| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2848033 | 12 | F | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
No adverse event
No adverse event
|
Nil
Nil
|
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| 2848034 | 10 | F | WI | 07/01/2025 |
COVID19 |
MODERNA |
80020 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Medical staff administered a SpikeVax vaccine to a 10 year old child. Medical staff was unaware of ...
Medical staff administered a SpikeVax vaccine to a 10 year old child. Medical staff was unaware of the age recommendations for the SpikeVax. Child left facility without incident. Provider followed up and child was stated to be in fine health still.
More
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| 2848035 | 64 | M | 07/01/2025 |
COVID19 |
MODERNA |
8080803 |
Expired product administered
Expired product administered
|
Expired vaccine was administered to the patient.
Expired vaccine was administered to the patient.
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| 2848036 | 30 | F | OR | 07/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Condition aggravated, Dizziness, Electrocardiogram ambulatory, Headache, Laborat...
Condition aggravated, Dizziness, Electrocardiogram ambulatory, Headache, Laboratory test; Migraine, Postural orthostatic tachycardia syndrome, Seizure
More
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dizziness, pots, worsening seizures and headaches, migraines
dizziness, pots, worsening seizures and headaches, migraines
|
โ | |||||
| 2848037 | 26 | M | CA | 07/01/2025 |
HEP MMR VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. MERCK & CO. INC. |
946062 y011711 y019318 |
Incorrect route of product administration; Incorrect route of product administra...
Incorrect route of product administration; Incorrect route of product administration; Incorrect route of product administration
More
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heplisav-B was given SQ in error. pt at the time reported no symptoms
heplisav-B was given SQ in error. pt at the time reported no symptoms
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| 2848038 | 1 | F | NC | 07/01/2025 |
DTAPIPV HIBV MMRV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
7745R X003663 X023401 HH9322 |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
More
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Kinrix given out of order and MMRV given as first dose instead of MMR and Varicella separately. Pt r...
Kinrix given out of order and MMRV given as first dose instead of MMR and Varicella separately. Pt reported no adverse events. Error was noticed on 7/1/25 when pt returned to clinic for next shot in series.
More
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| 2848039 | 1.92 | F | NC | 07/01/2025 |
DTAPHEPBIP HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
TC47K DN273 |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
More
|
Pediarix given when pt should have received Infanrix.
Pediarix given when pt should have received Infanrix.
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| 2848040 | 62 | F | NY | 07/01/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PD324 |
Diarrhoea, Headache, Nausea
Diarrhoea, Headache, Nausea
|
reaction started within 8 hrs of adm. started with severe h/a and nausea. next day, Thursday h/a c...
reaction started within 8 hrs of adm. started with severe h/a and nausea. next day, Thursday h/a cont with n/d, no vomiting. this cont until Saturday and sx resolved. no further c/o. pt did not have any local reaction at adm site. pt has not had a vaccine reaction in the past.
More
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| 2848041 | 53 | M | NY | 07/01/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7NX57 |
No adverse event
No adverse event
|
Patient aware of error not adverse events noted at this time
Patient aware of error not adverse events noted at this time
|
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| 2848042 | 56 | F | 07/01/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Pustule, Rash; Pustule, Rash
Pustule, Rash; Pustule, Rash
|
Pt states rash with pustules on face 2days later
Pt states rash with pustules on face 2days later
|
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| 2848043 | 0.67 | F | MI | 07/01/2025 |
DTAPIPVHIB PNC15 |
SANOFI PASTEUR MERCK & CO. INC. |
uk038aa y010035 |
Expired product administered; Expired product administered
Expired product administered; Expired product administered
|
when I put the vaccine into the system I realized it expired 6/30/25. I notified Clinic Coordinator...
when I put the vaccine into the system I realized it expired 6/30/25. I notified Clinic Coordinator ASAP and mom was contacted to notify her that expired vaccine was given and review recommendation to repeat the dose as the expired dose will not count. She had questions about whether child would have any untoward side effects - reviewed that the expired vaccine should not cause anything outside of a normal vaccine response, that the concern with giving an expired vaccine is efficacy past the expiry date. Reviewed common vaccine side effects and management of them.
