| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2850643 | F | IL | 07/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received her first dose of Shingrix in 2023. When can the patient receive the second dose; This non-...
received her first dose of Shingrix in 2023. When can the patient receive the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received her first dose of Shingrix in 2023. When can the patient receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 The pharmacist reported that the patient got her first dose of Shingrix in 2023 and asked when can the patient receive the second dose Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2850693 | AL | 07/22/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Z007214 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
the patient did not experience any adverse side effects from administered dose; no adverse event; TE...
the patient did not experience any adverse side effects from administered dose; no adverse event; TE for PROQUAD with a prior excursion on 6/18/2025 and a current excursion on 07/02/2025 that was administered post excursion to a patient on 06/30/2025; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 30-Jun-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (valid lot #Z007214, expiration date: 05-Oct-2026) 0.5 mL administered for prophylaxis (dose number, anatomical location and route of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on 18-JUN-2025: 6.8 Fahrenheit (F) for 0 hours, 47 minutes, 0 seconds (product storage error, onset date: 30-JUN-2025). The patient did not experience any adverse side effects from administered dose; no adverse event (no adverse event). This is one of several reports received from the same reporter.; Reporter's Comments: Keywords :
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| 2850694 | F | RI | 07/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not receive 2nd dose yet; This non-serious case was reported by a pharmacist via call center rep...
did not receive 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received 1st dose in 2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 09-JUL-2025 A patient received the first dose of Shingrix in 2020 and has not yet received the second dose, which led to incomplete course of vaccination. The reporter did not wish to provide the date of birth of the patient.
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| 2850695 | F | VA | 07/22/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
NG9E2 |
Expired product administered
Expired product administered
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expired dose administered; This non-serious case was reported by a other health professional and des...
expired dose administered; This non-serious case was reported by a other health professional and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number NG9E2, expiry date 30-JUN-2025) for prophylaxis. On 09-JUL-2025, the patient received Menveo (intramuscular) .5 ml. On 09-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 09-JUL-2025 The reporter reported that the patient received expired dose of Menveo which led to, expired vaccine used.
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| 2850696 | 07/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site pain
Injection site pain
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The shot hurts really bad for a few day; This non-serious case was reported by a consumer via intera...
The shot hurts really bad for a few day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The shot hurts really bad for a few day). The outcome of the pain was resolved. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a patient via interactive digital media. The reporter reported that the shot hurt really bad for a few days, if you were right handed take in the left one and vice versa It was reporter advice.
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| 2850697 | 07/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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had the initial Shingrix vaccine more than 2 years ago; This non-serious case was reported by a cons...
had the initial Shingrix vaccine more than 2 years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received more than 2 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: had the initial Shingrix vaccine more than 2 years ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt date: 09-JUL-2025 The patient had the initial Shingrix vaccine. The reporter asked he/she might safely and effectively get the second dose now or should start again with the first dose and take the second as directed 3 to 4 months later. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
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| 2850698 | 07/22/2025 |
HEP RVX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Herpes zoster; Herpes zoster; Herpes zoster
Herpes zoster; Herpes zoster; Herpes zoster
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had another outbreak within a week; This non-serious case was reported by a consumer via interactive...
had another outbreak within a week; 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. Co-suspect products included Hepatitis B vaccine for prophylaxis and RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included chickenpox (they had a horrible case of Chickenpox all over their body.) and shingles (documented total of Shingles 9 times since patient was in thirties). Previously administered products included Flu vaccine with an associated reaction of influenza (patient stopped getting the Flu shot because patient caught the flu within a week every time, they got one) and COVID- 19 vaccine with an associated reaction of cardiac failure congestive (Patient didn't get the Covid Vaccination and didn't get COVID for two years). On an unknown date, the patient received Shingles vaccine, Hepatitis B vaccine and RSV vaccine. On an unknown date, less than a week after receiving Shingles vaccine and an unknown time after receiving Hepatitis B vaccine and RSV vaccine, the patient experienced shingles (Verbatim: had another outbreak within a week). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine, Hepatitis B vaccine and RSV vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Hepatitis B vaccine and RSV vaccine. Additional Information: GSK receipt date: 09-JUL-2025 This case was reported by a patient via interactive digital media. Patient always took every vaccination offered and required all his/her life. Patient caught everything as a young child and the doctor would give them more vaccinations Then reporter was a Middle School Teacher and was required to get them including the Series of Hepatitis B shots. Patient kept getting Shingles because they had a horrible case of Chickenpox all over their body. Patient then had the first two Shingles vaccine. Patient had another case of Shingles in less than a week. Patient found out later the vaccine gave them. There was something wrong with the first Shingles vaccines. Then patient got two Shingrix Shingles Vaccinations. After having a documented total of Shingles 9 times since patient was in thirties, patient haven't had another case since they got the Shingrix vaccinations. Patient indicated that they work. Then patient stopped getting the Flu shot because patient caught the flu within a week every time, they got one. Patient didn't get the Covid Vaccination and didn't get COVID for two years. Patient have been sicker with many things and even got congestive heart failure since they took those shots. They had been proven to cause blood clots in some people. Patient have lost many younger friends that didn't had heart problems but died of massive heart attacks and strokes soon after they got the vaccinations. Patient indicated that every person's body different because of their medical history and they had a choice to take it or not. That's what freedom was all about. Everyone's immune system is different. Patient protect others by not going out if they get sick. Yet, patient indicated that they will be 78 soon and sick people cough all over and around them when they go anywhere. Patient was glad we are doing well, also asked especially be careful when a lot of people are sick.
