| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2855005 | F | VA | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Influenza like illness, Lymphadenopathy, Mammogram
Influenza like illness, Lymphadenopathy, Mammogram
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Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Oth...
Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Other HCP. A female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose 3 (booster), 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 1, SINGLE), administration date: 2021, for covid-19 immunization, reaction(s): "Generic flu like symptoms", "Lymph node enlargement"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2022, for covid-19 immunization, reaction(s): "Generic flu like symptoms", "Lymph node enlargement". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node enlargement"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Generic flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter had some side effects, to the extent where, she was no longer going to take the mrna vaccine. Clarified, there were 2 different side effects. There were 2 side effects, that would usually occur every time she got Covid vaccine, back in 2021, 2022, 2023. That is what reporter was guessing. This occurred when getting 2 dose primary series, occurring both with first and second doses, with third booster dose, got a little bit of it but, was not as much as first and second primary doses. Guessing about the 2021, 2022 and 2023. They were back to back. reporter were thinking it started with first Covid pandemic, which was back in 2020, did not remember if 2020 or 2021 but put 2021, 2022 and 2023, to the best of their knowledge. The lymph node enlargement required her to get a mammogram, and lasted about 6 months. Believes reporter recovered from it. Clarified second side effect as, just generic flu like symptoms, lasted about 4 days. 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-202500165794 same patient, different dose;US-PFIZER INC-202500165859 same patient, different dose;
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| 2855006 | 59 | F | NY | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0170 |
Pyrexia
Pyrexia
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bad fever; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old fe...
bad fever; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: EW0170) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: ER8733; anatomical location:Upper arm, pretty sure right arm.), administration date: 30Mar2021, when the patient was 59-year-old, for COVID-19 Immunization, reaction(s): "heart palpitations". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "bad fever". Additional information: Patient takes vitamins but stopped for a while. Caller stated well now, but nothing back in 2021 doesn't believe. Did the patient receive any other vaccines on the same date as the Pfizer vaccine reported as No. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as No.
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| 2855007 | M | GA | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
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second time testing positive for Covid; second time testing positive for Covid; This is a spontaneou...
second time testing positive for Covid; second time testing positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19, reaction(s): "Dysgeusia (metal taste)"; Paxlovid for COVID-19, reaction(s): "diarrhea"; Paxlovid for COVID-19, reaction(s): "Felt nauseated but didn't vomit"; Paxlovid for COVID-19, reaction(s): "lost his appetite". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Flu vaccine (flu vaccine decades ago, got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "AMPPE"; Flu vaccine (After treatment with high dose steroids, I was able to regain my vision, got a shot in the arm, Name of steroids unknown.), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost my central vision"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 nos (DOSE 3 (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 "second time testing positive for Covid". The patient underwent the following laboratory tests and procedures: Body temperature: maybe .1 or .2 increase; SARS-CoV-2 test: Positive, notes: The second time. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient had original 2 doses and believed he had had 3 boosters. He had contracted Covid twice after the Covid vaccine and boosters. The second time testing positive for Covid, the patient called his doctor on a Friday and he called in script for child dosage of Paxlovid, but he was unable to obtain it. On Monday he called his doctor back and said no one had Paxlovid and can't get it. The doctor asked him how he felt and his temperature was maybe .1 or .2 increase. His doctor said if you are not running a high fever and feel ok don't bother taking it and caller didn't take it the second time. Then he was fine after and his symptoms improved. He didn't need any other treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166339 same patient/event, different dose;
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| 2855008 | F | MO | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Feeling cold
Feeling cold
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body became very cold; This is a spontaneous report received from a Consumer or other non HCP. A fe...
body became very cold; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2), in 2021 as dose number 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: FEELING COLD (non-serious) with onset 2021, outcome "recovered" (2021), described as "body became very cold". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Additional information: The consumer told company representative about her experience with Pfizer Covid vaccine from 2021. Felt like he would just call it in, to be safe. When asked to provide experience reporter had reported to caller, he states, she relayed that, pretty immediately after she received her vaccination, her body became very cold for about 2 minutes, then subsided. That was really the only detail that was provided. Caller had asked her if she felt like it was chills, said it was not really chills, whole body felt cold. Caller did not know how to describe that. Reporter was mentally having to recall when this occurred. Was with her first Covid vaccine, which became available in 2021, caller believed. Clarified, as previously stated, was from 4 years ago, was not a recent event.
