| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829088 | 17 | M | TX | 03/03/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
5JX2E |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
seventeen year old patient received an adult dose of Engerix-B; seventeen year old patient received ...
seventeen year old patient received an adult dose of Engerix-B; seventeen year old patient received an adult dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis. On 25-NOV-2024, the patient received Engerix B adult. On 25-NOV-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: seventeen year old patient received an adult dose of Engerix-B) and overdose (Verbatim: seventeen year old patient received an adult dose of Engerix-B). The outcome of the adult product administered to child and overdose 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: 21-FEB-2025 The reporter reported that a seventeen year old patient received an adult dose of Engerix B last year, which led to adult product administered to child and overdose. The reporter added now this patient was 18 years old and asked if the patient needs to receive another dose, and wanted to know was the patient covered.
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| 2829089 | MD | 03/03/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Y3ME2 |
Expired product administered
Expired product administered
|
Administration of expired dose; This non-serious case was reported by a pharmacist via call center r...
Administration of expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix 720) (batch number Y3ME2, expiry date 25-FEB-2025) for prophylaxis. On 25-FEB-2025, the patient received Havrix 720. On 25-FEB-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). 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: 25-FEB-2025 The reporter reported that the patient had given expired hep A vaccine just 2 day later from the expiration day which led to expired vaccine used. The reporter had to re-vaccinated the patient or not. This adverse event was received via Webform. No further details provided.
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| 2829090 | 73 | M | NM | 03/03/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
he was supposed to received Tdap (Boostrix), unfortunately the medical assistant gave him the Dtap (...
he was supposed to received Tdap (Boostrix), unfortunately the medical assistant gave him the Dtap (Kinrix); Administration to a 73 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 73-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 24-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Boostrix. On 24-FEB-2025, an unknown time after receiving Kinrix and Boostrix, the patient experienced wrong vaccine administered (Verbatim: he was supposed to received Tdap (Boostrix), unfortunately the medical assistant gave him the Dtap (Kinrix)) and inappropriate age at vaccine administration (Verbatim: Administration to a 73 year old patient). 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: 25-Feb-2025 There was an error yesterday with a vaccine that was administered. The patient was supposed to received Tdap (Boostrix), unfortunately the medical assistant gave him the Dtap, the reporter believe is the Kinrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter need to know if that was going to cause the patient any issue. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2829091 | M | CA | 03/03/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
B9279 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Patient received second dose of Twinrix late; This non-serious case was reported by a pharmacist via...
Patient received second dose of Twinrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose of Twinrix on 6th May 2023 with batch number 2PG309 and expiry date 19th September 2025). On 09-JAN-2025, the patient received the 2nd dose of Twinrix. On 09-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received second dose of Twinrix late). The outcome of the drug dose administration interval too long 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: 25-FEB-2025 The reporter wanted to know how the second dose should have been administered. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. This is 1 of 4 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025023741:same reporter US-GSK-US2022160192:same reporter US-GSK-US2020191512:same reporter
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| 2829092 | F | CA | 03/03/2025 |
COVID19 |
JANSSEN |
Unknown |
Disability, Hypersensitivity, Mast cell activation syndrome, Postural orthostati...
Disability, Hypersensitivity, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome
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Mast Cell Activation Syndrome (MCAS); became disabled; Allergic reactions to covid-19 vaccine; Postu...
Mast Cell Activation Syndrome (MCAS); became disabled; Allergic reactions to covid-19 vaccine; Postural Orthostatic Tachycardia Syndrome (POTS); This spontaneous report received from a health care professional concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's concurrent conditions included: flu, ivf, and recurring ruptured ovarian cysts. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose and frequency not reported, administered on 2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. On 2021, the patient experienced mast cell activation syndrome (mcas), became disabled, allergic reactions to covid-19 vaccine, and postural orthostatic tachycardia syndrome (pots). (dose series 1). It was reported that patient experienced: The patient had an allergic reaction to the vaccine, after the allergic reaction to the COVID vaccine the patient developed Mast Cell Activation Syndrome (MCAS), Postural Orthostatic Tachycardia Syndrome (POTS), food allergies, food sensitivities, allergic to makeup, allergic to hair dye, and became disabled. The action taken with janssen covid-19 vaccine was not applicable. The patient had not recovered from mast cell activation syndrome (mcas), became disabled, allergic reactions to covid-19 vaccine and postural orthostatic tachycardia syndrome (pots). This report was serious (other medically important condition).; Sender's Comments: V0- Mast cell activation syndrome , disability, Drug hypersensitivity, : Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
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| 2829093 | M | 03/03/2025 |
COVID19 |
MODERNA |
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Feeling drunk
Feeling drunk
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After second moderna covid-19 shot whenever he drinks coffee, dairy, consume red meat, he feels &quo...
