was 22Mar2024 for the 8th shot. Had no symptoms, none of the shots gave caller any symptoms. Caller's theory, why calling about this, is that sometime in July2024 started itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg. Was scratching, scratching in July, but continued, didn't go away. Was not drawing blood at that time from scratching. Didn't think of it, didn't connect to COVID shot in caller's head. COVID vaccination included When getting these, they write so fast, not real legible, confirmed referring to the handwriting on vaccination card. Confirmed all 9 doses were the Pfizer COVID vaccination. 1st dose on 29Jan2021; NDC, lot, expiry: Only thing written down on card was EN5318; Dose, route: Unknown. 2nd dose on 26Feb2021; NDC, lot, expiry: Cannot even read handwriting under HCP, clinic area, says (redacted) Dose, route: Unknown. 3rd dose on 01Oct2021; NDC, lot, expiry: 30135, can't read it, thinks looks like BA. Got it at Pharmacy Store no.xxxx. Dose, route: Unknown. 4th dose on 17May2022; NDC, lot, expiry: FM9992, that's what it looks like. Got it at Pharmacy Store no. xxxx. Dose, route: Unknown. 5th dose on 09Sep2022; NDC, lot, expiry: GJ2524. Got it at Pharmacy Store no. xxxx. Dose, route: Unknown. 6th dose: Pfizer Bivalent on 20May2023; NDC, lot, expiry: Can't hardly read the handwriting, thinks 676F96. Could be 6 or G for first letter. Dose, route: Unknown. 7th dose (Pfizer Comirnaty 23/24) on 22Sep2023; NDC, lot, expiry: H, 6 or G, 4629, thinks H6, looks like the 6 in 4629; Dose, route: Unknown. 8th dose (Pfizer), so probably the same as above, Pfizer Comirnaty 23/24. Got it at Pharmacy Store no. xxxx on 22Mar2024; NDC, lot, expiry: Unknown, nothing on vaccination card. Dose, route: Unknown. Indication reported Caller was watching TV and caller's daughter is a nurse, and caller's daughter told caller to go get the COVID. Concomitant products included been on low dose blood pressure medication, clarified was on Lisinopril, but switched to a different one, clarified switched to amlodipine, because caller's daughter did research and said sometimes Lisinopril is a problem medication. Confirmed caller is currently on amlodipine. Lisinopril: Therapy dates: Unknown when started, doesn't remember, probably 3 or 4 years ago. Stopped in Dec2024 because switched to Amlodipine. Formulation, dose, route, frequency: 10mg tablet, one tablet a day, by mouth for Blood pressure. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
More
|
||||||
| 2832243 | 75 | M | NY | 03/19/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Arterial occlusive disease, Asthenia, Condition aggravated, Dyspnoea, Emotional ...
Arterial occlusive disease, Asthenia, Condition aggravated, Dyspnoea, Emotional disorder; Fatigue, Mental disorder, Prostate cancer, Radioisotope scan; COVID-19, Drug ineffective; Arterial occlusive disease, Asthenia, Condition aggravated, Dyspnoea, Emotional disorder; Fatigue, Mental disorder, Prostate cancer, Radioisotope scan; COVID-19, Drug ineffective
More
|
Later clarified as Prostate cancer, and it has been downhill from there; blocked arteries; blocked a...
Later clarified as Prostate cancer, and it has been downhill from there; blocked arteries; blocked arteries/Prostate cancer; psychological effect; Maybe accepts it better, but then the emotional part sets in; Has not gotten the energetic feeling that used to have/he has not gotten his full energetic feeling; Shortness of breath started first, sometimes it is worse and sometimes better; very tired; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer", start date: 2020 (ongoing); "blocked arteries", start date: 2020 (ongoing); "ringing in the ears", start date: 2020 (ongoing); "common cold" (unspecified if ongoing), notes: every year, except the last 2 years; "sick" (unspecified if ongoing), notes: very suspectable to getting sick; "cancer" (ongoing). The patient took concomitant medications which included antibiotics. Past drug history included: Vyndamax, reaction(s): "anxiety". Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: PROSTATE CANCER (medically significant), outcome "unknown", described as "Later clarified as Prostate cancer, and it has been downhill from there"; ARTERIAL OCCLUSIVE DISEASE (medically significant), outcome "not recovered", described as "blocked arteries"; CONDITION AGGRAVATED (medically significant), outcome "not recovered", described as "blocked arteries/Prostate cancer"; MENTAL DISORDER (non-serious), outcome "unknown", described as "psychological effect"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "Maybe accepts it better, but then the emotional part sets in"; ASTHENIA (non-serious), outcome "unknown", described as "Has not gotten the energetic feeling that used to have/he has not gotten his full energetic feeling"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath started first, sometimes it is worse and sometimes better"; FATIGUE (non-serious), outcome "unknown", described as "very tired". Caller states that he believes that his conditions was caused by the Pfizer COVID vaccine that he received. Caller states that after receiving the vaccine he all of a sudden wound up having cancer and blocked arteries and he had 4 stents put it and the fourth one was put about a month ago and he has not gotten his full energetic feeling should be taking this all and this play a psychological effect on anybody's life. Cancer- started about 5 years ago. Later clarified as Prostate cancer, noticed in 2020, and it has been downhill from there, came back, had to have more medication given to caller. Prostate cancer was notified prior to receiving covid 19 vaccines. Has received 43 cycles of radiation. Blocked arteries- Blocked arteries and cancer both started about 5 years ago, around the same time, but blocked arteries became more involved thereafter. The 4th one was done 14Feb2025. Clarified as stents. Did the first stents which required nuclear testing to monitor. Found still had blockages and found another. Later in call, caller stated had minor blockages prior to receiving covid 19 vaccine. Minor blockages did not require any action. Had to go back for check up, that is when had covid. Went unnoticed, in 6 months ago because of breathing, had 3 stents Aug2025. It is the arteries, protein on heart, cancer, and ringing in the ears started at the same time and not going away, it is five years. Has gotten hormones, the body goes through so much, it effects the brain. Went to neurologist due to shortness of breath. The events "shortness of breath started first, sometimes it is worse and sometimes better" required physician office visit. The patient underwent the following laboratory tests and procedures: Radioisotope scan: Unknown results. Therapeutic measures were taken as a result of prostate cancer, arterial occlusive disease, condition aggravated. Therapeutic measures were not taken as a result of dyspnoea. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
More
|
||||||
| 2832244 | M | TX | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
|
I did test COVID two years back after vaccination; I did test COVID two years back after vaccination...