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| 2855009 | F | OR | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
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Fasciitis
Fasciitis
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fasciitis in her lower leg; This is a spontaneous report received from a Nurse from medical informat...
fasciitis in her lower leg; This is a spontaneous report received from a Nurse from medical information team. A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 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 1, lot unknown), administration date: 07Mar2021, for covid-19 immunisation; Bnt162b2 (dose 2, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 3, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 4, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 5, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 6, lot unknown), for covid-19 immunisation. Her first Pfizer COVID-19 vaccine was on 07Mar2021 and stated that she already had at least seven Pfizer COVID-19 vaccines. The following information was reported: FASCIITIS (non-serious) with onset Oct2024, 1 week after the suspect product(s) administration, outcome "unknown", described as "fasciitis in her lower leg". The event "fasciitis in her lower leg" required physician office visit. Therapeutic measures were taken as a result of fasciitis. She also stated that she had Physical therapy and anti-inflammatory medications. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2855010 | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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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 73-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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 2024, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2855011 | 59 | F | MD | 08/21/2025 |
COVID19 |
PFIZER\BIONTECH |
FH8030 |
COVID-19, Drug ineffective, Weight
COVID-19, Drug ineffective, Weight
|
had actual Covid - bad case but not hospitalized; had actual Covid - bad case but not hospitalized; ...
had actual Covid - bad case but not hospitalized; had actual Covid - bad case but not hospitalized; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0164), in arm, on 07May2021 as dose 2, single (Lot number: EW0165), in arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 59 years, in arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2023 as dose number unknown (booster), single intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Strong Menopause symptoms" (unspecified if ongoing). There were no concomitant medications (the patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine, and did not receive any other vaccines on the same date as the Pfizer vaccine). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "had actual Covid - bad case but not hospitalized". The patient underwent the following laboratory tests and procedures: Weight: 160. Clinical course: had actual Covid-bad case but not hospitalized in early 2023.
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| 2855012 | M | MD | 08/21/2025 |
DTP IPV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Contraindicated product administered, Injection site erythema, Injection site in...
Contraindicated product administered, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth; Contraindicated product administered, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
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Contraindicated drug combination administered; received the polio and Dtap vaccines, is red; receive...
Contraindicated drug combination administered; received the polio and Dtap vaccines, is red; received the polio and Dtap vaccines, is red and inflamed; area around his bicep is hot; area around his bicep is hot and painful to touch; Initial information received on 05-Aug-2025 regarding an unsolicited valid non-serious case received from the patient's mother. This case involves a 4 years old male patient who received the polio and dtap vaccines, is red and inflamed, and area around his bicep is hot and painful to touch while receiving vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and POLIOMYELITIS VACCINE (INACTIVATED) and while treated with DUPILUMAB [DUPIXENT] via a prefilled pen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection(strength:300 mg) at a dose of 300 mg Q4W subcutaneous for Product used for unknown indication. On 04-Aug-2025, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. On 04-Aug-2025, the patient received a dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) On 04-AUG-2025 the patient developed a non-serious event "received the polio and dtap vaccines, is red and inflamed" (vaccination site inflammation) (Vaccination site erythema ) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB,POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. On 04-AUG-2025 the patient developed a non-serious event "area around his bicep is hot and painful to touch" (vaccination site pain) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB,POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "contraindicated drug combination administered" (contraindicated product administered) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB,POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. Information regarding the batch number and expiration date corresponding to the one at the time of event occurrence was requested. It was reported "he was given four vaccines on 0814/2025. Two shots on each shoulder. Mother reported the patient left shoulder where he received the polio and Dtap vaccines, is red and inflamed. Mother reported the area around his bicep is hot and painful to touch. Mother consented for the provider to be contacted and provided both the dermatologist and pediatrician information" Action taken with DUPILUMAB (DUPIXENT) was unknown for all events. Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (POLIOMYELITIS VACCINE (INACTIVATED)) and DIPHTHERIA, TETANUS AND PERTUSSIS (NOS) VACCINE was not applicable for all events. Corrective treatment:Not reported for all events. Outcome: Unknown for all events This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2855013 | NC | 08/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
Product preparation issue
Product preparation issue
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inappropriate use due to the hib portion of pentacel was administered to a patient without first rec...
