| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2844484 | 1.25 | M | WA | 06/10/2025 |
HEPA MMR PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
A3X2K Y000224 MF0416 Y013350 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
More
|
Patient was given 12 month vaccines instead of 15 month vaccines. Mother of patient was called and i...
Patient was given 12 month vaccines instead of 15 month vaccines. Mother of patient was called and informed by Provider that patient received duplicate vaccines. Mother of patient notes that he is doing well. No high temp, highest was 99.8F. Reports he is acting like himself. Eating well, drinking well, voiding and stooling well. Denies rash or sleeping concerns. Mother of patient was very understanding.
More
|
||||||
| 2844485 | 30 | F | FL | 06/10/2025 |
TDAP TYP YF |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U7999AA X2A231M UK065AB |
Dysgeusia, Throat clearing; Dysgeusia, Throat clearing; Dysgeusia, Throat cleari...
Dysgeusia, Throat clearing; Dysgeusia, Throat clearing; Dysgeusia, Throat clearing
More
|
On 6/6/2025 c/o metallic taste back of tognue after all vaccinations were adminstrated. Was clearin...
On 6/6/2025 c/o metallic taste back of tognue after all vaccinations were adminstrated. Was clearing her throat, stated like when having reflux. No other symptoms, no other findings. No distress noted. No SOB, no stridor, no wheezing, throat and tongue appear normal, no rash, no itching. Observed one hour. Pt said the metallic taste was decreasing. Vital signs remained normal thru out. Left health unit in no distress. Advised to seek immediate medical attention if worsen. Advised to consult with PCP. Follow up: she said the symptom resolved later that afternoon.
More
|
||||||
| 2844486 | 1 | F | CA | 06/10/2025 |
MMR |
MERCK & CO. INC. |
Y011711 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
I BY MISTAKE GAVE PT MMR2 WHEN PROQUAD WAS OREDERED
I BY MISTAKE GAVE PT MMR2 WHEN PROQUAD WAS OREDERED
|
||||||
| 2844487 | 53 | F | GA | 06/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Mobility decreased, Myalgia
Mobility decreased, Myalgia
|
Muscle pain has been so bad I can't lift my arm days later. Tomorrow it will have been a week a...
Muscle pain has been so bad I can't lift my arm days later. Tomorrow it will have been a week and I still can't fully lift the arm the vaccine was given in. I am taking Aleve and using heating pad and ice. Today I can move it a little mor but it is still painful to get dressed.
More
|
||||||
| 2844488 | 55 | F | GA | 06/10/2025 |
HEP HEP PNC20 PNC20 |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION PFIZER\WYETH PFIZER\WYETH |
|
Bone pain, Deafness unilateral, Erythema, Influenza like illness, Pain in extrem...
Bone pain, Deafness unilateral, Erythema, Influenza like illness, Pain in extremity; Skin warm; Bone pain, Deafness unilateral, Erythema, Influenza like illness, Pain in extremity; Skin warm
More
|
For the first 6 days, patient experienced what she describes as severe bone pain, especially from th...
For the first 6 days, patient experienced what she describes as severe bone pain, especially from the waist down, so bad that she had to lay down. Patient says she still has bone pain as of day 8, but not as bad. Flu-like symptoms are ongoing as of day 8 and have been since she received the vaccines. Also after receiving the vaccines, she has experienced loss of hearing in her right ear. Her left arm became red and hot to the touch on day 8. Arm has been swollen and sore since day one.
More
|
||||||
| 2844489 | 0.75 | M | 06/10/2025 |
PNC20 |
PFIZER\WYETH |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Vaccine given too early
Vaccine given too early
|
|||||||
| 2844490 | 12 | M | NE | 06/10/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
9X7CD 9X7CD |
Injection site cellulitis, Injection site erythema, Injection site induration, I...
Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling; Myalgia
More
|
Notable swelling, pain and redness on his left shoulder near the area he was given the Menveo vaccin...
