| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2841398 | 05/16/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain
Herpes zoster, Pain
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had a very painful episode of Shingles; This non-serious case was reported by a consumer via interac...
had a very painful episode of Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had a very painful episode of Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that someone yesterday who was under 50 and not eligible for the Shingle Vaccine but has had Shingles, this needs to change. Even if you have had the one Shot 1st generation Shingles Vaccine you really need the two Shot 2nd generation Shingles Vaccine. Reporter had the one shot 1st generation Shingles Vaccine and had a very painful episode of Shingles that lasted for several months.
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| 2841399 | 05/16/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Incomplete course of vaccination
Herpes zoster, Incomplete course of vaccination
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got my 1st shot and a week later got shingles; This non-serious case was reported by a consumer via ...
got my 1st shot and a week later got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got my 1st shot and a week later got shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the first shot and a week later got shingles, it was a mild case got into doctor right away. Also stated that never did get second shot.
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| 2841400 | 05/16/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site erythema, Pain in extremity
Injection site erythema, Pain in extremity
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raised redness around the injection site; very sore arm; This non-serious case was reported by a con...
raised redness around the injection site; very sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: raised redness around the injection site) and pain in arm (Verbatim: very sore arm). The patient was treated with paracetamol (Tylenol). The outcome of the injection site erythema and pain in arm were not reported. It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingles vaccine. It was unknown if the company considered the injection site erythema and pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she just had a very sore arm with some raised redness around the injection site. The patient stated that the Tylenol and ice helped but nothing compared to a shingles outbreak. The patient asked others to get that shot.
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| 2841401 | CO | 05/16/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
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Underdose
Underdose
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Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non...
Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult patient) and underdose (Verbatim: Pediatric dose administered to adult patient). The outcome of the adult use of a child product and underdose 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: 02-MAY-2025 Other Health Professional reported that he/she administered a pediatric dose of the Engerix-B Hepatitis B to an adult patient, which led to adult use of a child product and underdose. And reporter wants to just trying to see how to advice in if can just administered another dose or if just need to administered an adult dose. No more details were left by reporter in the voicemail.
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| 2841402 | F | MI | 05/16/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
342rc |
Expired product administered
Expired product administered
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a 12 year old female patient was accidentally administered an expired dose of Priorix on 05/06/2025;...
a 12 year old female patient was accidentally administered an expired dose of Priorix on 05/06/2025; 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 12-year-old female patient who received MMR (Priorix) (batch number 342rc, expiry date 01-MAY-2025) for prophylaxis. On 06-MAY-2025, the patient received the 2nd dose of Priorix. On 06-MAY-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: a 12 year old female patient was accidentally administered an expired dose of Priorix on 05/06/2025). 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 : 06-MAY-2025 A medical assistant called in to report that a 12 year old female patient was accidentally administered an expired dose of Priorix on 6th May 2025 which led to expired vaccine used.
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| 2841403 | 05/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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a teenager was accidentally given the shingrix vaccuine; This non-serious case was reported by a oth...
a teenager was accidentally given the shingrix vaccuine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a teenager was accidentally given the shingrix vaccuine). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date: 06-MAY-2025 On 06/May/2025, a healthcare professional started a chat and informed that what do I need to look out for if a teenager was accidentally given the shingrix vaccine this led to Inappropriate age at vaccine administration. After that message, reporter ended the chat on their end, so no additional details could be collected.
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| 2841404 | 74 | M | FL | 05/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
TS525 |
Incorrect route of product administration
Incorrect route of product administration
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Shingrix - Subcutaneous injection; This non-serious case was reported by a pharmacist via call cente...
Shingrix - Subcutaneous injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis. On 07-MAY-2025, the patient received Shingrix (subcutaneous). On 07-MAY-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix - Subcutaneous injection). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK receipt date: 07-MAY-2025 A pharmacist reported the administration of Shingrix via subcutaneous injection instead of intramuscular injection, which led to intramuscular formulation administered by other route. The pharmacist asked if the dose should be repeated.
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| 2841405 | MI | 05/16/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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Priorix possible administration after being exposed to freezing temperatures; This non-serious case ...
Priorix possible administration after being exposed to freezing temperatures; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients who received MMR (Priorix) for prophylaxis. On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patients experienced incorrect storage of drug (Verbatim: Priorix possible administration after being exposed to freezing temperatures). The outcome of the incorrect storage of drug 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: 07-MAY-2025 Nurse called to report Priorix vaccines were stored in the facility freezer at lowest of minus 11.6 degree Fahrenheits probably since shipment was received on 4th February. Two vaccines were no longer in the box, so nurse suspects they were administered but did not have specific patient information yet, which led incorrect storage of drug. The reporter mentioned that the vaccines were administered to two different patients but when asking more details about the event she explained no report with information was made yet, so no more information was available at moment of call. During the call the reporter mentioned that the vaccines were not frozen at the moment of administration.
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| 2841406 | 40 | F | SC | 05/16/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
M4B34 |
Extra dose administered
Extra dose administered
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Late 2nd and 3rd dose/received 1st dose on 13-Nov-2024, 2nd one not until 26-Apr-2025; This non-seri...
Late 2nd and 3rd dose/received 1st dose on 13-Nov-2024, 2nd one not until 26-Apr-2025; 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 40-year-old female patient who received HAB (Twinrix) (batch number M4B34) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 13th November 2024 of lot number H7RF2). On 26-APR-2025, the patient received the 2nd dose of Twinrix. On 26-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd and 3rd dose/received 1st dose on 13-Nov-2024, 2nd one not until 26-Apr-2025). 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: 07-MAY-2025 A registered pharmacist called and reported a question on the Twinrix vaccine dosing schedule, so the patient received her 1st dose on 13th November 2024, her 2nd one not until 26th April 2025, so the reporter was unsure about when she needs her 3rd dose. 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 vaccine schedule.
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| 2841407 | 2 | M | PA | 05/16/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3ZH27 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Boostrix instead of Infanrix administration; Infanrix second dose out of the recommended age adminis...