I did test COVID two years back after vaccination; I did test COVID two years back after vaccination; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 38-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I did test COVID two years back after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: two years back; after vaccination. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient and his wife took Pfizer vaccines. Saturday (29Jun2024), patient's wife got diagnosed with COVID. On 03Jul2024, patient was told to have tested positive and picking up the same Paxlovid for COVID-19. Patient tested COVID two years back after vaccination and complained that Paxlovid was never this expensive then.
More
|
|||||||
| 2832245 | M | FL | 03/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Alopecia, Bipolar I disorder, Cardiac disorder, Craniocerebral injury, Mental im...
Alopecia, Bipolar I disorder, Cardiac disorder, Craniocerebral injury, Mental impairment; Schizophrenia
More
|
CHI (Life threatening illness); schizophrenia; bipolar one; mental fog; My heart, my hair fell out; ...
CHI (Life threatening illness); schizophrenia; bipolar one; mental fog; My heart, my hair fell out; My heart, my hair fell out; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 17Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 56-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications within 2 weeks prior to the event onset. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: CRANIOCEREBRAL INJURY (life threatening), outcome "unknown", described as "CHI (Life threatening illness)"; SCHIZOPHRENIA (medically significant), outcome "unknown"; BIPOLAR I DISORDER (medically significant), outcome "unknown", described as "bipolar one"; MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "mental fog"; ALOPECIA (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "My heart, my hair fell out". The patient had post vaccination problems. Therapeutic measures were taken as a result of craniocerebral injury. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
✓ | ||||||
| 2832246 | FL | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
|
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received fr...
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 48-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 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 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2024) Positive; (Jul2024) Positive. During an inbound call for financial assistance, the caller explained that they tested positive for COVID-19 and are staying at their parents' house. All three of them tested positive after doing two tests each. The caller's mother had attended a gathering with her three sisters, and they all got infected. The mother felt very ill the previous night, so the caller tested her, themselves, and their father in the morning, and all three tested positive. The caller's parents are 82 and 85 years old, and they don't want to take them for re-testing. Although they are quite sick, the symptoms have been lingering since the service they attended a week ago. The father started feeling unwell on Thursday, the mother felt worse on Friday, and the caller's symptoms worsened on Friday as well. Fortunately, they have all been vaccinated with Pfizer, including the latest available dose. They have been taking the vaccines at the withheld location. The caller is wondering if they should contact their parents' doctors from withheld to get a prescription for them. Later, the caller mentioned that both parents take several medications. The caller is very concerned about their parents due to their age. They believe it's fortunate they got infected now since they have been vaccinated. They have been taking the Pfizer vaccine from the beginning and are up to date, with the last vaccination being three or four months ago. They have received all the shots, including the third or fourth kind. Whenever Pfizer released a new vaccine for a new strain, they got it. This has helped them manage the symptoms. The caller's aunt mentioned that she and her husband took Paxlovid, and now the caller is trying to figure out how to get it for their parents and themselves as quickly as possible.; Sender's Comments: Linked Report(s): US-PFIZER INC-202500058182 same reporter/product/event, different patient.; US-PFIZER INC-202500058181 same reporter/product/event, different patient.;
More
|
||||||||
| 2832247 | MS | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
Covid-19 shot didn't work good on me; Covid-19 shot didn't work good on me; This is a spon...
Covid-19 shot didn't work good on me; Covid-19 shot didn't work good on me; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 shot didn't work good on me". Clinical course: During an inbound call for financial assistance, the patient said, "COVID-19 shot didn't work good on me." When asked to repeat, the caller said, "The COVID-19 shot didn't work too good on me".
More
|
||||||||
| 2832248 | F | TX | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that; she ...
she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that; she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500031663 same reporter/product/event, different patient;
More
|
|||||||
| 2832250 | OH | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or...
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), 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), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID". Clinical course: During an inbound call for assistance with a rejection, the reporter advised, "I'm trying to get Paxlovid. I was diagnosed on Tuesday with COVID. I got all the Pfizer shots for COVID back in Mar2021, Apr2021, Nov2021, Apr2022 and the last one at Dec2022. I got them all at the (Clinic name) at (withheld). So I don't know where I picked this up at I think I got it from a store, where the guy went to (withheld) for to weeks, that's the only place that I can think of where I might've picked something like this up because I don't know anybody that's got it." "Yeah, I don't feel good."
More
|
||||||||
| 2832251 | FL | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A...
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 60-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient had Covid maybe 3 or 4 years ago from time of the report. Patient got it pretty soon after it all hit. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient had Covid 3 or 4 years ago and the patient recovered very quickly but this one, this version of Covid was not fun, it was awful. The patient stated that he had 3 total injections, the Covid injection, the original one and 2 boosters (as reported), all Pfizer.
More
|
||||||||
| 2832252 | CO | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
|
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A...
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 65-year-old 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. Vaccination history included: Bnt162b2 (PRIMARY IMMUNIZATION SERIES COMPLETED), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, BOOSTER, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
||||||||
| 2832253 | 77 | CO | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Cataract, Drug ineffective
COVID-19, Cataract, Drug ineffective
|
Cataracts; COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A...
