| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2854213 | VA | 08/15/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP reporting that a patient received a dose of improperly stored VARIVAX. Reference TE case #02843...
HCP reporting that a patient received a dose of improperly stored VARIVAX. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the VARIVAX was administered following the excursion. HCP reported; No symptoms or side effects were reported by HCP; This spontaneous report was received from a Nurse 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 10-JUL-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y019318, expiration date reported as 21-NOV-2026, 0.5 mL (route of administration and anatomical location of vaccine were not reported) diluted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported); as treatment for prophylaxis. The dose experienced a temperature excursion of 52.2 Fahrenheit for an unspecified time frame. No additional adverse event were repoted.
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| 2854214 | 08/15/2025 |
PNC21 |
MERCK & CO. INC. |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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FBE calling regarding a potential AE on behalf of an HCP. Caller stated that the facility might have...
FBE calling regarding a potential AE on behalf of an HCP. Caller stated that the facility might have purchased adult CAPVAXIVE vaccine and it may have been given it to pediatric patient. No further information was available from the FBE upon probing.; No adverse event; This spontaneous report was received from a physician and refers to a child 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 an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), administered for prophylaxis (dose, lot #, expiration date, route of administration and anatomical site of injection were not reported). It was reported that the facility might have purchased an adult vaccine, and it may have been given to a pediatric patient (Product administered to patient of inappropriate age). No further information was available, no additional adverse event (No adverse event).
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| 2854215 | 20 | F | OR | 08/15/2025 |
COVID19 COVID19 HPV9 HPV9 TTOX TTOX |
MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Emotional disorder, Fatigue, Headache, Hypertension, Mast cell activation syndro...
Emotional disorder, Fatigue, Headache, Hypertension, Mast cell activation syndrome; Photophobia, Rash, Raynaud's phenomenon; Emotional disorder, Fatigue, Headache, Hypertension, Mast cell activation syndrome; Photophobia, Rash, Raynaud's phenomenon; Emotional disorder, Fatigue, Headache, Hypertension, Mast cell activation syndrome; Photophobia, Rash, Raynaud's phenomenon
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She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic,; Shell of herself; headaches;...
She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic,; Shell of herself; headaches; high blood pressure; sensitivity to light; rashes; patient was diagnosed with Raynaud's Disease/Some days are better than others, but no comparison to how she was prior to receiving the three shots; fatigue; This spontaneous report was received from a consumer referring her daughter as a 20-year-old female patient. The patient's medical history was not reported. Her concurrent conditions included Raynaud's disease which was diagnosed on 2 different times, once in middle school and once in high school. Concomitant therapies were unknown. She had not known allergies. On 13-May-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 1 dosage form (dosage regimen, anatomical location, route of administration, batch/lot # and expiration date were not reported) administered as prophylaxis; with elasomeran (COVID-19 VACCINE MODERNA) (reported as "Covid shot [Moderna]") 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported); and with tetanus vaccine (reported as "Tetanus shot"), 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported.) Since 13-May-2024 (reported as "ever since receiving the shots"), she had been a shell of herself (emotional disorder). On unspecified date (s) in May-2024, she experienced high blood pressure (hypertension), rashes (rash), fatigue, sensitivity to light (photophobia), and headaches (headache). The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. It was also reported regarding her Raynaud's disease that patient's fingers were painful and had difficulty opening bottles, with some days better than others, but no comparison to how she was prior to receiving the three vaccines (reported as "shots") (Raynaud's phenomenon) She had been to numerous doctors while in college. She also went to the other facility. The patient underwent bloodwork, Ziopatch for heart monitoring, Gold Standard Potts Diagnosis, but the tests results were not provided. On unspecified date, she had Mast Cell Activation Syndrome (MCAS) by an allergy clinic. At the reporting time, the patient had not recovered from the events and was on unspecified medications. The causal relationship between the events and the suspect vaccines was unknown, and the reporter wanted to know if it was safe to administer the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) along with the "Covid and Tetanus shots", and how to know for sure which vaccine was causing the issues. Upon internal review, the event mast cell activation syndrome was considered to be medically significant. Batch/lot # is being requested and will be submitted if received.
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| 2854216 | F | CA | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
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Syncope
Syncope
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Patient had brief episode of syncope, no additional injury.; This spontaneous report was received fr...
Patient had brief episode of syncope, no additional injury.; This spontaneous report was received from a health care worker and refers to a 11-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (TDAP) . On 07-AUG-2025, the patient was vaccinate with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection (1 injection) (lot #, expiration date, route of administration, anatomical location of vaccine were not reported) in her arm for prophylaxis. On 07-AUG-2025, the patient experienced Patient had brief episode of syncope, no additional injury. In August 2025, the patient recovered from the event. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. Upon internal review, the event of Syncope was determined to be medically significant. Lot # is being requested and will be submitted if reported.
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| 2854217 | 61 | F | IN | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
332L4 |
Product preparation issue
Product preparation issue
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Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component; were pote...
Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component; were potentially administered with the adjuvant alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 332L4, expiry date 04-APR-2027) for prophylaxis. On 29-JUL-2025, the patient received Shingrix. On 29-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component) and inappropriate dose of vaccine administered (Verbatim: were potentially administered with the adjuvant alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-AUG-2025 Clinical supervisor called to ask about the specific timeframe or additional vaccine administration for a valid dose of Shingrix, since five patients were potentially administered (they were not sure) with the adjuvant alone, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided. The vaccine administration facility was the same as primary reporter. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025103160:same reporter US-GSK-US2025103644:Same reporter US-GSK-US2025103164:same reporter US-GSK-US2025103636:same reporter
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| 2854218 | MI | 08/15/2025 |
TD |
SANOFI PASTEUR |
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No adverse event, Product storage error
No adverse event, Product storage error
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patient under their care had experienced an adverse event while taking Tenivac.; one of a patient un...
patient under their care had experienced an adverse event while taking Tenivac.; one of a patient under their care had experienced an adverse event while taking Tenivac; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from other health care professional. This case involves an unknown age and unknown gender patient who was administered with Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac] experienced an 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 an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number not reported (dose, strength, lot/batch number and expiration date: not provided) for prophylactic vaccination (immunization) and experienced an adverse event (poor quality product administered) and (adverse event). Reportedly, Reason: Misplaced probes, Max /low temperature reached: She said that the previous reported temperature was 30๏ฟฝF but she said that she told one of her workmates that day to place it on the correct spot: new temperature: 32๏ฟฝF. Duration: Half-day after they got the previous temperature gauge. He was not sure of the whole duration.Previous Excursion- None, Human error- Yes, Administered post-excursion- No, Does extended stability data cover the excursion- No. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event of (no adverse event). At time of reporting, the outcome was Unknown for the event of (no adverse event). 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. Additional information was received on 17-Jul-2025 from Other Health Care Professional: Case validity updated from non case to non valid case; text amended accordingly. Additional information was received on 30-Jul-2025 from other healthcare professional: Case updated from non-valid to valid. Based on data previously received, the following information has been amended (removed the case classification Non valid case and follow on deleted the initial justification, updated the number of patient from 0 to 1)
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| 2854219 | 1.33 | F | 08/15/2025 |
HIBV |
SANOFI PASTEUR |
UK359AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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administered ACTHIB using a pre-made 0.4% saline solution containing 0.7mL instead of the accompanyi...
administered ACTHIB using a pre-made 0.4% saline solution containing 0.7mL instead of the accompanying saline diluent, with no reproted adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves a 16 months old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] using a pre-made 0.4% saline solution containing 0.7ml instead of the accompanying saline diluent, with no reproted adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine (Hepatitis A) for Immunisation. On 12-Aug-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose 0.5 ml 1x(once) (strength standard) lot UK359AA expiry date-31-Aug-2026 via intramuscular route in the right thigh for Immunisation, using a pre-made 0.4% saline solution containing 0.7ml instead of the accompanying saline diluent, with no reproted adverse event (product preparation error) (latency same day). 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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| 2854238 | 50 | F | GA | 08/15/2025 |
COVID19 |
MODERNA |
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Insomnia
Insomnia
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Drug-resistant insomnia
Drug-resistant insomnia
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| 2854239 | 3 | M | TX | 08/15/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
HR4RB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Havrix adult dose administered to pediatric patient; Havrix adult dose administered to pediatric pat...
Havrix adult dose administered to pediatric patient; Havrix adult dose administered to pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 3-year-old male patient who received HAV (Havrix adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. On 05-AUG-2025, the patient received Havrix adult. On 05-AUG-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Havrix adult dose administered to pediatric patient) and overdose (Verbatim: Havrix adult dose administered to pediatric patient). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK receipt date: 05-AUG-2025 The nurse called to report a pediatric patient of 3 years and 8 months was given an adult dose of the Havrix vaccine which led to adult product administration to child and overdose.
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| 2854240 | 11 | M | NC | 08/15/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMAB072A |
Product preparation issue
Product preparation issue
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Liquid was not combined with the dry component.; Liquid was not combined with the dry component.; Th...
Liquid was not combined with the dry component.; Liquid was not combined with the dry component.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB072A, expiry date 30-APR-2026) for prophylaxis. On 06-AUG-2025, the patient received Menveo. On 06-AUG-2025, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Liquid was not combined with the dry component.) and inappropriate preparation of medication (Verbatim: Liquid was not combined with the dry component.). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 06-AUG-2025 The reporter asked was there any vaccine component in the liquid vial which was the vial 1 in the liquid or it was just saline? The reason why the reporter was asking was that the patient today was only given, they wasn't given the whole dosage cause they know that was supposed to be a combination 2 part the vaccine there and liquid was not combined with the dry component which led to inappropriate preparation of medication and Inappropriate dose of vaccine administration. The reporter did not realize few minutes ago was trying to see what steps they should take as this the first this has happened.
