| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2840570 | CA | 05/12/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call ...
hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 2023). 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: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-MAY-2025 The pharmacist called on 6th May 2025, to report a patient received a first dose of Twinrix in 2023 and had not received a second dose yet which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. Exact vaccination date and adverse event details were asked and declined. Only information provided was that the Twinrix was administered during year 2023.
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| 2840571 | F | IA | 05/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose; received a...
15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose; received at 15 months of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for prophylaxis. Previously administered products included Dtap (received 3 doses on an unknown date). On 08-NOV-2024, the patient received Boostrix. On an unknown date, the patient received the 4th dose of Dtap. On 08-NOV-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose) and inappropriate age at vaccine administration (Verbatim: received at 15 months of age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: The nurse reported that a 15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose (previously vaccinated with 3 Dtap doses), which led to wrong vaccine administered. The patient received a dose of Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
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| 2840572 | 50 | M | KS | 05/12/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
NT9X3 |
Expired product administered
Expired product administered
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dose administered was the 2nd dose of Engerix-B, and that it had expired; This non-serious case was ...
dose administered was the 2nd dose of Engerix-B, and that it had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis. On 08-MAY-2025, the patient received the 2nd dose of Engerix B. On 08-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: dose administered was the 2nd dose of Engerix-B, and that it had expired). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 08-MAY-2025 The nurse reported that she had administered a HepB vaccination, and it is expired which led to, expired vaccine used.
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| 2840573 | IN | 05/12/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Expired product administered
Expired product administered
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accidentally administered an expired hepatitis A pediatric vaccine (Havarix); This non-serious case ...
accidentally administered an expired hepatitis A pediatric vaccine (Havarix); This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix pediatric) (expiry date MAY-2025) for prophylaxis. On 07-MAY-2025, the patient received Havrix pediatric. On 07-MAY-2025, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired hepatitis A pediatric vaccine (Havarix)). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 08-MAY-2025 Reporter stated that their clinic accidentally administered an expired hepatitis A pediatric vaccine (Havrix) to a patient, it was expired by 2 days, which led to expired vaccine used. Also wanted to know if any known risks/concerns of receiving an expired vaccine and if this vaccine is still valid (like if it is still ok up to a few days).
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| 2840574 | 05/12/2025 |
COVID19 |
MODERNA |
3046731 |
Device issue, No adverse event
Device issue, No adverse event
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HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This s...
HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. Not Provided For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. This case contains information for the 2nd patient out of 4 patients described by the reporter. Concomitant medication information was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live follow up received that non-significant information. References added. On 29-Apr-2025: Live follow up received that non-significant information; reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785794:Patient 2 of 4
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| 2840575 | 05/12/2025 |
COVID19 |
MODERNA |
3046731 |
Device issue, No adverse event
Device issue, No adverse event
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HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This s...
HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. Not Provided For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. This case contains information for the 3rd patient out of 4 patients as described by the reporter. Concomitant medication was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live follow up received that non-significant information. References added. On 29-Apr-2025: Live follow up received that non-significant information; reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785794:Patient 3
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| 2840576 | 05/12/2025 |
COVID19 |
MODERNA |
3046731 |
Device issue, No adverse event
Device issue, No adverse event
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HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This s...
HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. This case was created for 4th out of 4 patients reported. Concomitant medication was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live non-significant follow-up received. References added. On 29-Apr-2025: Live non-significant follow-up received. Reporter details and reference ID added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785794:Patient 4
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| 2840577 | 75 | F | IL | 05/12/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
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Alanine aminotransferase, Aldolase, Aspartate aminotransferase, Autoimmune hepat...
Alanine aminotransferase, Aldolase, Aspartate aminotransferase, Autoimmune hepatitis, Biopsy liver; Biopsy skin, Blood alkaline phosphatase, Blood bilirubin, Blood creatine phosphokinase, COVID-19; Hepatic enzyme, Hepatitis viral test, Idiopathic inflammatory myopathy, Physical examination, Prothrombin time; Rash pruritic, Ultrasound liver elastography, Vaccination site pruritus, Vaccination site rash
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mild non-specific acute hepatitis/AIH/mild hepatic steatosis; Inflammatory myopathy/Bilateral should...