Cataracts; COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A 77-year-old patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for COVID-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2024, outcome "unknown" and all described as "COVID-19"; CATARACT (medically significant), outcome "unknown", described as "Cataracts". The event "covid-19" required physician office visit. The patient was trying to get some nirmatrelvir/ ritonavir (PAXLOVID) as the patient was just diagnosed with COVID-19 for the second time and the patient was trying to get the pills so the patient could take them to get rid of this thing. The patient went to urgent care that morning (23Sep2024). The patient commented that this is miserable. It's the second time and the patient just had a Pfizer booster shot a month ago (Aug2024). And the patient got this thing (COVID-19) the other day (21Sep2024), but didn't know how. The patient also has cataracts. That's the next thing the patient was taking care of as the patient was becoming old. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
|||||||
| 2832254 | 16 | F | DE | 03/19/2025 |
MEN |
UNKNOWN MANUFACTURER |
U7594AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
they gave patient their dose of menquadfi and when pressing they thought that the expiration date wa...
they gave patient their dose of menquadfi and when pressing they thought that the expiration date was 30 mar2025 but it was 04mar2025 with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 year old female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] and when pressing they thought that the expiration date was 30-Mar-2025 but it was 04 Mar-2025 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Mar-2025, the patient received a 0.5ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection standard strength, frequency-once, (lot U7594AA) (expiry date-04-Mar-2025) via intramuscular route in the left deltoid for Immunization and when pressing they thought that the expiration date was 30-Mar-2025 but it was 04 Mar-2025 with no reported adverse event (expired product administered). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
|
||||||
| 2832255 | 0.42 | F | PA | 03/19/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
1973310 |
Product preparation error
Product preparation error
|
administered the act-hib component of pentacel with a sterile water diluent from mmr instead of the ...
administered the act-hib component of pentacel with a sterile water diluent from mmr instead of the dtap-ipv liquid component with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old female patient who was administered with act-hib component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile water diluent from MMR (measles mumps rubella) instead of the Dtap-IPV liquid component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Rotavirus vaccine live oral 1v (Rotarix) for Immunisation. On 11-Feb-2025, the patient received 0.5mL (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) vaccine (lot 1973310, expiry date 07-Sep-2026, strength standard and formulation unknown) via intramuscular route in the right thigh for Immunisation and administered with act-hib component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile water diluent from MMR (measles mumps rubella) instead of the Dtap-IPV liquid component with no reported adverse event (product preparation error). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. .
More
|
||||||
| 2832256 | WI | 03/19/2025 |
YF |
SANOFI PASTEUR |
UK133AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
possible administration of YF-VAX that was incorrectly reconstituted with sterile water instead of t...
possible administration of YF-VAX that was incorrectly reconstituted with sterile water instead of the saline diluent that it comes with, with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administered with yellow fever vaccine - [YF-Vax] which was incorrectly reconstituted with sterile water instead of the saline diluent that comes with vaccine, 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 in Mar-2025, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection, Unknown strength and lot UK133AB with expiry date 31-Oct-2025 via unknown route in unknown administration site for Immunization, which was possibly incorrectly reconstituted with sterile water instead of the saline diluent that comes with vaccine, with no reported adverse event (product preparation issue) (latency same days). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
|
||||||||
| 2832257 | M | CA | 03/19/2025 |
FLU3 |
SEQIRUS, INC. |
No batch number |
Urticaria
Urticaria
|
Hives on his wrists 10 days after taking Flucelvax; Allergic reaction 10 days after taking Flucelvax...
Hives on his wrists 10 days after taking Flucelvax; Allergic reaction 10 days after taking Flucelvax; Sore; This spontaneous case from United States, initially received on 07-Mar-2025, was reported by a non health professional and concerns an child male patient. Medical History: No. Patient's mom mentioned that he never had a adverse reaction or allergic reaction to a vaccine before. Concomitant medications reported as no. Administration of company suspect drug: On 25-Feb-2025, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, Dose regimen: 0.5 ml, Route of administration: Unknown, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Mar-2025, the patient experienced hives on his wrists 10 days after taking Flucelvax (outcome: not recovered / not resolved), allergic reaction 10 days after taking Flucelvax (outcome: not recovered / not resolved), sore (outcome: not recovered / not resolved). Consumer inquired that her son had an allergic reaction 10 days after taking Flucelvax, he started to sore, presented some hives on his wrists. But he never had an allergic reaction specially related to the skin. She wants to know if we ever had any report such as hers, any adverse reaction report related to skin. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Patient's mom reported that she took him to a doctor and his on medication for the allergy reaction. Reporter assessment: The reporter considered events hives on his wrists 10 days after taking Flucelvax, allergic reaction 10 days after taking Flucelvax and sore and causality was not reported.; Reporter's Comments: The causality of events were related to the administration of the product Flucelvax (TIV)
More
|
|||||||
| 2832267 | NM | 03/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Pneumococcal infection, Vaccination failure
Pneumococcal infection, Vaccination failure
|
the limited protection of PPSV23 against mucosal disease could have made the patient susceptible to ...
the limited protection of PPSV23 against mucosal disease could have made the patient susceptible to the development of IPD; This literature marketed report as received from the authors of a published literature article, and refers to a 66-year-old patient of unknown gender. The patient had a history of tobacco smoking, chronic obstructive pulmonary disease, and poorly controlled diabetes. On an unknown date in 2019 (reported as 3 years prior), the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). It was reported, the patient had presence of multiple comorbidities and the limited protection of PPSV23 against mucosal disease could have made the patient development of invasive pneumococcal disease (IPD) (Vaccination failure). The event vaccination failure was considered to be related to pneumococcal Vaccine, Polyvalent (23-valent).