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| 2848044 | 1.17 | F | CT | 07/01/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
z005150 |
Product preparation error
Product preparation error
|
Patient was given a vaccine with the Pentacel diluent was mixed with the MMRV powder
Patient was given a vaccine with the Pentacel diluent was mixed with the MMRV powder
|
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| 2848045 | 18 | F | KY | 07/01/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 77KA5 |
Arthralgia, Back pain, Impaired driving ability, Loss of personal independence i...
Arthralgia, Back pain, Impaired driving ability, Loss of personal independence in daily activities, Mobility decreased; Pain, Pain in extremity
More
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She reports experiencing pain in her right shoulder, which she describes as severe and debilitating....
She reports experiencing pain in her right shoulder, which she describes as severe and debilitating. The pain is so intense that it restricts her mobility, making daily activities such as showering and driving extremely difficult. She also mentions a sharp, shooting pain that radiates down her entire arm to her forearm, past her elbow, and into her back. She has not noticed any swelling, redness, numbness, or tingling in the area. She has been managing the pain with ibuprofen and Tylenol for the past week, along with the application of heat and IcyHot, but these measures have not provided relief. She received a meningitis B vaccine (Bexsero) 7 days ago. This was the second (and final dose). She has never had any other experiences like this with a vaccine. No fevers. Right shoulder pain with limited range of motion of the right upper extremity. There is point tenderness of the posterior (over the superior angle of the scapular) shoulder. She has pain moving the right arm up to 90 degrees and is unable to fully raise her arm over her head. The pain radiates down the arm past the elbow to the forearm. No redness or swelling or subjective warmth is noted. She describes the pain elicited as sharp and shooting. Determined this is acute right shoulder pain after meningococcal vaccine - Likely result of meningitis B vaccine administered on 06/24/2025 - Pain not improved with ibuprofen, Tylenol, heat, or IcyHot - Prescription for meloxicam 15 mg provided; take half a tablet (7.5 mg) once daily, can increase to twice daily if necessary - Follow regimen for a maximum of one week - Referral to consultant for further evaluation - Advised to call if worsening pain; consider oral or intra-articular steroid injection if there's no improvement but I'd like to see what hand or orthopedic surgery would think
More
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| 2848046 | 18 | F | MA | 07/01/2025 |
PNC20 |
PFIZER\WYETH |
LK6653 |
Wrong product administered
Wrong product administered
|
Patient received the wrong vaccine by the Medical Assistant. Provider ordered patient to receive the...
Patient received the wrong vaccine by the Medical Assistant. Provider ordered patient to receive the HPV vaccine. Instead, the Medical Assistant prepared and administered the PCV vaccine to patient.
More
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| 2848047 | 22 | M | MA | 07/01/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Expired product administered, No adverse event
Expired product administered, No adverse event
|
THERE WAS NO ADVERSE EVENT; HOWEVER, AN EXPIRED VACCINE WAS GIVEN TO THE PATIENT
THERE WAS NO ADVERSE EVENT; HOWEVER, AN EXPIRED VACCINE WAS GIVEN TO THE PATIENT
|
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| 2848048 | 0.17 | F | OH | 07/01/2025 |
RV5 |
MERCK & CO. INC. |
2052023 |
Haematochezia
Haematochezia
|
Pt developed blood in stool within 2 days after receiving first rotavirus vaccine
Pt developed blood in stool within 2 days after receiving first rotavirus vaccine
|
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| 2848049 | 54 | F | VA | 07/01/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4913 LN4913 |
Arthralgia, Immediate post-injection reaction, Mobility decreased, Myalgia, Pain...
Arthralgia, Immediate post-injection reaction, Mobility decreased, Myalgia, Pain; Product administered at inappropriate site
More
|
Patient sent message with below complaint of vaccine concern, "I am still having pain from the ...
Patient sent message with below complaint of vaccine concern, "I am still having pain from the shot last Monday. My shoulder is painful with zero activity. I have limited mobility. Ie: hurts to raise arms to get dressed and resonates done my arm. The shot was very high and very painful when administered. I waited a week to see if it was just muscle pain but something is not right. " Recommendation from physician "Spoke with patient, she reports vaccine administration was very high up on her arm and she had immediate pain, has not improved in >1 week, pain with any overhead movement. Located at top of shoulder radiating to bicep. Suspect vaccine induced tendonitis, recommend ice and medrol pack to reduce inflammation, will send in. Will check in after 1 week."