mild non-specific acute hepatitis/AIH/mild hepatic steatosis; Inflammatory myopathy/Bilateral shoulder girdle muscle weakness; developed acute COVID-19 infection; circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site; circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site; circular, raised, pruritic chest rash; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis) and IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Concurrent medical conditions included Hyperlipidemia and Gastroesophageal reflux disease. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis) (seriousness criterion medically significant), IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness) (seriousness criterion medically significant), COVID-19 (developed acute COVID-19 infection), VACCINATION SITE RASH (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site), VACCINATION SITE PRURITUS (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site) and RASH PRURITIC (circular, raised, pruritic chest rash). The patient was treated with Nirmatrelvir;Ritonavir for COVID-19, at an unspecified dose and frequency; Immunoglobulin human normal (Immunoglobulin) (intravenous use) for Idiopathic inflammatory myopathy, at an unspecified dose and frequency and Budesonide for Autoimmune hepatitis, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis), IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness), COVID-19 (developed acute COVID-19 infection), VACCINATION SITE RASH (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site), VACCINATION SITE PRURITUS (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site) and RASH PRURITIC (circular, raised, pruritic chest rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: did not improve, 153 U/L 3 months after receiving the Moderna COVID-19 booster and 124 U/L Nine months later the level remained elevated.. On an unknown date, Aldolase: 49 U/L Elevated. On an unknown date, Aspartate aminotransferase: did not improve, 90 U/L Elevated, 3 months after receiving the Moderna COVID-19 booster and 95 U/L Nine months later the level remained elevated.. On an unknown date, Biopsy liver: revealed mild non-specific acute hepatitis. On an unknown date, Biopsy skin: concerned for autoimmune process. On an unknown date, Blood alkaline phosphatase: levels remained normal throughout. On an unknown date, Blood bilirubin: levels remained normal throughout. On an unknown date, Blood creatine phosphokinase: 4098 U/L Elevated. On an unknown date, Hepatic enzyme: normalized over 2 months and began increasing again after the patient developed acute COVID-19 infection.. On an unknown date, Hepatitis viral test: Negative. On an unknown date, Physical examination: revealed a circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site. On an unknown date, Prothrombin time: levels remained normal throughout. On an unknown date, Ultrasound liver elastography: revealed no fibrosis and mild hepatic steatosis. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis), IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness), COVID-19 (developed acute COVID-19 infection), VACCINATION SITE RASH (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site), VACCINATION SITE PRURITUS (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site) and RASH PRURITIC (circular, raised, pruritic chest rash) to be related. The author presented a case of multi-organ autoimmune pathology that developed after repeated exposure to COVID-19 through infection and vaccination. The patient discontinued all statin and alcohol use. Empiric treatment was received for AIH with budesonide did not improve AST and ALT levels. Elevated creatine kinase and aldolase were suspicious for inflammatory myopathy. The author reported that it was the first documented case of liver injury associated with COVID-19 exposure that contributed to a multi-organ autoimmune process. Though AST and ALT elevations could be seen in muscle injury, liver elastography and liver biopsy confirmed hepatic involvement. Given worsening symptoms with repeated COVID-19 exposure, prior autoimmune reactions should be reviewed when considering future COVID-19 booster doses. Patient history of other autoimmune reactions to COVID-19 raised clinician suspicion for viral exposure as an etiology for unexplained symptoms.; Reporter's Comments: Company comment: Occurrence of COVID 19 infection remains as confounder for worsening of the condition. The benefit-risk relationship of product is not affected by this report.
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| 2840578 | 05/12/2025 |
COVID19 |
MODERNA |
3046731 |
Device issue, No adverse event
Device issue, No adverse event
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HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This s...
HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. This case was created for 1st patient out of 4 patients as described by the reporter. Concomitant medication information was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. This case was linked to US-MODERNATX, INC.-MOD-2025-785803, US-MODERNATX, INC.-MOD-2025-785807, US-MODERNATX, INC.-MOD-2025-785810 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live non-significant follow-up received. References added. On 29-Apr-2025: Live non-significant follow-up received. Reporter details and reference ID added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785810:Patient 4 US-MODERNATX, INC.-MOD-2025-785807:Patient 3 US-MODERNATX, INC.-MOD-2025-785803:Patient 2
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| 2840579 | F | 05/12/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Tinnitus; Tinnitus
Tinnitus; Tinnitus
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I wound up getting tinnitus; This spontaneous case was reported by a patient and describes the occur...
I wound up getting tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I wound up getting tinnitus) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (had received "6 or 7" doses of Spikevax already). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (I wound up getting tinnitus). At the time of the report, TINNITUS (I wound up getting tinnitus) outcome was unknown. No concomitant medications were reported. It was reported that the patient received 6 or 7 doses of Spikevax throughout her life, with the most recent Spikevax 24-25 administered in Sep-2024. The patient received high-dose flu vaccine, whose manufacturer and date were not reported. The patient developed tinnitus following flu shot. The patient emphasized that the event was related to the flu shot and not the COVID vaccine, which she had received multiple times. She also reported the event tinnitus to the company responsible for administering the flu shot, clarifying that it was not related to Spikevax. No treatment medications were reported.
