| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2794661 | 0.5 | M | NY | 09/30/2024 |
COVID19 COVID19 DTPPVHBHPB PNC20 RV5 |
PFIZER\BIONTECH PFIZER\BIONTECH MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
LN8272 LN8272 U7296AA LC1279 Y011480 |
Incorrect dose administered, No adverse event; Incorrect dose administered, Irri...
Incorrect dose administered, No adverse event; Incorrect dose administered, Irritability, Pyrexia; Incorrect dose administered, Irritability, Pyrexia; Incorrect dose administered, Irritability, Pyrexia; Incorrect dose administered, Irritability, Pyrexia
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No adverse symptoms reported. 1.1 mL of the diluted Covid vaccine was administered to patient instea...
No adverse symptoms reported. 1.1 mL of the diluted Covid vaccine was administered to patient instead of the ordered 0.3 mL.
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| 2824599 | 59 | F | FL | 02/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3zh27 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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The patient received another dose of Boostrix in less than a 1-year time frame. The patient does not...
The patient received another dose of Boostrix in less than a 1-year time frame. The patient does not have any symptoms or side effects. She got a vaccine in June of 2024 and again yesterday, 2/4/25.
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| 2824600 | 75 | F | GA | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Duplicate administration. Previously administered 11/2023. No reported ADR. Reported to patient who ...
Duplicate administration. Previously administered 11/2023. No reported ADR. Reported to patient who denies knowledge of previous administration.
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| 2824601 | 78 | M | GA | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
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No ADR. Duplicate vaccine. Previously administered in 11/2023. Pt denied knowledge of previous vacci...
No ADR. Duplicate vaccine. Previously administered in 11/2023. Pt denied knowledge of previous vaccination.
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| 2824602 | 54 | F | AL | 02/04/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013009 Y013009 |
Blister, Blister rupture, Hypersensitivity, Injection site pain, Pruritus; Pyrex...
Blister, Blister rupture, Hypersensitivity, Injection site pain, Pruritus; Pyrexia, Swelling face
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Patient called the pharmacy 2 days post vaccine of Capvaxive. Patient was inquiring about possible s...
Patient called the pharmacy 2 days post vaccine of Capvaxive. Patient was inquiring about possible side effects. Patient explained that she was itching all over with swelling of the face. Patient also stated she had blisters arise on her hands and legs that have since ruptured due to itching. Patient stated she had a low grade fever with injection site pain. Patient clarified she DID NOT have any difficulty breathing at the moment. RPH on staff explained that what she was experiencing describes an allergic reaction and directed her to take benadryl (diphenhydramine). Pharmacist emphasized to seek emergency help if difficulty breathing or altered mental state occurs. Patient verified understanding.
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| 2824603 | 78 | F | CO | 02/04/2025 |
PNC20 |
PFIZER\WYETH |
LG5577 |
Rash
Rash
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PT STATED SHE HAD A LOCAL RASH (NOT RAISED) and rash on her torso, inner upper right thigh. pt said...
PT STATED SHE HAD A LOCAL RASH (NOT RAISED) and rash on her torso, inner upper right thigh. pt said it was not itchy.
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| 2824604 | 67 | M | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given a second dose of RSV (Arexvy) vaccine. Patient stated no side effects.
Patient was given a second dose of RSV (Arexvy) vaccine. Patient stated no side effects.
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| 2824605 | 59 | M | OH | 02/04/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Asthenia, Ear discomfort, Impaired work ability, Myalgia, Nasal congestion; Pain...
Asthenia, Ear discomfort, Impaired work ability, Myalgia, Nasal congestion; Pain, Pain in extremity
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Arm pain 2 days, muscle aches, nasal congestion, ears plugged, weakness and pain after exercising 5 ...
Arm pain 2 days, muscle aches, nasal congestion, ears plugged, weakness and pain after exercising 5 days and still running. Missed work.
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| 2824606 | 66 | F | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given a second dose of RSV (Arexvy); had previously received in 2023. Patient stated no ...
Patient was given a second dose of RSV (Arexvy); had previously received in 2023. Patient stated no side effects.
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| 2824607 | 50 | F | SC | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Peripheral swelling
Peripheral swelling
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Patient received shingrix shot Monday Feb 3 and woke up Tuesday Feb 4 to swollen hand on the same si...