inappropriate use due to the hib portion of pentacel was administered to a patient without first reconstituting with the dtap-ipv portion with no reported adverse event; Initial information received on 19-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient with inappropriate use due to the hib portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel(VERO)]l was administered to a patient without first reconstituting with the dtap-ipv portion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received inappropriate use due to the hib portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Powder and suspension for suspension for injection (strength, dose, batch and expiry date unkown) via unknown route in unknown administration site for Immunisation without first reconstituting with the dtap-ipv portion with no reported adverse event (single component of a two-component product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Reportedly, One of the clinic nurses mistakingly used the Hib vial (green top) And did not reconstitute it with the contents in the corresponding blue capped vial. Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2855014 | 28 | M | 08/21/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300212A |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient came in for 3 immunizations, one being Anthrax. Upon reading the expiration date, it was rea...
Patient came in for 3 immunizations, one being Anthrax. Upon reading the expiration date, it was read wrong. The sticker annotating when it was opened cause some confusion as well. The patient has had no adverse effects to the immunization.
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| 2855015 | 63 | F | TN | 08/21/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Unevaluable event
Unevaluable event
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NONE
NONE
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| 2855016 | 5 | F | OH | 08/21/2025 |
DTAP IPV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
223Y9 Y1D03P1 |
Eye movement disorder, Visual acuity tests; Eye movement disorder, Visual acuity...
Eye movement disorder, Visual acuity tests; Eye movement disorder, Visual acuity tests
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Parents noticed tic like movements of patient's eyes, frequently moving both eyes right superol...
Parents noticed tic like movements of patient's eyes, frequently moving both eyes right superolateral. Random frequency. No visual disturbance. No other neurologic symptoms. Behavior slightly more irritable after the immunizations, otherwise normal behavior. Patient evaluated by me on 8/20/25, noted to be of her normal behavior, unchanged from day of vaccine (I saw her that day also). Vision screen unchanged from 8/13/25. Observed to have tic like movements of both eyes to right superolateral. Eye exam otherwise normal. No nystagmus, able to follow finger with her eyes appropriately. Being referred to pediatric neurology.
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| 2855017 | 4 | M | FL | 08/21/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8198AA U8198AA Z005150 Z005150 |
Cough, Heart rate increased, Nausea, Pruritus, Throat tightness; Urticaria; Coug...
Cough, Heart rate increased, Nausea, Pruritus, Throat tightness; Urticaria; Cough, Heart rate increased, Nausea, Pruritus, Throat tightness; Urticaria
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Patient returned about 45 minutes after vaccines were given with coughing and full body hives. He wa...
Patient returned about 45 minutes after vaccines were given with coughing and full body hives. He was nauseated. He said he felt like his throat was being squeezed. Very itchy. HR slightly increased (115 bpm) but O2 was normal. Patient was given epinephrine IM as well as Benadryl for suspected anaphylaxis. He recovered and was sent home. No issues following. Had never had a reaction to a previous vaccine.
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| 2855018 | 17 | F | PA | 08/21/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
49N9M XL223 |
Inflammation; Inflammation
Inflammation; Inflammation
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Local inflammation requiring assessment in office. Topical and oral antiinflammatory meds recommende...
Local inflammation requiring assessment in office. Topical and oral antiinflammatory meds recommended.
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| 2855019 | 64 | F | WI | 08/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Cellulitis, Erythema, Peripheral swelling, Pruritus
Cellulitis, Erythema, Peripheral swelling, Pruritus
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Patient presented at clinic with swollen red, itching upper arm resulting in diagnosis of cellulitis...