Notable swelling, pain and redness on his left shoulder near the area he was given the Menveo vaccine yesterday. He reports he initially felt fine after the vaccine. About an hour after the vaccine, he started to have some muscles soreness. He became more concerned today when he woke up and saw the left shoulder was very visibly more swollen than the right shoulder as well as red and hard to the touch. He has no past history of allergies or vaccine reactions. He denies any breathing issues like wheezing or shortness of breath. The onset was 1 day ago with worsening symptoms since that time. No fever. Symptoms include erythema located on left shoulder to the side of the injection site of the vaccine, pain is moderate.. Denies fever and chills. There is history of trauma to the area. Involved area: Location: left shoulder in the deltoid area. There is a 10 cm by 10 cm area of erythema without fluctuance noted. The area is tender, warm and indurated. There is not presence of axillary lymphadenopathy. No rash or swelling elsewhere. The mark from where his vaccine was given is just posterior on the deltoid to the area of erythema and swelling Assessment: 1. Vaccine reaction, initial encounter 2. Cellulitis of left upper extremity Plan: The diagnosis was discussed along with the usual course and treatment. We discussed that the initial swelling could be a localized allergy to the vaccine, so I would like him to see allergy prior to him getting his second Menveo. I offered allergy referral today but mom would like to hold off on this until he is older and closer to needing his second Menveo vaccine. Supportive care of swelling with icing and NSAIDs Will prescribe prednisone for a couple days to help get the swelling down.
More
|
||||||
| 2844491 | 44 | F | MD | 06/10/2025 |
HPV9 |
MERCK & CO. INC. |
z00505 |
Peripheral swelling, Rash, Skin swelling
Peripheral swelling, Rash, Skin swelling
|
Hands are swollen and puffy. Patient has a rash on the arms. Counseled patient to go to urgent care ...
Hands are swollen and puffy. Patient has a rash on the arms. Counseled patient to go to urgent care and let their primary care physician know.
More
|
||||||
| 2844492 | 33 | F | CO | 06/10/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300217A |
Injection site discolouration, Injection site erythema, Injection site irritatio...
Injection site discolouration, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
More
|
3 days post vaccination, patient reported greater than normal swelling/irritation at injection site....
3 days post vaccination, patient reported greater than normal swelling/irritation at injection site. Noticed yellow/purple discoloration in a ~3-inch diameter around injection site with pain, redness and swelling also present in same area.
More
|
||||||
| 2844493 | 16 | M | TN | 06/10/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
7MN4C u8494aa |
Malaise, Syncope; Malaise, Syncope
Malaise, Syncope; Malaise, Syncope
|
Patient got shots and waited 15 minutes after injections. Nurse checked arm and patient. Patient was...
Patient got shots and waited 15 minutes after injections. Nurse checked arm and patient. Patient was told they could leave. Mother and child were standing at the check out window. Patient told his mother that he did not feel well. Mother of child assisted child to the floor. Child had a syncopal episode. Episode was approximately 2 minutes long. He awoke and remained on the floor while his legs were elevated. Heart rate and blood pressure were checked. Patient was given Gatorade to drink, assisted into a wheelchair, and placed back on the exam table in a supine position. Cold rags were placed on patients forehead and chest. Vital signs were checked again. Patient was given 4 more Gatorades to drink and a protein bar to eat. Patient became stable after 20 minutes in room. Patient left office with mother.
More
|
||||||
| 2844494 | 1.5 | M | 06/10/2025 |
HEPA |
MERCK & CO. INC. |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Hep A given too early
Hep A given too early
|
|||||||
| 2844495 | 93 | M | IA | 06/10/2025 |
COVID19 |
MODERNA |
LW230528 |
Death
Death
|
Passed away
Passed away
|
โ | |||||
| 2844496 | 66 | F | CA | 06/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Arthralgia, Injection site discomfort, Injection site erythema, Injection site p...
Arthralgia, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
More
|
first day soreness in injection site and warm sensation second day redness , itching and discomfort ...
first day soreness in injection site and warm sensation second day redness , itching and discomfort , pt stated that redness i moving down in the arm, advised pt to take Ibuprofen and Benadryl
More
|
||||||
| 2844497 | 51 | M | MI | 06/10/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
334T3 334T3 |
Blood triglycerides increased, Slit-lamp tests normal, Visual acuity tests abnor...