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| 2854242 | 16 | M | PA | 08/15/2025 |
PNC20 |
PFIZER\WYETH |
LJ5282 |
Product storage error
Product storage error
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POWER OUTAGE RESULTING IN IMMUNIZATION FRIDGE TEMP. TO GO OUT OF RANGE
POWER OUTAGE RESULTING IN IMMUNIZATION FRIDGE TEMP. TO GO OUT OF RANGE
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| 2854268 | M | KY | 08/15/2025 |
VARCEL |
MERCK & CO. INC. |
Y006523 |
No adverse event, Product storage error
No adverse event, Product storage error
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Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature exc...
Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion. Caller stated VARIVAX vaccine was "issued" to the facility on 8/9/2024 and was inadvertently stored in the refrigerated throughout administrat; No adverse event; Improper transportation of vaccine from pharmacy to clinic; This spontaneous report was received from a pharmacist and refers to a 20-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unspecified date from 02-Oct-2024 to 07-Oct-2024, the patient was inadvertently vaccinated with with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) after a temperature excursion (Temperature 2 to 8 C) (lot number Y006523 and expiration date of 25-Mar-2026) administered by subcutaneous route. The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) vaccine was "issued" to the facility on 09-Aug-2024 and was inadvertently stored in the refrigerated throughout administrations. The reporter refused to perform a temperature excursion assessment stating assessment has already been performed. No additional adverse events reported. The reporter informed improper transportation of vaccine from pharmacy to clinic with use of refrigeration vaccine transport equipment used. Additionally, improper storage of vaccine in clinic. Placed in refrigeration when storage. Requirements were kept frozen and only stable for 72 hours in refrigerator.; Reporter's Comments: Keywords: ; Sender's Comments: Priority : 5 , Is case serious : No , number : 02842181-02842148 , number : , number : , number : 500UW00000gVDaKYAW|13082025230037|2645 , Central date : 2025-08-14 , Classification : DMC, Attachment description : Call , Safety case number : 2311714 , case number : 02842181 , Interaction number : 02842148 , Integration log UniqueID : 500UW00000gVDaKYAW|13082025230037|2645 , Service cloud CaseID : 500UW00000gVDaKYAW
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| 2854269 | 62 | F | VA | 08/15/2025 |
PNC21 |
MERCK & CO. INC. |
Z004302 |
Hypoaesthesia, Injection site rash, Pain, Tenderness
Hypoaesthesia, Injection site rash, Pain, Tenderness
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numbness on her arm; rash at the injection site; soreness; This spontaneous report was received from...
numbness on her arm; rash at the injection site; soreness; This spontaneous report was received from a pharmacist and refers to a 62-year-old female patient. The patient's medical history, drug reactions and concomitant therapies were reported as none. The patient's concurrent conditions were not reported. On 15-Jul-2025, the patient received Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #z004302, expiration date: 04-Sep-2026, 1 dosage form (1 dose), formulation and strength were not reported) via intramuscular for prophylaxis. On 15-Jul-2025, on the first day of the vaccination, the patient experienced soreness. On 19-Jul-2025, on the fifth day of the vaccination, the patient developed rash at the injection site and numbness on her arm. She couldn't put pressure on her arm when she goes to sleep. No medical attention was sought. No treatment was given for the events. At the reporting time, the patient had not recovered from numbness on her arm, soreness and rash at the injection site. The causal relationships between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) were not provided.
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| 2854270 | VA | 08/15/2025 |
MMRV |
MERCK & CO. INC. |
Y017516 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms or side effects were reported by HCP.; HCP reporting that a patient received a dose of i...
No symptoms or side effects were reported by HCP.; HCP reporting that a patient received a dose of improperly stored PROQUAD. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion. HCP reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-May-2025, the patient was vaccinated with a dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL (lot #Y017516 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as: 19-Apr-2026) (strength and route of administration were not provided) as prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). Temperature was 52.2 F, time frame was unknown by reporter. Operator of device was health professional. The reporter did not know the date the excursion occurred. No symptoms or side effects were reported by HCP (No adverse event).
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| 2854271 | VA | 08/15/2025 |
MMRV |
MERCK & CO. INC. |
Z003309 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms or side effects were reported by HCP. No additional AE/No PQC.; HCP reporting that a pat...
No symptoms or side effects were reported by HCP. No additional AE/No PQC.; HCP reporting that a patient received a dose of improperly stored PROQUAD. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion. HCP reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-Jun-2025, the patient was vaccinated with a dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL (lot #Z003309 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as: 21-Jul-2026) (strength and route of administration were not provided) as prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). Temperature was 52.2 F, time frame was unknown by reporter. Operator of device was health professional. The reporter did not know the date the excursion occurred. No symptoms or side effects were reported by HCP. No additional adverse event (AE) (No adverse event).
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| 2854272 | FL | 08/15/2025 |
RVX |
UNKNOWN MANUFACTURER |
X025233 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No symptoms reported and no additional details provided. No other AE; HCP calling to report the inad...