Patient presented at clinic with swollen red, itching upper arm resulting in diagnosis of cellulitis recieved rocephin in office and doxycycline twice daily for 7 days.
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| 2855020 | 25 | F | WV | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y004553 |
Antibody test, Feeling abnormal, Pyrexia, Rash
Antibody test, Feeling abnormal, Pyrexia, Rash
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PATIENT CALLED THE HEALTH DEPT 8/21/25 STATED THAT SHE DEVELOPED A FEVER OF 101.6 THAT LASTED FOR 2 ...
PATIENT CALLED THE HEALTH DEPT 8/21/25 STATED THAT SHE DEVELOPED A FEVER OF 101.6 THAT LASTED FOR 2 DAYS APPROX 12-14 DAYS AFTER THE VACCINE AND THE DEVELOPED A RASH THAT RESEMBLED ACNE BUT IT WAS OVER HER BODY WITH AN AREA OF CLUSTERS. SHE STATED" THAT SHE FELT AWFUL." WE ADVISED HER TO COVER UP ANY PUSTLE OR MACROPAPULAR AREAS AND TO VISIT HER PCP.
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| 2855021 | 63 | M | VA | 08/21/2025 |
YF |
SANOFI PASTEUR |
UK138AA |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Medication accidently administered via IM injection instead of Subcutaneous. Yellow Fever physician...
Medication accidently administered via IM injection instead of Subcutaneous. Yellow Fever physician notified. Patient observed for adverse reactions, did not have any. Injection did not need to be readministered.
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| 2855022 | 4 | M | MO | 08/21/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
5g23d 5g23d y009348 y009348 |
Barrel chest, Cough, Rash, Rash erythematous, Rash macular; Respiratory distress...
Barrel chest, Cough, Rash, Rash erythematous, Rash macular; Respiratory distress, Tachypnoea, Use of accessory respiratory muscles, Vomiting; Barrel chest, Cough, Rash, Rash erythematous, Rash macular; Respiratory distress, Tachypnoea, Use of accessory respiratory muscles, Vomiting
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The patient presented to Clinic on 08/18/2025 at approximately 0800 for routine immunizations. ProQu...
The patient presented to Clinic on 08/18/2025 at approximately 0800 for routine immunizations. ProQuad was administered in the left thigh and Kinrix in the right thigh. The patient tolerated the injections without complication and departed the clinic at approximately 0910. At 0915, the patient?s father called reporting a new onset rash and cough. He was advised to return to the clinic for further evaluation. Upon arrival, the patient was noted to be in respiratory distress. Dr. and FNP-BC evaluated the patient. Oxygen saturation was 92% on room air. Examination revealed barrel chest, retracted breathing, and a splotchy erythematous rash across the torso. The patient also demonstrated tachypnea and vomiting. At 0950, Dr. administered Epinephrine 0.15 mg IM to the left thigh, followed by Decadron 4 mg/mL and Diphenhydramine 50 mg/mL. The patient showed an adequate response to treatment with improvement in oxygen saturation to 98% on room air and a pulse of 132 bpm. An ambulance was dispatched for transfer to Emergency Department for continued monitoring. The patient arrived at approximately 1043. He remained stable throughout observation and was prescribed Prednisolone 15 mg/5 mL for home use. The patient was discharged in stable condition at 1252.
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| 2855023 | 18 | M | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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Varicella vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and a...
Varicella vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed patency of vaccination with no need to revaccinate.
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| 2855024 | 2 | F | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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Proquad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) ...
Proquad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed patency of vaccination with no need to revaccinate.
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| 2855025 | 0.5 | M | MO | 08/21/2025 |
DTAPIPVHIB HEP PNC20 RV1 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
UK232AB AZ4TN LN4932 7YS93 |
Feeling hot, Injection site reaction, Rash erythematous; Feeling hot, Injection ...