Boostrix instead of Infanrix administration; Infanrix second dose out of the recommended age administration; Infanrix first dose out of the recommended age administration/Infanrix second dose out of the recommended age administration/Boostrix out of the recommended age administration; 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 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3ZH27, expiry date 25-JAN-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa (Infanrix) for prophylaxis. On 02-MAY-2025, the patient received Boostrix. On an unknown date, the patient did not receive the 3rd dose of Infanrix. In JUL-2024, the patient received the 2nd dose of Infanrix. In DEC-2023, the patient received the 1st dose of Infanrix. In DEC-2023, not applicable after receiving Boostrix, Infanrix and Infanrix and an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix first dose out of the recommended age administration/Infanrix second dose out of the recommended age administration/Boostrix out of the recommended age administration). In JUL-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix second dose out of the recommended age administration). On 02-MAY-2025, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Infanrix administration). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration 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: 08-MAY-2025 Medical Assistant wanted to know if there would be any harm to a 2-year-old patient that received Boostrix instead of Infanrix as a third dose in the diphtheria, tetanus and pertussis immunization scheme which led to wrong vaccine administered. Also, it was reported that when the patient received the first and second dose of Infanrix, both being also given out of the recommended age of administration (first dose in December 2023 and second in July 2024, when the patient was over 1 year of age) which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.
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| 2841408 | 19 | F | CA | 05/16/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
CT2Z7 |
Incorrect dose administered
Incorrect dose administered
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Engerix-B inadvertent 20mcg dose to 19 year old; Engerix-B inadvertent 20mcg dose to 19 year old; Th...
Engerix-B inadvertent 20mcg dose to 19 year old; Engerix-B inadvertent 20mcg dose to 19 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) (batch number CT2Z7) for prophylaxis. On 08-APR-2025, the patient received Engerix B adult. On 08-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engerix-B inadvertent 20mcg dose to 19 year old) and overdose (Verbatim: Engerix-B inadvertent 20mcg dose to 19 year old). 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: 08-MAY-2025 Pharmacist calls today on 08th May 2025 to report 19 years and 2-month-old patient received the adult dose inadvertently on 08th April 2025 which led to adult product administered to child and overdose. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2841409 | M | NH | 05/16/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
H3074 |
Expired product administered
Expired product administered
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possible expired dose; This non-serious case was reported by a pharmacist via call center representa...
possible 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 male patient who received HBV (Engerix B) (batch number H3O74) and (batch number H3074) for prophylaxis. On 08-MAR-2025, the patient received Engerix B. On 08-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: possible 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: 09-MAY-2025 Reporter stated that a nurse have administered a vaccine (Engerix-B), and the expiration date that they discharged , if that was the correct expiration date, it will be expired at the time of the administration. The patient received expired vaccine, which led to expired vaccine used.
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| 2841410 | 57 | F | GA | 05/16/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
92DJ3 |
Expired product administered, Underdose
Expired product administered, Underdose
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An adult patient received a pediatric dose of Engerix-B; An adult patient received a pediatric dose ...
An adult patient received a pediatric dose of Engerix-B; An adult patient received a pediatric dose of Engerix-B; An adult patient received a pediatric dose of Engerix-B that was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 57-year-old female patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis. On 12-MAY-2025, the patient received Engerix B. On 12-MAY-2025, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: An adult patient received a pediatric dose of Engerix-B), underdose (Verbatim: An adult patient received a pediatric dose of Engerix-B) and expired vaccine used (Verbatim: An adult patient received a pediatric dose of Engerix-B that was expired). The outcome of the adult use of a child product, underdose and expired vaccine used 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: 12-MAY-2025 On 12th May 2025, a medical assistant called to report that they had administered a pediatric dose of Engerix-B to an adult female patient (57 years old), but it had expired on 3rd May 2025, which led to Adult use of a child product, Underdose and Expired vaccine used. The dose had been administered on 12th May 2025.
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| 2841411 | F | KS | 05/16/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
TC47K |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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wrong vaccine administered; a patient received a fourth dose of Pediarix; This non-serious case was ...
wrong vaccine administered; a patient received a fourth dose of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Pediarix and did not receive Infanrix. On an unknown date, an unknown time after receiving Pediarix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine administered) and extra dose administered (Verbatim: a patient received a fourth dose of Pediarix). The outcome of the wrong vaccine administered and extra dose administered 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: 13-MAY-2025 The registered nurse reported a patient received a fourth dose of Pediarix instead of a dose of Infanrix which led to wrong vaccine administered and extra dose administration.
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| 2841412 | M | NJ | 05/16/2025 |
COVID19 |
MODERNA |
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Myocarditis
Myocarditis
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Her husband is now diagnosed with myocarditis too; This spontaneous case was reported by a patient f...
Her husband is now diagnosed with myocarditis too; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (Her husband is now diagnosed with myocarditis too) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Her husband is now diagnosed with myocarditis too) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Her husband is now diagnosed with myocarditis too) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No vaccines within the past 4 weeks prior to the Moderna vaccine was reported. No concomitant medications were reported. The reporter inquired about methods for removing the COVID spike protein from the body of someone who had received the Moderna COVID vaccine. The reporter stated that the patient had been diagnosed with myocarditis despite never having contracted COVID. It was reported that for some people, the spike protein naturally dissipates, but for others, it remains and causes ongoing health issues. She reported that doctors had not devised a treatment plan, and she criticized claims that myocarditis primarily affects men aged 19 to 30, asserting that individuals up to the age of 80 had reported similar issues. She sought answers regarding the removal of the spike protein. She confirmed that neither her daughter nor son-in-law had experienced any other side effects. She reported that Moderna had known that myocarditis could result from the vaccine but failed to disclose it properly. She mentioned clinical trials she saw on TV, saying that myocarditis had been documented but was reportedly considered a temporary issue in young people. The reporter reiterated that Moderna had known that myocarditis would result from it. The reporter questioned whether the company had a plan to treat vaccine-induced myocarditis, and she also found it strange that both her daughter and her husband had developed the condition. It is unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786196 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786196:same reporter different patient
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| 2841413 | F | 05/16/2025 |
COVID19 |
MODERNA |
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Condition aggravated, Dyspnoea, Extrasystoles, Fatigue
Condition aggravated, Dyspnoea, Extrasystoles, Fatigue
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breathlessness; fatigue; exacerbated a preexisting intermittent ectopic heartbeat; it exacerbated a ...