Patient received shingrix shot Monday Feb 3 and woke up Tuesday Feb 4 to swollen hand on the same side she received vaccine. No swelling in arm or at injection site, just swollen hand.
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| 2824608 | 50 | F | WA | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Abdominal discomfort, Erythema, Inflammation, Myalgia, Pyrexia
Abdominal discomfort, Erythema, Inflammation, Myalgia, Pyrexia
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Arm was red from my shoulder to my elbow, and was inflamed. I had incredible muscle aches, fever, an...
Arm was red from my shoulder to my elbow, and was inflamed. I had incredible muscle aches, fever, and was sick to my stomach for 5 -7 days
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| 2824117 | U | IL | 02/03/2025 |
MMRV |
MERCK & CO. INC. |
Y010050 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptomatic adverse events were reported.; HCP called to report a Temperature Excursion on case ...
No symptomatic adverse events were reported.; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROPQUAD was inadvertently administered after suffering from a T; This spontaneous report was received from a registered nurse (RN) concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (reported as "Diluent MRK".) On 09-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) injection, 0.5ml/series, lot #Y010050, expiration date 25-NOV-2025 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis. The vaccine was inadvertently administered after suffering from a temperature excursion (product storage error.) It was reported that the product reached -11.6 degrees Celsius (c) and was out of range for 3 hours 5 minutes 0 seconds. Previous excursions could not be confirmed and at the reporting time, temperature excursion was ongoing and it was not possible to confirm if the products were still supported. No symptomatic adverse events were reported (no adverse event). No additional information available. This was one of several reports received from the same reporter.; Sender's Comments: US-009507513-2501USA007066: US-009507513-2501USA008866: US-009507513-2501USA008885: US-009507513-2501USA008880: US-009507513-2501USA008935: US-009507513-2501USA008877: US-009507513-2501USA008882: US-009507513-2501USA007047: US-009507513-2501USA007446: US-009507513-2501USA008861:
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| 2824118 | 14 | F | IN | 02/03/2025 |
MMRV |
MERCK & CO. INC. |
Y012077 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that a 14 year old female pa...
HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that a 14 year old female patient was administered a dose of the PROQUAD vaccine. HCP did not report any side effects from the administration of the PROQUAD vaccine. HCP did not; HCP did not report any side effects from the administration of the PROQUAD vaccine.; This spontaneous report was received from registered nurse (RN) concerning to a 14-year-old female patient. Her medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) injection, lot #Y012077, expiration date 05-JAN-2026 (exact dose, dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product administered to patient of inappropriate age.) The reporter did not inform any side effects from the administration of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine (no adverse event), did not state the reason for the administration of the vaccine and provided limited pertinent information and demographic data.
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| 2824120 | U | MO | 02/03/2025 |
MMR |
MERCK & CO. INC. |
X026222 |
Device connection issue, No adverse event
Device connection issue, No adverse event
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No additional AE; Nurse called to report that the needle "popped off" a prefilled DILUENT ...
No additional AE; Nurse called to report that the needle "popped off" a prefilled DILUENT syringe after it was used to administer a dose of MMR II.; Nurse called to report that the needle "popped off" a prefilled DILUENT syringe after it was used to administer a dose of MMR II.; Nurse called to report that the needle "popped off" a prefilled DILUENT syringe after it was used to administer a dose of MMR II.; This spontaneous report was received from nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-JAN-2025, the patient was vaccinated with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, unk, valid lot #1973259, expiration date: 03-MAR-2026 (strength, route of administration, and indication were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, valid lot #X026222, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that the needle popped off a diluent syringe after it was used to administered a vaccine. The problem occurred when the staff member tried to engage the safety on the needle and it instead came off the syringe and caused a needle stick in the staff member left hand (needle issue, device connection issue and poor quality device used). The reporter stated that the patient received full dose and no issue was noted prior to or during administration. The reporter stated that no patient symptoms have been reported. No additional adverse event (AE) was reported.
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| 2824121 | U | TX | 02/03/2025 |
HPV9 |
MERCK & CO. INC. |
W029724 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE; Medical Assistant called to report expired GARDASIL 9 administered to a patient.; ...