More
|
||||||||
| 2832268 | 0.5 | F | IL | 03/19/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVBO44A |
Product preparation issue
Product preparation issue
|
liquid portion of Menveo was administered; liquid portion of Menveo was administered; This non-serio...
liquid portion of Menveo was administered; liquid portion of Menveo was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVBO44A, expiry date 31-JUL-2025) for prophylaxis. Concurrent medical conditions included sickle cell disease. On 07-MAR-2025, the patient received Menveo. On 07-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid portion of Menveo was administered) and inappropriate dose of vaccine administered (Verbatim: liquid portion of Menveo was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 11-MAR-2025 The nurse called to report that a patient received only the liquid portion of Menveo vaccine, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was getting this vaccine because they have a high-risk medical condition. The vaccine administration facility was the same as primary reporter.
More
|
||||||
| 2832269 | 50 | F | MD | 03/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Fatigue, Nausea, Pain, Pain in extremity, Vomiting
Fatigue, Nausea, Pain, Pain in extremity, Vomiting
|
developed sore arm, body aches, fatigue and nausea and vomtting, morning after vaccine
developed sore arm, body aches, fatigue and nausea and vomtting, morning after vaccine
|
||||||
| 2832288 | 25 | F | 03/19/2025 |
HPV9 |
MERCK & CO. INC. |
|
Injected limb mobility decreased
Injected limb mobility decreased
|
pain and limited ROM in the vaccinated upper arm, that has lasted 1 month after vaccination, though ...
pain and limited ROM in the vaccinated upper arm, that has lasted 1 month after vaccination, though is starting to resolve (reduced pain, full ROM in the last few days)
More
|
|||||||
| 2832289 | 77 | M | PR | 03/19/2025 |
PNC21 RSV VARZOS |
MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
Y019158 LL8391 27LR2 |
Breast discomfort, Breast swelling, Ultrasound scan; Breast discomfort, Breast s...
Breast discomfort, Breast swelling, Ultrasound scan; Breast discomfort, Breast swelling, Ultrasound scan; Breast discomfort, Breast swelling, Ultrasound scan
More
|
On day 12 after receiving the vaccine, the patient's right breast became swollen and uncomforta...
On day 12 after receiving the vaccine, the patient's right breast became swollen and uncomfortable.
More
|
||||||
| 2832290 | 77 | F | AL | 03/19/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4lj4t |
Hypoaesthesia, Paraesthesia
Hypoaesthesia, Paraesthesia
|
The patient called 3/18/25 reported she has been experiencing tingling and numbness in her legs and ...
The patient called 3/18/25 reported she has been experiencing tingling and numbness in her legs and face since she received the vaccination. She has been treated in the past for the symptoms thinking they were caused by something else . She asked about other symptoms of the RSV vaccination can cause and said she is experiencing them . She still presently is experiencing the tingling and numbness.
More
|
||||||
| 2832291 | 82 | F | WA | 03/19/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4BN95 |
Confusional state, Contusion, Erythema, Swelling face
Confusional state, Contusion, Erythema, Swelling face
|
She received the vaccine 3/7 and felt fine went to bed and woke up the next day 4 pm with a swollen ...
She received the vaccine 3/7 and felt fine went to bed and woke up the next day 4 pm with a swollen face and bruising and some confusion
More
|
||||||
| 2832292 | 72 | M | CA | 03/19/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Limb discomfort, Tremor; Limb discomfort, Tremor
Limb discomfort, Tremor; Limb discomfort, Tremor
|
By 10:30 pm, I experienced an uncontrollable, heavy, and severe shaking of my both arms, it lasted f...
By 10:30 pm, I experienced an uncontrollable, heavy, and severe shaking of my both arms, it lasted for a minute. By 2 o'clock in the morning, it happened again.
More
|
||||||
| 2832293 | 74 | M | CA | 03/19/2025 |
COVID19 |
MODERNA |
008C21A |
Diarrhoea
Diarrhoea
|
About 10 days after the "booster shot," I developed diarrhea. At first, I had to go to th...
About 10 days after the "booster shot," I developed diarrhea. At first, I had to go to the toilet 4 times a day. Within three days, I needed to go about 10 times to the toilet! Many times, I was not able to reach the toilet in time. I contacted my Doctor's office and purchased Diarrhea Medication, but nothing could stop the diarrhea! It was a life-changing experience. I stayed in Bed because my toilet was close by. Even then, I could not make it to the toilet in time! The diarrhea lasted about ONE YEAR and a HALF!
More
|
||||||
| 2832294 | 67 | F | CO | 03/19/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5J959 |
Injection site erythema, Product administered at inappropriate site
Injection site erythema, Product administered at inappropriate site
|
Prescriber called pharmacy to report incorrect vaccination administration site for patient, adverse ...
Prescriber called pharmacy to report incorrect vaccination administration site for patient, adverse site reaction, and to requesting follow up training for vaccine administrator. Reported injection site looked like it was over the radial nerve of the arm, halfway down arm, vs on deltoid. Said does not look infection but site is erythematous.
More
|
||||||
| 2832295 | 61 | F | WI | 03/19/2025 |
FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Axillary pain, Computerised tomogram head, Computerised tomogram tho...
Arthralgia, Axillary pain, Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram; Electromyogram, Hypoaesthesia, Magnetic resonance imaging head, Muscular weakness, Musculoskeletal pain; Neuralgic amyotrophy, Pain in extremity, Radiculitis brachial, Scan with contrast, Ultrasound scan
More
|
Diagnosed as Brachial Neuritis/ Neuralgic Amyotrophy. Symptoms: severe pain in left armpit, left sh...
Diagnosed as Brachial Neuritis/ Neuralgic Amyotrophy. Symptoms: severe pain in left armpit, left shoulder blade, left arm, left wrist, weakness of left arm, left hand and fingers, numbness in fingers 4 and 5. Symptoms lasting for 2months (2 flares 5 weeks apart), then decreasing in severity to mild weakness and low grade pain over 2 more months. Treatment was tapered prednisone during the 2 flares (from 60mg/day to 0.5mg/day); gabapentin 900mg/day, tapered to 300mg/day across 4 months; tylenol 2g/day during the first 2 months; ibuprofen, vitamin B12, occupational therapy, physical therapy. Mild weakness in left hand and fingers persist after 4 months.