breathlessness; fatigue; exacerbated a preexisting intermittent ectopic heartbeat; it exacerbated a preexisting intermittent ectopic heartbeat; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathlessness) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ectopic heartbeats (Intermittent ectopic heartbeat). On 10-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathlessness) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), EXTRASYSTOLES (exacerbated a preexisting intermittent ectopic heartbeat) and CONDITION AGGRAVATED (it exacerbated a preexisting intermittent ectopic heartbeat). At the time of the report, DYSPNOEA (breathlessness), FATIGUE (fatigue), EXTRASYSTOLES (exacerbated a preexisting intermittent ectopic heartbeat) and CONDITION AGGRAVATED (it exacerbated a preexisting intermittent ectopic heartbeat) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that usually the patient had pretty much all the side effects which resolved after a week. It was reported that the patient had exacerbated a pre-existing intermittent ectopic heartbeat. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: Company comment: The medical history of Intermittent ectopic heartbeat is considered as a confounder. The benefit-risk relationship of product is not affected by this report.
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| 2841414 | M | MS | 05/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Headache, Post-acute COVID-19 syndrome
Headache, Post-acute COVID-19 syndrome
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bad headaches; long covid symptoms; This is a spontaneous report received from a Consumer or other n...
bad headaches; long covid symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 54-year-old male patient received BNT162b2 (BNT162B2), on 30May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09May2021, for Covid-19 Immunization, reaction(s): "headaches", "chills", "insomnia". The following information was reported: HEADACHE (life threatening), outcome "unknown", described as "bad headaches"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid symptoms". Clinical course: The patient had side effects like headaches, chills, insomnia & many other side effects. The patient had previously received the unspecified Pfizer vaccine "RM" (as reported) and experienced coughing, insomnia, shortness of breath, headaches, depression, anxiety (severe). It was reported that the patient bad headaches, as a result of taking the covid vaccines. The patient also had long covid symptoms because of the shots. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500034218 same patient, different vaccine dose/event;US-PFIZER INC-202500099734 same patient, different vaccine dose/event;
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| 2841415 | 74 | F | FL | 05/16/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
EM9809 EM9809 |
Arthralgia, COVID-19, Cervical spinal stenosis, Drug ineffective, Femur fracture...
Arthralgia, COVID-19, Cervical spinal stenosis, Drug ineffective, Femur fracture; Lymphoedema, Ovarian cancer, Pneumonia; Arthralgia, COVID-19, Cervical spinal stenosis, Drug ineffective, Femur fracture; Lymphoedema, Ovarian cancer, Pneumonia
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mild covid; mild covid; femur break; pneumonia; right knee occasionally becomes painful/Experiences ...
mild covid; mild covid; femur break; pneumonia; right knee occasionally becomes painful/Experiences Joint pain in the right knee; ovarian cancer; Cervical spinal stenosis-mild; lymphedema; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID. A 74-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EM9809) at the age of 74 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CERVICAL SPINAL STENOSIS (medically significant) with onset 10Feb2021, outcome "not recovered", described as "Cervical spinal stenosis-mild"; LYMPHOEDEMA (non-serious) with onset Feb2021, outcome "unknown", described as "lymphedema"; OVARIAN CANCER (medically significant) with onset 10Dec2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mild covid"; FEMUR FRACTURE (medically significant), outcome "unknown", described as "femur break"; PNEUMONIA (medically significant), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "right knee occasionally becomes painful/Experiences Joint pain in the right knee". The events "ovarian cancer", "femur break", "pneumonia", "cervical spinal stenosis-mild", "lymphedema" and "right knee occasionally becomes painful/experiences joint pain in the right knee" required physician office visit. Therapeutic measures were taken as a result of ovarian cancer, cervical spinal stenosis. Clinical course: patient stated the she had her first Pfizer Covid shot on 09Feb2021. She didn't have trouble that day, the next morning she could not walk (10Feb2021) without a walker afterwards. She's had this feeling almost 3 yrs but haven't reported, after she had the first Pfizer BioNTech Covid-19 shot everything was fine but when she slept at night but she couldn't walk since then. She was asking if there could be any problems walking after having the first Pfizer Covid shot. She's been to neurologists and they said they don't know why she couldn't walk, she had been diagnosed with ovarian cancer recently on 10Dec2024. She did chemotherapy and everything and still wasn't able to walk, she's not able to walk without a walker. She also mentioned that she had a back surgery, but she couldn't walk before having the back surgery, the diagnosis was "Cervical spinal stenosis-mild". HCP told her it can decrease balance, she was not walking before she had the back surgery. She have used canes, walker, & a wheelchair. She had balance problems. She doesn't have any muscle pain. She had "Lymphedema" after the first Covid shot. Her right knee occasionally becomes painful. She mentioned that she's a very healthy person who couldn't walk without a walker. She had mild asthma that's why she had other covid shots and mentioned that she had any covid vaccine available. She had a femur break and got pneumonia. She acquired mild covid in the hospital anyway, she didn't notice that she had it. She already talked to too many people, she's been doing her research. She's been asking HCP and patients who experienced same side effects after the first shot. She's wondering why she couldn't walk when she got over cancer easily. She had no family history that had trouble walking. She had been to two neurologists, the other HCP was recommending a surgery to regain some balance and there's a good chance there's no change at all, so she was hesitant. She was told/suggested to see a physiatrist, to control pain. She has been to an orthopedic specialist, she had been to rehab and had physical therapy. She then mentioned she experiences joint pain in the right knee.
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| 2841416 | 52 | F | 05/16/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; Large, red, s...
Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14May2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 14May2025 at 10:00, outcome "recovering" and all described as "Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, vaccination site swelling. Additional information: As of 14May2025, facility where vaccine was administered was doctor's office/urgent care. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. It was unknown whether the patient was taking any other medications within 2 weeks of the event starting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2841417 | 80 | F | NJ | 05/16/2025 |
PNC20 |
PFIZER\WYETH |
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Pain
Pain
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Pain all over body; This is a spontaneous report received from a Consumer or other non HCP. An 80-y...
Pain all over body; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Apr2025 at 11:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 28Apr2025, outcome "recovered" (01May2025), described as "Pain all over body". Therapeutic measures were taken as a result of pain. Additional information: Facility where vaccine was administered was doctor's office/urgent care. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The patient had pain all over body, could not get out of bed to go to bathroom. Husband had to help to get out of bed and walk her to the bathroom. Started taking Tylenol and Advil was resting at home for 2 days. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2841418 | F | 05/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood lactate dehydrogenase, Haemolysis, Platelet count
Blood lactate dehydrogenase, Haemolysis, Platelet count
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active hemolysis/Breakthrough Hemolysis Associated With COVID-19 Vaccination/recurrent Breakthrough ...
active hemolysis/Breakthrough Hemolysis Associated With COVID-19 Vaccination/recurrent Breakthrough haemolysis; This is a literature report for the following literature source(s). This literature case received on 05-MAY-2025, with additional information received on 07-MAY-2025, was reported by a physician, and concerned a patient in (redacted). The case describes the occurrence of Breakthrough haemolysis, recurrent Breakthrough haemolysis, Covid-19, blood lactate dehydrogenase increased, Haemoglobin decreased. The case concerned a 29 Years old, female patient. The patient's medical history included pregnancy in year 2013, at age of 20. At that time, she was noted to have a platelet count of 23,000 and was initially diagnosed with immune thrombocytopenic purpura (ITP). In the subsequent years, the patient was unresponsive to steroid and intravenous immunoglobin (IVIG) therapy. Her diagnosis was modified to PNH in 2017. In 2017, eculizumab therapy was initiated. In February of 2021, maintenance of eculizumab was no longer effective as the patient developed symptomatic disease activity characterized by severe, worsening fatigue, brain fog, chest pain, and active hemolysis. Past drug history included Eculizumab from 2017 to 2021 for PNH (paroxysmal nocturnal hemoglobinuria). On an unknown date in FEB-2021, the patient started pegcetacoplan under an expanded access protocol, at an unspecified dose, route and frequency for an unspecified duration. The product was indicated for PNH (paroxysmal nocturnal hemoglobinuria). The last dose administered was on an unknown date. On an unknown date in JUL-2021, the patient received co-suspect product Pfizer SARS-CoV-2 vaccine, 1st dose, at an unspecified dose, route and unspecified frequency and on an unknown date in AUG-2021, received Pfizer SARS-CoV-2 vaccine, 2nd dose (unknown dose route and frequency). In JUL-2021, the patient received her first dose of the Pfizer SARS-CoV-2 vaccine. She subsequently developed fatigue, lethargy, and evidence Her condition improved to near remission level with a resolution of fatigue, lethargy, and hemolysis approximately one week after the first vaccination. In AUG-2021, the patient received her second dose of Pfizer SARS-CoV-2 vaccine and similar symptoms developed, accompanied by active hemolysis (lactate dehydrogenase (LDH) 783 U/L and a drop in hemoglobin to 7.6 gm/dL). Subsequent to her receiving the second Pfizer SARS-CoV-2 vaccine, the symptoms outlined above slowly improved but nevertheless persisted, accompanied by continued low-grade hemolysis. In JAN-2022, the patient tested seropositive for COVID-19. At that point, she was short of breath (SOB), experiencing exertional chest pain, bleeding from her gums upon brushing her teeth, and easy bruising. Her LDH was 1056 U/L, and her hemoglobin was 6.1 g/d. Platelet and RBC transfusions were administered over two weeks. Her LDH and hemoglobin have yet to fully stabilize to previous baseline levels since the completion of her Pfizer SARS-CoV-2 vaccination schedule. In MAY-2022, the patient requires packed RBC transfusions every two to three months and has undergone a bone marrow transplant evaluation. The patient did not retest following initial seropositivity testing for COVID-19; however, any symptoms directly related to COVID-19 infection have resolved. Breakthrough haemolysis, blood lactate dehydrogenase increased, and Haemoglobin decreased were Requiring Intervention. The action taken with pegcetacoplan was unknown. On an unknown date, the 1st occurrence of events Breakthrough haemolysis had resolved. The outcome for the recurrent Breakthrough haemolysis, blood lactate dehydrogenase increased, Haemoglobin decreased was not resolved. Outcome for Covid-19 was resolved on an unknown date. Relevant lab tests (normal ranges are provided in parenthesis if available): In 2023, Lab Test for Platelet count with range (unknown low - unknown high): unknown result 23,000. On an unknown date, Lab Test for Blood lactate dehydrogenase with range (unknown low - unknown high): result 200s U/L, in Aug-2021 result was 783 U/L and in Jan-2022 result was: 1056 U/L. On an unknown date in Aug-2021, Lab Test for Haemoglobin with range (unknown low - unknown high): result was 7.6 gm/dL and in Jan-2022, result was 6.1 g/d. Company comment: The reporter assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased to have an unknown relationship to pegcetacoplan. The reporter assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased to be related to Pfizer SARS-CoV-2 vaccine. Apellis assessed Breakthrough haemolysis (1st and 2nd occurrence), blood lactate dehydrogenase increased, and Haemoglobin decreased as not related to pegcetacoplan, and can be plausibly explained by the underlying paroxysmal nocturnal hemoglobinuria triggered by the administration of COVID-19 vaccine. Apellis assessed Covid-19 as not related to pegcetacoplan since it can be considered as an intercurrent condition with an infectious etiology which is common in the general population. Apellis assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased as related to Pfizer SARS-CoV-2 vaccine. The case was deemed as serious due to it requiring intervention.; Sender's Comments: 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-PV202500056953 same patient/drug, different event;US-PFIZER INC-PV202500056950 Same reporter/patient/suspect vaccine/event; different dose;
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| 2841419 | F | 05/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood lactate dehydrogenase, Disease recurrence, Haemoglobin, Haemolysis, Platel...