Feeling hot, Injection site reaction, Rash erythematous; Feeling hot, Injection site reaction, Rash erythematous; Feeling hot, Injection site reaction, Rash erythematous; Feeling hot, Injection site reaction, Rash erythematous
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Baby started feeling warm about an hour after getting vaccines and breaking out with red bumps every...
Baby started feeling warm about an hour after getting vaccines and breaking out with red bumps everywhere but especially around where the vaccine was administered. Mother was going to give baby Benadryl, Tylenol and contact PCP. Will call and check on child for follow up on how they are doing.
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| 2855026 | 1.17 | M | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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Varicella vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and a...
Varicella vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate
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| 2855027 | 4 | M | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) ...
ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate.
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| 2855028 | 43 | F | MI | 08/21/2025 |
COVID19 |
MODERNA |
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Alopecia
Alopecia
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Since 2 months post vax, my hair fell out in copious amounts. The first year, I lost at least 1/3 of...
Since 2 months post vax, my hair fell out in copious amounts. The first year, I lost at least 1/3 of my hair. Now, still, in 2025, I lose hair in cycles. So does my 18 year old daughter who was 14 at time of "vaccination" thus making it unlikely to be a hormonal thing related to menopause. There are many of us out there- who lost a lot of hair. Please research.
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| 2855029 | 44 | F | TX | 08/21/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945663 |
Joint swelling
Joint swelling
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Swelling of left shoulder 3 days after administration
Swelling of left shoulder 3 days after administration
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| 2855030 | 3 | M | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) ...
ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate.
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| 2855031 | 1 | F | 08/21/2025 |
VARCEL |
MERCK & CO. INC. |
Y003891 |
Needle issue
Needle issue
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During administration of varicella vaccine, the vaccine squirted around the needle and was not admin...
During administration of varicella vaccine, the vaccine squirted around the needle and was not administered to patient. Upon assessment needle was appropriately connected to vaccine. Provider notified and parent notified, new vaccine readministered. Lot-Y003891 Ex- 2/6/2026 NDC- 0006-4827-01
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| 2855032 | 1.42 | F | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) ...
ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate.
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| 2855033 | 1.5 | M | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) ...
ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate.
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| 2855034 | 1 | F | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) ...
ProQuad (MMRV) vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate.
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| 2855035 | 10 | F | NY | 08/21/2025 |
HPV9 |
MERCK & CO. INC. |
Z002903 |
Vomiting
Vomiting
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patient and parent stating the following 2 days after vaccine she had multiple episodes of vomiting.
patient and parent stating the following 2 days after vaccine she had multiple episodes of vomiting.
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| 2855036 | 27 | F | WI | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
1960074 |
No adverse event
No adverse event
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Varicella vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and a...
Varicella vaccine was reconstituted with a potentially-expired sterile diluent (sterile water) and administered to the patient. Patient did not experience any adverse reactions. Merck was contacted and Merck confirmed potency of vaccination with no need to revaccinate.
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| 2855037 | 30 | F | CA | 08/21/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4T443 |
Exposure during pregnancy, Product use issue, Wrong product administered
Exposure during pregnancy, Product use issue, Wrong product administered
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Patient given Arexvy instead of Abrysvo. Pt reports EGA 35+2. Patient at risk of adverse event due t...
Patient given Arexvy instead of Abrysvo. Pt reports EGA 35+2. Patient at risk of adverse event due to side effects of pregnant patient receiving Arexvy. Patient remained at clinic for one hour after event. Patient did not report any s/s of preterm labor. Patient's OB provider made aware of incident. Pt reports that her OB provider would call her to discuss what happened, possible side effects, precautions, and next steps. Incident also reported to (withheld) Clinical Consult Team (phone# withheld opt.1).
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| 2855038 | 78 | F | NY | 08/21/2025 |
PNC20 |
PFIZER\WYETH |
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Pain in extremity
Pain in extremity
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Ptn claims to have strong pain in the arm which has decreased but remains a week later
Ptn claims to have strong pain in the arm which has decreased but remains a week later
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| 2855039 | 25 | F | MO | 08/21/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5P2P7 |
Exposure during pregnancy
Exposure during pregnancy
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Patient came into the clinic to receive her 2nd dose of Hepatitis B vaccine but received Meningococc...