More
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| 2848050 | 1.5 | M | TX | 07/01/2025 |
TDAP |
SANOFI PASTEUR |
3CA22C1 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
PATIENT WAS GIVEN THE WRONG VACCINE IT SHOULD HAVE BEEN Dtap INSTEAD OF Tdap, we did notified mom a...
PATIENT WAS GIVEN THE WRONG VACCINE IT SHOULD HAVE BEEN Dtap INSTEAD OF Tdap, we did notified mom and if she had any concerns to bring him in to the clinic
More
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| 2848051 | 54 | M | OR | 07/01/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
32M5G |
Adverse reaction, Underdose
Adverse reaction, Underdose
|
Patient was given pediactric dose instead of aldult dose. Patient didn't have any adverse react...
Patient was given pediactric dose instead of aldult dose. Patient didn't have any adverse reaction at the time vaccine was given. He waited 15 minutes after administration. Patient was contacted 07/01/25 @ 2:30 pm and he verified he wasn't having any adverse reactions. He stated he was feeling well.
More
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| 2848052 | 24 | M | NJ | 07/01/2025 |
ADEN_4_7 FLU3 HEP IPV MMR MNQ TDAP VARCEL |
TEVA PHARMACEUTICALS SEQIRUS, INC. DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood cultur...
Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash; Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash
More
|
Patient has what appears to be a leukocytoclastic vasculitis type rash. The etiology is unclear at ...
Patient has what appears to be a leukocytoclastic vasculitis type rash. The etiology is unclear at this time. He had associated fever; now resolved. Blood cultures reveal no growth to date. He received multiple vaccines on 5/21/2025 and 5/27/2025. He has had a cough for the past 6 or 7 weeks. This rash could represent a vaccine reaction or signs/symptoms from a viral syndrome. He appears to be improving off antibiotic therapy.
More
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โ | |||||
| 2848053 | 47 | F | MO | 07/01/2025 |
COVID19 |
MODERNA |
|
Hypertension
Hypertension
|
I have dismissed this for years because I did not want to admit it could be possible. When I first ...
I have dismissed this for years because I did not want to admit it could be possible. When I first started bringing it up to healthcare providers it was kind of dismissed. I have not even discussed it with my current provider.
More
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| 2848054 | 23 | F | 07/01/2025 |
HPV9 |
MERCK & CO. INC. |
2005469 |
Chest discomfort
Chest discomfort
|
About 10 minutes after receiving first dose of this vaccine student developed chest pressure, lastin...
About 10 minutes after receiving first dose of this vaccine student developed chest pressure, lasting about 8 minutes and resolved on its own. Denies shortness of breath, diaphoresis, rash, dizziness, nausea/vomiting or LOC.
More
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| 2848055 | 1.67 | M | MT | 07/01/2025 |
RV5 |
MERCK & CO. INC. |
2037482 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
The child was given 1st dose of Rotateq at 20 months; he is aged out of the recommended time frame.
The child was given 1st dose of Rotateq at 20 months; he is aged out of the recommended time frame.
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| 2848056 | 4 | M | TX | 07/01/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5KR3R |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
No adverse events noted, parent (mother) stated that he is doing well and denied any side effects.
No adverse events noted, parent (mother) stated that he is doing well and denied any side effects.
|
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| 2848057 | 18 | F | OH | 07/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
CD44A |
Injection site erythema, Injection site swelling, Pain
Injection site erythema, Injection site swelling, Pain
|
Redness and swelling of the injection site the day after receiving the vaccination. Swelling and pai...
Redness and swelling of the injection site the day after receiving the vaccination. Swelling and pain persisting x 2 weeks, slowly improving.
More
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| 2848058 | 0.17 | F | 07/01/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
77J49 |
Injection site abscess, Injection site erythema, Injection site induration, Inje...
Injection site abscess, Injection site erythema, Injection site induration, Injection site swelling
More
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Patient developed a sterile abscess, redness, swelling, and hardness at the injection site.