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| 2850699 | 07/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain, Injection site warmth
Injection site pain, Injection site warmth
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sharp pain near injection site; Hot at injection site; This non-serious case was reported by a consu...
sharp pain near injection site; Hot at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain (Verbatim: sharp pain near injection site) and injection site warmth (Verbatim: Hot at injection site). The outcome of the injection site pain and injection site warmth were not reported. It was unknown if the reporter considered the injection site pain and injection site warmth to be related to Shingrix. It was unknown if the company considered the injection site pain and injection site warmth to be related to Shingrix. Additional Information: GSK Receipt date: 12-JUL-2025 The patient had hot and sharp pain near injection site.
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| 2850700 | 07/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache
Headache
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How to reduce headache; This non-serious case was reported by a consumer via interactive digital med...
How to reduce headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: How to reduce headache). The outcome of the headache was not reported. It was unknown if the reporter considered the headache to be related to Shingrix. It was unknown if the company considered the headache to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUL-2025 This case was reported by a patient via interactive digital media. The reporter asked that how to reduce headache.
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| 2850701 | 07/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Rash, Rash pruritic, Skin burning sensation, Vaccination failure
Herpes zoster, Rash, Rash pruritic, Skin burning sensation, Vaccination failure
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Suspected vaccination failure; I got the shingles shots in 2020/a month ago I got shingles on my thi...
Suspected vaccination failure; I got the shingles shots in 2020/a month ago I got shingles on my thigh; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In JUN-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingles shots in 2020/a month ago I got shingles on my thigh). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the shingles shots in 2020 and a month ago, got shingles on thigh. The patient's whole thigh was broken out, burned really bad, still have botches and now it itches. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2850702 | 07/22/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Illness, Productive cough, Respiratory syncytial virus infection, Sputum discolo...
Illness, Productive cough, Respiratory syncytial virus infection, Sputum discoloured, Vaccination failure
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Suspected vaccination failure; still contracted RSV; coughing up green phlegm; Sickness; This seriou...
Suspected vaccination failure; still contracted RSV; coughing up green phlegm; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sickness). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: still contracted RSV) and phlegm discolored (Verbatim: coughing up green phlegm). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved (duration 1 month) and the outcome of the phlegm discolored was not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness and phlegm discolored to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, sickness and phlegm discolored to be related to RSV vaccine. Additional Information: GSK Receipt Date: 12-JUL-2025 This case was reported by a consumer via interactive digital media. The patient was vaccinated too but still contracted RSV. The patient was sick for a month and that was 2 months ago and he/she was still coughing up green phlegm. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
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| 2850703 | 07/22/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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got sick in less than 48 hours and very sick for two weeks; This non-serious case was reported by a ...
got sick in less than 48 hours and very sick for two weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 84-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 48 hrs after receiving RSV vaccine, the patient experienced sickness (Verbatim: got sick in less than 48 hours and very sick for two weeks). The outcome of the sickness was resolved (duration 2 weeks). It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 13-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine, got sick in less than 48 hours and was very sick for two weeks.
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| 2850704 | 1.5 | F | MI | 07/22/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LN4932 LK59T |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Patient was given a dose to Tdap instead of Dtap for her 4th dose. There has be no reaction at this...