Blood lactate dehydrogenase, Disease recurrence, Haemoglobin, Haemolysis, Platelet count
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active hemolysis/Breakthrough Hemolysis Associated With COVID-19 Vaccination/recurrent Breakthrough ...
active hemolysis/Breakthrough Hemolysis Associated With COVID-19 Vaccination/recurrent Breakthrough haemolysis; active hemolysis/Breakthrough Hemolysis Associated With COVID-19 Vaccination/recurrent Breakthrough haemolysis; This is a literature report for the following literature source(s). This literature case received on 05-MAY-2025, with additional information received on 07-MAY-2025, was reported by a physician, and concerned a patient in (redacted). The case describes the occurrence of Breakthrough haemolysis, recurrent Breakthrough haemolysis, Covid-19, blood lactate dehydrogenase increased, Haemoglobin decreased. The case concerned a 29 Years old, female patient. The patient's medical history included pregnancy in year 2013, at age of 20. At that time, she was noted to have a platelet count of 23,000 and was initially diagnosed with immune thrombocytopenic purpura (ITP). In the subsequent years, the patient was unresponsive to steroid and intravenous immunoglobin (IVIG) therapy. Her diagnosis was modified to PNH in 2017. In 2017, eculizumab therapy was initiated. In February of 2021, maintenance of eculizumab was no longer effective as the patient developed symptomatic disease activity characterized by severe, worsening fatigue, brain fog, chest pain, and active hemolysis. Past drug history included Eculizumab from 2017 to 2021 for PNH (paroxysmal nocturnal hemoglobinuria). On an unknown date in FEB-2021, the patient started pegcetacoplan under an expanded access protocol, at an unspecified dose, route and frequency for an unspecified duration. The product was indicated for PNH (paroxysmal nocturnal hemoglobinuria). The last dose administered was on an unknown date. On an unknown date in JUL-2021, the patient received co-suspect product Pfizer SARS-CoV-2 vaccine, 1st dose, at an unspecified dose, route and unspecified frequency and on an unknown date in AUG-2021, received Pfizer SARS-CoV-2 vaccine, 2nd dose (unknown dose route and frequency). In JUL-2021, the patient received her first dose of the Pfizer SARS-CoV-2 vaccine. She subsequently developed fatigue, lethargy, and evidence Her condition improved to near remission level with a resolution of fatigue, lethargy, and hemolysis approximately one week after the first vaccination. In AUG-2021, the patient received her second dose of Pfizer SARS-CoV-2 vaccine and similar symptoms developed, accompanied by active hemolysis (lactate dehydrogenase (LDH) 783 U/L and a drop in hemoglobin to 7.6 gm/dL). Subsequent to her receiving the second Pfizer SARS-CoV-2 vaccine, the symptoms outlined above slowly improved but nevertheless persisted, accompanied by continued low-grade hemolysis. In JAN-2022, the patient tested seropositive for COVID-19. At that point, she was short of breath (SOB), experiencing exertional chest pain, bleeding from her gums upon brushing her teeth, and easy bruising. Her LDH was 1056 U/L, and her hemoglobin was 6.1 g/d. Platelet and RBC transfusions were administered over two weeks. Her LDH and hemoglobin have yet to fully stabilize to previous baseline levels since the completion of her Pfizer SARS-CoV-2 vaccination schedule. In MAY-2022, the patient requires packed RBC transfusions every two to three months and has undergone a bone marrow transplant evaluation. The patient did not retest following initial seropositivity testing for COVID-19; however, any symptoms directly related to COVID-19 infection have resolved. Breakthrough haemolysis, blood lactate dehydrogenase increased, and Haemoglobin decreased were Requiring Intervention. The action taken with pegcetacoplan was unknown. On an unknown date, the 1st occurrence of events Breakthrough haemolysis had resolved. The outcome for the recurrent Breakthrough haemolysis, blood lactate dehydrogenase increased, Haemoglobin decreased was not resolved. Outcome for Covid-19 was resolved on an unknown date. Relevant lab tests (normal ranges are provided in parenthesis if available): In 2023, Lab Test for Platelet count with range (unknown low - unknown high): unknown result 23,000. On an unknown date, Lab Test for Blood lactate dehydrogenase with range (unknown low - unknown high): result 200s U/L, in Aug-2021 result was 783 U/L and in Jan-2022 result was: 1056 U/L. On an unknown date in Aug-2021, Lab Test for Haemoglobin with range (unknown low - unknown high): result was 7.6 gm/dL and in Jan-2022, result was 6.1 g/d. Company comment: The reporter assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased to have an unknown relationship to pegcetacoplan. The reporter assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased to be related to Pfizer SARS-CoV-2 vaccine. Apellis assessed Breakthrough haemolysis (1st and 2nd occurrence), blood lactate dehydrogenase increased, and Haemoglobin decreased as not related to pegcetacoplan, and can be plausibly explained by the underlying paroxysmal nocturnal hemoglobinuria triggered by the administration of COVID-19 vaccine. Apellis assessed Covid-19 as not related to pegcetacoplan since it can be considered as an intercurrent condition with an infectious etiology which is common in the general population. Apellis assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased as related to Pfizer SARS-CoV-2 vaccine. The case was deemed as serious due to it requiring intervention.; Sender's Comments: 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-PV202500056880 Same reporter/patient/suspect vaccine/event; different dose; US-PFIZER INC-PV202500056953 Same reporter/patient/suspect vaccine; different dose/event;
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| 2841420 | M | DC | 05/16/2025 |
RSV |
UNKNOWN MANUFACTURER |
|
Death
Death
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killed from a botched RSV vaccine developed and produced by Pfizer; This is a spontaneous report rec...
killed from a botched RSV vaccine developed and produced by Pfizer; This is a spontaneous report received from a Lawyer from legal division. A male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "killed from a botched RSV vaccine developed and produced by Pfizer". The date and cause of death for the patient were unknown. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: killed from a botched RSV vaccine developed and produced by Pfizer
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| 2841421 | M | PA | 05/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Multiple sclerosis
Multiple sclerosis
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Asked if I knew a great class action lawyer he thinks he got MS from the Covid Vaccine.; This is a s...