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| 2840580 | F | 05/12/2025 |
COVID19 |
MODERNA |
030M20A |
Injection site reaction
Injection site reaction
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Experiencing prolonged healing at the injection site; This spontaneous case was reported by a patien...
Experiencing prolonged healing at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE REACTION (Experiencing prolonged healing at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE REACTION (Experiencing prolonged healing at the injection site). At the time of the report, INJECTION SITE REACTION (Experiencing prolonged healing at the injection site) had not resolved. Concomitant medication was not provided. Patient called to report that the injection site from her Moderna COVID-19 vaccine, received in 2021, had not healed. She had been experiencing prolonged healing at the injection site. Despite consulting multiple doctors over the years, she had not received a satisfactory explanation. She expressed concern about the unusual duration for healing and inquired if others experienced similar issues. One doctor mentioned mercury from the needle, while another ordered blood tests, which she recently completed, but results are pending. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported.
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| 2840581 | M | CA | 05/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Biopsy, Burning mouth syndrome, Investigation, Magnetic resonance imaging head, ...
Biopsy, Burning mouth syndrome, Investigation, Magnetic resonance imaging head, Neurological examination; Physical examination
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Burning Mouth Syndrome; This is a literature report for the following literature source(s). A 39-ye...
Burning Mouth Syndrome; This is a literature report for the following literature source(s). A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypoplastic right lung" (unspecified if ongoing); "attention deficit hyperactive disorder" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lithium for bipolar disorder; Oxcarbazepine for bipolar disorder. Vaccination history included: Bnt162b2 (Lot Number unknown; Dose 1), for COVID-19 immunization, reaction(s): "burning mouth syndrome". The following information was reported: BURNING MOUTH SYNDROME (medically significant), outcome "recovering". The event "burning mouth syndrome" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: which did not show any pathology., notes: normal oral mucosa confirmed on biopsy; Magnetic resonance imaging head: which was unremarkable.; Neurological examination: normal; physical exam: unremarkable, notes: normal-appearing oral mucosa without lesions or erythema (consistent with a diagnosis of BMS); severity: from a 6 to 10. Therapeutic measures were taken as a result of burning mouth syndrome. Clinical course: In the below report, we present the first known case of a male patient who presented with burning mouth syndrome subsequently after Pfizer COVID-19 vaccination, as well as a unique, multimodal approach to effective treatment. A 39-year-old male with a past medical history of hypoplastic right lung, bipolar disorder (on lithium and oxcarbazepine), attention deficit hyperactive disorder, and migraines presented to the clinic with a burning sensation located on the dorsal aspect of his tongue with an altered sensation of old food residues and xerostomia. This sensation was constant and fluctuated in severity from a 6 to 10. One year earlier, the patient received the first Pfizer COVID-19 vaccination. He noted that about 90 min after the vaccination, he began to feel a burning sensation in his feet that extended up towards his mouth and cheeks. He had an episode of presumed vasovagal syncope shortly after that resolved without treatment or further workup. The burning sensation in his mouth has persisted since. He also noted that after the second vaccination dose 1 month after the first, he developed stiffness throughout his body and could not eat for 2 days. Although the burning pain in his mouth had slightly improved since the initial onset, it still affected his ability to work. The patient subsequently underwent an MRI of the head, which was unremarkable. He also underwent a biopsy of the tongue, which did not show any pathology. Prior to presenting in our clinic, the patient tried gabapentin, Lyrica, dexamethasone oral wash, saliva supplements, and CBD with titration to maximum dosages without relief. He noted that oral lidocaine and nystatin swish and spit provided mild relief for 30 min at a time. The physical exam was unremarkable, including a normal neurologic examination as well as normal-appearing oral mucosa without lesions or erythema. At his 2-month follow-up appointment post zinc initiation, the patient reported that he started acupuncture on the tongue. This combined with zinc and oral capsaicin washes provided a near-complete resolution of his pain and xerostomia. In this case, the patient presented with a history and physical exam consistent with a diagnosis of BMS. The patient gained significant benefits from oral capsaicin, oral zinc supplementation, as well as acupuncture of the tongue. This is the first known case in which a unique, multimodal approach to treatment was effective in a patient with new-onset BMS immediately following the first dose of the Pfizer COVID-19 vaccination. This case demonstrated the successful management of post-vaccine BMS through a unique multimodal approach. Oral capsaicin 0.02% rinse provided the patient with good, transient relief. Oral daily zinc supplementation also provided the patient with significant relief of the pain symptoms. Nearly 2 months of daily acupuncture was beneficial in not only this patient's pain but xerostomia symptoms as well.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of burning mouth syndrome might not be fully ruled out, considering the temporal relationship. More epidemiologic and accumulative clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate ,Linked Report(s) : US-PFIZER INC-PV202500055482 Same patient/drug; different dose;
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| 2840582 | 39 | M | CA | 05/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Biopsy tongue, Burning mouth syndrome, Magnetic resonance imaging head, Neurolog...