Patient was given a dose to Tdap instead of Dtap for her 4th dose. There has be no reaction at this point that has been made aware of.
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| 2850705 | 0.75 | M | TX | 07/22/2025 |
RV5 |
MERCK & CO. INC. |
2142142 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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There was not an adverse event. Patient was administered Rotateq at 9 months, after the indicated ag...
There was not an adverse event. Patient was administered Rotateq at 9 months, after the indicated age range for vaccine. This is for reporting purposes only.
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| 2850706 | 74 | F | MN | 07/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
En6704 En6704 |
Anxiety, Brain fog, Cardiac disorder, Malaise, SARS-CoV-2 antibody test positive...
Anxiety, Brain fog, Cardiac disorder, Malaise, SARS-CoV-2 antibody test positive; Tremor
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Heart problems Tremere's inside brain fog Anxiety sick all the time
Heart problems Tremere's inside brain fog Anxiety sick all the time
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โ | |||||
| 2850707 | 46 | F | NY | 07/22/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
3M9DS |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Vaccine Error - When the provider first told me about the vaccine the pt has increase primordiality,...
Vaccine Error - When the provider first told me about the vaccine the pt has increase primordiality, she is 4 years out the recommended age group.
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| 2850708 | 16 | M | NC | 07/22/2025 |
HEP HEP MENB MENB MNQ MNQ |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR SANOFI PASTEUR |
4D333 4D333 49M9N 49M9N U8375AB U8375AB |
Arthralgia, Injected limb mobility decreased, Joint noise, Musculoskeletal disco...
Arthralgia, Injected limb mobility decreased, Joint noise, Musculoskeletal discomfort, Musculoskeletal pain; Pain, Rotator cuff syndrome, Sleep disorder; Arthralgia, Injected limb mobility decreased, Joint noise, Musculoskeletal discomfort, Musculoskeletal pain; Pain, Rotator cuff syndrome, Sleep disorder; Arthralgia, Injected limb mobility decreased, Joint noise, Musculoskeletal discomfort, Musculoskeletal pain; Pain, Rotator cuff syndrome, Sleep disorder
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Right Shoulder Pain - Persistent right shoulder discomfort began with a few hours after an injection...
Right Shoulder Pain - Persistent right shoulder discomfort began with a few hours after an injection in the right deltoid during the last visit. - Limited mobility prompted an urgent care visit on 7/10 - He describes a sensation of the shoulder blade caving in when both arms are raised and notes a size difference between shoulders. - Pain occurs when sleeping on the right side and crossing the right arm over the body, accompanied by a crunching sound. He is unable to fully adduct and flex to start a golf swing - Pain and reduced flexion, extension, abduction and adduction - No swelling, redness, or rash. - No strenuous activities since onset. - Pain subsided after 3 days, leading to cancellation of follow-up from facility, but continued limited ROM prompted a visit with PCP on 7/21/25 - Using lidocaine patch, ice, ibuprofen, and Tylenol as recommended, providing some relief. - on Exam- limited right shoulder ROM with pain over the posterolateral deltoid in the groove c/w rotator cuff tendonitis
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โ | |||||
| 2850709 | 67 | M | TX | 07/22/2025 |
COVID19 |
PFIZER\BIONTECH |
|
B-cell lymphoma, Lymph node palpable
B-cell lymphoma, Lymph node palpable
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Felt lymph nodes in neck, now has b cell lymphoma
Felt lymph nodes in neck, now has b cell lymphoma
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โ | |||||
| 2850710 | 07/22/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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had been sick ever since they took the stupid shot; This non-serious case was reported by a consumer...
had been sick ever since they took the stupid shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: had been sick ever since they took the stupid shot). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 12-JUL-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had been sick ever since they took the stupid shot. Consumer mentioned he/she will take it never again. The follow-up could not be possible as no contact details were available.
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| 2850711 | 54 | F | AR | 07/22/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
eb499 eb499 |
Arthralgia, Chills, Immediate post-injection reaction, Oropharyngeal pain, Pain;...
Arthralgia, Chills, Immediate post-injection reaction, Oropharyngeal pain, Pain; Pain in extremity, Pharyngeal swelling, Rash
More
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Immediately, normal sore arm, body aches. Within 48 hours progressed to full body joint pain, sore...