Blood triglycerides increased, Slit-lamp tests normal, Visual acuity tests abnormal, Visual impairment, Vitreous degeneration; Vitreous detachment, Vitreous floaters
More
|
Patient presents with flashes, floaters, dark spots in vision. Last saw Dr. 4/25/25 for similar con...
Patient presents with flashes, floaters, dark spots in vision. Last saw Dr. 4/25/25 for similar concerns but was diagnosis with syneresis. States that flashes of light have improved since then but still noticing a handful of floaters. Received Shingrix vaccine in 4/18/25. When the patient spoke with his PCP, his PCP suggested seeing ophthalmology d/t concern for possible reaction from the vaccine. Reports mild pain worsened with EOM's. OS floater in central vision, and flashes superotemporal (12 times per day, fleeting) Past Ocular History - Wears glasses, no contacts - No prior surgery or laser - No prior trauma - High myope -7/-6 sphere
More
|
||||||
| 2844498 | 1.58 | M | 06/10/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
dtap and polio given to early
dtap and polio given to early
|
|||||||
| 2844499 | 68 | F | AR | 06/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PJ353 |
Hypotension, Syncope
Hypotension, Syncope
|
Patient reported having very low blood pressure the morning after receiving her second dose of Shing...
Patient reported having very low blood pressure the morning after receiving her second dose of Shingrix (Systolic of 90 and 70), and fainting twice. She stated she slept for several hours during the day yesterday and is now feeling back to normal. She reported the reaction today to the pharmacy and to her provider this morning. She is not seeking care currently.
More
|
||||||
| 2844500 | 2 | M | AL | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
ln8272 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1...
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
More
|
||||||
| 2844501 | 2 | F | AL | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Inappropriate schedule of product administration, Incorrect dose administered, N...
Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
More
|
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1...
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
More
|
||||||
| 2844502 | 90 | F | TX | 06/10/2025 |
COVID19 |
MODERNA |
3043837 |
Injection site bruising, Injection site erythema, Pruritus, Tenderness
Injection site bruising, Injection site erythema, Pruritus, Tenderness
|
Patient received vaccination on Friday 6/10/25 at about 4:30 p.m. Patient states she felt fine the r...
Patient received vaccination on Friday 6/10/25 at about 4:30 p.m. Patient states she felt fine the remainder of Friday and all day Saturday. On Sunday she began to notice itching on the right arm. Patient presented to the pharmacy on Tuesday 6/10/25 at 1:15 p.m. with a red circle roughly 4 inches in diameter about an inch and a half below the injection site. There was some bruising and patient reported tenderness in the elbow.
More
|
||||||
| 2844503 | 16 | M | DC | 06/10/2025 |
MMRV |
MERCK & CO. INC. |
Y016874 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Provider ordered Proquad (MMRV) for pt. Pt is past manufacture's age range for immunization.
Provider ordered Proquad (MMRV) for pt. Pt is past manufacture's age range for immunization.
|
||||||
| 2844504 | 4 | M | AL | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1...
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
More
|
||||||
| 2844505 | 26 | M | MD | 06/10/2025 |
MMRV |
MERCK & CO. INC. |
Y008280 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Patient administered Proquad vaccine. Database was not verified before given. called and spoke with ...
Patient administered Proquad vaccine. Database was not verified before given. called and spoke with vaccine company Merck and was advised per CDC ages 13 & older it is Valid administration as it is no recommended but not harmful to patient and will close the series for the patient and will be consider the booster for the patient. No side affect or medical concerns at this time reported from patient.
More
|
||||||
| 2844506 | 0.67 | F | 06/10/2025 |
DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
TC47K TC47K TC47K |
Fatigue, Irritability, Lethargy, Swollen tongue; Asthenia, Drooling, Dyspnoea, I...
Fatigue, Irritability, Lethargy, Swollen tongue; Asthenia, Drooling, Dyspnoea, Infant irritability, Nasal congestion; Nausea, Pyrexia, Respiratory tract congestion, Swollen tongue, Vomiting; Fatigue, Irritability, Lethargy, Swollen tongue; Asthenia, Drooling, Dyspnoea, Infant irritability, Nasal congestion; Nausea, Pyrexia, Respiratory tract congestion, Swollen tongue, Vomiting
More
|
Patient received Pediarix vaccine and immediately at home began to be lethargic, had a swollen tongu...