After second moderna covid-19 shot whenever he drinks coffee, dairy, consume red meat, he feels "drunk."; This spontaneous case was reported by a patient and describes the occurrence of FEELING DRUNK (After second moderna covid-19 shot whenever he drinks coffee, dairy, consume red meat, he feels "drunk.") in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FEELING DRUNK (After second moderna covid-19 shot whenever he drinks coffee, dairy, consume red meat, he feels "drunk."). At the time of the report, FEELING DRUNK (After second moderna covid-19 shot whenever he drinks coffee, dairy, consume red meat, he feels "drunk.") outcome was unknown. No concomitant medications were reported. Patient also felt like drunk driving. The caller wanted to ask if there was any reversal for this and any information of how often this kind of event was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. Reporter did not allow further contact
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| 2829094 | 57 | M | AR | 03/03/2025 |
COVID19 |
MODERNA |
|
Apathy, Fatigue, Feeling abnormal, Illness, Influenza
Apathy, Fatigue, Feeling abnormal, Illness, Influenza
|
Patient had absolutely lost all motivation; Patient was so sick of being sick; Tired; Patient had de...
Patient had absolutely lost all motivation; Patient was so sick of being sick; Tired; Patient had described as flu which was same effect after booster but for longer; Patient laid around sick and it was utterly miserable; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Patient had described as flu which was same effect after booster but for longer), FEELING ABNORMAL (Patient laid around sick and it was utterly miserable), APATHY (Patient had absolutely lost all motivation), ILLNESS (Patient was so sick of being sick) and FATIGUE (Tired) in a 55-year-old male patient who received mRNA-1273 (Spikevax) for Emesis. Concurrent medical conditions included COPD and Blood pressure high. On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 14-Apr-2022, the patient experienced INFLUENZA (Patient had described as flu which was same effect after booster but for longer) and FEELING ABNORMAL (Patient laid around sick and it was utterly miserable). On an unknown date, the patient experienced APATHY (Patient had absolutely lost all motivation), ILLNESS (Patient was so sick of being sick) and FATIGUE (Tired). At the time of the report, INFLUENZA (Patient had described as flu which was same effect after booster but for longer) and FEELING ABNORMAL (Patient laid around sick and it was utterly miserable) had not resolved and APATHY (Patient had absolutely lost all motivation), ILLNESS (Patient was so sick of being sick) and FATIGUE (Tired) outcome was unknown. No concomitant medication was reported. Patient was laid around sick to stomach and utterly miserable. He had absolutely lost all motivation and would do anything that bought pleasure to him. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment information was reported.
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| 2829095 | 54 | F | WA | 03/03/2025 |
COVID19 |
MODERNA |
|
Deafness, Tinnitus
Deafness, Tinnitus
|
moderate hearing loss; tinnitus; This spontaneous case was reported by a patient and describes the o...
moderate hearing loss; tinnitus; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (moderate hearing loss) in a 54-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (moderate hearing loss) (seriousness criterion medically significant) and TINNITUS (tinnitus). At the time of the report, DEAFNESS (moderate hearing loss) and TINNITUS (tinnitus) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No Concomitant medications provided by the reporter. It was reported that patient was developed Tinnitus and moderate hearing loss over a period of a month. No treatment medications provided by the reporter.; Reporter's Comments: Company Comments; The benefit-risk relationship of product is not affected by this report
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| 2829096 | 85 | F | VA | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death, Lethargy, Malaise
Death, Lethargy, Malaise
|
Lethargic, very unwell, death
Lethargic, very unwell, death
|
โ | โ | ||||
| 2829097 | 4 | M | SC | 03/03/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5H95B X021755 |
Expired product administered; Expired product administered
Expired product administered; Expired product administered
|
MMRV (ProQuad) was given on 02/25/25 and expired on 02/23/25.