Patient developed a sterile abscess, redness, swelling, and hardness at the injection site.
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| 2848059 | 11 | M | MI | 07/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
49M9N |
Wrong product administered
Wrong product administered
|
The incorrect vaccine was scanned and administered to patient on accident
The incorrect vaccine was scanned and administered to patient on accident
|
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| 2848072 | M | SC | 07/01/2025 |
PNC VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster; Herpes zoster
Herpes zoster; Herpes zoster
|
Patient developed shingles the day after receiving the Shingles vaccine/ rash; This non-serious case...
Patient developed shingles the day after receiving the Shingles vaccine/ rash; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for prophylaxis. Concomitant products included gabapentin. On 21-JUN-2025, the patient received the 1st dose of Shingrix (unknown arm) and Prevnar. On 22-JUN-2025, 1 days after receiving Shingrix and Prevnar, the patient experienced shingles (Verbatim: Patient developed shingles the day after receiving the Shingles vaccine/ rash). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix and Prevnar. It was unknown if the company considered the shingles to be related to Shingrix and Prevnar. Additional Information: GSK Receipt Date: 23-JUN-2025 The patient received the first dose of Shingrix vaccine and developed shingles the day after receiving the Shingles vaccine (Shingrix) as well as the Prevnar vaccine. The Health Care Professional mentioned that patient received the Shingles vaccine and Prevnar vaccine in the same day. The doctor mentioned patient went to urgent care and received Gabapentin after rash presented.
More
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| 2848073 | F | TX | 07/01/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
47XP4 |
Underdose
Underdose
|
A 23 years old female patient received a pediatric dose of Engerix-B; A 23 years old female patient ...
A 23 years old female patient received a pediatric dose of Engerix-B; A 23 years old female patient received a pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 23-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 23-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: A 23 years old female patient received a pediatric dose of Engerix-B) and accidental underdose (Verbatim: A 23 years old female patient received a pediatric dose of Engerix-B). The outcome of the adult use of a child product and accidental underdose were 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: 23-JUN-2025 On 23 June 2025 a practice manager called to report that they accidentally administered a pediatric dose of Engerix-B to a 23 years old female adult patient which led to adult use of a child product and Accidental underdose. This was the first dose of Engerix-B for the patient.
More
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| 2848074 | M | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Thinking abnormal
Thinking abnormal
|
multiversal experiences of parallel universes; This is a spontaneous report received from a Consumer...
multiversal experiences of parallel universes; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THINKING ABNORMAL (non-serious), outcome "unknown", described as "multiversal experiences of parallel universes". Additional information: That was clarified and confirmed with the caller. Stated he took vaccination back in 2019 he got it from pharmacy. Clarified he got the vaccination Pfizer for corona. Reported he was experiencing multiversal experiences of parallel universes. How long did report take. Declined to report, he was late to therapy at redacted clinic. He might had to call back later. When queried reporter type caller stated they called him Dr. Redacted. He was a quantum theorist. They could contact him on his handler with social media. Caller asked if call handler had got any pym particles. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
More
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| 2848076 | M | LA | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Vaccination failure
COVID-19, Vaccination failure
|
went through a round of Paxlovid; went through a round of Paxlovid; This is a spontaneous report rec...
went through a round of Paxlovid; went through a round of Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "recovering" and all described as "went through a round of Paxlovid". The clinical course was reported as follows: The patient's wife mentioned herself, her husband and son, had all Pfizer vaccines and updates, last vaccination occurred on Oct2024. The patient got sick with COVID, and he went through a round of Paxlovid. The patient's prescription was filled on 16Jun2025. It was reported the patient felt better and was able to return to work. Therapeutic measures were taken as a result of vaccination failure, covid-19.
More
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| 2848077 | 72 | F | CT | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Arthralgia, Asthenia, Bone pain, Brain fog, Fatigue
Arthralgia, Asthenia, Bone pain, Brain fog, Fatigue
|
Left arm bone pain; L shoulder pain; weakness; brain fog; fatigue; This is a spontaneous report rece...