No additional AE; Medical Assistant called to report expired GARDASIL 9 administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-JAN-2025, the patient was vaccinatedwith hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, valid lot #W029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No symptoms reported. No additional adverse event (AE).
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| 2824122 | 1 | U | NH | 02/03/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y011215 X028613 |
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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No events were reported; Nurse calling to report that a dose of VARIVAX and PROQUAD were administere...
No events were reported; Nurse calling to report that a dose of VARIVAX and PROQUAD were administered concomitantly to a 1 year old patient. No clinical events were reported. No PQC. No additional information.; This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. On 21-JAN-2025, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X028613, expiration date: 13-DEC-2025 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis concomitantly with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) # Y011215, expiration date: 18-DEC-2025 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis . No clinical events were reported.
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| 2824123 | U | MO | 02/03/2025 |
PPV |
MERCK & CO. INC. |
X018273 |
Expired product administered
Expired product administered
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No additional AE/PQC reported; Medical Assistant calling with a report of an adverse event regarding...
No additional AE/PQC reported; Medical Assistant calling with a report of an adverse event regarding an expired dose of PNEUMOVAX 23 that was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-JAN-2025, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, lot #X018273, expiration date: 07-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Medical Assistant confirmed the patient involved had not had any medical concerns or symptoms after the administration of the expired dose of the vaccine.
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| 2824124 | U | IL | 02/03/2025 |
MMRV |
MERCK & CO. INC. |
Y010050 |
Product storage error
Product storage error
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Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC...
Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC. No additional information.; This spontaneous report was received from a nurse and and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, lot #Y010050, expiration date: 25-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). On 23-JAN-2025, the patient experienced Customer calling to report temperature excursion (Product storage error ). PROQUAD dose was administered on 1/23/2025. No PQC. No additional information.. At the time of reporting, the outcome of the event Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC. No additional information. was not known. The action taken with PROQUAD regarding Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC. No additional information. was reported as Not Applicable.
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| 2824125 | U | IL | 02/03/2025 |
MMRV |
MERCK & CO. INC. |
Y010050 |
Product storage error
Product storage error
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Customer calling to report temperature excursion. PROQUAD dose was administered on 1/29/2025. No PQC...
Customer calling to report temperature excursion. PROQUAD dose was administered on 1/29/2025. No PQC. No additional information.; This spontaneous report was received from registered Nurse referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 29-JAN-2025, the patient started therapy with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y010050, expiration date: 25-NOV-2025, administered for prophylaxis (strength, dose number, frequency, scheme, route of administration, and anatomical location were not reported). The vaccine underwent a temperature excursion (Improper storage of product in use). The duration of temperature excursion, and if there were previous temperature excursions were not reported.
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| 2824126 | 12 | F | 02/03/2025 |
HPV9 |
MERCK & CO. INC. |
X024251 |
Conversion disorder, Syncope
Conversion disorder, Syncope
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diagnosed with functional neurological disorder/Doctors are saying the fainting is the result of thi...
diagnosed with functional neurological disorder/Doctors are saying the fainting is the result of this diagnosis; toothache; Drug reactions: AMOXYCILLIN/she broke out in hives; This spontaneous report was received from the patient's mother regarding her approximately 13-year-old daughter (female). The patient's medical history was not reported. Historical drugs included lurasidone hydrochloride (LATUDA). The patient's concurrent conditions included seasonal allergy and allergy to lurasidone hydrochloride (LATUDA). Concomitant medications included aripiprazole (ABILIFY) and topiramate (reported as ''topirmate''). On 08-NOV-2024, the patient was vaccinated with the second dos of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 virus like particle (VLP) vaccine (yeast) (GARDASIL 9) injection, lot #X024251 (expiration date was not provided but upon validation it was found to be 15-MAY-2026), administered intramuscularly to prevent HPV (strength was not provided). On an unknown date, the patient started therapy with amoxicillin, administered for toothache (strength, formulation, dose, lot #, expiry date, and route of administration were not provided). After which she broke out in hives On an unknown date (after the second dose of the suspect vaccine), the patient began to experience side effects with the suspect vaccine, such as fainting, that was later diagnosed as functional neurological disorder (Conversion disorder), as the doctors thought was the cause of fainting. Therefore, the patient was admitted to the hospital (date of admission not reported), to seek medical attention, but no treatment was given for this event. The action taken with amoxicillin regarding the events was not reported. At the time of this report the patient ad not recovered from conversion disorder; the outcome of the remaining events was not provided. The causal relationship between amoxicillin and hives was not reported, but given wording and company guidelines it was considered as related; the causality between this suspect drug and toothache was considered as not related; and for conversion disorder was not reported. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and all the events was not provided.