Patient received Pediarix vaccine and immediately at home began to be lethargic, had a swollen tongue, was extremly fussy and fatigue. Patient was seen at an urgent care & given prednisone. MOP stated that this form of medication did not work and it subsided a few days later.
More
|
|||||||
| 2844507 | 12 | F | HI | 06/10/2025 |
HPV9 |
MERCK & CO. INC. |
X022737 |
Cardiac monitoring normal, Dizziness, Postural orthostatic tachycardia syndrome,...
Cardiac monitoring normal, Dizziness, Postural orthostatic tachycardia syndrome, Presyncope, Thyroid function test
More
|
Complaints of POTS x 6 months after vaccine administration. Last episode was 2 days ago associated w...
Complaints of POTS x 6 months after vaccine administration. Last episode was 2 days ago associated with near-syncope, dizziness
More
|
||||||
| 2844508 | 0.92 | M | AL | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1...
The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent on 12/18/2024 and 01/10/2025. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
More
|
||||||
| 2844509 | 1.33 | M | MT | 06/10/2025 |
PPV |
MERCK & CO. INC. |
HR3650 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
PPSV23 given to 16 month old patient instead of PCV20
PPSV23 given to 16 month old patient instead of PCV20
|
||||||
| 2844510 | 0.92 | M | AL | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
ln8272 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
The child covid vaccine, age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted...
The child covid vaccine, age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
More
|
||||||
| 2844511 | 4 | M | CO | 06/10/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
NG9E2 |
Wrong product administered
Wrong product administered
|
Pt. received a Menveo shot instead of PCV20 shot.
Pt. received a Menveo shot instead of PCV20 shot.
|
||||||
| 2844512 | 0.5 | F | WA | 06/10/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
EX434 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient was given a 3rd dose of Rotarix at their 6month Well Child visit in error, not s/sx of adver...
Patient was given a 3rd dose of Rotarix at their 6month Well Child visit in error, not s/sx of adverse reaction noted. Patients physician was notified and patient's mother was notified prior to leaving the visit that day.
More
|
||||||
| 2844513 | 76 | M | SC | 06/10/2025 |
PNC21 TD |
MERCK & CO. INC. SANOFI PASTEUR |
Y013009 U8021BA |
Contusion, Skin warm; Contusion, Skin warm
Contusion, Skin warm; Contusion, Skin warm
|
Right arm large bruised area & warm
Right arm large bruised area & warm
|
||||||
| 2844514 | 0.5 | F | CO | 06/10/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
n/a
n/a
|
||||||
| 2844515 | 0.33 | F | UT | 06/10/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
2CA53C1 LX4483 Y014317 |
Tremor; Tremor; Tremor
Tremor; Tremor; Tremor
|
Tremor of head after immunizations, started within a couple days of immunization and lasted 2-3 week...
Tremor of head after immunizations, started within a couple days of immunization and lasted 2-3 weeks. No tremor of extremities. Tremor was nearly constant and infant was always responsive with tremor. Touch did not diminish tremor. Tremor lasted lasted 2-3 weeks and was also noted at daycare. Not facial paralysis or drooping. no weakness noted.
More
|
||||||
| 2844516 | 55 | M | MD | 06/10/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
MF0416 93N4J |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
|
Patient had no physical effects from either vaccine. However, patient had a Libre 3 sensor on the r...
Patient had no physical effects from either vaccine. However, patient had a Libre 3 sensor on the right arm. Patient states that after he received the vaccines the sensor had a low reading, and a few minutes later the sensor went dead. During administration of the vaccines, the sensor did not appear to be stable on patient's arm, as patient continued to press the sensor down to keep it stuck to arm.
More
|
||||||
| 2844517 | 58 | F | NC | 06/10/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Heart rate increased, Herpes zoster, Malaise, Neuralgia, Pain in extremity; Pyre...