Biopsy tongue, Burning mouth syndrome, Magnetic resonance imaging head, Neurological examination, Physical examination
More
|
Burning Mouth Syndrome; This is a literature report for the following literature source(s). A 39-ye...
Burning Mouth Syndrome; This is a literature report for the following literature source(s). A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "hypoplastic right lung" (unspecified if ongoing); "attention deficit hyperactive disorder" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lithium for bipolar disorder; Oxcarbazepine for bipolar disorder. The following information was reported: BURNING MOUTH SYNDROME (medically significant), 90 min after the suspect product(s) administration, outcome "recovering". The event "burning mouth syndrome" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy tongue: which did not show any pathology., notes: normal oral mucosa confirmed on biopsy; Magnetic resonance imaging head: which was unremarkable.; Neurological examination: normal; physical exam: unremarkable, notes: normal-appearing oral mucosa without lesions or erythema. (consistent with a diagnosis of BMS). Therapeutic measures were taken as a result of burning mouth syndrome. Clinical course: In the below report, we present the first known case of a male patient who presented with burning mouth syndrome subsequently after Pfizer COVID-19 vaccination, as well as a unique, multimodal approach to effective treatment. A 39-year-old male with a past medical history of hypoplastic right lung, bipolar disorder (on lithium and oxcarbazepine), attention deficit hyperactive disorder, and migraines presented to the clinic with a burning sensation located on the dorsal aspect of his tongue with an altered sensation of old food residues and xerostomia. This sensation was constant and fluctuated in severity from a 6 to 10. One year earlier, the patient received the first Pfizer COVID-19 vaccination. He noted that about 90 min after the vaccination, he began to feel a burning sensation in his feet that extended up towards his mouth and cheeks. He had an episode of presumed vasovagal syncope shortly after that resolved without treatment or further workup. The burning sensation in his mouth has persisted since. He also noted that after the second vaccination dose 1 month after the first, he developed stiffness throughout his body and could not eat for 2 days. Although the burning pain in his mouth had slightly improved since the initial onset, it still affected his ability to work. The patient subsequently underwent an MRI of the head, which was unremarkable. He also underwent a biopsy of the tongue, which did not show any pathology. Prior to presenting in our clinic, the patient tried gabapentin, Lyrica, dexamethasone oral wash, saliva supplements, and CBD with titration to maximum dosages without relief. He noted that oral lidocaine and nystatin swish and spit provided mild relief for 30 min at a time. The physical exam was unremarkable, including a normal neurologic examination as well as normal-appearing oral mucosa without lesions or erythema. At his 2-month follow-up appointment post zinc initiation, the patient reported that he started acupuncture on the tongue. This combined with zinc and oral capsaicin washes provided a near-complete resolution of his pain and xerostomia. In this case, the patient presented with a history and physical exam consistent with a diagnosis of BMS. The patient gained significant benefits from oral capsaicin, oral zinc supplementation, as well as acupuncture of the tongue. This is the first known case in which a unique, multimodal approach to treatment was effective in a patient with new-onset BMS immediately following the first dose of the Pfizer COVID-19 vaccination. This case demonstrated the successful management of post-vaccine BMS through a unique multimodal approach. Oral capsaicin 0.02% rinse provided the patient with good, transient relief. Oral daily zinc supplementation also provided the patient with significant relief of the pain symptoms. Nearly 2 months of daily acupuncture was beneficial in not only this patient's pain but xerostomia symptoms as well.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of burning mouth syndrome might not be fully ruled out, considering the temporal relationship. More epidemiologic and accumulative clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate ,Linked Report(s) : US-PFIZER INC-202500097610 Same patient/drug; different dose;
More
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| 2840583 | 32 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
No adverse event
No adverse event
|
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
More
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||||||
| 2840585 | 19 | M | WI | 05/12/2025 |
HEPA |
MERCK & CO. INC. |
X026485 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine administered 5/12/2025, it expired the day before on 5/11/2025. No adverse affects noted.
Vaccine administered 5/12/2025, it expired the day before on 5/11/2025. No adverse affects noted.
|
||||||
| 2840586 | 1.25 | F | IL | 05/12/2025 |
DTAP PNC20 VARCEL |
SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
3CA25C1 LG5574 Y013350 |
Injection site pain, Injection site swelling; Injection site pain, Injection sit...
Injection site pain, Injection site swelling; Injection site pain, Injection site swelling; Injection site pain, Injection site swelling
More
|
Mom reports swelling to injection site left thigh the following day after receiving 3 vaccines. Tend...