No symptoms reported and no additional details provided. No other AE; HCP calling to report the inadvertent administration of an expired dose of ROTATEQ to a patient.; This spontaneous report was received from a physician Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Jul-2025, the patient was vaccinated with and expire dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral solution (lot #X025233, expiration date: 03-Jul-2025), dose number 1, administered by Oral route administered as prophylaxis. The reporter stated that the patient was inadvertently administered of an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). It was also confirmed that the patient did not experience any symptoms, no additional adverse events.
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| 2854273 | IL | 08/15/2025 |
MMR |
MERCK & CO. INC. |
X028353 |
Product storage error
Product storage error
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HCP called and reported T/E. HCP stated MMR II was administered on 7/08/2025.; No additional AE repo...
HCP called and reported T/E. HCP stated MMR II was administered on 7/08/2025.; No additional AE reported; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 08-Jul-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot #X028353, expiration date: 11-Dec-2025), reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported), 0.5 mL (route of administration and anatomical location were not reported) as prophylaxis; that had been involved in a temperature excursion of 9.69 degree Celsius for 15 minutes. No previous excursions had occurred.
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| 2854274 | F | CA | 08/15/2025 |
RAB RAB RAB RAB RAB RAB RAB RAB RAB RAB RAB RAB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 FDP00683 |
Bacterial test, Computerised tomogram, Confusional state, Contrast echocardiogra...
Bacterial test, Computerised tomogram, Confusional state, Contrast echocardiogram, Decreased appetite; Disorientation, Dizziness, Encephalitis, Fungal test, Insomnia; Laboratory test, Lumbar puncture abnormal, Magnetic resonance imaging, Malaise, Mental status changes; Product administered at inappropriate site; Asthenia, CSF lymphocyte count increased, CSF monocyte count increased, Cerebral thrombosis, Cerebrovascular accident; Computerised tomogram head abnormal, Lumbar puncture abnormal, Pleocytosis, Product administered at inappropriate site; Bacterial test, Computerised tomogram, Confusional state, Contrast echocardiogram, Decreased appetite; Disorientation, Dizziness, Encephalitis, Fungal test, Insomnia; Laboratory test, Lumbar puncture abnormal, Magnetic resonance imaging, Malaise, Mental status changes; Product administered at inappropriate site; Asthenia, CSF lymphocyte count increased, CSF monocyte count increased, Cerebral thrombosis, Cerebrovascular accident; Computerised tomogram head abnormal, Lumbar puncture abnormal, Pleocytosis, Product administered at inappropriate site
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purs...
encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like ๏ฟฝput your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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| 2854275 | M | GA | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center ...
Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in April 2018). 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: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 04-AUG-2025 The reporter was the patient. He received his first Shingrix dose in Apr 2018. He did not know he should receive the second dose to complete the series. He plans to get the second Shingrix dose this week. Nothing else was reported. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2854276 | 80 | F | MI | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2m7gr |
Erythema, Headache, Pain in extremity, Swelling
Erythema, Headache, Pain in extremity, Swelling
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severe swelling; Erythema; Headache; severe arm pain; This non-serious case was reported by a pharma...
severe swelling; Erythema; Headache; severe arm pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 2m7gr, expiry date 31-JAN-2027) for prophylaxis. On 01-AUG-2025, the patient received the 1st dose of Shingrix .5 ml. In AUG-2025, less than a week after receiving Shingrix, the patient experienced swelling (Verbatim: severe swelling), erythema (Verbatim: Erythema), headache (Verbatim: Headache) and pain in arm (Verbatim: severe arm pain). The outcome of the swelling, erythema, headache and pain in arm were not resolved. It was unknown if the reporter considered the swelling, erythema, headache and pain in arm to be related to Shingrix. It was unknown if the company considered the swelling, erythema, headache and pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 04-AUG-2025 The reporter stated that an 80 year old female had her first dose of Shingrix administered on 1 AUG 2025 and reported having severe swelling, erythema approximately 4 inches wide and 5 inches long moving towards the armpit, headache and severe arm pain (onset of adverse events not disclosed). No further information was obtained/provided.
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| 2854277 | 08/15/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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hurts a lot; This non-serious case was reported by a consumer via interactive digital media and desc...
hurts a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: hurts a lot). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient just got the vaccine for shingles, stated that it hurts a lot.
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| 2854278 | F | 08/15/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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arm were quite sore for about a week; This non-serious case was reported by a consumer via interact...
arm were quite sore for about a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm were quite sore for about a week). The outcome of the pain in arm was resolved (duration 1 week). It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-AUG-2025 This case was reported by a patient via interactive digital media. The patient were at the doctor the minute the vaccine was available. The arm were quite sore for about a week. The patient would did it again in a heartbeat. This was 1 of the 3 cases, reported by the different reporter.; Sender's Comments: US-GSK-US2025AMR101940:same reporter different patient US-GSK-US2025AMR101941:same reporter different patient
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| 2854279 | 08/15/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Feeling of body temperature change, Headache, Influenza like illness, Pain
Feeling of body temperature change, Headache, Influenza like illness, Pain
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headaches; felt like I had the flu; feeling hot; feeling cold; aches; This non-serious case was repo...
