| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2838205 | F | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
She has not yet received her second; This non-serious case was reported by a consumer via call cente...
She has not yet received her second; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine in 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: She has not yet received her second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 Reporter stated that the patient only received her first dose of Shingrix in 2018. She has not yet received her second. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025049321:Same reporter,Different patient
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| 2838206 | F | WA | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash vesicular
Rash vesicular
|
spots that look like chickenpox; This non-serious case was reported by a consumer via call center re...
spots that look like chickenpox; This non-serious case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-APR-2025, the patient received Shingrix (intramuscular, left arm). On 22-APR-2025, 18 days after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: spots that look like chickenpox). The outcome of the varicella-like rash was not resolved. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. It was unknown if the company considered the varicella-like rash to be related to Shingrix. Additional Information: GSK Receipt Date: 23-APR-2025 The spots that look like chickenpox on right arm, axilla and lower abdomen. The reporter stated that she received her second dose of Shingrix in her left arm. Consumer reported that on 22nd April 2025 she noticed a spot resembling chickenpox on her right arm, one on her axilla, and one or two on her abdomen. Consumer reported that this morning she noticed that she has 7 spots on her abdomen. No other information was provided/obtained.
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| 2838207 | 04/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache, Pain, Pyrexia, Vomiting
Headache, Pain, Pyrexia, Vomiting
|
fever; body aches; throwing up; headache; This non-serious case was reported by a consumer via inter...
fever; body aches; throwing up; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: fever), general body pain (Verbatim: body aches), vomiting (Verbatim: throwing up) and headache (Verbatim: headache). The outcome of the fever, general body pain, vomiting and headache were resolved (duration 1 week). It was unknown if the reporter considered the fever, general body pain, vomiting and headache to be related to Arexvy. It was unknown if the company considered the fever, general body pain, vomiting and headache to be related to Arexvy. Additional Information: GSK Receipt Date: 18-APR-2025 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient just got the shot and reactions were more severe, fever, body aches, throwing up, headache for a week.
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| 2838208 | F | NY | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
had not completed the series yet; This non-serious case was reported by a other health professional ...
had not completed the series yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose anywhere between 2 to 5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had not completed the series yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-APR-2025 An office manager informed that a patient had gotten the first dose of Shingrix vaccine anywhere between 2 to 5 years ago and had not completed the series yet at the moment of the call. 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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| 2838209 | 0.33 | M | KS | 04/28/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J5T9Z |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Underage; This non-serious case was reported by a nurse via call center representative and described...
Underage; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis. On 17-APR-2025, the patient received FluLaval 2024-2025 season. On 17-APR-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). The outcome of the inappropriate age at vaccine administration 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: 18-APR-2025 Registered nurse called to report an Adverse Event regarding an underage administration and they just gave out a dose to a four month old patient, which led to inappropriate age at vaccine administration. The registered nurse wanted to have Medical Information advise on this situation. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further detail was obtained in this call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
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| 2838210 | 70 | F | TX | 04/28/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
4T93R |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Inappropriate Vaccination Schedule (less than 6 months after first dose); This non-serious case was ...
Inappropriate Vaccination Schedule (less than 6 months after first dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received HAV (Havrix) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. Previously administered products included Havrix (received 1st dose on 12th December 2024, batch number : 4T93R and expiry date:11-JUL-2026 00:00). On 22-APR-2025, the patient received the 2nd dose of Havrix. On 22-APR-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Vaccination Schedule (less than 6 months after first dose)). The outcome of the drug dose administration interval too short 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:22-APR-2025 Pharmacist called to report a patient was vaccinated for the second dose on month four after the first dose instead of sixth month after the first dose. The reporter asked if they need to revaccinate. The vaccination date (first and second dose), vaccine detail (first and second dose) and patient demographics were obtained in this call. No further information was obtained in this call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
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| 2838211 | 45 | F | TN | 04/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
AX2D5 |
Expired product administered
Expired product administered
|
Engerix-B expired dose administration; This non-serious case was reported by a other health professi...