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| 2824127 | U | IN | 02/03/2025 |
HEPA |
MERCK & CO. INC. |
Y007585 |
No adverse event, Product storage error
No adverse event, Product storage error
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administered after temperature excursions; no adverse event; This spontaneous report was received fr...
administered after temperature excursions; no adverse event; This spontaneous report was received from Other Health Professional and refers to a currently 22-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #Y007585, expiration date: 31-OCT-2025, administered for prophylaxis (strength, dose, dose number, frequency, scheme, anatomical location, and route of administration were not provided) (Improper storage of product in use). The vaccine underwent a temperature excursion during 1h 30 m under 60 Fahrenheit Degrees. No previous temperature excursions. No adverse event reported. This case was previously reported as non-valid due to lack of individual patient identifiers, but upon follow-up information on 17-JAN-2025, was updated to valid. This case was one of three from the same reporter. ; Sender Comments: Keywords : MUL US-009507513-2502USA000139:Original Case : 2501USA004754 US-009507513-2501USA004754:Original Case : 2501USA004754
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| 2824128 | U | IN | 02/03/2025 |
HIBV RV5 |
MERCK & CO. INC. MERCK & CO. INC. |
y003145 2052020 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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administered after temperature excursions; no adverse event; This spontaneous report was received fr...
administered after temperature excursions; no adverse event; This spontaneous report was received from Other Health Professional and refers to a currently 3-months-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # y003145, expiration date: 12-SEP-2026, administered for prophylaxis (strength, dose, dose number, frequency, scheme, anatomical location, and route of administration were not provided); and on an unknown date, the patient started therapy with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 2052020, expiration date: 10-MAR-2026, administered orally for prophylaxis (strength, dose, dose number, frequency, and scheme were not provided); (Improper storage of product in use). The vaccine underwent a temperature excursion during 1h 30 m under 60 Fahrenheit Degrees. No previous temperature excursions. No adverse event reported. This case was previously reported as non-valid due to lack of individual patient identifiers, but upon follow-up information on 17-JAN-2025, was updated to valid. This case was one of three from the same reporter. ; Sender's Comments: US-009507513-2501USA004754:Original Case : 2501USA004754 US-009507513-2502USA000138:Original Case : 2501USA004754
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| 2824129 | M | MD | 02/03/2025 |
HPV9 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No additional AE; Patient received the first dose on October 19, 2023 and the second dose in the ser...
No additional AE; Patient received the first dose on October 19, 2023 and the second dose in the series on 12/20/2024.; This spontaneous report was received from a registered pharmacist and refers to a 28-year-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was provided. On 19-OCT-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (lot #, expiration date, route and site of administration were not reported) for prophylaxis. On 20-DEC-2024, he received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (lot #, expiration date, route and site of administration were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse event was reported.
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| 2824130 | 0.17 | U | CO | 02/03/2025 |
VARCEL |
MERCK & CO. INC. |
Y011712 |
No adverse event, Product administered to patient of inappropriate age, Product ...
No adverse event, Product administered to patient of inappropriate age, Product storage error
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2 month old patient was administered a dose of VARIVAX on 11/8/2024 "due to an error in their v...
2 month old patient was administered a dose of VARIVAX on 11/8/2024 "due to an error in their vaccine storage".; No additional AE; 2 month old patient was administered a dose of VARIVAX on 11/8/2024 "due to an error in their vaccine storage".; This spontaneous report was received from a physician assistant via an office manager and refers to a 2-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 08-NOV-2024 at the age of 2 months, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # Y011712 was confirmed to be valid, expiration date 02-JUL-2026 (route and site of administration were not provided) for prophylaxis, due to error in vaccine storage (Product administered to patient of inappropriate age, Product storage error). It was confirmed that the patient did not experience any medical concerns or symptoms. No additional adverse event reported.