More
|
||||||
| 2831829 | 13 | M | ID | 03/18/2025 |
HPV9 |
MERCK & CO. INC. |
Y000205 |
Product storage error
Product storage error
|
Medical Assistant calling to report an adverse event regarding improperly stored and administered RO...
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they have not had any reports of patients experiencing any medical concerns or symptoms after being administered; This spontaneous report was received from medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On 11-DEC-2024, the patients were vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X023403, expiration date: 03-APR-2025, 2 milliliter (route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024560, expiration date: 31-MAY-2026 (exact dose, route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # Y000205, expiration date: 23-SEP-2026 (exact dose, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y007585, expiration date: 31-OCT-2025 (exact dose, route of administration and anatomical location were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # X026480, expiration date: 12-JAN-2026 (exact dose, route of administration and anatomical location were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X011431, expiration date: 19-APR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 11-DEC-2024, administered doses of vaccines were involved in a temperature excursion (product storage error), they have not had any reports of patients experiencing any medical concerns or symptoms after being administered (no adverse event). Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained a 13-year-old male patient. He did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 02-JAN-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, lot#Y000205 (expiration date: 23-SEP-2026), in the left deltoid as prophylaxis (dose and route of administration were not provided) that had gone through a temperature excursion as the storage fridge had been out of range, but this vaccine was viable , and no events occurred to the patient after the administration. The vaccine had been given in a clinic by a medical professional. It was not available for return. This case was preciously classified as non-valid, as there were no temperature excursions, but per follow-up, the reporter provided all the information regarding the patients and the vaccines that they had received after excursion. This was one reported received from the same reporter. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2236361. The previous case ID: 2501USA001924. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
More
|
||||||
| 2831830 | F | CT | 03/18/2025 |
PPV |
MERCK & CO. INC. |
|
Allergy to vaccine, Epistaxis
Allergy to vaccine, Epistaxis
|
Allergy to pneumovax; This spontaneous report was received from a consumer referring to an 80-year-o...
Allergy to pneumovax; This spontaneous report was received from a consumer referring to an 80-year-old female patient. The patient's Historical drugs included Phenoxymethylpenicillin potassium (PENICILLIN VK), Influenza vaccine rHA 3v (baculovirus) (FLUBLOK), Chlorpheniramine, Morphine sulfate, Acetaminophen (Paracetamol), Acyclovir, Chlorphenamine maleate (+) Paracetamol (+) Phenylephrine hydrochloride (DRISTAN COLD MULTI-SYMPTOM FORMULA), Xylometazoline hydrochloride (SUDAFED), Pethidine hydrochloride (MEPERIDINE HCl), and Sulfamethoxazole (+) Trimethoprim (SULFAMETHOPRIM). Concurrent condition was not reported. On an unknown date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection (Lot #, expiration date, dose, strength, anatomical location of vaccine and route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced Allergy to pneumovax. At the reporting time, the outcome of Allergy to pneumovax was unknown. On an unknown date in 2024, the patient started therapy with sotatercept (WINREVAIR) injection (strength, dose, frequency, lot#, expiry date, route and indication were not reported). On an unknown date in 2024, the patient experienced nosebleed (Captured on Case # 2055804). The reporter considered the event of Allergy to pneumovax to be related to Pneumococcal Vaccine, Polyvalent (23-valent). Lot # is being requested and will be submitted if reported. This is one of the two reports from the same reporter.
More
|
|||||||
| 2831831 | F | MD | 03/18/2025 |
HPV9 |
MERCK & CO. INC. |
|
Papilloma viral infection
Papilloma viral infection
|
HPV infection; This spontaneous report was received from a Physician and refers to an Adult (late 20...
HPV infection; This spontaneous report was received from a Physician and refers to an Adult (late 20s or 30s) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, at age 10 or 11, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced HPV infection. At the reporting time, the outcome of HPV infection was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. The causal relationship between the event of HPV infection and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided. This is one of two reports received from the same reporter (case # 2265116).;
More
|
|||||||
| 2831832 | 11 | F | GA | 03/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
X025115 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; Fridge dropped below freezing over the weekend while office was closed; This spont...
No additional AE; Fridge dropped below freezing over the weekend while office was closed; This spontaneous report has been received from a healthcare professional regarding a 11-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 24-OCT-2024, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection, administered intramuscularly as prophylaxis (lot number reported as X025115, which has been verified as valid, expiration date reported and validated as 19-MAY-2026). It was reported that the fridge dropped below freezing over the weekend while office was closed (Product storage error). No additional adverse events were reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-03-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 02743778 RD , Central date : 2025-03-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
More
|
||||||
| 2831834 | F | NJ | 03/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
Missed dose; This non-serious case was reported by a pharmacist via call center representative and d...
Missed dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 3 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 13-MAR-2025 The reporter stated that a patient received the first dose of Shingrix 3 years ago but never received the second dose. No patient information was available. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
More
|
|||||||
| 2831835 | 1 | M | CA | 03/18/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
9R5LC |
Expired product administered
Expired product administered
|
Expired product used; This non-serious case was reported by a other health professional via call cen...
Expired product used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-month-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-JAN-2024) for prophylaxis. On 11-MAR-2025, the patient received Havrix. On 11-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired product used). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-MAR-2025 The office manager called to reported that one of their new staff members administered an expired dose of Havrix to a patient, which led to an expired vaccine used. The reporter wanted to know do they have to call the patient to receive a new dose. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
More
|
||||||
| 2831850 | 13 | F | TX | 03/18/2025 |
HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Blood test abnormal, Brain fog, Dizziness, Electroencephalogram abnormal, Headac...