Engerix-B expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HBV (Engerix B) (batch number AX2D5, expiry date 07-DEC-2024) for prophylaxis. On 21-APR-2025, the patient received Engerix B. On 21-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B expired dose administration). 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:23-APR-2025 Medical Assistant wanted to know how to proceed after administering an expired dose of Engerix-B to a patient, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
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| 2838212 | 0.17 | F | OH | 04/28/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
H54F9 |
Expired product administered
Expired product administered
|
Expired drug administered; This non-serious case was reported by a nurse via call center representat...
Expired drug administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number H54F9, expiry date 11-APR-2025) for prophylaxis. On 22-APR-2025, the patient received Pediarix. On 22-APR-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired drug administered). 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: 23-APR-2025 Nurse reported that Pediarix was administered to a baby but the dose was expired, which led to expired vaccine used. HCP was going to consider this dose valid and proceed with the regular schedule. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2838213 | 0.33 | M | OK | 04/28/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
Patient was supposed to receive Pediarix but instead he received Kinrix; This non-serious case was r...
Patient was supposed to receive Pediarix but instead he received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 23-APR-2025, the patient received the 1st dose of Kinrix. On an unknown date, the patient did not receive Pediarix. On 23-APR-2025, immediately after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Patient was supposed to receive Pediarix but instead he received Kinrix). The outcome of the wrong vaccine administered 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: 23-APR-2025 The clinic had called because they had mistakenly administered the Kinrix vaccine to a four-month-old, even though it was indicated for children four years and older. As a result, they had a few questions regarding the situation. The patient was supposed to have received Pediarix, but instead, had been given Kinrix, which led to wrong vaccine administered. They had consented to a follow-up.
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| 2838217 | 24 | M | CA | 04/28/2025 |
DTAP |
SANOFI PASTEUR |
|
Arthralgia, Mobility decreased, Pain, Pain in extremity
Arthralgia, Mobility decreased, Pain, Pain in extremity
|
Arm/shoulder has been in pain and I cannot move it within its entire range, I get really bad pain if...
Arm/shoulder has been in pain and I cannot move it within its entire range, I get really bad pain if I try to scratch my back or reach up.
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| 2838221 | 31 | F | NJ | 04/28/2025 |
HEPA |
MERCK & CO. INC. |
Y017625 |
Wrong product administered
Wrong product administered
|
The provider ordered Hepatitis B, and as a result the medical assistant administered Hepatitis A.
The provider ordered Hepatitis B, and as a result the medical assistant administered Hepatitis A.
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| 2838248 | 69 | F | KS | 04/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Biopsy skin, Blister, Blood immunoglobulin G, Dermatitis, Eosinophilia; Patholog...
Biopsy skin, Blister, Blood immunoglobulin G, Dermatitis, Eosinophilia; Pathology test
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onset of serology positive bullous pemphigoid 10 days following vaccine administration
onset of serology positive bullous pemphigoid 10 days following vaccine administration
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| 2838249 | 25 | F | MN | 04/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5S397 |
Exposure during pregnancy, Product use issue, Wrong product administered
Exposure during pregnancy, Product use issue, Wrong product administered
|
Arexvy RSV Vaccine given to pregnant patient instead of Abrysvo. 33 weeks and 3d days pregnant at ti...
Arexvy RSV Vaccine given to pregnant patient instead of Abrysvo. 33 weeks and 3d days pregnant at time of vaccination.
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| 2838250 | 12 | M | FL | 04/28/2025 |
HPV9 |
MERCK & CO. INC. |
Y012776 |
Injection site swelling
Injection site swelling
|
Swelling where vaccine was given. Patient was prescribed an antibiotic for 3 days. Mom states patien...