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| 2824131 | U | 02/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got shingles; This serious case was reported by a consumer via intera...
Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 19-JAN-2025 The reporter reported that did not stress at all was a way not to get them and no vaccines. The number one cause of it everyone he/she know get the Shingrix shot and they got Shingles. Just like Covid vaccines all got Covid and it was bad Covid vaccine was to bring on the virus and did that makes no sense. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2824132 | F | CT | 02/03/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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got her 1st dose of Twinrix on 7/1/2024...she is scheduled coming today; This non-serious case was r...
got her 1st dose of Twinrix on 7/1/2024...she is scheduled coming today; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 01-JUL-2024, batch number:H7RF72 and expiry date:17-JAN-2026). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: got her 1st dose of Twinrix on 7/1/2024...she is scheduled coming today). The outcome of the incomplete course of vaccination was unknown. 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: 07-JAN-2025 The reporter called to inform that they had a patient, she got her 1st dose of Twinrix on 7th January 2024 and she was scheduled coming at the time of reporting for the 2nd dose, she's long overdue. Did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
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| 2824133 | F | NJ | 02/03/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
55M72 |
Expired product administered
Expired product administered
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received an expired dose of Havrix; This non-serious case was reported by a physician via call cente...
received an expired dose of Havrix; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis. On 07-JAN-2025, the patient received the 1st dose of Havrix. On 07-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Havrix). The outcome of the expired vaccine used was unknown. 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: 07-JAN-2025 Reporter explained that a patient received an expired dose of Havrix on January 7th 2025 and vaccine was expired on December 13th 2024 which led to expired vaccine used. It was the first dose of a Hepatitis A vaccine for the patient.
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| 2824134 | 48 | F | MI | 02/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
342rc |
Incorrect route of product administration
Incorrect route of product administration
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Priorix intramuscular route instead of subcutaneous route; This non-serious case was reported by a n...
Priorix intramuscular route instead of subcutaneous route; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 48-year-old female patient who received MMR (Priorix) (batch number 342rc, expiry date 01-MAY-2025) for prophylaxis. On 09-JAN-2025, the patient received Priorix (intramuscular). On 09-JAN-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix intramuscular route instead of subcutaneous route). The outcome of the subcutaneous injection formulation administered by other route was unknown. 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: 09-JAN-2025 The reporter reported that a staff member gave Priorix intramuscular route instead of subcutaneous route at the time of reporting, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up.
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| 2824135 | F | CO | 02/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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incomplete course of vaccination; This non-serious case was reported by a consumer via call center r...
incomplete course of vaccination; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included brain injury. Previously administered products included Shingrix (Patient received first dose couple of years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 The patient received the first dose of Shingrix a couple of years ago, and not yet received the second dose, which led to incomplete course of vaccination.
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| 2824136 | 78 | F | OH | 02/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
94SE2 |
Incorrect dose administered
Incorrect dose administered
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Incomplete dose/some came out of it; This non-serious case was reported by a other health profession...
Incomplete dose/some came out of it; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 94SE2, expiry date 09-AUG-2026) for prophylaxis. On 15-JAN-2025, the patient received the 1st dose of Shingrix. On 15-JAN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete dose/some came out of it). The outcome of the incomplete dose administered was unknown. Additional Information: GSK Receipt Date: 15-JAN-2025 A pharmacy intern called to inform that a patient came for her 1st dose of the Shingrix vaccine and when it was being administered, there was an issue with the syringe, and some came out of it, which led to incomplete dose administered. According to the reported, that happened earlier that day. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
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| 2824137 | 0.25 | F | NH | 02/03/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK022AA |
Product preparation issue
Product preparation issue
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she administered the pentacel to a patient, but when she administered it, she only gave the diluent ...
she administered the pentacel to a patient, but when she administered it, she only gave the diluent with no reported adverse event; Initial information received on 30-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, a 3 months old female patient who was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel], but when she administered it, she only gave the diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine (HEP B VAX); Pneumococcal Vaccine and Rotavirus Vaccine for Immunization. On 17-Jan-2025, the patient was administered 0.5 ml dose of the (Standard) Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (once) (lot UK022AA, expiry date: 30-Apr-2025) (unknown route) in the right thigh for immunization, but when she administered it, she only gave the diluent with no reported adverse event (single component of a two-component product administered) (latency-same day). Reportedly, The MA (Medical Assistant) did not mix it with the compound. The patient didn't get that part of the vaccine. 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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| 2824143 | 50 | F | KY | 02/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Nasal discomfort, Pain in extremity, Pyrexia, Rhinorrhoea, Skin warm; Sneezing
Nasal discomfort, Pain in extremity, Pyrexia, Rhinorrhoea, Skin warm; Sneezing
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Arm remains extremely sore and hot to touch on Day 5. Started with runny nose yesterday (day 4). Aw...