headaches; felt like I had the flu; feeling hot; feeling cold; aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: headaches), influenza like illness (Verbatim: felt like I had the flu), feeling hot (Verbatim: feeling hot), feeling cold (Verbatim: feeling cold) and pain (Verbatim: aches). The outcome of the headache, influenza like illness, feeling hot, feeling cold and pain were not reported. It was unknown if the reporter considered the headache, influenza like illness, feeling hot, feeling cold and pain to be related to Shingles vaccine. It was unknown if the company considered the headache, influenza like illness, feeling hot, feeling cold and pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient just had 2nd dose of the vaccine, suffered from the aches, headaches then feeling hot / feeling cold and the headache. Patient felt like had the flu, but was sure having the shingles would feel a lot worse.
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| 2854280 | F | MD | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product administered at inappropriate site
Product administered at inappropriate site
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Alternatives Sites for Intramuscular Administration of Shingrix; This non-serious case was reported...
Alternatives Sites for Intramuscular Administration of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included lymph node excision (lymph nodes removed from patient's arm). Concurrent medical conditions included cancer. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Alternatives Sites for Intramuscular Administration of Shingrix). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK receipt date: 01-AUG-2025 Pharmacist had an adult female patient who is on cancer treatment and she has had her lymph nodes removed from her arm. Patient would like to received Shingrix first dose but she declined to have the injection on her deltoid muscle which led to vaccine administered at inappropriate site.
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| 2854281 | FL | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Circumstance or information capable of leading to medication error, Extra dose a...
Circumstance or information capable of leading to medication error, Extra dose administered
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Shingrix Potential 3rd dose; Shingrix Potential 3rd dose; This non-serious case was reported by a ...
Shingrix Potential 3rd dose; Shingrix Potential 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix Potential 3rd dose) and circumstance or information capable of leading to medication error (Verbatim: Shingrix Potential 3rd dose). The outcome of the extra dose administered and circumstance or information capable of leading to medication error were not applicable. Additional Information: GSK receipt date: 01-AUG-2025 It was reported that a patient who went to pharmacy for her first Shingrix shot. Upon returning for her second shot, the pharmacy told her they gave her the Covid shot the first time and not Shingrix. The patient thought the pharmacy messed up the records and that she distinctly remembers getting Shingrix. The pharmacy gave her the subsequent Shingrix vaccine and set her up again to complete the series which led to extra dose administered and circumstance or information capable of leading to medication error. The patient would like to know the safety of getting 3 Shingrix vaccines in case the pharmacy did make a clerical error.
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| 2854282 | 56 | F | CA | 08/15/2025 |
PNC20 |
PFIZER\WYETH |
LN4932 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pyrexia
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Redness at the injection site; Warm and tenderness at the injection site; Warm and tenderness at the...
Redness at the injection site; Warm and tenderness at the injection site; Warm and tenderness at the injection site; Chilled fever; Itchiness at at the injection site; This is a spontaneous report received from a Nurse. A 56-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Aug2025 at 12:09 as dose number unknown, 0.5ml single (Lot number: LN4932, Expiration Date: 30Aug2026) at the age of 56 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness at the injection site"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Warm and tenderness at the injection site"; PYREXIA (non-serious), outcome "unknown", described as "Chilled fever"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itchiness at at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site warmth, pyrexia, vaccination site pruritus. Causality for "redness at the injection site", "warm and tenderness at the injection site", "chilled fever" and "itchiness at at the injection site" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Doctor prescribed Doxycycline, Prednisone, Triamcinolone Cream and Pepcid. NDC number of Prevnar 20: 0005200001; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500157347 Same reporter and suspect product different patient/AE;US-PFIZER INC-202500157363 Same reporter and suspect product different patient/AE;
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| 2854283 | 08/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Malaise
Malaise
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feel very ill; This is a spontaneous report received from a Consumer or other non HCP, Program ID. ...
feel very ill; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Immunization. The following information was reported: MALAISE (non-serious), 5 days after the suspect product(s) administration, outcome "unknown", described as "feel very ill". Additional information: Patient reported that just got 4th booster and after 5 days felt very ill. No Hospitalization Prolonged. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2854284 | M | 08/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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tested positive for COVID last night/ on like day three of symptoms; This is a spontaneous report re...
tested positive for COVID last night/ on like day three of symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underlying health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 vaccination; Bnt162b2 (Dose 2, single), for COVID-19 vaccination. The following information was reported: COVID-19 (non-serious) with onset Aug2025, outcome "unknown", described as "tested positive for COVID last night/ on like day three of symptoms". The event "tested positive for covid last night/ on like day three of symptoms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did three of the boosters in a row, but the last one was in Oct2022. The patient was on like day three of symptoms, and tested positive for COVID last night (12Aug2025). The patient's wife got a tele visit with doctor this morning (13Aug2025). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500098451 same reporter, same drug/event, different patient;
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| 2854285 | 16 | M | TX | 08/15/2025 |
MENB MNQ |
PFIZER\WYETH NOVARTIS VACCINES AND DIAGNOSTICS |
LF5308 9X7CD |
Erythema, Headache; Erythema, Headache
Erythema, Headache; Erythema, Headache
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Localized erythema; Headaches; This is a spontaneous report received from a Consumer or other non HC...