Swelling where vaccine was given. Patient was prescribed an antibiotic for 3 days. Mom states patient is doing better.
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| 2838251 | 77 | M | IA | 04/28/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
|
end of life
end of life
|
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| 2838252 | 50 | F | SC | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Pain, Pain in extremity
Arthralgia, Pain, Pain in extremity
|
Three to four hours after the injection, my arm began to hurt. By six hours after the injection the ...
Three to four hours after the injection, my arm began to hurt. By six hours after the injection the pain radiated from shoulder to finger tips. The following morning, the paid had lessened but was was still present. The following morning (approximately seventeen hours after the injection), I began to experience muscle aches and chills. This worsened over the following twelve hours as I experienced severe muscle aches and low grade fever. The following day (approximately 30 hours after the injection), I am experiencing mild muscle aches and fatigue but no fever. My arm still hurts, but not as severely as it did the evening after the injection. The injection site is mildly swollen and warm to the touch.
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| 2838253 | 11 | M | NC | 04/28/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
NR394 |
Injection site discomfort, Injection site swelling
Injection site discomfort, Injection site swelling
|
SWELLING ON LT ARM VACCINE SITE WITH MILD DISCOMFORT ZYRTEC GIVEN AND COLD COMPRESS QID WITH MOTRIN ...
SWELLING ON LT ARM VACCINE SITE WITH MILD DISCOMFORT ZYRTEC GIVEN AND COLD COMPRESS QID WITH MOTRIN PRN
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| 2838254 | 64 | F | CA | 04/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9l944 9l944 |
Dyspnoea, Injection site erythema, Injection site induration, Injection site pai...
Dyspnoea, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling; Pruritus, Rash
More
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: look like allergic reaction to vaccine. pt had rash red and swollen at the injection site
More
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| 2838255 | 55 | F | CA | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5y9ca |
Limb injury
Limb injury
|
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
|
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| 2838256 | 83 | F | PA | 04/28/2025 |
COVID19 |
MODERNA |
3046731 |
Injection site pain, Pain, Pain in jaw, Paraesthesia
Injection site pain, Pain, Pain in jaw, Paraesthesia
|
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Sharp, radiating...
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Sharp, radiating, shooting pain on rotating sides of jaw-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient called pharmacy 04/21/2025 to report a reaction suspected to be related to recent vaccination with Moderna 2024-25 Spikevax vaccine. Patient reported radiating, shooting pain starting the day after vaccination localized mainly to lower jaw (rotating sides). Patient described pain as similar to a toothache with symptoms worsening with hot and cold drinks / food. Patient reported having strong immune reactions to Moderna vaccinations in past, but these symptoms are new.
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| 2838259 | 61 | M | UT | 04/28/2025 |
MNQ |
SANOFI PASTEUR |
u8194aa |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2838260 | 72 | M | TX | 04/28/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
99HE4 99HE4 99HE4 |
Abdominal pain, Abdominal pain upper, Blood disorder, Central venous catheterisa...
Abdominal pain, Abdominal pain upper, Blood disorder, Central venous catheterisation, Chills; Dizziness, Gastrooesophageal reflux disease, Haematological infection, Injection site pain, Pain in extremity; Pruritus, Thrombosis mesenteric vessel
More
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Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Seve...
Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Severe, Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Received vaccine tuesday 04/1@11:44AM.Felt fine & mowed lawn later that day.Around 4-5Pm began to have stomach pain,itching on legs.later that night, chills and leg pain.Did not feel better and eventually went to ER on thursday. Developed blood clot in stomach, started on eliquis, Currently has PICC line x6 weeks for abx due to blood infection. Not sure if caused by vaccine or other external factor, but wanted to document timeline.
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| 2838261 | 68 | F | CA | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ts525 |
Facial pain, Mouth ulceration, Oral mucosal eruption, Paraesthesia, Stomatitis
Facial pain, Mouth ulceration, Oral mucosal eruption, Paraesthesia, Stomatitis
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Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient stated dev...
Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient stated developed Mouth sores/ulcers in gum and pain on left side of face. feel tingling sensation and rash inside of mouth in only 1 side of the face (left side). went to dentist and gave peridex mouthwash.
More
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| 2838262 | 80 | F | CA | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2211 |
Chills
Chills
|
Systemic: Chills-Medium
Systemic: Chills-Medium
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| 2838263 | 77 | F | CA | 04/28/2025 |
COVID19 |
MODERNA |
017F21A |
Chills
Chills
|
Systemic: Chills-Medium
Systemic: Chills-Medium
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| 2838264 | 59 | F | NV | 04/28/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2838265 | 75 | F | PA | 04/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
E754F E754F |
Arthralgia, Arthritis, Asthenia, Chills, Condition aggravated; Dizziness, Headac...
Arthralgia, Arthritis, Asthenia, Chills, Condition aggravated; Dizziness, Headache, Pain, Pyrexia, Tremor
More
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Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadnes...
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: arthritis flare up-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Severe
More
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| 2838266 | 65 | F | TN | 04/28/2025 |
COVID19-2 |
MODERNA |
3043029 |
Asthenia, Fatigue, Lethargy, Pain, Sluggishness
Asthenia, Fatigue, Lethargy, Pain, Sluggishness
|
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-...
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Medium, Additional Details: Feeling very tired, very weak, sluggish, and barely stay awake and slept under multiple covers
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| 2838267 | 72 | F | OK | 04/28/2025 |
COVID19-2 |
MODERNA |
8079568 |
Injection site pain, Injection site paraesthesia, Limb injury, Paraesthesia
Injection site pain, Injection site paraesthesia, Limb injury, Paraesthesia
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Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-,...
Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Tingling/electrical pulses at shoulder and around injection site. Difficulty raising arm.
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| 2838269 | 74 | F | AZ | 04/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5y9ca 5y9ca |
Injection site erythema, Injection site swelling, Mouth swelling, Oral herpes, S...
Injection site erythema, Injection site swelling, Mouth swelling, Oral herpes, Swelling face; Swelling of eyelid, Swollen tongue
More
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Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic:...
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: On day of vaccination, All questions reviewd and patient was healthy and confirmed that no immune system issues & managed for 15 minutes after getting the shot. I recieved a call from ED, patient admited to hospital on 04/21/2025 getting facial swelling, fever blisters on her mouth & both eyes shut down. Symptoms managed by Prescriber & she is responding to medications.
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| 2838270 | 71 | F | SC | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
53hx9 |
Eye pruritus, Injection site pruritus, Rash
Eye pruritus, Injection site pruritus, Rash
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-M...
Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient experienced rash on the leg and eye itching . referred patient to her provider for treatment .
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| 2838271 | 59 | F | SC | 04/28/2025 |
PNC21 |
MERCK & CO. INC. |
y019157 |
Injection site erythema, Injection site swelling, Rash, Rash erythematous, Skin ...
Injection site erythema, Injection site swelling, Rash, Rash erythematous, Skin warm
More
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: generalized r...
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: generalized red rash on arm. Does not itch, but warm to the touch-Mild, Additional Details: Pt exhibited a generalized red rash on the right arm. Said it presented approximately 4 days after vaccine administration. I did tell her that that is a common side effect with any vaccine, to apply ice and cortisone to area and observe. If it continues to spread, contact dr, Other Vaccines: VaccineTypeBrand: shingrix; Manufacturer: GSK; LotNumber: 9l5p2; Route: IM; BodySite: right arm; Dose: 1; VaxDate: 04/18/2025
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| 2838272 | 68 | F | TN | 04/28/2025 |
COVID19-2 |
MODERNA |
3042560 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
More
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| 2838273 | 23 | F | PA | 04/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3046731 3046731 |
Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain; Injec...
Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site swelling, Pain
More
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: HORRIBLE HEADACHE, FATIGUE, WHITE STOOL-Severe, Systemic: Headache-Severe, Systemic: Weakness-Medium
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| 2838274 | 70 | F | FL | 04/28/2025 |
COVID19-2 |
MODERNA |
Unknown |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Medium
Site: Pain at Injection Site-Medium
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| 2838275 | 67 | M | CA | 04/28/2025 |
COVID19 |
MODERNA |
3043420 |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: Patient reported that he experiences pain at ...
Site: Pain at Injection Site-Mild, Additional Details: Patient reported that he experiences pain at injection site after all vaccination. Pain usually last 2 days , Other Vaccines: VaccineTypeBrand: Fluzone High-Dose; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 10/08/2024
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| 2838276 | 74 | M | FL | 04/28/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
32yb4 32yb4 |
Abdominal pain, Diarrhoea, Dizziness, Hyperhidrosis, Injection site bruising; In...
Abdominal pain, Diarrhoea, Dizziness, Hyperhidrosis, Injection site bruising; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Mild, Additional Details: sweating
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| 2838278 | 75 | F | FL | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
md3414 |
Injection site erythema, Injection site pain, Injection site pruritus
Injection site erythema, Injection site pain, Injection site pruritus
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Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ...
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: covid-19 commirnaty; Manufacturer: pfizer pharm; LotNumber: MD3414; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2838279 | 0.75 | F | TX | 04/28/2025 |
DTAPIPVHIB HEP HEPA PNC20 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
UK168AB 7NX57 J4K4X LJ5282 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Patient received a Hep A outside of recommended dosing time frame by accident. Child was kept in off...
Patient received a Hep A outside of recommended dosing time frame by accident. Child was kept in office for 15 minute shot time, during that time no signs or symptoms of reactions noted. Nurse did inform child's mother immediately and incident and the provider.
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| 2838280 | 75 | F | KS | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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no adverse reaction. The vaccine expired 04/24/2025 and was given the morning of 04/25/2025
no adverse reaction. The vaccine expired 04/24/2025 and was given the morning of 04/25/2025
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| 2838281 | 75 | M | KS | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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The vaccine expired on April 24th 2025 and was given the morning of April 25th 2025. No adverse reac...
The vaccine expired on April 24th 2025 and was given the morning of April 25th 2025. No adverse reaction.
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| 2838282 | 66 | F | SC | 04/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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Pt came in 04/28/25 reporting redness, swelling, itching, pain at injection site that had spread bil...
Pt came in 04/28/25 reporting redness, swelling, itching, pain at injection site that had spread bilatterally. It is currently subsiding but still red at injection site
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| 2838283 | 29 | F | MI | 04/28/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3043000 U8523AA |
No adverse event, Underdose; No adverse event, Underdose
No adverse event, Underdose; No adverse event, Underdose
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CLIENT ADMINISTERED 0.25 ML DOSE OF MODERNA VACCINE. CLIENT WAS NOTIFIED PER PC WHEN DISCOVERED DOSE...
CLIENT ADMINISTERED 0.25 ML DOSE OF MODERNA VACCINE. CLIENT WAS NOTIFIED PER PC WHEN DISCOVERED DOSE ADMINISTERED IS A NON COUNTABLE DOSE. PT INFORMED AND MADE AWARE OF RECOMMENDATION TO REPEAT MODERNA VACCINE WITH 0.5 ML DOSE TO ENSURE EFFICACY AND ADEQUATE PROTECTION. CLIENT DENIES ADVERSE EFFECTS, VERBALIZED UNDERSTANDING, AND INTENT TO REPEAT IN FUTURE.
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| 2838284 | 4 | F | NY | 04/28/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y49BZ Y014305 |
Injection site rash, Rash, Rash macular; Injection site rash, Rash, Rash macular
Injection site rash, Rash, Rash macular; Injection site rash, Rash, Rash macular
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Patient developed a small rash around the injection site. A day later her face broke out in a red, s...