Mom reports swelling to injection site left thigh the following day after receiving 3 vaccines. Tender to touch. Dr examined patient. Treatment Cephalexin 125 mg/5ml take 150 mg = 6 ml by mouth every 8 hours x 5 days.
More
|
||||||
| 2840587 | 86 | F | CA | 05/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Balance disorder, Confusional state, Dizziness, Dysstasia, Gait disturbance; Mus...
Balance disorder, Confusional state, Dizziness, Dysstasia, Gait disturbance; Musculoskeletal disorder, Pain, Pain in extremity, Visual impairment
More
|
About fifteen minutes after, as I was outside waiting for my ride I experienced a series of alarmin...
About fifteen minutes after, as I was outside waiting for my ride I experienced a series of alarming side effects: first it was a vision problem, then severe dizziness and confusion that lasted for several hours. I had trouble seeing the ramp to access the bus and finding the seat belt. Thanks to the caring driver I could safely return home. Next morning I woke up to severe pain in my left arm, that extended to all the left side of my body. I had trouble standing as my left hip and left knee seem very wobbly and unable to sustain my weight. This condition as remained like that to this day, and seems to be permanent. No pain reliever was able to allow me recover the complete use of my left leg and hip. What worries me is that it has affected my ability to walk already somehow a little diminish due to my age. I am eighty seven and experience the normal decline in the agility that I had before. I had the Moderna vaccine before twice without any side effects. I feel that I have the duty to report my reaction to warn other elderly person about possible severe side effects of the new vaccine.
More
|
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| 2840588 | 33 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
No adverse event
No adverse event
|
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
More
|
||||||
| 2840589 | 71 | F | MI | 05/12/2025 |
RSV VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
ln5464 47n3y |
Injection site pruritus, Injection site rash; Injection site pruritus, Injection...
Injection site pruritus, Injection site rash; Injection site pruritus, Injection site rash
More
|
patient reported itching, pudging on the back of arm, and small rash around the injection site. Took...
patient reported itching, pudging on the back of arm, and small rash around the injection site. Took benadryl which helped the itching
More
|
||||||
| 2840590 | 24 | F | 05/12/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Erythema, Pain, Pruritus, Rash
Erythema, Pain, Pruritus, Rash
|
Rash, itching, soreness, redness
Rash, itching, soreness, redness
|
|||||||
| 2840591 | 42 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
No adverse event
No adverse event
|
The treatment was the first of a two-series vaccination. The outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination. The outcome was uneventful, with no symptoms or signs of reactions reported.
More
|
||||||
| 2840592 | 18 | F | CA | 05/12/2025 |
VARCEL |
MERCK & CO. INC. |
Y011015 |
Pruritus, Rash
Pruritus, Rash
|
Pt has rash and itching. Pt was given Benadryl and Ibuprofen
Pt has rash and itching. Pt was given Benadryl and Ibuprofen
|
||||||
| 2840593 | 53 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00017 |
No adverse event
No adverse event
|
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
More
|
||||||
| 2840594 | 43 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00016 |
No adverse event
No adverse event
|
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of any reactions reported.
More
|
||||||
| 2840595 | 62 | F | MN | 05/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Discomfort, Injection site paraesthesia, Injection site reaction, Mass, Pain; Pa...
Discomfort, Injection site paraesthesia, Injection site reaction, Mass, Pain; Paraesthesia, Swelling
More
|
Injection given at the County Medical Center Kidney Transplant Clinic on 4/14/25. Developed local re...
Injection given at the County Medical Center Kidney Transplant Clinic on 4/14/25. Developed local reaction a few hours after the injection with lump, pain, swelling that persisted for several days. 2 weeks later, begin to notice tingling sensation intermittently that started near injection site & then radiates down arm and forearm in radial nerve distribution, including tingling in thumb, index, and third fingers. Intermittently feeling a tight squeezing sensation of the upper arm now for the past few days that she describes as feeling as if a blood pressure cuff is intermittently tightening and squeezing her upper arm. Presented today, 5/12/25, for evaluation as symptoms seem to be worsening. No other explanation for symptoms other than the vaccination.
More
|
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| 2840596 | 44 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00015 |
No adverse event
No adverse event
|
The treatment was the first of a two-seried vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-seried vaccination; the outcome was uneventful, with no symptoms or sighs of reaction reported.
More
|
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| 2840597 | 39 | F | GA | 05/12/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Brachial plexus injury, Immediate post-injection reaction, Muscle twitching, Mus...
Brachial plexus injury, Immediate post-injection reaction, Muscle twitching, Muscular weakness, Nerve injury; Neuritis, Pain, X-ray
More
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Disgnosed with brachial plexus injury/ neuritis pain was immediate and had nerve injury including mu...