Asked if I knew a great class action lawyer he thinks he got MS from the Covid Vaccine.; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2025US060768 (Novartis Pharmaceuticals Corporation). A 41-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "Asked if I knew a great class action lawyer he thinks he got MS from the Covid Vaccine.". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : NUS2025US060768 Novartis Pharmaceuticals Corporation;
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| 2841424 | 48 | F | MN | 05/16/2025 |
HEPAB TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
P2443 Y3Z9P |
Asthenia, Fatigue, Flushing; Asthenia, Fatigue, Flushing
Asthenia, Fatigue, Flushing; Asthenia, Fatigue, Flushing
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Imz given at 10:30. Received a call from patient asking if it was normal to feel flush throughout he...
Imz given at 10:30. Received a call from patient asking if it was normal to feel flush throughout her body. She thought it was due to the TDaP. She said she also felt weak and tired. I encouraged her to go to the Emergency Room to be evaluated.
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| 2841425 | 66 | M | AK | 05/16/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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None noted
None noted
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| 2841426 | 20 | F | WI | 05/16/2025 |
HEPA IPV |
MERCK & CO. INC. SANOFI PASTEUR |
X026485 Y1A201M |
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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patient received an expired vaccine (Vaqta Hep A) on 05/16/2025 that expired on 05/11/2025. no signs...
patient received an expired vaccine (Vaqta Hep A) on 05/16/2025 that expired on 05/11/2025. no signs or symptoms after the administration. patient was observed for 15 minutes with no signs or symptoms. patient was advised to call the office if they experience any symptoms. patient verbalized understanding.
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| 2841427 | 35 | F | WI | 05/16/2025 |
HEP MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
47XP4 32YB4 |
Underdose; Underdose
Underdose; Underdose
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The incorrect dose (Engerix-B, 10 mcg / 0.5ml) was prepared and administered rather than the adult d...
The incorrect dose (Engerix-B, 10 mcg / 0.5ml) was prepared and administered rather than the adult dose 20 mcg/1mL Engerix-B
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| 2841437 | 55 | F | ME | 05/16/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944665 |
Pustule, Rash, Urticaria
Pustule, Rash, Urticaria
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PATIENT DEVELOPED RASH ON STOMACH AND WELTS WITH PUS
PATIENT DEVELOPED RASH ON STOMACH AND WELTS WITH PUS
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| 2841438 | 21 | M | IL | 05/16/2025 |
HPV9 |
MERCK & CO. INC. |
z002903 |
Dizziness
Dizziness
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pt felt woozy and lightheaded and faint
pt felt woozy and lightheaded and faint
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| 2841439 | 71 | M | OR | 05/16/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Nausea, Vomiting
Nausea, Vomiting
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Patient received PCV20 vaccine and then about 5 minutes after receiving vaccine patient began to fee...
Patient received PCV20 vaccine and then about 5 minutes after receiving vaccine patient began to feel nauseous and vomited multiple times. After vomiting patient felt better and waited the 15 minutes in clinic and all symptoms resolved. Patient went home.
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| 2841440 | 21 | F | IL | 05/16/2025 |
HPV9 |
MERCK & CO. INC. |
z002903 |
Dizziness
Dizziness
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pt felt woozy, dizzy and lightheaded
pt felt woozy, dizzy and lightheaded
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| 2841441 | 48 | M | ME | 05/16/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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THE WIFE CALLED ME TODAY TO REPORT THAT OVER THE PAST 4 WEEKS THE PATIENT HAS DEVELOPED A SWOLLEN AR...
THE WIFE CALLED ME TODAY TO REPORT THAT OVER THE PAST 4 WEEKS THE PATIENT HAS DEVELOPED A SWOLLEN AREA AROUND SITE OF INJECTION AND A BURNING FEELING THAT HAS NOT GONE AWAY.
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| 2841442 | 75 | F | KY | 05/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2M7GR |
Bladder disorder, Mobility decreased
Bladder disorder, Mobility decreased
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Vaccine received 5/9/25 at noon. At 2 am 5/10/25 I was unable to move my legs and had no control ov...
Vaccine received 5/9/25 at noon. At 2 am 5/10/25 I was unable to move my legs and had no control over my bladder. By 10:30 am feeling had returned.
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| 2841443 | 46 | F | MO | 05/16/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Anxiety, Balance disorder, Brain fog, Cholecystectomy, Cholecystitis; Food intol...
Anxiety, Balance disorder, Brain fog, Cholecystectomy, Cholecystitis; Food intolerance, Hepatic cyst, Injection site pain, Irritable bowel syndrome, Nausea; Nervous system disorder, Stress, Vertigo, Vision blurred, Visual impairment; Vomiting
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Nausea, vomiting, pain at injection site. Vision issues, blurry, cloudy vision, neurological issues,...
Nausea, vomiting, pain at injection site. Vision issues, blurry, cloudy vision, neurological issues, brain fog, balance issues, vertigo , iBS, stress, anxiety, food intolerance, chronic gall bladder inflammation, gall bladder removal 2025, liver cysts,
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| 2841444 | 51 | F | NV | 05/16/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
y013009 9l944 |
Injection site rash, Injection site warmth; Injection site rash, Injection site ...
Injection site rash, Injection site warmth; Injection site rash, Injection site warmth
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Patient states that she got redness that looks like a rash and a little bit of warmth in the injecti...
Patient states that she got redness that looks like a rash and a little bit of warmth in the injection site of right arm. She just started having symptoms yesterday.
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| 2841445 | 64 | M | CA | 05/16/2025 |
COVID19 |
NOVAVAX |
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Condition aggravated, Eczema
Condition aggravated, Eczema
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Severe eczema flare up that persists 18 months after vaccination. Patient had previous diagnosis of ...