Localized erythema; Headaches; This is a spontaneous report received from a Consumer or other non HCP. A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Aug2025 as dose 1, single (Lot number: LF5308) at the age of 16 years, in left arm for immunisation; meningococcal vaccine a/c/y/w conj (CRM197) (MENVEO), on 13Aug2025 as dose 2, single (Lot number: 9X7CD), in right arm. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 14Aug2025, outcome "recovering", described as "Headaches"; ERYTHEMA (non-serious) with onset 14Aug2025, outcome "recovering", described as "Localized erythema". Therapeutic measures were taken as a result of erythema, headache. Additional information: The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which they were reporting. The patient was not taking any other medications within 2 weeks of the event starting. Treatment included IBUPROFEN 800 mg three times a day.
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| 2854286 | M | GA | 08/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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I did test positive for it; I did test positive for it; This is a spontaneous report received from a...
I did test positive for it; I did test positive for it; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Jan2021 as dose 2, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 07Aug2025, outcome "unknown" and all described as "I did test positive for it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2025) positive. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Clinical Course :Additional Information: The Patient stated last Thursday (07Aug2025), he went to the doctor, and they tested for COVID, and he had strep throat also, double, so it wasn't good. When asked for clarification if he had picked up the medication on Thursday, the patient stated," After he went to a friend's house to borrow the money, he did. He was scared as he never had COVID or the Corona virus or whatever he never had before. The patient got a terrible headache and a cough, and he didn't want to play around with this. The patient stated "for the record, back in Jan2021 he did get the Pfizer Vaccine. Two separate trips to the Hospital down. And he hasn't had any Covid symptoms or signs of anything since then until last week. He must have come in contact with it somehow, because he did test positive for it. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2854287 | F | TX | 08/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Prog...
have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reason that she was calling is because she have COVID and they prescribed the Paxlovid. Later, she stated, Don't mind me, I'm like delirious with this COVID." Pfizer is the one that gave her the shot. After confirming if the shot was for COVID, stated, "Yes. I took two. Number one and number two. Yeah, with Pfizer." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2854288 | 1.58 | F | MI | 08/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
CX4HL |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient was given a 7 years and older TDaP instead of the DTaP vaccine. No adverse events reported b...
Patient was given a 7 years and older TDaP instead of the DTaP vaccine. No adverse events reported by patient's mother.
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| 2854290 | 4 | M | KY | 08/15/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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PATIENT'S LEFT LEG AT INJECTION SITE WAS SWOLLEN TO THE KNEE, REDNESS NOTED AND WARMTH. PATIENT...
PATIENT'S LEFT LEG AT INJECTION SITE WAS SWOLLEN TO THE KNEE, REDNESS NOTED AND WARMTH. PATIENT C/O OF OF PAIN. REFERRED. PCP SAW AND DX INJECTION SITE REACTION. RX MOTRIN AS NEEDED.
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| 2854291 | 13 | F | IN | 08/15/2025 |
DTAP HPV9 MNQ |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR |
PT2RK U8573AA U8573AA |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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Administered Infanrix instead of Boostrix
Administered Infanrix instead of Boostrix
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| 2854292 | 17 | F | OH | 08/15/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Burning sensation, Cardiac monitoring, Computerised tomogram, Electrocardiogram,...
Burning sensation, Cardiac monitoring, Computerised tomogram, Electrocardiogram, Electroencephalogram; Immediate post-injection reaction, Laboratory test normal, Loss of consciousness, Seizure like phenomena, Vomiting
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Patient had an event where she passed out as soon as the injection was administered. The nurse who ...
Patient had an event where she passed out as soon as the injection was administered. The nurse who administered the injection said it looked like she had a seizure. Patient was seen by a different doctor regarding the event, but nothing was found. We didn't get any additional Gardasil shots after this event occurred. Patient has continued to have these types of events at random frequencies, where she loses consciousness for a few seconds, since the date of the first shot. The events are becoming more frequent now and she's also started vomiting when she regains consciousness and she now feels that her head burns too. She will typically have one to two of these events a year. She has seen multiple doctors over the course of time and nobody could figure out what was causing the events to occur. Doctors had considered POTS, but they said the frequency wasn't routine enough, so they kept looking. A medical clinic put a monitor on patient and she had to push a button if she felt an event was occurring. She did and the results are leading to a diagnosis of Dysautonomia.
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| 2854293 | 0.5 | F | 08/15/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7801AA LG5574 2032349 |
Infant irritability, Injection site discolouration, Peripheral coldness, Pyrexia...