MMRV (ProQuad) was given on 02/25/25 and expired on 02/23/25.
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| 2829098 | 0.17 | M | 03/03/2025 |
DTPPVHBHPB HEP |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS |
|
Gastrooesophageal reflux disease, Hypotonia, Lethargy, Respiratory arrest, Seizu...
Gastrooesophageal reflux disease, Hypotonia, Lethargy, Respiratory arrest, Seizure like phenomena; Gastrooesophageal reflux disease, Hypotonia, Lethargy, Respiratory arrest, Seizure like phenomena
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Same day seizure like sounds and body language. 2 days later lethargic., breathing complications. S...
Same day seizure like sounds and body language. 2 days later lethargic., breathing complications. Stopped breathing and was limp.. We went to the ER and spent the night on monitors. It was ruled as acid reflux but he doesn?t have reflux due to nissen surgery which was done at 1month. I brought up how he had his 2 month shots and they said this wouldn?t be from that.
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| 2829099 | 15 | F | SC | 03/03/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
w026152 u7996ba |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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HPV Vaccine expired 01/29/2025 and was given 02/27/2025. No adverse events reported as of 03/03/2025...
HPV Vaccine expired 01/29/2025 and was given 02/27/2025. No adverse events reported as of 03/03/2025. Parent/guardian notified of expired dose being administered, and advised to bring child in for re-vaccination.
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| 2829100 | 53 | F | MI | 03/03/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004089 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Client took all 4 doses of Oral Typhoid as one dose on 2/13/25. No reported symptoms.
Client took all 4 doses of Oral Typhoid as one dose on 2/13/25. No reported symptoms.
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| 2829101 | 53 | F | CT | 03/03/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Graves' disease; Graves' disease; Graves' disease; Graves' d...
Graves' disease; Graves' disease; Graves' disease; Graves' disease; Graves' disease
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Diagnosed with Graves Disease.
Diagnosed with Graves Disease.
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| 2829102 | 15 | F | SC | 03/03/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
w026152 U8351CA |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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HPV Vaccine expired 01/29/2025 and was given 02/27/2025. No adverse events reported as of 03/03/2025...
HPV Vaccine expired 01/29/2025 and was given 02/27/2025. No adverse events reported as of 03/03/2025. Parent/guardian notified of expired dose being administered, and advised to bring child in for re-vaccination.
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| 2829103 | 2 | F | MI | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Product preparation issue, Pyrexia
Product preparation issue, Pyrexia
|
I administered 0.3 ml of the COVID vaccine to this patient ( concentrated dose ) I didn't know ...
I administered 0.3 ml of the COVID vaccine to this patient ( concentrated dose ) I didn't know that I had to dilute it with 1.1 ml of saline. Error was reported, and patient's parent was notified via interpreter. Per patient's parent patient is doing well, and had a fever of 101.0 F the night of the event, and resolved the next day. Per parents no other adverse reactions were observed. Answered parent's questions to the best of my knowledge, no other questions at this time.
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| 2829104 | 93 | M | FL | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
lt5636 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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no adverse effects reported, patient got vaccine out of CDC recommended dosing schedule. Last dose w...
no adverse effects reported, patient got vaccine out of CDC recommended dosing schedule. Last dose was 1/9/25, most recent dose was 3/2/25.
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| 2829105 | 0.5 | M | MI | 03/03/2025 |
COVID19 DTPPVHBHPB FLU3 PNC20 RV5 |
PFIZER\BIONTECH MSP VACCINE COMPANY SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
LN8272 U8265AA U8523DA Y011797 |
Altered state of consciousness, Infantile diarrhoea, Infantile vomiting, Pyrexia...