Left arm bone pain; L shoulder pain; weakness; brain fog; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jun2025 at 09:45 as dose 01, single at the age of 72 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "exercise intolerance associated with abnormal thyroid levels" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "exercise intolerance" (unspecified if ongoing); "Statins Allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; HCTZ. The following information was reported: ARTHRALGIA (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered", described as "L shoulder pain"; BONE PAIN (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered", described as "Left arm bone pain"; BRAIN FOG (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered"; FATIGUE (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered"; ASTHENIA (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of bone pain, arthralgia, asthenia, brain fog, fatigue. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient taking other medications within 2 weeks of the event starting. The patient had history of exercise intolerance associated with abnormal thyroid levels, currently within normal limits.
More
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| 2848078 | 1.25 | M | NJ | 07/01/2025 |
PNC20 VARCEL |
PFIZER\WYETH UNKNOWN MANUFACTURER |
|
Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria
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Rash; Hives; This is a spontaneous report received from a Physician. A 15-month-old male patient re...
Rash; Hives; This is a spontaneous report received from a Physician. A 15-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08May2025 as dose 4, single (Batch/Lot number: unknown) at the age of 15 months for immunisation; varicella zoster vaccine (VARICELLA VACCINE), on 08May2025 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Ear infection" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for ear infection, start date: 05May2025. Vaccination history included: Prevnar 20 (dose 1), for Immunization; Prevnar 20 (dose 2), for Immunization; Prevnar 20 (dose 3), for Immunization. The following information was reported: URTICARIA (medically significant) with onset 09May2025, outcome "recovered" (14May2025), described as "Hives"; RASH (medically significant) with onset 09May2025, outcome "recovered" (14May2025). Therapeutic measures were taken as a result of rash, urticaria. Clinical course: The reporter clarified, it was Pfizer varicella vaccine. It was the one usually given to 15 month olds. The reporter was not the person who gave vaccine to the patient, the pediatrician did. This Pediatrician sent patient to reporter, as allergist, to evaluate what have given this reaction. The reporter was later asked to evaluate if rash was related to the varicella vaccine. The reporter was asking Pfizer how to evaluate whether there was allergy to vaccine and, if the vaccine can be given. The patient was given Zyrtec by the pediatrician for events rash, hives, and, by 14May2025, everything was gone. The reporter clarified that the rash and hives were gone. The seriousness criteria was nothing critical, patient was not in respiratory distress. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: The events rash, and urticaria conservatively assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
More
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| 2848079 | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Cardiac disorder, Discomfort, Heart rate irregular
Cardiac disorder, Discomfort, Heart rate irregular
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I feel a little bit weird in my heart; feel like I have an issue with my heart; My heart is missing ...
I feel a little bit weird in my heart; feel like I have an issue with my heart; My heart is missing the beat, I did not have this issue before; I do not feel comfortable; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "I feel a little bit weird in my heart; feel like I have an issue with my heart"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "My heart is missing the beat, I did not have this issue before"; DISCOMFORT (non-serious), outcome "unknown", described as "I do not feel comfortable". Additional information: Consumer stated, when patient had COVID back in the days in 2020. The patient had a very bad COVID and patient did their vaccine (clarified as Pfizer COVID-19 Vaccine) like everyone is supposed to do and patient did vaccine of Pfizer. After a while when the patient did the vaccine the patient felt a little bit weird in my heart. The patient felt like patient had an issue with my heart. The patient went check heart but everything okay back in the days but patient just want to report you again. The patient think patient had issue with heart. The patient heart is missing the beat and patient didn't know what is that really and patient felt it connected to what patient did back in the days when patient took the vaccine because patient did not have this issue before, after patient did the vaccine patient felt like patient had issue with my heart and patient know these are recorded and patient didn't feel comfortable." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. .
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| 2848080 | 79 | F | CA | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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severe pain in hips, shoulder; severe pain in hands; This is a spontaneous report received from a Co...
severe pain in hips, shoulder; severe pain in hands; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jun2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunization; Covid-19 vaccine (dose 2), for COVID-19 immunization; Covid-19 vaccine (dose 3), for COVID-19 immunization; Covid-19 vaccine (dose 4), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Jun2025, outcome "recovering", described as "severe pain in hands"; ARTHRALGIA (non-serious) with onset 16Jun2025, outcome "recovering", described as "severe pain in hips, shoulder". Therapeutic measures were not taken as a result of arthralgia, pain in extremity. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2848081 | F | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease
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COPD; This is a spontaneous report received from a Consumer or other non HCP from medical informatio...