Heart rate increased, Herpes zoster, Malaise, Neuralgia, Pain in extremity; Pyrexia
More
|
ved Capvaxive vaccine. The following day (5/20/25) had fever, an elevated heart rate (increase from...
ved Capvaxive vaccine. The following day (5/20/25) had fever, an elevated heart rate (increase from 83 to 88 bpm resting heart rate, and approx 24 hours after vaccination HR was as high as 118 while resting) and a very sore arm (pain 6/10). Patient overall didn't feel well. About a week after vaccination, developed a shingles rash in several areas, include L side of torso (2 spots, one mid side and one higher up) as well as some spots on the back of each arm just outside of the armpit area. This patient had chicken pox as a child and has not been vaccinated against shingles. Had one prior flare up of shingles in 2017 when undergoing a stressful life event. Nothing since until this episode. This is all self-report. Patient did not visit her physician. As of this report, shingles rash is resolving with only mild postherpetic neuralgia
More
|
||||||
| 2844518 | 32 | M | CO | 06/10/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
Y020516 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Patient had received a dose of Varicella on 5/6/25 and then went to Urgent care for an appointment a...
Patient had received a dose of Varicella on 5/6/25 and then went to Urgent care for an appointment and they gave him a Dose of MMR on the that day. The dose of MMR is considered invalid. Patient did not have any side effect or symptoms post vaccination.
More
|
||||||
| 2844519 | 66 | M | FL | 06/10/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Dizziness, Erythema, Peripheral swelling
Dizziness, Erythema, Peripheral swelling
|
The patient presented with a red and swollen arm. She stated the she felt dizziness after taking the...
The patient presented with a red and swollen arm. She stated the she felt dizziness after taking the vaccine but reported to the pharmacy on 06/10/2025
More
|
||||||
| 2844520 | M | MA | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chills, Pain in extremity
Chills, Pain in extremity
|
Chills; Arm soreness; This is a spontaneous report received from a Consumer or other non HCP. An 82...
Chills; Arm soreness; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing); "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: DOXAZOSIN; MELATONIN; METOPROLOL; MIRALAX; SIMVASTATIN; VITAMIN D [VITAMIN D NOS]. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness". Additional information: When the patient received the original two shots, the only reactions were chills and arm soreness. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient and drug, different dose and events;US-PFIZER INC-202500117641 same patient and drug, different dose and events;US-PFIZER INC-202500117116 same patient and drug, different dose and events;US-PFIZER INC-202500117114 same patient and drug, different dose and events;
More
|
|||||||
| 2844521 | M | MA | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chills, Pain in extremity
Chills, Pain in extremity
|
chills; arm soreness; This is a spontaneous report received from a Consumer or other non HCP. An el...
chills; arm soreness; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing), notes: heart arrhythmia; "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "chills", "arm soreness". The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Additional information: When the patient received the original two shots, his only reactions were chills and arm soreness. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient, different dose/events;US-PFIZER INC-202500117641 same patient, different dose/events;US-PFIZER INC-202500117114 same patient, different dose/events;US-PFIZER INC-202500117115 same patient, different dose/events;
More
|
|||||||
| 2844522 | M | MA | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Fatigue
Fatigue
|
tired; This is a spontaneous report received from a Consumer or other non HCP. An elderly male pati...
tired; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing), notes: heart arrhythmia; "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "chills", "arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chills", "arm soreness". The following information was reported: FATIGUE (non-serious) with onset Sep2022, 12 hrs after the suspect product(s) administration, outcome "recovered", described as "tired". Additional information: When the patient received the original two shots, his only reactions were chills and arm soreness. He is not sure if he had any other reaction besides these and being tired for the first few booster shots. These started about 12 hours after the shot and ended after about 24 hours. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient, different dose/events;US-PFIZER INC-202500117114 same patient, different dose/events;US-PFIZER INC-202500117115 same patient, different dose/events;US-PFIZER INC-202500117116 same patient, different dose/events;
More
|
|||||||
| 2844523 | 06/10/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Ankle fracture, Aphonia, Chest discomfort, Degenerative bone disease, Foot fract...