Severe eczema flare up that persists 18 months after vaccination. Patient had previous diagnosis of ectopic dermatitis or numular eczema.
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| 2841446 | 45 | F | NV | 05/16/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
645665 |
Circumstance or information capable of leading to medication error, Inappropriat...
Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
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Date: May 16, 2025 1. Incident Summary On May 16, 2025, at approximately 10:00AM, I administered...
Date: May 16, 2025 1. Incident Summary On May 16, 2025, at approximately 10:00AM, I administered a Hepatitis B (Heplisav-B) vaccination to patient at Pharmacy. Prior to administration, I conducted a full profile review and a Drug Utilization Review (DUR), confirming no contraindications, no active prescription on file, and no DUR rejections. The prescription record for the first dose was marked ?deactivated,? leading me to believe patient had not yet received her initial vaccination. Even the patient did not say anything and asked my tech so Hep B vaccine. My tech told me she needs Hep B vaccine. 2. Discovery of Prior Dose Hours after administration, the Pharmacy Manager notified me by a phone call to the pharmacy that patient had, in fact, received her first Hep B dose on May 15, 2025. Neither the patient nor my pharmacy technician informed me of that prior administration, likely due to the prescription?s deactivated status in our system. As a result, patient inadvertently received her second dose 29 days after her first, instead of at the manufacturer-recommended interval of 28 days. 3. Actions Taken & Procedural Compliance I performed all standard checks: patient identity, vaccination history, and DUR, with no system alerts or overrides required. I adhered strictly to the ACIP guidelines for Hepatitis B administration based on the information available. I documented the administration of the May 16 dose in patient?s profile immediately after the procedure. 4. Immediate Risks & Regulatory Implications This event constitutes a misfill and deviation from the recommended dosing schedule, which may: Compromise vaccine efficacy and patient safety. Expose the pharmacy to regulatory scrutiny and potential licensure risk under Board of Pharmacy standards. Violate internal quality assurance protocols regarding prescription activation/deactivation procedures. 5. Required Investigation & Corrective Measures To protect patient health and the integrity of our pharmacy operations, I request an immediate, in-depth investigation into: Who administered the first Heplisav-B dose on May 15, 2025, and under what prescription or documentation. Why the original prescription was deactivated in the system without clinical notation or DUR alert. Whether system settings or staff workflows inadvertently allowed the deactivation to override critical vaccination history. I fulfilled my professional duty by relying on the system records available at the time. I expect a prompt response outlining the investigation?s findings and the measures that will be implemented to safeguard both our patients and our license compliance. Thank you for addressing this matter with the urgency it requires.
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| 2841470 | 42 | F | CO | 05/16/2025 |
HPV9 |
MERCK & CO. INC. |
Y015180 |
Paraesthesia
Paraesthesia
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When she woke up on 3/4/25 in the morning, she noticed that both her hands were tingling. She recei...
When she woke up on 3/4/25 in the morning, she noticed that both her hands were tingling. She received the first HPV shop on 3/3/25 in the left deltoid. At the same time she had recently finished treatment with metronidazole for bacterial vaginosis. This was reported to VAERS on 5/16/2025 and patient was told not to take HPV vaccines in future due to component / contra indications regarding yeast as mentioned in the package insert.
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| 2841731 | 3 | F | DE | 05/16/2025 |
DTAP HEP HEPA HIBV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5KR3R 4BX39 H3N97 BE9G7 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; 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 an adult dose (20mL) of Hepatitis B instead of the pediatric dose of (10mL). Provid...
Patient received an adult dose (20mL) of Hepatitis B instead of the pediatric dose of (10mL). Provider followed up with mom. No side effects were detected by parent.
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| 2841034 | M | OR | 05/15/2025 |
HPV9 UNK UNK |
MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Y007197 |
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S...
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope
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Inbound call from HCP regarding GARDASIL 9. HCP states that she gave the first dose of GARDASIL 9 to...
Inbound call from HCP regarding GARDASIL 9. HCP states that she gave the first dose of GARDASIL 9 to her 18 year old male patient on Tuesday 6MAY2025 and the patient experienced immediate syncope. The patient then laid down and the syncope resolved w; This spontaneous report was received from a Nurse Practitioner and refers to a 18-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-May-2025, the patient started therapy with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (TDAP), (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis. The patient started therapy with meningococcal vaccine (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis; it was reported that the patient did not experience any immediate symptoms with those vaccines. On the same date, a few minutes after, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) lot #Y007197, expiration date: 18-Aug-2026, 0.5ml, administered by Intramuscular route, first dose, (strength, frequency, vaccination scheme, and anatomical location were not reported), as Human Papillomavirus (HPV) prevention. On the same date, the patient experienced immediate syncope. The patient then laid down and the syncope resolved within 15 minutes. The patient sought medical attention and had been treated for the event. The causal relationship between the event syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) was reported as related, but unknown with the other suspect vaccines. Upon internal review, the event was determined to be important medical event. This is one of four reports from the same reporter.
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| 2841035 | 1.08 | ME | 05/15/2025 |
VARCEL |
MERCK & CO. INC. |
Z002625 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; HCP called to report TE where one patient received a dose of VARIVAX after stored ...
no adverse event; HCP called to report TE where one patient received a dose of VARIVAX after stored improperly; This spontaneous report was received from 09-MAY-2025 and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAY-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z002625, expiration date: 09-JAN-2027), dose: 0.5 mL (route and dose number were not reported) and with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (route, dose number, lot # and expiration date were not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 7.1 Fahrenheit for 1-hour hour with no previous excursions. There was no adverse effect reported.