Altered state of consciousness, Infantile diarrhoea, Infantile vomiting, Pyrexia; Altered state of consciousness, Infantile diarrhoea, Infantile vomiting, Pyrexia; Altered state of consciousness, Infantile diarrhoea, Infantile vomiting, Pyrexia; Altered state of consciousness, Infantile diarrhoea, Infantile vomiting, Pyrexia; Altered state of consciousness, Infantile diarrhoea, Infantile vomiting, Pyrexia
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Altered level of consciousness 4 months after receiving Vaxelis, prevnar, rotateq, COVID and flu. So...
Altered level of consciousness 4 months after receiving Vaxelis, prevnar, rotateq, COVID and flu. Some vomiting, Diarrhea and fever. Patient did go to ER when these symptoms occurred in the early afternoon.
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| 2829106 | 57 | F | TN | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0153 |
Asthenia, Exercise tolerance decreased, Gait disturbance, SARS-CoV-2 antibody te...
Asthenia, Exercise tolerance decreased, Gait disturbance, SARS-CoV-2 antibody test
More
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Day of shot - I was very weak and could barely walk. This lasted for +/- 36 hours. Have felt weak ...
Day of shot - I was very weak and could barely walk. This lasted for +/- 36 hours. Have felt weak ever since. Ability to exercise, decreased over time. I was taking 5 classes a week and that decreased to a handful a times per year.
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| 2829107 | 1 | M | NJ | 03/03/2025 |
HEPA MMRV VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
|
Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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Proquad was given instead of MMR so patient received an extra dose of varicella.
Proquad was given instead of MMR so patient received an extra dose of varicella.
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| 2829108 | 57 | F | MN | 03/03/2025 |
MMR |
MERCK & CO. INC. |
Y007613 |
Antibody test positive, Contraindication to vaccination, Immunodeficiency
Antibody test positive, Contraindication to vaccination, Immunodeficiency
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Patient was given MMR vaccine while on Skyrizi and therefore immunocompromised.
Patient was given MMR vaccine while on Skyrizi and therefore immunocompromised.
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| 2829109 | 74 | M | FL | 03/03/2025 |
PNC20 |
PFIZER\WYETH |
lk6650 |
Extra dose administered
Extra dose administered
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duplicate vaccine 3 years apart.
duplicate vaccine 3 years apart.
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| 2829110 | 60 | F | MN | 03/03/2025 |
TDAP TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
L5229 L5229 L5229 L5229 |
Mobility decreased; Discomfort, Mobility decreased, Musculoskeletal discomfort, ...
Mobility decreased; Discomfort, Mobility decreased, Musculoskeletal discomfort, Musculoskeletal stiffness, Pain in extremity; Mobility decreased; Discomfort, Mobility decreased, Musculoskeletal discomfort, Musculoskeletal stiffness, Pain in extremity
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Patient said her ROM was limited. 2/25/25 she took generic Aleve and on 2/27/25 she took a generic ...
Patient said her ROM was limited. 2/25/25 she took generic Aleve and on 2/27/25 she took a generic Aleve. The ROM is getting better but not 100%. Wanted the report completed and to ask how long she should have symptoms?
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| 2829111 | 4 | F | WV | 03/03/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Erythema, Rash, Skin warm
Erythema, Rash, Skin warm
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Area of erythema @ 6" laterally @ longest area of redness. 3.5" X 4". Area also had r...
Area of erythema @ 6" laterally @ longest area of redness. 3.5" X 4". Area also had rash noted and was warm to the touch
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| 2829112 | 3 | F | VA | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
Lt7427 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient was scheduled vaccine. The vaccine (COVID 6 months- 4 years) was reconstituted on 2/21/25. V...
Patient was scheduled vaccine. The vaccine (COVID 6 months- 4 years) was reconstituted on 2/21/25. Vaccine was still in the refrigerator and administered on 2/24/25 to patient's right thigh. I realized the vaccine should have been discarded on 2/22/25, end of the day, but was not. The last dose in the reconstituted vial was administered to patient. The physician was informed of the incident. No adverse reactions noted during or after the administration of the vaccine. Pfizer was contacted. Pfizer replied they do not have supporting stability data. No additional dose was administered to patient after event.
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| 2829113 | 58 | F | CA | 03/03/2025 |
HEPA |
MERCK & CO. INC. |
y017625 |
Asthenia, Chills, Constipation, Headache
Asthenia, Chills, Constipation, Headache
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After receiving the Hep A vaccine on the afternoon of Wednesday 2/26/25, I got a headache 3 days l...