Patient developed a small rash around the injection site. A day later her face broke out in a red, spotty rash. The rash continued to spread to her upper arms and legs, progressing down her arms and legs over the next 24-48 hours. Patient now has small spotty rashes breaking out on her chest and back. -- Patient received MMRV 4/10/25 and DTAP/IPV 4/22/25
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| 2838285 | 78 | F | VA | 04/28/2025 |
COVID19 |
PFIZER\BIONTECH |
md3414 |
Erythema, Pain in extremity, Peripheral swelling, Skin warm
Erythema, Pain in extremity, Peripheral swelling, Skin warm
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Patient called on 4/24/25 reported that her arm was still sore, red, hot to touch and swollen. Patie...
Patient called on 4/24/25 reported that her arm was still sore, red, hot to touch and swollen. Patient asked if she could take Ibuprofen and ice the area which patient was told ok. If no improvement instructed patient to go see PCP and have them look at area. Asked patient to call us back 4/25/25 to let us know how she was doing and if any improvement
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| 2838286 | 0.5 | F | SD | 04/28/2025 |
PNC15 |
MERCK & CO. INC. |
Y010032 |
Dermatitis, Injection site rash
Dermatitis, Injection site rash
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Persistent rash at vaccine injection site. Area of dermatitis still present at 9 month well child ex...
Persistent rash at vaccine injection site. Area of dermatitis still present at 9 month well child examination. No topicals trialed, other than moisturizer.
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| 2838287 | 62 | F | FL | 04/28/2025 |
PNC21 TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
y011819 u8115aa |
Cellulitis; Cellulitis
Cellulitis; Cellulitis
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cellulitis; pt was prescribed antibiotic on 4/27/25
cellulitis; pt was prescribed antibiotic on 4/27/25
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| 2838288 | 1.5 | M | CT | 04/28/2025 |
HEPA |
MERCK & CO. INC. |
Y011643 |
Injection site rash, Rash, Rash erythematous, Urticaria
Injection site rash, Rash, Rash erythematous, Urticaria
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Patient came into office on 4/28 for Rash - Appeared on his arm 3 days ago after a physical exam whe...
Patient came into office on 4/28 for Rash - Appeared on his arm 3 days ago after a physical exam where he had received Hep A - Worsened progressively, especially with heat - Treated with Benadryl and Tylenol Skin: red round rash all over face, chest, back, arms and legs- urticaria multiforme
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| 2838289 | 60 | F | GA | 04/28/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
fh8027 FP7150 en6206 8732 |
Arthralgia, Blood test normal, Pain in extremity, Paraesthesia, X-ray normal; Ar...
Arthralgia, Blood test normal, Pain in extremity, Paraesthesia, X-ray normal; Arthralgia, Blood test normal, Pain in extremity, Paraesthesia, X-ray normal; Arthralgia, Blood test normal, Pain in extremity, Paraesthesia, X-ray normal; Arthralgia, Blood test normal, Pain in extremity, Paraesthesia, X-ray normal
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extreme pain in lower extremities, both legs, and back of hips, - given pain medicines, needle stic...
extreme pain in lower extremities, both legs, and back of hips, - given pain medicines, needle sticks in legs, xrays and dozens of blood work....all tests were negative for muscle weakness
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| 2838290 | 77 | M | NC | 04/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
ND3C7 |
Abdominal distension, Fatigue, Joint swelling
Abdominal distension, Fatigue, Joint swelling
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Reported to pharmacy on 04/28/20/25 ---Patient noticed that after receiving the RSV VACCINE on 12/11...
Reported to pharmacy on 04/28/20/25 ---Patient noticed that after receiving the RSV VACCINE on 12/11/2024 had bloating , started feel tired for next couple of days. Stated he started having swollen ankles after that.
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