Arm remains extremely sore and hot to touch on Day 5. Started with runny nose yesterday (day 4). Awoke a 2am this morning (day 5) with sneezing every few minutes. Inside nose/sinus is irritated with constant thin discharge from left nostril (clear, thin). Irregular low grade fever since late evening day 1. Symptoms ongoing. Annoying but no life threat. Symptoms lasting longer than published information, with new ones presenting. Treating with Tylenol, advil, ice to site and rest.
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| 2824146 | U | 02/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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the first made me feel sick for a few days; This non-serious case was reported by a consumer via int...
the first made me feel sick for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: the first made me feel sick for a few days). The outcome of the sickness was resolved. The reporter considered the sickness to be related to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: GSK receipt date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she just got his/her second vaccine yesterday (day before reporting). The reporter mentioned that first vaccine made him/her feel sick for a few days. The reporter hoping this one was not as bad but, he/she was sure the side effects were a drop in the bucket compared to shingles. The patient mentioned that the thought of getting shingles was terrifying.
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| 2824150 | 39 | F | MT | 02/03/2025 |
FLU3 |
SANOFI PASTEUR |
QFAA1815 |
Erythema multiforme, Rash
Erythema multiforme, Rash
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Reported Symptoms: 1015218:ERYTHEMA MULTIFORME; 10037844:RASH; Narrative: Other Relevant HX: Other:
Reported Symptoms: 1015218:ERYTHEMA MULTIFORME; 10037844:RASH; Narrative: Other Relevant HX: Other:
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| 2824151 | 72 | M | MT | 02/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4LP5Y 4LP5Y |
Erythema multiforme, Injection site rash, Pruritus, Rash, Rash pruritic; Skin we...
Erythema multiforme, Injection site rash, Pruritus, Rash, Rash pruritic; Skin weeping
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Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10023092:ITCHY RASH; 10037087:PRURITUS; 10037844:RA...
Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10023092:ITCHY RASH; 10037087:PRURITUS; 10037844:RASH; 10074684:RAISED RASH; 10080560:SKIN WEEPING; Narrative: Other Relevant HX: Other: RASH COVERED FROM INJECTION SITE DOWN TO WRIST. VERY ITCHY, RAISED, BUMPS; SOME WHEEPING WHERE BUMPS WERE SCRATCHED. LASTED APPROX 1 WEEK.
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| 2824152 | 66 | M | MT | 02/03/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
YF41708 X11327 |
Lip swelling; Lip swelling
Lip swelling; Lip swelling
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Reported Symptoms: 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: Lip Swelling
Reported Symptoms: 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: Lip Swelling
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| 2824153 | 66 | M | MT | 02/03/2025 |
PNC13 |
PFIZER\WYETH |
X11327 |
Angioedema, Lip swelling
Angioedema, Lip swelling
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Reported Symptoms: 10002424:ANGIOEDEMA; 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: ...
Reported Symptoms: 10002424:ANGIOEDEMA; 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: LIP SWELLING
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| 2824154 | 68 | M | MT | 02/03/2025 |
PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. |
N014946 N014946 |
Angioedema, Cellulitis, Erythema multiforme, Myalgia, Oedema peripheral; Periphe...
Angioedema, Cellulitis, Erythema multiforme, Myalgia, Oedema peripheral; Peripheral swelling, Phlebitis, Pruritus, Rash, Skin warm
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Reported Symptoms: 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10034879:PHLEBITIS; 10037087:P...