Disgnosed with brachial plexus injury/ neuritis pain was immediate and had nerve injury including muscle weakness and twitching down to hand.
More
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✓ | |||||
| 2840598 | 21 | M | AZ | 05/12/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00015 |
No adverse event
No adverse event
|
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
More
|
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| 2840599 | 60 | F | OR | 05/12/2025 |
PNC21 RSV VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y019157 94CC4 47N3Y |
Injection site pain, Injection site rash, Urticaria; Injection site pain, Inject...
Injection site pain, Injection site rash, Urticaria; Injection site pain, Injection site rash, Urticaria; Injection site pain, Injection site rash, Urticaria
More
|
Per patient, localized injection site pain in both arms following administration. Urticaria on righ...
Per patient, localized injection site pain in both arms following administration. Urticaria on right arm same day. Rash developed around right arm at injection area. approximately 2 days after vaccine administration. Patient took Benadryl to manage symptoms with success. Rash lessened and eventually went away after a few days.
More
|
||||||
| 2840612 | 57 | M | MD | 05/12/2025 |
HEP HEP |
MERCK & CO. INC. MERCK & CO. INC. |
|
Arthralgia, C-reactive protein increased, Complement factor C3, Impaired work ab...
Arthralgia, C-reactive protein increased, Complement factor C3, Impaired work ability, Joint stiffness; Sleep disorder
More
|
Received first shot in series on 31 Jan 2025. Soon started noticing stiffness in finger joints but I...
Received first shot in series on 31 Jan 2025. Soon started noticing stiffness in finger joints but I didn't make the connection to the vaccine. Received second shot on March 5 2025. Symptoms worsened. Pain and stiffness in finger joints, wrists, toes and and one point knees. Pain sufficient to interfere with work and prevent sleep.
More
|
||||||
| 2840613 | 0.42 | M | MN | 05/12/2025 |
DTAP HIBV PNC15 RV5 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
|
Product administered at inappropriate site; Product administered at inappropriat...
Product administered at inappropriate site; Product administered at inappropriate site; Product administered at inappropriate site; Product administered at inappropriate site
More
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DATACEL vaccination was given in the same vaccination site as another vaccine.
DATACEL vaccination was given in the same vaccination site as another vaccine.
|
||||||
| 2840614 | 40 | F | CO | 05/12/2025 |
MMR |
MERCK & CO. INC. |
y014096 |
Extra dose administered
Extra dose administered
|
Pt was given 2 doses of MMR vaccine
Pt was given 2 doses of MMR vaccine
|
||||||
| 2840615 | 62 | M | WI | 05/12/2025 |
MMR |
MERCK & CO. INC. |
Y013172 DILUEN |
Arthralgia, Injection site discomfort, Injection site pain, Musculoskeletal disc...
Arthralgia, Injection site discomfort, Injection site pain, Musculoskeletal discomfort, Pain
More
|
THE PATIENT COMPLAINED THAT HIS RIGHT ARM IN THE DELTOID AND/OR SHOULDER AREA HAD SOME PAIN AND DISC...
THE PATIENT COMPLAINED THAT HIS RIGHT ARM IN THE DELTOID AND/OR SHOULDER AREA HAD SOME PAIN AND DISCOMFORT WHEN HE RAISED HIS ARM UP HALF WAY UP. HE ALSO MENTIONED THAT THIS ARM( RIGHT ARM) IN THE SHOULDER AREA WAS INJURED FORM SNOW SHOVELING AND THAT SOME TIME IT SILL HURTS. ON 5/12/25 HE CAME IN FOR HIS SECOND SHINGRX VACCINE. IT WAS PUT IN HIS LEFT DELTOID. I INSTRUCTED HIM TO CHECK WITH HIS PROVIDER IF HIS RIGHT ARM CONTINUED TO BOTHER HIM.
More
|
||||||
| 2840616 | 29 | M | CA | 05/12/2025 |
MNQ |
SANOFI PASTEUR |
U8558AA |
Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Syncope
Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Syncope
|
Patient was getting 2 vaccines at the pharmacy. Patient got the first vaccine (flu shot) on the righ...
Patient was getting 2 vaccines at the pharmacy. Patient got the first vaccine (flu shot) on the right arm and the patient fainted during the 2nd shot (meningitis vaccine) on the left arm. Patient was seated in a chair with arm rests. During the vaccine administration, he said that he felt dizzy. Immediately after, he fainted. His head tilted back and his eyes rolled back. Father and Pharmacist restrained the patient to keep him from falling. Patient was passed out for about 30 seconds and woke up. He was also sweating. Initial blood pressure was 108/53 with a pulse of 58. We called 911 and paramedics came. Paramedics examined. Vitals were all good. On the consent form, he stated that he had never fainted or felt dizzy after receiving an immunization. After the incident, the father and patient then mentioned that he fainted about 3 months ago during a blood draw. Patient had meal(s) during the day and was hydrated.