Blood test abnormal, Brain fog, Dizziness, Electroencephalogram abnormal, Headache; Injection site erythema, Loss of consciousness, Migraine, Nausea, Nodule; Pain in extremity, Seizure, Skin warm
More
|
Red spot at injection site, raised knot, sore arm for 4 days, hot at touch. 3 weeks later- migraine...
Red spot at injection site, raised knot, sore arm for 4 days, hot at touch. 3 weeks later- migraine & nausea, 4 weeks later- unexplained seizures, dizziness, loss of consciousness, brain fog, headache, still lasting after 6 days.
More
|
✓ | ✓ | ||||
| 2831852 | 0.25 | M | 03/18/2025 |
HIBV HIBV MEN MEN MMR MMR PNC13 PNC13 UNK UNK UNK UNK VARCEL VARCEL |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; D...
Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion; Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion; Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion; Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion; Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion; Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion; Atelectasis, Bronchiolitis, Chest X-ray abnormal, Condition aggravated, Cough; Dyspnoea, Intensive care, Renal function test normal, Respiratory tract congestion
More
|
Bronchiolitis; This 16-month-old male subject was enrolled in a blinded study. The subject received ...
Bronchiolitis; This 16-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-JUL-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 21-DEC-2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 17-OCT-2018, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 21-DEC-2018, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 16-JUL-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 16-JUL-2019, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) on 16-JUL-2019, for prophylaxis. Concurrent medical conditions included bronchiolitis (Multiple episodes) and otitis media chronic. Concomitant products included ofloxacin and amoxicillin. On 30-OCT-2019, 106 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 313 days after receiving DTPa-HBV-IPV and Hiberix and 378 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 bronchiolitis (Verbatim: Bronchiolitis). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol). The outcome of bronchiolitis was resolved on 07-NOV-2019. Relevant Tests: On 31Oct2019 Chest x-ray, showed atelectasis (no pneumonia). On 01Nov2019, Renal function panel performed unremarkable. The investigator considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. The company considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Linked case(s) involving the same subject: US2020047884 GSK Receipt Date: 04-NOV-2019 Subject presented with one day cough, congestion and increased work of breathing. Went to OSH (outside hospital) first, chest x-ray with possible pneumonia was referred to emergency department for further care. In the ED,subject required vapotherm support to 14L and was admitted to the PICU for further care. Admitted for approximately 1 day with diagnosis of Bronchiolitis. Max respiratory support was 14L high flow. He improved with nasal suction and albuterol treatments. Respiratory support was weaned and he was able to be transferred to the hospital floor. Remained hospitalized for additional 2 days, able to wean down oxygen support to room air and remained stable on room air overnight prior to discharge. Subject was admitted 31Oct2019 and was discharged 03Nov2019. Follow up information received on 31-JUL-2024 Summary of changes: Concomitant medications updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of bronchiolitis, 106 days after receiving the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, 1st dose of M-M-R II, Varivax, Prevnar 13, 313 days after receiving 3rd dose of DTPa-HBV-IPV with DTPa-HBV-IPV vaccine pre-filled syringe device, Hiberix and 378 days after receiving 2nd dose of Rotarix lyophilized formulation with Rotarix vaccine Oral Applicator Device, in a 16-month-old male subject. Report is inconsistent with causal relation to the vaccine products, considering implausible time to onset, absence of biological plausibility and alternate etiology of concurrent medical condition bronchiolitis (Multiple episodes) based on medical history. US-GLAXOSMITHKLINE-US2020047884:
More
|
✓ | ||||||
| 2831853 | 0.17 | M | 03/18/2025 |
HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Human rhinovirus test positive, Laboratory test, Laboratory test normal, Lumbar ...
Human rhinovirus test positive, Laboratory test, Laboratory test normal, Lumbar puncture, Pyrexia; Respiratory pathogen panel, Rhinovirus infection; Human rhinovirus test positive, Laboratory test, Laboratory test normal, Lumbar puncture, Pyrexia; Respiratory pathogen panel, Rhinovirus infection; Human rhinovirus test positive, Laboratory test, Laboratory test normal, Lumbar puncture, Pyrexia; Respiratory pathogen panel, Rhinovirus infection; Human rhinovirus test positive, Laboratory test, Laboratory test normal, Lumbar puncture, Pyrexia; Respiratory pathogen panel, Rhinovirus infection; Human rhinovirus test positive, Laboratory test, Laboratory test normal, Lumbar puncture, Pyrexia; Respiratory pathogen panel, Rhinovirus infection
More
|
fever; Rhinovirus; This 2-month-old male subject was enrolled in a blinded study. The subject receiv...
fever; Rhinovirus; This 2-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 24th September 2018, for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix), Hib (Hiberix), Rota (Rotarix) and PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis. The subject's past medical history included acute upper respiratory tract infection. On 26th September 2018, 2 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed mild - grade 1 fever. Serious criteria included hospitalization. Additional event(s) included mild - grade 1 rhinovirus infection on 26th September 2018 with serious criteria of hospitalization. The subject was treated with PARACETAMOL (TYLENOL). Bexsero vs Placebo co-administered with PCV and routine vaccines was continued with no change. The outcome of fever was recovered/resolved on 27th September 2018. The outcome(s) of the additional event(s) included rhinovirus infection (recovered/resolved on 9th October 2018). The investigator considered that there was a reasonable possibility that the fever may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. The investigator considered that there was no reasonable possibility that the rhinovirus infection may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. Other possible causes of the fever included pediarix and hiberix. Relevant Tests: On 27Sep2018, Respiratory Panel collected and result was positive for Rhinovirus On 27Sep2018, Chemistry panel collected and result was normal On an unknown date in Sep2018 nasal swab result was positive for rhinovirus. Diagnostic results (unless otherwise stated, normal values were not provided): In September 2018, Body temperature result was 102 degree F and Body temperature result was 99 degree F. Investigator Text: Developed fever of 102 given Tylenol and came down to 99, Emergency room with labs, failed attempt at lumbar puncture, nasal swab positive for rhinovirus. Elected observation overnight. No further fever and no medication given. Admission: 9/27/18 00:38 Discharge: 9/27/18 15:12. Additional information received on 01Oct2018: Fever in 66 day old was principal reason for the admission and may have been from vaccine or from rhinovirus which was positive on testing. Additional details: On 26 Sep 2018, 2 days after receiving 1st dose of Pediarix (GSK product, taken as prophylaxis), Hiberix (GSK product, taken as prophylaxis), Rotarix (GSK product, taken as prophylaxis), and PREVNAR 13 (non GSK product, taken as prophylaxis), the subject experienced Fever. The investigator considered that there was a reasonable possibility that the fever may also have been caused by Pediarix and Hiberix. The investigator considered that there was no reasonable possibility that the fever may have been caused by Rotarix and Prevenar 13. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Pyrexia and Rhinovirus infection , 2 days after receiving 1st dose of Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation and Prevnar 13 in a 2-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility for Rhinovirus infection and alternative risk factors (Age, h/o acute upper respiratory tract infection, multiple concomitant vaccines).