COPD; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 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: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".
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| 2848082 | 07/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident, Death
Cerebrovascular accident, Death
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stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022; passed away; This is a s...
stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022; passed away; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): GL-062425-24239. A 64-year-old patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in 2022 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: DEATH (death) with onset 16May2023, outcome "fatal", described as "passed away"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022". The patient date of death was 16May2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: The consumer reported that her husband had a stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022. The consumer stated that she knows the vaccine was not Moderna brand. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death
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| 2848083 | 77 | F | FL | 07/01/2025 |
COVID19 PNC21 |
PFIZER\BIONTECH MERCK & CO. INC. |
MD3414 YO19157 |
Injection site erythema, Injection site pruritus; Injection site erythema, Injec...
Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus
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pink circle around injection site about 2.5 inches wide, itchy
pink circle around injection site about 2.5 inches wide, itchy
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| 2848084 | 66 | F | IL | 07/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3273h |
Injection site erythema, Injection site reaction, Injection site warmth
Injection site erythema, Injection site reaction, Injection site warmth
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likely injection site reaction -- red, warm to touch, patient states the red "circle" appe...
likely injection site reaction -- red, warm to touch, patient states the red "circle" appears to have gotten bigger this morning. Pt states the redness has improved. Patient very concerned of reaction despite being told injection site reactions are common. Agreed to submit VAERS report on pt's reaction. Pt states soreness is no longer present but she did experience "normal" amount of soreness for the day or two following the vaccination. Encouraged pt to continue monitoring and to try reaching out to doctor if still no improvement seen in the next 24 hours.
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| 2848085 | 11 | F | NM | 07/01/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UNKNOWN UNKNOWN UNKNOWN |
Dizziness, Feeling hot, Syncope; Dizziness, Feeling hot, Syncope; Dizziness, Fee...
Dizziness, Feeling hot, Syncope; Dizziness, Feeling hot, Syncope; Dizziness, Feeling hot, Syncope
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Child felt hot, dizzy and fainted ~20 minutes after vaccines administered. Immediately woke up, but ...
Child felt hot, dizzy and fainted ~20 minutes after vaccines administered. Immediately woke up, but went to ER out of an abundance of caution.
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| 2848092 | 61 | F | TX | 07/01/2025 |
MMR |
MERCK & CO. INC. |
Y014096 |
Arthralgia, Discomfort, Pain, Pain in extremity
Arthralgia, Discomfort, Pain, Pain in extremity
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Patient reports with concerns of lasting pain as a potential side effect of the vaccine in her arm, ...
Patient reports with concerns of lasting pain as a potential side effect of the vaccine in her arm, mentions radiating pain up to the shoulder, and discomfort chronically, but could not give me a lot of details. Urged to follow up with provider and follow up regarding the pain she is experiencing .
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| 2848093 | 50 | F | NJ | 07/01/2025 |
PNC21 PNC21 TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y019158 Y019158 D4J9L D4J9L |
Chills, Feeling cold, Injection site mass, Injection site swelling, Injection si...
Chills, Feeling cold, Injection site mass, Injection site swelling, Injection site warmth; Pyrexia; Chills, Feeling cold, Injection site mass, Injection site swelling, Injection site warmth; Pyrexia
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Patient reported a small lump on right arm only after getting vaccinate with the Capvaxive vaccine. ...
Patient reported a small lump on right arm only after getting vaccinate with the Capvaxive vaccine. On friday 6/27/25, the following day after patient got the vaccine she has fever , chills, feeling cold, and had felt warmth and swelling and a small lump on deltoid area of right arm for one week.
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| 2848094 | 42 | F | WI | 07/01/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
33026BD 33026BD 33026BD 33026BD 33026BD |
Acute kidney injury, Balance disorder, Calcinosis, Cardiomyopathy, Chest pain; C...