After receiving the Hep A vaccine on the afternoon of Wednesday 2/26/25, I got a headache 3 days later, on the afternoon of 3/1/25. I was very low energy all day on 3/2/25. This morning, 3/3, I woke up uncomfortably constipated. I am feeling weak and I have chills. As the day progresses, I am starting to feel better.
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| 2829114 | 84 | M | NY | 03/03/2025 |
UNK VARZOS |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
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Seizure; Seizure
Seizure; Seizure
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12 hrs after a single dose shingles vaccine he has a seizure event
12 hrs after a single dose shingles vaccine he has a seizure event
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| 2829115 | 41 | F | MI | 03/03/2025 |
MMR |
MERCK & CO. INC. |
Y011484 |
Induration, Limb mass, Pain in extremity, Skin warm
Induration, Limb mass, Pain in extremity, Skin warm
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She developed a hot, firm, painful mass in her left upper arm, in the location of the vaccine, but 2...
She developed a hot, firm, painful mass in her left upper arm, in the location of the vaccine, but 2 weeks AFTER the vaccine.
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| 2829116 | 72 | F | AZ | 03/03/2025 |
COVID19 |
MODERNA |
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COVID-19, Chills, Decreased appetite, Myalgia, Pyrexia
COVID-19, Chills, Decreased appetite, Myalgia, Pyrexia
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Patient did report that a few years ago she had come down with an infection of COVID and as a result...
Patient did report that a few years ago she had come down with an infection of COVID and as a result held her dose of Humira for some time. She thinks she got Covid in December of 2022 but was not too sure about that. She stated at the time she was vaccinated with the first three doses of Moderna Covid vaccine (two doses in the series for the initial vaccination and a "booster" injection after that. She reported that she no longer gets the COVID vaccines because with all three vaccines she had muscle pains, chills, loss of appetite, and mild fever that lasted about 2 weeks. She reports that all issues have since resolved, however.
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| 2829117 | 20 | F | FL | 03/03/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
1802068 1802068 1802068 1802068 1802068 1802068 FD0809 FD0809 FD0809 FD0809 FD0809 FD0809 |
Anosmia, Antibody test positive, Bedridden, COVID-19, Chest X-ray; Chest pain, C...
Anosmia, Antibody test positive, Bedridden, COVID-19, Chest X-ray; Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram, Exercise tolerance decreased; Fatigue, Fibrin D dimer increased, Gastrointestinal tube insertion, General physical health deterioration, Hyperacusis; Hyperaesthesia, Impaired work ability, Laboratory test, Magnetic resonance imaging, Malaise; Myalgia, Photophobia, Postural orthostatic tachycardia syndrome, Respiratory tract congestion, Viral infection; Weight decreased, Wheelchair user; Anosmia, Antibody test positive, Bedridden, COVID-19, Chest X-ray; Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram, Exercise tolerance decreased; Fatigue, Fibrin D dimer increased, Gastrointestinal tube insertion, General physical health deterioration, Hyperacusis; Hyperaesthesia, Impaired work ability, Laboratory test, Magnetic resonance imaging, Malaise; Myalgia, Photophobia, Postural orthostatic tachycardia syndrome, Respiratory tract congestion, Viral infection; Weight decreased, Wheelchair user
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A previously healthy 24-year-old female with no significant medical history received the Janssen COV...