Infant irritability, Injection site discolouration, Peripheral coldness, Pyrexia, Somnolence; Infant irritability, Injection site discolouration, Peripheral coldness, Pyrexia, Somnolence; Infant irritability, Injection site discolouration, Peripheral coldness, Pyrexia, Somnolence
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That evening of the injection the mother reached out and said that the child was fussy, sleeping all...
That evening of the injection the mother reached out and said that the child was fussy, sleeping all day, started running a fever, and wouldn't hold down Tylenol. She had 2 wet and 1 soiled diaper. I explained to the mother that those reactions are a possibility of the injections. Encouraged tepid baths and BF to stay hydrated. I encouraged to monitor a bit longer. The following day 8/14/25 the mother reached out and said that her leg on the right side was discolored compared to the left side. Her foot was cooler to the touch than the left. She had only drank 6 oz of breastmilk and had 2 wets all day. Fever was down to 99.4. Due to the temp and discoloration of the leg we informed the mother to call their provider as soon as possible. Once the appointment was made, I called the clinic and provided all immunization information and what the mon had reported to me regarding the immunization reactions. Later that day, I followed up with the mother and she said that the dr did not know why her leg was discolored. Mom also reported that once she got patient to the dr's office, her leg was back to normal color and temp. They attempted to give patient tylenol in the clinic and she was unable to keep it down, they eventually gave her an injection and mom said she was doing better. She was unable to tell me what they gave patient, only that it was something similar to Tylenol, but stronger.
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| 2854295 | 50 | M | ME | 08/15/2025 |
PNC20 |
PFIZER\WYETH |
LN4932 |
Erythema, Injection site paraesthesia, Swelling
Erythema, Injection site paraesthesia, Swelling
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Intermittent tingling to the left deltoid region. Localized redness and swelling (visualized on 8/15...
Intermittent tingling to the left deltoid region. Localized redness and swelling (visualized on 8/15, 1 week after vaccine). No pain at all or tenderness to palpation. Dr advised ibuprofen and heat therapy.
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| 2854296 | 6 | F | KS | 08/15/2025 |
DTAPIPV VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Z004454 |
Injection site erythema, Pain in extremity; Injection site erythema, Pain in ext...
Injection site erythema, Pain in extremity; Injection site erythema, Pain in extremity
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Mom let this RN know today that the left arm is sore and is red. Picture was sent and the area that ...
Mom let this RN know today that the left arm is sore and is red. Picture was sent and the area that patient received the shot is pink from the top of the shoulder to the upper middle arm in a circle. Guessing maybe 3 inches in diameter, mom didn't measure. She has given her Ibuprofen. Mom states that she noticed the redness yesterday. Advised ice, allergy medication, Ibuprofen/Tylenol PRN and monitoring. Encouraged mom to reach out to primary care if she would like to do so, or if it persists.
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| 2854297 | 75 | M | TX | 08/15/2025 |
PNC21 |
MERCK & CO. INC. |
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Erythema, Malaise, Skin warm
Erythema, Malaise, Skin warm
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As the day went on, It got a big knot 3 inches across the skin went red and got hot. It spread all t...
As the day went on, It got a big knot 3 inches across the skin went red and got hot. It spread all the way down to the wrist. On Aug 6th it was better but there is still knot. He has never had a reaction to any other vaccine he has taken but this one. And he didn't feel well for 3 days.
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| 2854298 | 67 | F | NJ | 08/15/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
Lm2210 Lm2210 UT8473DA UT8473DA |
Biopsy skin, Cellulitis, Full blood count, Herpes zoster, Macule; Neuralgia, Pai...
Biopsy skin, Cellulitis, Full blood count, Herpes zoster, Macule; Neuralgia, Pain, Peau d'orange, Rash, Rash pruritic; Biopsy skin, Cellulitis, Full blood count, Herpes zoster, Macule; Neuralgia, Pain, Peau d'orange, Rash, Rash pruritic
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December 28, 2024 Left arm and forearm itchy rash, diffuse red macules, cellulitis, herpetic neuralg...
December 28, 2024 Left arm and forearm itchy rash, diffuse red macules, cellulitis, herpetic neuralgia and zoster, redness, swelling, moderate pain, Peau d'orange skin changes, neuralgia C5-C6 dermatome
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| 2854299 | 17 | M | NV | 08/15/2025 |
HEPA HPV9 MNQ |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR |
42DM9 Y013407 u8369ba |
Circumstance or information capable of leading to medication error, Inappropriat...
Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration; Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration; Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
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The patient had two state records, but only one was provided to the provider. This resulted in the v...
The patient had two state records, but only one was provided to the provider. This resulted in the vaccines being ordered and administered that the patient was not due for at that time.
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| 2854300 | 16 | M | ID | 08/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PG3RP |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Pt was not due for the TdaP. He came to the office to get a Men B, Men ACWY, and HPV. A different n...
Pt was not due for the TdaP. He came to the office to get a Men B, Men ACWY, and HPV. A different nurse prepped the vaccines and I needled and administered the vaccines without properly checking they were the right ones. Pt received the Bexero within 15 minutes of the other vaccines and has had no negative reactions.