Acute kidney injury, Balance disorder, Calcinosis, Cardiomyopathy, Chest pain; Coagulopathy, Connective tissue disorder, Dizziness, Dyspnoea, Imaging procedure; Inflammation, Laboratory test, Left ventricular failure, Metabolic acidosis, Pain; Palpitations, Quality of life decreased, Reactive perforating collagenosis, Rhabdomyolysis, Temperature regulation disorder; Visual impairment
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Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rh...
Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rhabdomyolysis chronic, calcification of soft tissues, perforating fibrosis multiple systems., system wide inflammation, sob, chest pain, palpitations, neurological issues such as balance, dizziness., extreme pain, I have no quality of life, inability to regulate body temperature, vision issues, akf, clotting issues,
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| 2848095 | 29 | F | GA | 07/01/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946063 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Vaccine given outside of dosing interval. No adverse effects reported
Vaccine given outside of dosing interval. No adverse effects reported
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| 2848096 | 67 | F | CO | 07/01/2025 |
PNC20 PNC20 VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LX2497 LX2497 5A4XG 5A4XG |
Chills, Erythema, Hyperhidrosis, Peripheral swelling, Pyrexia; Tremor; Chills, E...
Chills, Erythema, Hyperhidrosis, Peripheral swelling, Pyrexia; Tremor; Chills, Erythema, Hyperhidrosis, Peripheral swelling, Pyrexia; Tremor
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Pt HAD cellulitis in right arm so she received both vaccinations in the left arm on 06/28 around 1:1...
Pt HAD cellulitis in right arm so she received both vaccinations in the left arm on 06/28 around 1:15pm. Starting the evening of 06/28, she experienced arm swelling and redness. On 06/29, she experienced fever, chills, sweating, shaking which lasted about 1 day. As of today 07/01, she is still experiencing arm soreness and redness. She has taken advil (which did not help) and Tylenol. She has also used ice packs and heat. Referred patient to contact PCP tomorrow for follow up.
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| 2848097 | 81 | F | MN | 07/01/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
p2443 |
Injected limb mobility decreased, Injection site pain
Injected limb mobility decreased, Injection site pain
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Patient has left arm soreness in the muscle where the vaccine was given. Patient is having a hard ti...
Patient has left arm soreness in the muscle where the vaccine was given. Patient is having a hard time lifting her arm above her shoulder. There is no swelling, no bruising, and no redness.
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| 2848098 | 0.75 | M | CA | 07/01/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
EX434 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a dose of vaccine on 07/01/2025 at 3:00 PM. The patient was checked out at 3:21 PM....
Patient received a dose of vaccine on 07/01/2025 at 3:00 PM. The patient was checked out at 3:21 PM. At the time of the visit, neither the patient nor the parent expressed any concerns. Following the visit, the physician contacted the parent on 07/01/2025 to discuss any current symptoms and to disclose an error related to the vaccine administered. The parent reported no symptoms or concerns during the call. The physician provided ER precautions and gave the parent specific instructions regarding signs and symptoms of intussusception to monitor for at home.
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| 2848099 | 73 | F | FL | 07/01/2025 |
COVID19 RSV |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
md3414 jb27a |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Pt has not reported any adverse effects, however the dose of Arexvy was unnecessary. Patient previou...
Pt has not reported any adverse effects, however the dose of Arexvy was unnecessary. Patient previously received a single dose of Arexvy on03/24/2024, making this an extraneous dose
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| 2848100 | 29 | M | CO | 07/01/2025 |
HPV9 |
MERCK & CO. INC. |
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Dizziness, Eye pain, Headache
Dizziness, Eye pain, Headache
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On Sunday I started to get pain behind my eyes I felt dizzy and I have a headache this has occurred ...
On Sunday I started to get pain behind my eyes I felt dizzy and I have a headache this has occurred since June 29th at 8 am I received the vaccine on June 27th at 9:00 am
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| 2848101 | 12 | M | VA | 07/01/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793 PT |
Confusional state, Fatigue, Headache, Pyrexia, Vomiting
Confusional state, Fatigue, Headache, Pyrexia, Vomiting
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Fever, headache, fatigue nausea, vomiting and confusion
Fever, headache, fatigue nausea, vomiting and confusion
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