Reported Symptoms: 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10034879:PHLEBITIS; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient had no complications after the vaccine was administered on 1/29/2018 and went home after. Patient then called the clinic, per telemedicine, that same day and reported he had developed increasing increasing generalized pain over his deltoid, triceps, bicep are with warmth and swelling. Patient came into the clinic 1/30/2018 and showed continuous edema in a rectangular area covering now all of his bicep and to a less extent triceps, with no local injection site that could be identified at that time, instead a generalized area of either cellulitis or phlebitis to be developed. No fever chills or other complaints from the patient. Other Relevant HX: Other:
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| 2824155 | F | MT | 02/03/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
HS75G |
Headache, Pruritus, Rash
Headache, Pruritus, Rash
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Reported Symptoms: 10037844:RASH; Narrative: Approximately one hour after receiving the flu shot pat...
Reported Symptoms: 10037844:RASH; Narrative: Approximately one hour after receiving the flu shot patient developed itchiness to body, and severe headache. Hands and feet very itchy. Patient went to ER for evaluation. Other Relevant HX: Other: RASH
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| 2824156 | 71 | M | MT | 02/03/2025 |
COVID19 |
MODERNA |
032B21A |
Extra dose administered
Extra dose administered
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Reported Symptoms: 10064366: EXTRA DOSE ADMINISTERED; Narrative: Patient received first dose of COVI...
Reported Symptoms: 10064366: EXTRA DOSE ADMINISTERED; Narrative: Patient received first dose of COVID-19 Moderna vaccine on 02/26/2021, Patient received second dose of COVID-19 Moderna vaccine on 03/20/2021. Patient returned to clinic on 04/17/2021 to receive what he believed was his second dose of COVID-19 vaccine. A third dose of the two dose series was administered prior to the chart being reviewed for appropriateness. When asked for his vaccination card, Patient produced two cards indicating two doses on two different dates had been given as well. These dates were then confirmed through accurate reporting in the patient's chart. Other Relevant HX: Other: Third dose of two dose series given
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| 2824157 | 72 | M | MT | 02/03/2025 |
FLU3 TDAP |
SEQIRUS, INC. SANOFI PASTEUR |
WT55507 U5489AA |
Pruritus, Rash; Pruritus, Rash
Pruritus, Rash; Pruritus, Rash
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Reported Symptoms: 10037844:RASH; Narrative: whole body rash with itching benadryl was helpful had i...
Reported Symptoms: 10037844:RASH; Narrative: whole body rash with itching benadryl was helpful had itching with 2016 vaccine but no rash Other Relevant HX: Other:
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| 2824160 | 68 | M | NV | 02/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
X3M27/3S354 |
Asthenia, Chills, Tremor
Asthenia, Chills, Tremor
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Reported Symptoms: 10008531:CHILLS; 10040527:SHAKINESS; 10047862:WEAKNESS; Narrative: Other Relevant...
Reported Symptoms: 10008531:CHILLS; 10040527:SHAKINESS; 10047862:WEAKNESS; Narrative: Other Relevant HX: Other: Shakes, chills, weakness
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| 2824161 | 72 | M | MT | 02/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2453L 2453L |
Injection site cellulitis, Injection site erythema, Injection site induration, I...
Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth; Swelling
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Reported Symptoms: 10028411:MYALGIA; 10042674:SWELLING; Narrative: A: 72 y/o male develops mild cell...
Reported Symptoms: 10028411:MYALGIA; 10042674:SWELLING; Narrative: A: 72 y/o male develops mild cellulitis in the left deltoid a rea with redness, warm, firm and tenderness 4 x 4 cm, requires pain medication (Patient has tramadol that helps slightly) and antibiotic, need close follow up and return to clinic and also has an appointment on November 14, 2018. Pt states he still has some Tramadol left. P: Keflex 1000 mg PO BID x 10 days, return to outpatient clinic if the conditions gets worse. Other Relevant HX: Patient already had a prescription for tramadol for chronic back pain. Provided did not provide tramadol as a treatment drug, only the antibiotic. Just advised to take the tramadol as prescribed. Other: Swelling
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| 2824162 | 78 | M | MT | 02/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
539a2 |
Angioedema, Peripheral swelling
Angioedema, Peripheral swelling
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Reported Symptoms: 10002424:ANGIOEDEMA; 10002471:ANGIONEUROTIC EDEMA; 10042680:SWELLING ARM; Narrati...