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| 2854301 | 12 | F | MO | 08/15/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
X025115 U7983AA |
Dysgeusia, Malaise, Throat tightness, Tinnitus; Dysgeusia, Malaise, Throat tight...
Dysgeusia, Malaise, Throat tightness, Tinnitus; Dysgeusia, Malaise, Throat tightness, Tinnitus; Dysgeusia, Malaise, Throat tightness, Tinnitus
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Immediately after 3rd vaccine administered into left deltoid patient complained that throat felt li...
Immediately after 3rd vaccine administered into left deltoid patient complained that throat felt like it was tight and ringing in her ears. Also stated she could taste something in her mouth and said she did'nt feel well. Laid her down and got cool wet wash cloth. No rash or edema noted. Heart rate regular at 74 and lungs CTA. Skin warm and dry. No undue anxiety noted. Father and brother in room .Within several minutes she said throat and ears were improving. Gave her a few more minutes, sat her up and drank an entire 8 oz bottle of orange juice and then some cold water, without difficulty. Another couple of minutes later she said throat and ears were back to normal and no other symptoms occurred. Remained without rash or edema. Monitored for approx another 30 minutes and both father and patient felt ready to go. Did tell both father and patient that she must remain in view of responsible adult for remainder of the day and should any rash, swelling, trouble breathing or throat swelling occur call 911 immediately. Also informed both them that she must never take another vaccine without first informing the provider about this episode. Both acknowledged understanding.
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| 2854302 | 31 | F | FL | 08/15/2025 |
HPV9 |
MERCK & CO. INC. |
Y018389 |
Syncope
Syncope
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FAINT
FAINT
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| 2854303 | 72 | F | TX | 08/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Multiple use of single-use product, Pain in extremity, Product administered at i...
Multiple use of single-use product, Pain in extremity, Product administered at inappropriate site, Product preparation issue
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Guest was vaccinated with an empty syringe (Arexvy was not reconstituded). Afterwards, the pharmaci...
Guest was vaccinated with an empty syringe (Arexvy was not reconstituded). Afterwards, the pharmacist realized that there was not vaccine in the syringe. She used a new needle to draw diluent and reconstitute. She then used the initial syringe to draw up the vaccine and injected the guest (used the same syringe in the arm twice). Then, allegedly, the vaccine was given too high in the arm. The guest left and at a point after this, she had extreme pain in her arm and went to the E.R. The doctor said that the vaccine was given way too high.
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| 2854304 | 0.5 | M | 08/15/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
49M2F |
Contraindication to vaccination
Contraindication to vaccination
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Patient received MMR vaccine within 30 days of Rabies Immunoglobin. MA staff member administered vac...
Patient received MMR vaccine within 30 days of Rabies Immunoglobin. MA staff member administered vaccine mistakenly.
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| 2854305 | 24 | M | MO | 08/15/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0176 EW0196 |
Multiple sclerosis, Myocardial infarction, Myocarditis; Multiple sclerosis, Myoc...
Multiple sclerosis, Myocardial infarction, Myocarditis; Multiple sclerosis, Myocardial infarction, Myocarditis; Multiple sclerosis, Myocardial infarction, Myocarditis
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I had at myocardial infarct the day after I got my booster. I now have Multiple Sclerosis since 2024
I had at myocardial infarct the day after I got my booster. I now have Multiple Sclerosis since 2024
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| 2854306 | 1 | M | IN | 08/15/2025 |
HEPA PNC20 VARCEL |
MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
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Incorrect dose administered; Incorrect dose administered; Incorrect dose adminis...
Incorrect dose administered; Incorrect dose administered; Incorrect dose administered
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Patient was given adult dose (1ml) of Hepatitis A Vaqta vaccination, instead of pediatric dose. Mom...
Patient was given adult dose (1ml) of Hepatitis A Vaqta vaccination, instead of pediatric dose. Mom was called by RN and by Dr. called, recommending watching out for localized injection site swelling or increased redness, and potential for illness (fever & headache) following vaccination.
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| 2854307 | 58 | F | 08/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
Gj952 |
Pain in extremity
Pain in extremity
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patient reported pain in left arm for 4 days after vaccine
patient reported pain in left arm for 4 days after vaccine
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| 2854308 | 30 | F | IA | 08/15/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
y012921 y012921 |
Arthralgia, Lymphadenopathy, Neck pain, Nodule, Pain in extremity; Tenderness
Arthralgia, Lymphadenopathy, Neck pain, Nodule, Pain in extremity; Tenderness
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She reports L sharp arm pain starting that evening along with lymphadenopathy on shoulder/neck area....
She reports L sharp arm pain starting that evening along with lymphadenopathy on shoulder/neck area. Patient reports Monday night after receiving the vaccine her arm was very sore and had traveled into her shoulder. Wednesday afternoon she put her seatbelt on and noticed her neck was sore and tender to touch. Thursday the pain became worse and she felt a nodule in her neck. The pain has become constant. Patient reports using ibuprofen and ice with minimal relief.
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