Patient came into the clinic to receive her 2nd dose of Hepatitis B vaccine but received Meningococcal B instead, patient is currently pregnant and was 6 months pregnant during the time of vaccination.
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| 2855040 | 52 | F | TX | 08/21/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2HJ99 2HJ99 |
Erythema, Feeling hot, Headache, Influenza like illness, Pyrexia; Rash
Erythema, Feeling hot, Headache, Influenza like illness, Pyrexia; Rash
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Pt showed up at pharmacy on 8/21/25 with concerns about possible allergic rxn with shingrix vaccine ...
Pt showed up at pharmacy on 8/21/25 with concerns about possible allergic rxn with shingrix vaccine dose given on 8/18/25. Pt reported a brief episodes of SOB that went away after a few seconds after receiving the vaccine on 8/18/25. Pt reported mild headache that appeared 2 days after vaccine admin, feverish, flu-like symptoms that appeared 2 days after vaccine admin as well. Upon visual examination, Pt's arm showed signed of local reaction such as warmth, erythema, (swelling that happened the day before and went down). Rash appeared to migrate. RPh on duty troubleshoot Pt's reports of symptoms and explained to Pt that all the local reactions happened to Pt as well as systemic adverse reactions and that those are common with shingrix vaccine and vaccines in general. Prior to going to the pharmacy today, Pt went to seek advice at local pharmacy and was told by RPh that her local reaction was possibly due to too low or too high site of vaccine administration. RPh on duty demonstrated the technique to the Pt and concluded that it was a proper site for administration and to reiterate to Pt that all her symptoms are norm al adverse reactions that were reported in the literature as high incidence of occurrence and local reactions are normal with vaccine in general, which is an indication of her immune system and the vaccine are working well the way it was supposed to. RPh on duty counseled Pt to continue taking benadryl 25mg q46h prn redness, motrin q6h prn swelling and pain , hydrocortisone 1% crm for redness, icepack for pain/swelling. Pt was also counseled to continue monitoring her erythema and make sure it does not spread any further and if it does, she should go see her PCP or urgent care. Pt was reassured that no vaccine errors or error in administration occurred and seemed to be understanding about it. Pt was counseled risk vs benefits, even though erythema and rash might occur with the vaccine but the vaccine is every effective so it's still more beneficial for her to get her second dose and maybe some post-admin meds such as benadryl and motrin/apap should be taken after receiving the vaccine.
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| 2855041 | 12 | F | CA | 08/21/2025 |
TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
ze4n7 z004246 |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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Very nice girl, came in with her mom, vaccinated her and then we stayed in the vaccine room for a fe...
Very nice girl, came in with her mom, vaccinated her and then we stayed in the vaccine room for a few minutes while I finished filling out her vaccination immunization record for the day. then we walked together out the vaccine room to the register. While ringing them out at the register patient appeared to lean against her mom and put her face into her arm/shoulder area, and then she slide down her moms side to the floor passed out. I jumped to the floor to hold her head, we remained on the floor for a few minutes before transferring to chair. She was passed out but breathing, took 10 seconds or so and she blinked and woke. was able to get up and sit in the waiting room chairs with her mom. They stayed here at least another 20min. We provided water, snacks, cold compress on her neck head and chest. She did not hit her head with the way she slid and fell off her mom. We did call to check on her on 08/18/2025, mail box full no way to leave message.
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| 2855042 | 66 | F | CA | 08/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5Y9CA |
Herpes zoster, Rash
Herpes zoster, Rash
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Patient developed shingles rash 6 hours after vaccination
Patient developed shingles rash 6 hours after vaccination
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| 2855043 | 37 | F | NV | 08/21/2025 |
COVID19 HEP HPV9 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Lip swelling, Urticaria; Lip swelling, Urticaria; Lip swelling, Urticaria
Lip swelling, Urticaria; Lip swelling, Urticaria; Lip swelling, Urticaria
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Many hours after the shot, I developed hives, which eventually covered about 80% of my body. My top ...