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| 2841036 | 36 | M | IN | 05/15/2025 |
TYP |
SANOFI PASTEUR |
X1A271M |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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administered typhim vi subcutaneously instead of the recommended intramuscular route with no reporte...
administered typhim vi subcutaneously instead of the recommended intramuscular route with no reported ae; Initial information received on 12-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 36 years old male patient who was administered Typhoid Vi Polysaccharide Vaccine [Typhim Vi] subcutaneously instead of the recommended intramuscular route with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap) and Tetanus Vaccine (Tetanus B) for Immunisation. On 12-May-2025, the patient received 0.5ml (once) dose of suspect Typhoid Vi Polysaccharide Vaccine, Solution for injection, Strength standard, lot X1A271M and expiry date 31-Mar-2026 for immunization via subcutaneous route in the left triceps instead of the recommended intramuscular route with no reported adverse event (incorrect route of product administration) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2841037 | 7 | F | PA | 05/15/2025 |
DTAP |
SANOFI PASTEUR |
3CA20C1 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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7 years old received Daptacel on not approved age group with no reported adverse event; Initial info...
7 years old received Daptacel on not approved age group with no reported adverse event; Initial information received on 13-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7-year-old female patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to not approved age group with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation. On 06-May-2025, the 7 years old patient received a 0.5 (ml) dose (dose 5) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection strength: standard, frequency: once of lot 3CA20C1 and expiry date: 28-Feb-2026 via intramuscular route in the left arm for Immunization to not approved age group with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day). Reportedly, She further asked if a Tdap (Tetanus, Diphtheria, and acellular Pertussis) would have to be given. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2841049 | 30 | F | CA | 05/15/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
Ew0196 Ew0196 Ew0196 Ew0196 |
Autonomic nervous system imbalance, Blood test normal, Computerised tomogram nor...
Autonomic nervous system imbalance, Blood test normal, Computerised tomogram normal, Dizziness, Fatigue; Gluten sensitivity, Headache, Heart rate decreased, Hyperacusis, Hypotension; Magnetic resonance imaging normal, Migraine with aura, Milk allergy, Muscle spasms, Pain; Pain in extremity, Photophobia, Tinnitus
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Within 10 minutes pain going up left arm into head. Headache. Headache 24 hours per day every day si...
Within 10 minutes pain going up left arm into head. Headache. Headache 24 hours per day every day since then. Bouts of lightheadedness, constant fatigue, food sensitivities including dairy and gluten, muscle spasms in right pointer finger and calfs, whole body pain. Constant migraines with aura (no previous migraines). Sensitivity to sound, ringing in the ears, light sensitivity, slow heart rate, low blood pressure, Dysautonomia
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| 2841050 | 41 | F | AL | 05/15/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
011J20A 011J20A 0220A 0220A |
Aphasia, Dysarthria, Feeling abnormal, Impaired work ability, Laboratory test; L...
Aphasia, Dysarthria, Feeling abnormal, Impaired work ability, Laboratory test; Loss of employment, Malaise, Stress at work, Tremor; Aphasia, Dysarthria, Feeling abnormal, Impaired work ability, Laboratory test; Loss of employment, Malaise, Stress at work, Tremor
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I didn?t WANT to get this Vax. But, as a CCMA at an Internal Medicine practice, also in another area...
I didn?t WANT to get this Vax. But, as a CCMA at an Internal Medicine practice, also in another area, I was UNDERSTOOD That we were to all get it. I?m a single Mom. Since I had drug allergies, I had to wait the 15 minutes following each time I went. Within 2 hours, I felt very ill, after the first vax on 01/08/2021. I understand the science behind how my cells were doing what they allegedly were supposed to do. Within a week, I began to have an intermittent tremor, causing difficulty to sleep chart when rooming patients. The P.A. whom I was working with, had been causing a lot of stress for me. She couldn?t keep a MA because of how difficult she was. So in Feb 11, 2021, by then I?d developed trouble speaking, finding words, ?spacing out?, life became difficult. I was hospitalized on 07/09/2021. I thought I was having a stroke in the middle of clinic. It was terrifying! I have documentation, pictures, I even LOST THE JOB THST I GOT VACCINATED FOR!! They fired me. My life has been garbage since. I?d love to tell you the whole story.
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| 2841051 | M | PA | 05/15/2025 |
CHOL |
PAXVAX |
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Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age
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None stated.
None stated.
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| 2841052 | 66 | M | MA | 05/15/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
808748 808748 |
Autopsy, Bedridden, Death, Injection site bruising, Malaise; Pain in extremity, ...
Autopsy, Bedridden, Death, Injection site bruising, Malaise; Pain in extremity, Vomiting
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My father was complaining about pain in his arm within an hour of taking his vaccine, was complainin...
My father was complaining about pain in his arm within an hour of taking his vaccine, was complaining about not feeling well within 4-5 hours after, was vomiting continuously within 15 hours of getting his vaccine, and was dead within 60 hours. He was bed ridden for the two days following the vaccine and stayed that way until he passed in the early hours of November 21st. On the second day of severe illness he contacted the transplant department of hospital (they were the doctors that made this vaccine mandatory for further treatment) and they assured him it was normal for adverse reactions to pass after 48 hours and due to that he decided to wait it out instead of going to the hospital. He died in his bed that night. He had a bruise in his right deltoid where he got the vaccine at the time of his death.
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| 2841053 | 12 | F | PA | 05/15/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
Headache, Injection site reaction, Muscle swelling, Nausea
Headache, Injection site reaction, Muscle swelling, Nausea
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Headache rated 6/10, with nausea, mild swelling of L deltoid muscle.
Headache rated 6/10, with nausea, mild swelling of L deltoid muscle.
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| 2841056 | 61 | F | TX | 05/15/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Erythema, Injection site swelling, Peripheral swelling, Pruritus, Swelling
Erythema, Injection site swelling, Peripheral swelling, Pruritus, Swelling
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Swelling of arm @ injection site, swelling into chest wall & into hand. Patient reports with a...
Swelling of arm @ injection site, swelling into chest wall & into hand. Patient reports with a reaction to the pneumonia vaccine (5/12/2025). Saw her PCP and was given a pneumonia vaccine last week. She has developed redness on her left arm. The swelling and redness has increased. Arm has been itchy and she is having pain. It's trending a little worse with time. She has tried Advil and took some Benadryl. Denies fever and chills. Patient reports further spread of redness today (5/13/2025), so I'm sending in a prescription to start her on Keflex.
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