A previously healthy 24-year-old female with no significant medical history received the Janssen COVID-19 vaccine on March 10, 2021. In October 2021, she contracted COVID-19, experiencing fatigue, congestion, and loss of smell, which has not returned. After recovering, she resumed physical activity, which triggered a relapse of symptoms with increased fatigue. She then received the Pfizer COVID-19 booster on January 22, 2022. Over the following months, she developed persistent fatigue, shortness of breath, chest pain, and post-exertional malaise. In mid-2022, she was diagnosed with POTS after participating in a Long COVID study. By early 2023, her condition worsened significantly, leading to chronic fatigue, muscle pain, and exercise intolerance, requiring extended leave from work. In December 2023, she left her job due to severe fatigue and mobility issues, later requiring a wheelchair. In July 2024, after a viral illness, her health rapidly declined, with significant weight loss, extreme fatigue, and severe hypersensitivity to light, noise, and touch. She was hospitalized, where workup showed an elevated D-Dimer but no other significant findings. Due to extreme fatigue and an inability to meet caloric needs, a feeding tube was placed. By September 2024, she lost the ability to move on her own and became fully bedbound, requiring 24/7 care. She was readmitted in December 2024, but extensive testing (MRI, CT scan, chest X-ray, ECHO, and labs) was inconclusive aside from continued elevation of D-Dimer. No further treatment was offered. Before discharge, a spike protein test was drawn and later found to be extremely elevated. Since February 12, 2025, she has been on a spike protein detox protocol, but her condition remains severe, with no significant improvement yet. She continues to experience extreme sensitivities to light, noise, and touch, remains fully bedbound, and requires 24/7 care. Despite her critical condition, insurance has denied nursing care, categorizing her case as "respite" rather than medical necessity. This has placed a severe burden on her father, who is her primary caregiver while also trying to maintain his job. The family has struggled to secure adequate care, resorting to hiring a nurse, but consistent, professional medical support remains a major challenge. She will need intensive rehabilitation, including physical and occupational therapy, to regain mobility. Given the timeline of symptoms and deterioration following vaccination and booster administration, this case represents a severe post-vaccine injury with possible long COVID overlap.
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| 2829118 | 23 | M | AZ | 03/03/2025 |
VARCEL |
MERCK & CO. INC. |
Y005920 |
Hypersensitivity, Throat tightness, Urticaria
Hypersensitivity, Throat tightness, Urticaria
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started having allergic reaction approx. 5 min after receiving vaccine. presented with hives on ba...
started having allergic reaction approx. 5 min after receiving vaccine. presented with hives on back, chest, face and legs. stated that his throat seems a little tight. Fire department was called and they treated received Benadryl, Solu-Medrol, and Epi IM. was transported to ER for evaluation.
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| 2829119 | 11 | M | VA | 03/03/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y012865 X7R4Z X449Y |
Swelling face; Swelling face; Swelling face
Swelling face; Swelling face; Swelling face
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ISOLATED FACIA SWELLING
ISOLATED FACIA SWELLING
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| 2829120 | 27 | F | OH | 03/03/2025 |
HEP |
MERCK & CO. INC. |
T5D73 |
Urticaria
Urticaria
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Following morning pt reported waking up with hives on chest that started as mild. Two days after the...
Following morning pt reported waking up with hives on chest that started as mild. Two days after the injection pt reported hives worsening and spreading to chest, stomach, and arms. Pt. took zyrtec with little relief. Pt encouraged to return to facility for treatment. Pt has not returned. Pt told to seek immediate medical attention if hives spread to facial area, difficulty breathing/SOB, or if tongue feels heavy swollen.
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| 2829121 | 70 | M | NY | 03/03/2025 |
COVID19 |
MODERNA |
033p21a |
Biopsy prostate, Condition aggravated, Magnetic resonance imaging, Prostate canc...
Biopsy prostate, Condition aggravated, Magnetic resonance imaging, Prostate cancer, Prostatic specific antigen increased
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After five years of minimal cancer of prostate and normal psa results, within a few weeks of covid b...
After five years of minimal cancer of prostate and normal psa results, within a few weeks of covid booster, my psa started climbing rapidly. Within a couple of months I was re-diagnosed with aggressive prostate cancer.
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| 2829122 | 59 | F | TX | 03/03/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LM2219 A5T73 |
Product storage error; Product storage error
Product storage error; Product storage error
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The Comirnaty COVID-19 vaccine administered to the patient had previously been subject to a temperat...
The Comirnaty COVID-19 vaccine administered to the patient had previously been subject to a temperature excursion in January 2025, when a different pharmacist in charge (PIC) was overseeing operations. The vial was removed from refrigeration and left at room temperature for one to two days due to its upcoming expiration date of March 29, 2025. It was later returned to refrigeration for potential return but was administered to a patient on March 3, 2025. Patient also received Shingrix along with Comirnaty.