More
|
||||||
| 2840617 | 32 | F | NM | 05/12/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
Flushing, Injection site erythema, Injection site pruritus, Injection site rash,...
Flushing, Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction; Urticaria
More
|
Rash, large welt running down tricep that vaccine was administer in, flushed skin, bright red skin c...
Rash, large welt running down tricep that vaccine was administer in, flushed skin, bright red skin color, itchy,
More
|
||||||
| 2840621 | 11 | M | CA | 05/12/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y007197 U8438AA 3RE73 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
More
|
Vaccine injection sites - red, warm, swollen. Non-tender.
Vaccine injection sites - red, warm, swollen. Non-tender.
|
||||||
| 2840352 | 17 | F | MO | 05/11/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
|
Allergy to vaccine, Chills, Injection site erythema, Injection site swelling, My...
Allergy to vaccine, Chills, Injection site erythema, Injection site swelling, Myalgia; Nausea, Pyrexia
More
|
Fever muscle pain chills nausea injection site redness and swelling. Redness and swelling continuing...
Fever muscle pain chills nausea injection site redness and swelling. Redness and swelling continuing to worsen as the days pass. Went to urgent care they added vaccine to allergy list prescribed steroids if it gets worse. Took Zyrtec in am and Benadryl at h.s. Woke up to it more swollen and more red. Starting steroids today.
More
|
||||||
| 2840353 | 62 | M | WV | 05/11/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945664 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient did not report an adverse event- patient had already received both doses of a 2 dose series ...
Patient did not report an adverse event- patient had already received both doses of a 2 dose series and received an unneeded third dose on 04/05/2025.
More
|
||||||
| 2840354 | 45 | F | AZ | 05/11/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
021C021A 021C021A 021C021A 066D21A 066D21A 066D21A |
Antibody test positive, Bradycardia, Epstein-Barr virus test, Fatigue, Laborator...
Antibody test positive, Bradycardia, Epstein-Barr virus test, Fatigue, Laboratory test; Multisystem inflammatory syndrome, Muscular weakness, Nervous system disorder, Neuropathy peripheral, Postural orthostatic tachycardia syndrome; Scan brain; Antibody test positive, Bradycardia, Epstein-Barr virus test, Fatigue, Laboratory test; Multisystem inflammatory syndrome, Muscular weakness, Nervous system disorder, Neuropathy peripheral, Postural orthostatic tachycardia syndrome; Scan brain
More
|
- Proliferation of Anti-bodies, multisystem inflammatory syndrome, weak limbs, POTS, Bradycardia, ne...
- Proliferation of Anti-bodies, multisystem inflammatory syndrome, weak limbs, POTS, Bradycardia, neurological impairment, neuropathy, fatigue, and list goes on and on.
More
|
✓ | |||||
| 2840355 | 50 | F | VA | 05/11/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Injection site cellulitis, Injection site erythema, Injection site rash
Injection site cellulitis, Injection site erythema, Injection site rash
|
PATIENT NOTICED A RASH/ REDNESS OF SKIN NEAR THE INJECTION SITE. SHE WENT TO THE DOCTOR AND HE DIAG...
PATIENT NOTICED A RASH/ REDNESS OF SKIN NEAR THE INJECTION SITE. SHE WENT TO THE DOCTOR AND HE DIAGNOSED CELLULITIS
More
|
||||||
| 2840356 | 70 | M | FL | 05/11/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient requests getting Tdap and Shingle vaccines. The 2 vaccines were administered with out any pr...
Patient requests getting Tdap and Shingle vaccines. The 2 vaccines were administered with out any problem or adverse reaction. Afterward our screening system indicated that patient already received another Tdap vaccine 2 months ago. This make the new vaccine was a dupplication of therapy .
More
|
||||||
| 2840357 | 18 | F | 05/11/2025 |
HPV9 |
MERCK & CO. INC. |
Y007193 |
Dizziness, Syncope
Dizziness, Syncope
|
Patient fainted 5 minutes after receiving vaccination. She sat for monitoring due to a history of fa...
Patient fainted 5 minutes after receiving vaccination. She sat for monitoring due to a history of fainting post vaccination secondary to a fear of needles. Upon getting up to leave the pharmacy assisted by her family member she began to get lightheaded and fainted and they lowered her gently to the floor so she could lie down. Patient was able to sit up a few moments later and was alert and oriented.