Many hours after the shot, I developed hives, which eventually covered about 80% of my body. My top lip swelled but I did not have any breathing trouble. My doctor sent a steroid and now they are starting to go away, 2 days later.
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| 2855044 | 2 | M | IL | 08/21/2025 |
DTAP MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Pyrexia, Rash, Urticaria; Pyrexia, Rash, Urticaria
Pyrexia, Rash, Urticaria; Pyrexia, Rash, Urticaria
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Developed fever and urticarial rash x 3d post injection. Rash progressively spread throughout entire...
Developed fever and urticarial rash x 3d post injection. Rash progressively spread throughout entire body - scalp, face, neck, trunk, arms/hands, legs/feet, buttocks/groin.
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| 2855045 | 85 | M | MO | 08/21/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
429P7 |
Product preparation issue
Product preparation issue
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Vaccine was not reconstituted prior to administration, pharmacist injected syringe of only diluent.
Vaccine was not reconstituted prior to administration, pharmacist injected syringe of only diluent.
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| 2855046 | 5 | F | CA | 08/21/2025 |
DTAP MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
497n7 z008223 |
Injection site swelling; Injection site swelling
Injection site swelling; Injection site swelling
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Came to our pharmacy for vaccines needed for school, no issues while here, left feeling fine. We cal...
Came to our pharmacy for vaccines needed for school, no issues while here, left feeling fine. We called parent a couple days later for some insurance information clarification, on 08/13/2025- Dad reported her mmrv vaccine leg was swollen at injection site size of a baseball. We recommended Tylenol, cold compress and movement, and to follow up with provider or go to emergency room if it worsens.
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| 2855047 | 4 | F | CA | 08/21/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
u8009ab y019464 |
Pallor, Syncope; Pallor, Syncope
Pallor, Syncope; Pallor, Syncope
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PT WAS PALE,FAINTED
PT WAS PALE,FAINTED
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| 2855048 | 14 | F | MI | 08/21/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y013132 Y013132 |
Asthenia, Disorientation, Dizziness, Feeling hot, Head injury; Loss of conscious...
Asthenia, Disorientation, Dizziness, Feeling hot, Head injury; Loss of consciousness, Pallor, Syncope
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Client started walking down the hallway and fainted, hit the left side of her head on door frame. Br...
Client started walking down the hallway and fainted, hit the left side of her head on door frame. Briefly lost consciousness (a few seconds), and was disoriented, pale and felt weak and dizzy when she came to. She said she felt hot, temp was 97.2 F. She stated her throat felt a little funny and the left side of her neck and head hurt. There was no active bleeding or broken skin noted. She stated she had not eaten. BP was 100/60 and RR 18. Pupuls were equal and reactive to light. Given a juice and a granola bar and put a fan on her, encouraged to stay on the floor until she felt a little better. Her throat was feeling better once she had a couple drinks of juice. She became oriented and regained memory of the situation within 5-10 minutes. Her color began to improve. Discussed syncope after vaccinations with mom, and advised to have her eat something with protein before receiving any injections. Also discussed plan for future imms or other injections to be given sitting or laying (preferably laying) and to have her stay for observation and refrain from getting up directly afterwords. Mom agreed. Advised they seek further assessment due to hitting her head, and mom agreed. She was able to get herself into a wheelchair with supervisoin, and I wheeled her out to the vehicle and assisted her (spotting) into the passenger's seat. Encouraged mom to go straight to the ER ad that I would let them know they are coming, and she agreed. I let her know also that I would check in with them the next day and she requested this be done via text due to poor service at work. Report given to ER at 5:56 pm while patient and her mom were en route.
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| 2855049 | 11 | F | CA | 08/21/2025 |
HEPA HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
dn273 z005055 9x7cd xn575 |
Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor;...
Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor
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After receiving the final & fourth vaccine, patient stated she was dizzy, was extremely nauseous...
After receiving the final & fourth vaccine, patient stated she was dizzy, was extremely nauseous, pale white, we alerted pharmacists, who assessed, we provided water & a trashcan- she held onto it hovering over it for about 5 minutes while experiencing the nausea, continued to monitor for 15 minutes afterward.