Ankle fracture, Aphonia, Chest discomfort, Degenerative bone disease, Foot fracture; Hordeolum, Intervertebral disc degeneration, Malaise, Pyrexia, Rheumatoid arthritis; Stress
More
|
non zero rheumatoid so I'm flared up all over the place; broke my ankle; broke my heel; a stye ...
non zero rheumatoid so I'm flared up all over the place; broke my ankle; broke my heel; a stye in my eye; Stress causes my disease to flare up; keep losing my voice; stuff in my chest; degenerative bone; degenerative disc; not feeling good/I fell ill; fever; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) 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 complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "non zero rheumatoid so I'm flared up all over the place"; ANKLE FRACTURE (medically significant), outcome "unknown", described as "broke my ankle"; FOOT FRACTURE (medically significant), outcome "unknown", described as "broke my heel"; HORDEOLUM (non-serious), outcome "unknown", described as "a stye in my eye"; STRESS (non-serious), outcome "unknown", described as "Stress causes my disease to flare up"; APHONIA (non-serious), outcome "unknown", described as "keep losing my voice"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "stuff in my chest"; DEGENERATIVE BONE DISEASE (non-serious), outcome "unknown", described as "degenerative bone"; INTERVERTEBRAL DISC DEGENERATION (non-serious), outcome "unknown", described as "degenerative disc"; MALAISE (non-serious), outcome "unknown", described as "not feeling good/I fell ill"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of ankle fracture, foot fracture, chest discomfort. Clinical course: Caller was transferred to the escalations department to speak with a supervisor to provide their feedback regarding the changes to the patient assistance program for the medication Xeljanz. During the call caller stated the following." I'm sick I have crap in my chest I'm on enough antibiotics. I have nothing but good things to say about Pfizer, I got all the Pfizer boosters. Stress causes my disease to flare up. apparently I have a stye in my eye. Tuesday I got a shot in my ankle the foot doctor said yeah you got a stye in your eye. I'm permanently disabled, I'm handicapped. Unfortunately I fell ill I keep losing my voice I'm just not feeling good I'm running a fever I got stuff in my chest. I have rods and screws in my back I need a knee replacement, I broke my heel I was misdiagnosed and as a result I broke my ankle it never healed right that's why I gotta get shots every 4 months. It's all on my right leg. Unfortunately I got sick. I can't sit down and type up a whole paragraph I'm too sore. I have degenerative bone, degenerative disc. and I have non zero rheumatoid so I'm flared up all over the place I'm swollen and sore right now." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||||
| 2844524 | F | NY | 06/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Parosmia
Parosmia
|
she is experiencing unusual scents in smell.; This is a spontaneous report received from a Consumer ...
she is experiencing unusual scents in smell.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 40-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: PAROSMIA (non-serious) with onset 2025, outcome "unknown", described as "she is experiencing unusual scents in smell.". Additional information: Reporter mentioned when she had Covid 19 vaccine, after four years getting the shot she is experiencing unusual scents in smell. She experienced something that she shouldn't have experienced. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
More
|
|||||||
| 2844525 | 06/10/2025 |
PNC20 |
PFIZER\WYETH |
|
Drug ineffective, Pneumonia
Drug ineffective, Pneumonia
|
one patient in the last year who was hospitalized for pneumonia; This is a spontaneous report receiv...
one patient in the last year who was hospitalized for pneumonia; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2025 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), outcome "recovered", described as "one patient in the last year who was hospitalized for pneumonia". The patient was hospitalized for drug ineffective (start date: 2024). Additional information: Doctor believed he had one patient in the last year who was hospitalized for pneumonia, cant recall if they were vaccinated or not but if they were it would have been with Prevnar 20 because that was all he prescribed. Also mentioned that "like any vaccine some people have minor injection site reactions or temporary fever". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective with the suspect product PREVNAR 20 cannot be fully excluded.