More
|
✓ | ||||||
| 2831854 | 0.33 | M | 03/18/2025 |
HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage d...
Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative; Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative; Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative; Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative; Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative; Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative; Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage decreased, Blood calcium normal; Blood chloride normal, Blood creatine normal, Blood glucose increased, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Culture stool positive, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastroenteritis viral, Giardia test negative, Haematemesis; Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal; Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased; Monocyte percentage, Mucous stools, Neutrophil count increased, Neutrophil percentage increased, Occult blood positive; Parasite stool test negative, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal; Rotavirus test negative, Salmonella test negative, Ultrasound abdomen normal, Vomiting, White blood cell count increased; White blood cells stool negative
More
|
Viral Gastroenteritis; This 12-month-old male subject was enrolled in a blinded study. The subject r...
Viral Gastroenteritis; This 12-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 5th March 2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 10th September 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 9th July 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 10th September 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 5th March 2020, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 5th March 2020, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevnar 13 (Non-GSK Comparator) (Prevnar 13) for prophylaxis. On 10th March 2020 14:45, 5 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 182 days after receiving DTPa-HBV-IPV and Hiberix and 245 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 viral gastroenteritis. Serious criteria included clinically significant/intervention required. The subject was treated with sodium chloride (Sodium Chloride 0.9% Bolus) and ondansetron (Zofran (Ondansetron)). The outcome of viral gastroenteritis was recovered/resolved on 17th March 2020. The investigator considered that there was no reasonable possibility that the viral gastroenteritis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Varivax. Relevant Tests: On 12Mar2020 Stool tests was ordered and resulted on 16Mar2020: Test: Giardia Cryptosporidium Direct antigen Results: Giardia Antigen - Negative Cryptosporidium Antigen - Negative Test: Stool Pathogen Screen Result: No Salmonella or Shigella Isolated Test: Shigatoxin Screen Results: Shigatoxin 1 - Negative,Shigatoxin 2 - Negative Test: Campylobacter Antigen Result: Negative Test: Comprehensive Ova and Parasite Exam Result: No Parasites Seen Diagnostic results (unless otherwise stated, normal values were not provided): On 11th March 2020, Basophil percentage result was 0 % (normal low: 0.00, normal high: 2.00), Blood calcium result was 10.5 mg/dL (normal low: 8.80, normal high: 10.60), Blood chloride result was 103.00 mmol/L (normal low: 99.00, normal high: 108.00), Blood creatine result was 0.28 mg/dL (normal low: 0.26, normal high: 0.77), Blood glucose result was 140 mg/dL (normal low: 55.00, normal high: 199.00), Blood potassium result was 4.6 mmol/L (normal low: 3.50, normal high: 5.10), Blood sodium result was 141 mmol/L (normal low: 136.00, normal high: 145.00), Blood urea result was 19 (nitrogen) mg/dL (normal low: 7.00, normal high: 25.00), Carbon dioxide result was 19 mmol/L (normal low: 21.00, normal high: 31.00), Eosinophil percentage result was 0 % (normal low: 0.00, normal high: 9.00), Haematocrit result was 34 % (normal low: 32.00, normal high: 42.00), Haemoglobin result was 11.4 g/dL (normal low: 10.50, normal high: 14.00), Lymphocyte percentage result was 19 % (normal low: 49.00, normal high: 70.00), Mean cell haemoglobin concentration result was 29 pg (normal low: 24.00, normal high: 30.00), Mean platelet volume result was 7.1 fL (normal low: 6.00, normal high: 9.50), Monocyte percentage result was 5 % (normal low: 1.00, normal high: 12.00), Neutrophil percentage result was 76 % (normal low: 23.00, normal high: 44.00), Platelet count result was 511 K/uL (normal low: 150.00, normal high: 450.00), Red blood cell count result was 3.99 M/uL (normal low: 3.80, normal high: 5.40), Red cell distribution width result was 12.6 % (normal low: 11.50, normal high: 16.00) and White blood cell count result was 17.1 K/uL (normal low: 6.00, normal high: 14.00). On 12th March 2020, Stool analysis result was see text. In March 2020, Anion gap result was 19 (normal low: 3.00, normal high: 11.00), Basophil count result was 0.1 (Absolute) K/uL (normal low: 0.00, normal high: 0.20), Blood osmolarity result was 286 unit mOsm/kg (normal low: 270, normal high: 295), Culture stool result was Positive(A), Eosinophil count result was 0.00 (Absolute) K/uL (normal low: 0.00, normal high: 1.10), Lymphocyte count result was 3.2 (Absolute) K/uL (normal low: 2.90, normal high: 9.80), Mean cell volume result was 85 fL (normal low: 72.00, normal high: 88.00), Monocyte count result was 0.9 (Absolute) K/uL (normal low: 0.00, normal high: 1.40), Neutrophil count result was 12.8 (Absolute) K/uL (normal low: 1.40, normal high: 6.20), Occult blood result was Positive(A) POCT, Red blood cell nucleated morphology result was 0 range /100WBC, Rotavirus test result was Negative, Ultrasound abdomen result was No evidence of Intussusception is identified and White blood cells stool result was Rare WBC's. INVESTIGATOR TEXT Patient presented to Wake Med ED on 3/10/2020 for vomiting that started that day. In the ED he had several episodes that were blood streaked- non bilious. HE received Zofran and boluses of IV fluids. His lab work was reassuring. Prior to departure from the ED he had a large bowel movement that appeared to have blood and mucus. An ultrasound was obtained to rule out obstruction and /or intussusception, and that was negative. Stool studies were sent out and pending at the time of discharge 3/11/20 morning. His vomiting and diarrhea were suspected to be secondary to viral gastroenteritis. At followup office visit on 3/12/20 additional stool studies were obtained (Giardia, Cryptosporidium, Ova and parasite, Shigella, stool pathogen panel, salmonella, campylobacter) and all resulted negative. The diagnosis was presumed to be a viral gastroenteritis. Additional deatils: On 30Jun2021 SAE Diarrhea was deleted. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of gastroenteritis viral, 5 days after receiving the 4th dose of Bexsero vs Placebo, M-M-R II, Varivax, 182 days after receiving 3rd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, 182 days after receiving 3rd dose of Hiberix and 245 days after receiving 2nd dose of Rotarix vaccine oral applicator device in a 12 month old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
More
|
|||||||
| 2831855 | 0.33 | F | 03/18/2025 |
HIBV HIBV HIBV HIBV MMR MMR MMR MMR PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL VARCEL |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased...
Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration; Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration; Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration; Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration; Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration; Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration; Asthenia, Balance disorder, Blood sodium decreased, C-reactive protein increased, Differential white blood cell count abnormal; Documented hypersensitivity to administered product, Full blood count abnormal, Gait disturbance, Infant irritability, Joint swelling; Lethargy, Otitis media, Peripheral swelling, Platelet count increased, Pyrexia; Serum sickness, Skin discolouration
More
|
SERUM SICKINESS; This 13-month-old female subject was enrolled in a blinded study. The subject recei...
SERUM SICKINESS; This 13-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-APR-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 02-OCT-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 02-OCT-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 31-JUL-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 01-APR-2020, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 01-APR-2020, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis and amoxicillin trihydrate (Amoxicillin) for systemic antibacterial therapy. Concurrent medical conditions included penicillin allergy (Allergic to Amoxicillin). On 20-MAY-2020, 49 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 231 days after receiving DTPa-HBV-IPV and Hiberix and 294 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 serum sickness (Verbatim: SERUM SICKINESS). Serious criteria included clinically significant/intervention required. The subject was treated with clindamycin palmitate hydrochloride, hydroxyzine, sodium chloride (Normal Saline), ibuprofen, cetirizine and diphenhydramine. Bexsero vs Placebo was continued with no change. The outcome of serum sickness was resolved on 04-JUL-2020. Relevant Tests: On 22-May-2020 CBC (Complete blood count) with Automated Differential showed Abnormal On 22-May-2020 WBC (White blood cell) with Automated Differential Abnormal. Diagnostic results (reference ranges are provided in parenthesis if available): Blood sodium- 22-MAY-2020 134 mEq/L, (135.00-145.00). C-reactive protein- 22-MAY-2020 3.5 (0.00-0.90). Platelet count- 22-MAY-2020 623 K/uL, (140.00-400.00). The investigator considered that there was no reasonable possibility that the serum sickness may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the serum sickness may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. GSK Receipt Date: 19-DEC-2024 Thirteen-month-old infant who presented with fevers and fussiness at her doctors appointment on 13MAY2020. She was diagnosed with right otitis media and was prescribed amoxicillin to be taken for 10 days. On day7 21MAY2020 of her amoxicillin course she developed a rash that started on her ear and spread to the body. Per mom the infants fingers began to swell and the rash became itchy. The amoxicillin was stopped. The child started to had a low-grade fever and became extremely fussy on 21MAY2020. By that same afternoon, mom noticed that the child had an abnormal gait, imbalance when walking. She was seen in the Emergency Department on 22MAY2020. Labs were drawn, a normal saline bolus was given along with antihistamines that were ordered. Mom reported that the child seemed significantly weaker and more lethargic upon review of the systems. She was positive for fevers, leg swelling, joint swelling and color change, with no change in her rashes. She was stable for discharge from the Emergency Department on 22MAY2020. After the ED (emergency department) visit the child had multiple telephone appointments with different pediatricians and on 24MAY2020 was diagnosed with Serum Sickness. Parent continued to give antihistamines as needed as her symptoms slowly improved, per mom all symptoms ended on 04JUL2020. This case contains an event assessed by the investigator as a serious possible immune mediated disorder (pIMD). On 20 May 2020, 7 days after starting Amoxicillin (GSK product, taken for Antibiotic), subject experienced Serum sickness. Follow up information received on 11-MAR-2022. This follow up was considered non-significant. Summary of changes: No new information updated. Follow up information was received on 19-DEC-2024 Summary of changes: Treatment medication name updated from Clindamycin Palmitate to Clindamycin Palmitate Hydrochloride Upon internal review the case was updated on 23-Dec-2024 Device causality updated from no to unknown. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix, DTPa-HBV-IPV-HIB from World-MKT to World-INV, Rotarix lyophilized formulation from BB-9,231 to World-INV. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of serum sickness, 49 days after receiving the 4th doses of Bexsero vs Placebo, Prevnar 13, 1st doses of M-M-R II and Varivax, 231 days after receiving the 3rd doses of Hiberix and DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, and 294 days after receiving the 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 13-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology (event occurred after a 7 day course of amoxicillin).
More
|