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| 2855050 | 11 | F | MA | 08/21/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8493AA 3CA30C1 |
Injection site erythema; Injection site erythema
Injection site erythema; Injection site erythema
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localized reaction- redness worsening on injection site
localized reaction- redness worsening on injection site
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| 2855051 | 14 | F | MD | 08/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
95bj9 |
Wrong product administered
Wrong product administered
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I reviewed the patient?s chart at my desk to confirm the vaccine due. I then proceeded to the medica...
I reviewed the patient?s chart at my desk to confirm the vaccine due. I then proceeded to the medication room to retrieve the vaccine and believed I had selected the correct one. After scanning the vaccine in the room, I administered it to the patient. However, I later realized that the incorrect vaccine had been given. I promptly informed the provider and my supervisor, who have since spoken with the parent regarding the situation.
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| 2855052 | 90 | F | NY | 08/21/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4932 LN4932 |
Immediate post-injection reaction, Injection site pain, Loss of personal indepen...
Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Tendon calcification; X-ray limb abnormal
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On August 13, 2025, I gave this patient a Pneumococcal Conjugate 20 Valent (Prevnar 20 PCV 20) intra...
On August 13, 2025, I gave this patient a Pneumococcal Conjugate 20 Valent (Prevnar 20 PCV 20) intramuscular injection vaccine in her right deltoid muscle. The patient immediately complained of a pain in her deltoid muscle. I attributed this to the vaccine solution can sting sometimes at the injection site. I instructed the patient to move her arm around today and tomorrow, putting the deltoid muscle through range of motion. If her arm hurts, she can take whatever she takes for a headache, and if the site becomes warm or swollen she can apply ice to the site. On August 19, 2025: the patient's daughter called because the patient received the pneumonia vaccine and she has minimal ROM and still in quite a bit of pain. No redness or swelling. Per Dr.: the patient needs to go to urgent care tonight and then be seen in the office tomorrow at 12:45. Verbalized understanding and will contact the office if needed. Pt scheduled for 8/20/25 at 12:45 as per Dr. On August 20, 2025 "the patient is here for complaint of arm pain after she was given an injection last week. The patient presents for evaluation of joint pain/weakness in the arm following a pneumococcal vaccine. According to the patient the pain was significant enough to limit her arm mobility, requiring assistance from her aunt for daily activities such as hair combing and dressing. She sought medical attention at an urgent care facility, where she was prescribed prednisone. An x-ray revealed age-related changes and calcification in the rotator cuff. According to the daughter the injection may have aggravated a pre-existing condition. The attending physician at the urgent care recommended a follow-up with orthopedics and possibly an injection of prednisone if not fully alleviate the symptoms. She is currently on a 6-day course of prednisone, which has significantly improved her condition, allowing her to lift her arm. She also took Tylenol and Advil for pain management. joint pain post-vaccination: Acute. - Likely due to nerve damage from the pneumococcal vaccine. Significant pain immediately after the injection, with initial inability to move the arm, which has improved but still causes discomfort. Improved range of motion in the arm compared to yesterday, but there is still pain upon resistance. X-ray showed age-related changes and calcification in the rotator cuff, per report from the daughter - Prednisone regimen to reduce inflammation."
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| 2855053 | 20 | F | NY | 08/21/2025 |
MNQ |
SANOFI PASTEUR |
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Pyrexia, Urticaria
Pyrexia, Urticaria
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mother reported allergic reaction to meningitis vaccine, reported subjective fever at following nigh...
mother reported allergic reaction to meningitis vaccine, reported subjective fever at following night and hives all over her body in the morning. Improved after 1 dose of benadryl. Denied anaphylaxis sx. rec: zirtec daily for 1-2 days and discussed anaphylaxis ssx.
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| 2855054 | 5 | M | UT | 08/21/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Joint swelling, Rash
Joint swelling, Rash
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Patient had swelling of the right knee and a rash
Patient had swelling of the right knee and a rash
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