More
|
โ | ||||||||
| 2844526 | VA | 06/10/2025 |
PNC20 |
PFIZER\WYETH |
|
Product storage error
Product storage error
|
administration after the excursion; administration after the excursion; This is a spontaneous report...
administration after the excursion; administration after the excursion; This is a spontaneous report received from an Other HCP. An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "administration after the excursion". Additional information: The reporter wanted to get a stability report because of a temperature excursion for the PREVNAR 20 PEDIATRIC. The vaccine was administered to the patient after the excursion. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
More
|
||||||||
| 2844528 | 58 | F | MO | 06/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9L944 |
Rash, Rash erythematous, Rash papular
Rash, Rash erythematous, Rash papular
|
Pt describes a rash starting the day after administration on Friday 6/6/25 and continued getting pro...
Pt describes a rash starting the day after administration on Friday 6/6/25 and continued getting progressively worse through the weekend. She reported to the pharmacy to pickup a prescription after seeing Dr. regarding the reaction on Tuesday 6/10/25 and the rash was covering most of her right deltoid and was raised and very red. Dr. prescribed doxycycline to treat her for vasculitis and allergic reaction. Patient also reported nausea and body aches Friday thru Sunday.
More
|
||||||
| 2844529 | 18 | F | CO | 06/10/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Arthralgia, Fatigue, Injected limb mobility decreased, Injection site swelling, ...
Arthralgia, Fatigue, Injected limb mobility decreased, Injection site swelling, Limb discomfort
More
|
Unusual and prolonged pain at site of infection lasting at least 8 days. Initial swelling. Overall...
Unusual and prolonged pain at site of infection lasting at least 8 days. Initial swelling. Overall fatigue and ongoing limitation of L arm motion due to discomfort persisting at least 8 days
More
|
||||||
| 2844530 | 1.92 | F | MA | 06/10/2025 |
DTAP |
SANOFI PASTEUR |
|
Abnormal behaviour, Psychomotor hyperactivity, Pyrexia
Abnormal behaviour, Psychomotor hyperactivity, Pyrexia
|
My daughter started to act very wild and run around non-stop. She was jumping, rolling, and acting o...
My daughter started to act very wild and run around non-stop. She was jumping, rolling, and acting out of the ordinary for a normally calm toddler. She would not follow directions and is normally very calm. She started to have a fever. She would not go to bed. She acted out of character and wouldn't calm down for two days, and had a fever for about two days.
More
|
||||||
| 2844531 | 22 | F | 06/10/2025 |
HEP MMR TDAP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
947931 Y015020 U8353AA Z003767 |
Dizziness, Loss of consciousness, Vomiting; Dizziness, Loss of consciousness, Vo...
Dizziness, Loss of consciousness, Vomiting; Dizziness, Loss of consciousness, Vomiting; Dizziness, Loss of consciousness, Vomiting; Dizziness, Loss of consciousness, Vomiting
More
|
Patient received 4 vaccines (MMR, Adacel, Varivax, and Heplisav-B). The patient briefly passed out a...
Patient received 4 vaccines (MMR, Adacel, Varivax, and Heplisav-B). The patient briefly passed out and then came back to. She was feeling a little dizzy and vomited. The paramedics arrived and checked her vitals and they were all normal. She was feeling better about 30 minutes after the injections.
More
|
|||||||
| 2844532 | 4 | F | CA | 06/10/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
Injection Site had red and had a bump.
Injection Site had red and had a bump.
|
||||||
| 2844533 | 0.17 | M | UT | 06/10/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
B532G UK208AA LK6651 2096662 |
Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability,...
Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability, Pyrexia
More
|
"Fever and very fussy that day", lasting one day. Resolved
"Fever and very fussy that day", lasting one day. Resolved
|
||||||
| 2844534 | 49 | M | CT | 06/10/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
047A21A 045B21A |
Sudden death; Sudden death
Sudden death; Sudden death
|
Online report of sudden death in early 50's male EUA countermeasure recipient. DOSE#1 Date 03/1...
Online report of sudden death in early 50's male EUA countermeasure recipient. DOSE#1 Date 03/19/21 LOT# 047A21A DOSE#2 Date 04/18/21 LOT# 045B21A. Copy of vax available online. Unable to ascertain any other info on subsequent inoculations, the actual onset of post inoculation adverse events or the manner of death. His obituary implies cancer may have been a factor in his demise. Obituary directed donations to a local cancer charity.
More
|
โ |