Reported Symptoms: 10002424:ANGIOEDEMA; 10002471:ANGIONEUROTIC EDEMA; 10042680:SWELLING ARM; Narrative: Other Relevant HX: Other: angioneurotic edema of larynx, swelling of arm
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| 2824163 | 85 | M | AZ | 02/03/2025 |
COVID19-2 COVID19-2 |
PFIZER\BIONTECH PFIZER\BIONTECH |
GL2042 GL2042 |
Asthenia, Breakthrough COVID-19, Chest X-ray, Cough, Oropharyngeal pain; Respira...
Asthenia, Breakthrough COVID-19, Chest X-ray, Cough, Oropharyngeal pain; Respiratory tract congestion, SARS-CoV-2 test positive
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Reported Symptoms: 10054112:HOSPITALISATON; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-...
Reported Symptoms: 10054112:HOSPITALISATON; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: 86 YOM admitted through ED with complain of weakness, cough with congestion and throat pain. ED evaluation confirms COVID positive. Patient treated with remdesivir and discharged to home. Other relevant HX: HTN, Permanent A-Fib, recent CVA 5/24, T2DM, HF Other: Hospitalization for treatment of Covid infection s/p vaccination
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| 2824164 | 35 | M | AZ | 02/03/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
004M20A 004M20A 004M20A |
Abdominal pain upper, Breakthrough COVID-19, Chest X-ray, Chills, Computerised t...
Abdominal pain upper, Breakthrough COVID-19, Chest X-ray, Chills, Computerised tomogram abdomen; Cough, Haematemesis, Nausea, SARS-CoV-2 test positive, Vomiting; Wheezing
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: 39 YOM presented to the ED for evaluation of worsening epigastric pain with associated nausea, vomiting, and coffee-ground emesis that started 2 - 3 days ago. Initial incidental finding of Covid, but patient became symptomatic with bilateral wheezing, chills and cough on second day of hospitalization. Began treatment with remdesivir and dexamethasone. Patient discharged to continue treatment for mental health. Other Relevant HX: PMhx of bipolar disorder, alcohol use, substance use and homelessness Other: Hospitalization for treatment of Covid infection s/p vaccination
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| 2824165 | 46 | F | PA | 02/03/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7554T |
Erythema, Feeling hot, Pruritus
Erythema, Feeling hot, Pruritus
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Reported Symptoms: 10015150:ERYTHEMA; 10016357:FEELING OF WARMTH; 10037087:PRURITUS; Narrative: Pati...
Reported Symptoms: 10015150:ERYTHEMA; 10016357:FEELING OF WARMTH; 10037087:PRURITUS; Narrative: Patient is a 47 year old female who came to the clinic for follow-up for chronic conditions including but not limited to Environmental allergies, obesity, fatty liver, and hematuria. Patient received seasonal influenza vaccine during nurse visit and when being seen by provider complained of pruritis, erythema, and warmth to area. Provider diagnosed as mild allergic reaction to the vaccine and recommended IM injection of Benadryl which patient refused. Provider noted that symptoms were improved/resolved prior to patient leaving clinic and patient was counseled to take benadryl as needed or starting cetirizine for other environmental allergies/rhinitis that they were being seen for. Other Relevant HX: Other: PRURITIS; ERYTHEMA, WARMTH
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| 2824166 | M | TX | 02/03/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Diarrhoea, Dizziness
Diarrhoea, Dizziness
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Reported Symptoms: 10012727:DIARRHEA; 10016379:FELT FAINT; Narrative: Other Relevant HX: Other: FEEL...
Reported Symptoms: 10012727:DIARRHEA; 10016379:FELT FAINT; Narrative: Other Relevant HX: Other: FEELING FAINT; DIARRHEA
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| 2824167 | 70 | M | FL | 02/03/2025 |
COVID19 |
MODERNA |
058H21A |
Pain in extremity
Pain in extremity
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Reported Symptoms: 10033446:PAIN IN LEG; Narrative: Other relevant HX: PAIN IN LEG
Reported Symptoms: 10033446:PAIN IN LEG; Narrative: Other relevant HX: PAIN IN LEG
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| 2824168 | M | TX | 02/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Anaphylactic reaction
Anaphylactic reaction
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Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
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