More
|
|||||||
| 2840358 | 22 | F | MO | 05/11/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
Extra dose administered
Extra dose administered
|
when the patient was at the pharmacy we looked up the state registry and it didn't have her for...
when the patient was at the pharmacy we looked up the state registry and it didn't have her for any HPV vaccines, the patient wasn't aware of ever getting one and received it, left and her parents informed her she did receive it already when she was around 10
More
|
||||||
| 2840359 | 59 | M | FL | 05/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Rash
Rash
|
Patient came back to the pharmacy a few days after the second dose of Shingrix vaccine and reported ...
Patient came back to the pharmacy a few days after the second dose of Shingrix vaccine and reported breaking out into rash all over body. Patient was unsure if due to new medication or vaccine.
More
|
||||||
| 2840360 | 65 | F | ME | 05/11/2025 |
HEPAB PNC21 VARZOS |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
D4774 y019158 EK225 |
Injection site bruising, Injection site pain, Pyrexia; Injection site bruising, ...
Injection site bruising, Injection site pain, Pyrexia; Injection site bruising, Injection site pain, Pyrexia; Injection site bruising, Injection site pain, Pyrexia
More
|
vaccines was given on 04/30/2025 total 3 vaccines (1 on R arm and 2 vaccines on L arm)and on 05/18/...
vaccines was given on 04/30/2025 total 3 vaccines (1 on R arm and 2 vaccines on L arm)and on 05/18/2025 patient came to pharmacy and showed the right arm ( Twinrix) and had bruise on injection site. she said she had fever for 2 days on and off and had this bruise. No pain or itching at this time but hurts when touch. Patient advised to go and get it checked with Doctor and patient agreed to see doctor.
More
|
||||||
| 2840361 | 63 | F | AR | 05/11/2025 |
TDAP VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U82322AA 93KK4 |
Rash, Rash pruritic; Rash, Rash pruritic
Rash, Rash pruritic; Rash, Rash pruritic
|
rash on left side of torso under arm and left side of back only. Itches really bad and hurts. Pati...
rash on left side of torso under arm and left side of back only. Itches really bad and hurts. Patient took hot showers, used peroxide, Cortisone 10, calamine lotion , some spray for infection from the dollar store and Benadryl liquid gels. She was not any better until she started taking Benadryl Saturday night the 10th. She took 2 gel caps Saturday night and 2 Sunday morning the 11th and is doing much better. The rash is not itching any more. If the rash does not go away she is going back to the doctor's office to see if it may be Shingles.
More
|
||||||
| 2840362 | 77 | F | 05/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47N3Y |
Chills
Chills
|
Patient called stating that she has been having chills and asked if the vaccine can cause chills.
Patient called stating that she has been having chills and asked if the vaccine can cause chills.
|
|||||||
| 2840363 | 68 | M | MO | 05/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
LN4P2 |
Extra dose administered
Extra dose administered
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Arexvy immunization was given when not indicated as patient had received a single dose of Abrysvo in...
Arexvy immunization was given when not indicated as patient had received a single dose of Abrysvo in 2023 that he did not remember getting.
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| 2840364 | 52 | M | TX | 05/11/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
y011819 y011819 9L944 9L944 |
Cardiac monitoring, Chest pain, Echocardiogram, Electrocardiogram, Inflammation;...
Cardiac monitoring, Chest pain, Echocardiogram, Electrocardiogram, Inflammation; Injection site swelling, Magnetic resonance imaging, Swelling; Cardiac monitoring, Chest pain, Echocardiogram, Electrocardiogram, Inflammation; Injection site swelling, Magnetic resonance imaging, Swelling
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SWELLING/INFLAMMATION OF THE CHEST, SEVERE CHEST PAIN, SWELLING OF THE LEFT ARM AROUND INJECTION SI...
SWELLING/INFLAMMATION OF THE CHEST, SEVERE CHEST PAIN, SWELLING OF THE LEFT ARM AROUND INJECTION SITE,. CURRENTLY WEARING A HEART MONITOR. WAS PRESCRIBED FAMOTIDINE RECENTLY
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| 2840365 | 75 | F | TN | 05/11/2025 |
RSV TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7L3ST EB499 |
Arthralgia, Musculoskeletal stiffness, Neck pain; Arthralgia, Musculoskeletal st...
Arthralgia, Musculoskeletal stiffness, Neck pain; Arthralgia, Musculoskeletal stiffness, Neck pain
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Patient called 2 days after vaccine complaining of pain and stiffness in the shoulder/neck area of t...
Patient called 2 days after vaccine complaining of pain and stiffness in the shoulder/neck area of the right arm (opposite from injection site). Says pain relieved with rest, OTC APAP. No other symptoms reported. Said has gotten better since awakening. Advised to continue rest/OTC therapy and seek further care if symptoms worsen or do not get better over the next few days.
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