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| 2829123 | 75 | F | TN | 03/03/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
52F7M 52F7M 52F7M |
Antinuclear antibody, Blood creatine phosphokinase, Blood iron, Blood magnesium,...
Antinuclear antibody, Blood creatine phosphokinase, Blood iron, Blood magnesium, C-reactive protein; Differential white blood cell count, Full blood count, Myalgia, Red blood cell sedimentation rate, Serum ferritin; Vitamin B12
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Muscle pain, over-the-counter anti-inflammatory medications like ibuprofen occasionally, Try the mus...
Muscle pain, over-the-counter anti-inflammatory medications like ibuprofen occasionally, Try the muscle and nerve support supplement samples provided to assess their benefit, physical therapy, offered referral to ortho.
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| 2829124 | 11 | F | ME | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient did not have an adverse effect- was just given the wrong covid vaccine. Needed 5-11 covid, w...
Patient did not have an adverse effect- was just given the wrong covid vaccine. Needed 5-11 covid, was given 12+
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| 2829126 | 66 | F | NJ | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
EP7533 |
Sjogren's syndrome
Sjogren's syndrome
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Generalized autoimmune inflammation exacerbation of Sjogrens Syndrome
Generalized autoimmune inflammation exacerbation of Sjogrens Syndrome
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| 2829127 | 63 | M | FL | 03/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
No adverse event
No adverse event
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Patient experienced no side effects but was given the Arexvy vaccine twice. The patient had already ...
Patient experienced no side effects but was given the Arexvy vaccine twice. The patient had already gotten the vaccine in November 2023 which is not in accordance with current vaccine guidelines.
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| 2829128 | 75 | F | AZ | 03/03/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Erythema, Mobility decreased, Peripheral swelling, Skin warm
Erythema, Mobility decreased, Peripheral swelling, Skin warm
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Patient stated that the day after receiving Prevnar 20 her arm was swollen form her elbow to her sho...
Patient stated that the day after receiving Prevnar 20 her arm was swollen form her elbow to her shoulder. She stated that it was warm to the touch, red and she could not lift it.
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| 2829129 | 0.5 | F | MN | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient received a Covid vaccine for age range of 5 year- 11-year-old instead of the 6m-4-year conce...
Patient received a Covid vaccine for age range of 5 year- 11-year-old instead of the 6m-4-year concentration. The vaccine was diluted with 1.1 mL of 0.9% Sodium Chloride prior to injection. After discussing with manufacturer, it was determined that the correct dose was given based on the calculations. The vial contains 15.8 mg MRNA in 0.48 mL of liquid and was mixed with 1.1 mL of diluent, containing 3 mcg of MRNA in the 0.3 mL dose given to patient. Patient's family did not report any initial reactions.
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| 2829130 | 11 | F | MA | 03/03/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
y010656 x7r4z 3ca30c1 |
Asthenia, Headache, Pain, Pain in extremity; Asthenia, Headache, Pain, Pain in e...
Asthenia, Headache, Pain, Pain in extremity; Asthenia, Headache, Pain, Pain in extremity; Asthenia, Headache, Pain, Pain in extremity
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mom called office 2/24/2025 that pt on the night of2/21 was complaining of body aches and leg pain, ...
mom called office 2/24/2025 that pt on the night of2/21 was complaining of body aches and leg pain, pt is middle of the night woke up complaining of headache. mom did covid test was negative states the pt was very weak for a few days and feels it is vaccine related
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| 2829131 | 62 | F | TX | 03/03/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema
Injection site erythema
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round redness around the injection site. was swollen a bit but is going down overtime.
round redness around the injection site. was swollen a bit but is going down overtime.
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| 2829132 | 12 | F | TN | 03/03/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
E4A39 3CA22C1 |
Rash, Rash pruritic; Rash, Rash pruritic
Rash, Rash pruritic; Rash, Rash pruritic
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6 days post vaccine administration (2/20/25) patient developed itchy rash on extremities including h...
6 days post vaccine administration (2/20/25) patient developed itchy rash on extremities including hands and feet. Trunk was clear of rash. Remained afebrile during this time. Itching controlled with cortisone OTC cream. S/S resolved 2/24/25. Parent spoke with PCP no visit. She advised that PCP suggested not receiving another dose of meningococcal vaccine. Sibling received vaccines on same date with the exception of meningococcal vaccine with no ill effects.
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| 2829133 | 4 | M | VA | 03/03/2025 |
MMRV |
MERCK & CO. INC. |
Y009347 |
Product preparation issue
Product preparation issue
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Patient in clinic for 4 year wellness appt. Patient had Proquad and Quadracel vaccines ordered to be...
Patient in clinic for 4 year wellness appt. Patient had Proquad and Quadracel vaccines ordered to be given. After vaccines given the nurse found vaccines were reconstituted incorrectly. Proquad vaccine was diluted with Quadracel vaccine and administered. Sterile Diluent was administered by itself to patient. Quadracel vaccine in clinic depending on stock (Private vs VFC) can be in pre-drawn syringe or vial. The pre-drawn syringe looks similar to sterile diluent that is to be used with Proquad reconstitution. Mother was with patient for visit and was informed by CTL that this error had occurred and RN would be in touch with her regarding if vaccinations needed to be repeated, what signs/symptoms to look for, etc. Mother voiced understanding. Child had no signs/symptoms of local reaction after vaccination. Waited in office 15 minutes. RN reached out to VFC coordinator to inquire about error and information regarding repeating. She reached out to the CDC help desk and per CDC both vaccinations will need to be repeated. The Proquad will need to wait to be repeated in 28 days. RN called and spoke with mother regarding this and explained the reasoning behind re-vaccination and a letter was written in regards to the error as mother was needing vaccinations for child to start preschool. Vaccine only appointment made for 28 days out for repeat vaccinations. Mother to call back before then with any further questions or concerns. Education was done with the nurse that administered and a new work flow for preparation of these vaccines was discussed to prevent this error in the future.
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| 2829134 | 24 | F | MO | 03/03/2025 |
IPV |
SANOFI PASTEUR |
X1C891M |
Extra dose administered, Tuberculin test
Extra dose administered, Tuberculin test
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Polio was inadvertently given to the patient instead of a PPD skin test. When the error was noticed...
Polio was inadvertently given to the patient instead of a PPD skin test. When the error was noticed, the patient was immediately contacted and asked to return to the clinic. Patient was given the TB Skin test . The patient was informed the polio was given in error. The Health Center Manager was notified. Nurse manager followed up with the CDC. Spoke with customer service agent. Polio considered an extra dose. Nurse manager f/u with the patient to inform her of the error. Pt was understanding.
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| 2829135 | 72 | M | IN | 03/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Headache, Hyperhidrosis, Influenza like illness, Nausea; Pain, Pain in e...
Chills, Headache, Hyperhidrosis, Influenza like illness, Nausea; Pain, Pain in extremity, Pyrexia
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The patient shopped in store for 15-20 minutes and then a 20 minute drive home. Approximately 3 to ...
The patient shopped in store for 15-20 minutes and then a 20 minute drive home. Approximately 3 to 4 hours after administration patient developed the following: nausea, headache, arm pain, flu-like symptoms, everything in body hurt, body aches, feverish, chills, and sweating. The patient took an Aspirin and went to bed early. The patient did not have any reaction to the 1st dose.
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| 2829136 | 29 | F | NY | 03/03/2025 |
VARCEL |
MERCK & CO. INC. |
y014182 |
Asthenia, Headache, Injection site erythema, Injection site swelling
Asthenia, Headache, Injection site erythema, Injection site swelling
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Day of vaccine pt experienced headache and weakness. Over the weekend noticed redness and swelling t...
Day of vaccine pt experienced headache and weakness. Over the weekend noticed redness and swelling to injection site.
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| 2829137 | 86 | F | FL | 03/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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administration errors, was given a second dose. first was in 2023
administration errors, was given a second dose. first was in 2023
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| 2829138 | 0.5 | M | VA | 03/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Product preparation issue
Product preparation issue
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The dilute was given for Hiberix without the vaccination being mixed in. The Lot number for the Hib...
The dilute was given for Hiberix without the vaccination being mixed in. The Lot number for the Hiberix was 5JF75 EXP 7/14/2026.
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