Immediately, normal sore arm, body aches. Within 48 hours progressed to full body joint pain, sore throat, chills, full body rash. Throat swollen enough to feel like strep. Went to doctor, no strep, no cold, no covid, no flu. Three weeks later, still has full body rash and sore throat.
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| 2850712 | 69 | M | FL | 07/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Pain in extremity
Pain in extremity
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shingrex shot on 06-11-2025 right arm, extreme pain right arm never went away
shingrex shot on 06-11-2025 right arm, extreme pain right arm never went away
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โ | |||||
| 2850713 | 69 | M | VA | 07/22/2025 |
COVID19 |
PFIZER\BIONTECH |
unk |
Arthralgia, Fatigue, Laboratory test abnormal, Rheumatoid factor positive, Swell...
Arthralgia, Fatigue, Laboratory test abnormal, Rheumatoid factor positive, Swelling
More
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Extreme joint pain, fatigue, swelling. Tests have now been positive for Rheumatoid Arthritis, Lupus,...
Extreme joint pain, fatigue, swelling. Tests have now been positive for Rheumatoid Arthritis, Lupus, and Sjogren's.
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โ | |||||
| 2850714 | 0.17 | F | IN | 07/22/2025 |
RV5 |
MERCK & CO. INC. |
2124039 |
Diarrhoea, Fatigue, Vomiting
Diarrhoea, Fatigue, Vomiting
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Taken directly from visit note: patient is a 2 month old female who presents with mother and sibling...
Taken directly from visit note: patient is a 2 month old female who presents with mother and siblings today with vomiting after feedings. Pt was here on the 15th for a 2 month old well child check, and received vaccines at that time. That evening mother noticed pt had very watery diarrhea, which has continued since, with regular wet diapers. Also every time she would feed the pt, usually 3-4 oz at a time which is less than usual, she would vomit it all back up. States pt appears sad and fatigued. Denies fever or signs of dehydration such as decreased wet diapers or decreased saliva or tear production.
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| 2850715 | 54 | F | KY | 07/22/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Arthralgia, Blood test, Hypoaesthesia, Injection site pain, Injection site swell...
Arthralgia, Blood test, Hypoaesthesia, Injection site pain, Injection site swelling; Muscular weakness, Pain in extremity
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pt states when she got the injection for the vaccine that it was extremely painful. As soon as she g...
pt states when she got the injection for the vaccine that it was extremely painful. As soon as she got the injection she had pain run down her arm and fingers causing numbness on her radial side of her arm. Her arm is very weak and has no strength in it. She had swelling around the injection site that is going down but is still there and has pain in her right shoulder joint area. Her doctor prescribed anti-inflammatory meds but still continues to have same symptoms.
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| 2850716 | 31 | F | MO | 07/22/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
K72S4 |
Exposure during pregnancy
Exposure during pregnancy
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31 yo G4P3, EDD 5/30/2025, unknown birth weight
31 yo G4P3, EDD 5/30/2025, unknown birth weight
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| 2850717 | 12 | F | NC | 07/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
DY3K7 |
Dizziness, Hyperhidrosis, Loss of consciousness, Presyncope
Dizziness, Hyperhidrosis, Loss of consciousness, Presyncope
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Patient had Vasovagal response. Patient passed out near check out window ie became sweaty and dizzy ...
Patient had Vasovagal response. Patient passed out near check out window ie became sweaty and dizzy and passed out. Reports did not eat anything for breakfast. Patient given cold pack, cool air, sucker, time to rest. Vital Signs were stable. Within 10 minutes patient reported feeling normal and ambulated out of clinic
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| 2850718 | 18 | F | ND | 07/22/2025 |
MENB |
PFIZER\WYETH |
LF302 |
Wrong product administered
Wrong product administered
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Patient came in for second Men B shot in series. Patient had previously been given Bexero for first ...
Patient came in for second Men B shot in series. Patient had previously been given Bexero for first dose of Men B. Trumenba given for second dose by mistake. Dose 2 marked as invalid.
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| 2850719 | 4 | F | NY | 07/22/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5G23D Y016873 |
Injection site erythema, Injection site nodule, Injection site swelling; Injecti...
Injection site erythema, Injection site nodule, Injection site swelling; Injection site erythema, Injection site nodule, Injection site swelling
More
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localized swelling erythema and nodule at injection site
localized swelling erythema and nodule at injection site
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| 2850720 | 63 | F | GA | 07/22/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Extra dose administered
Extra dose administered
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Administration error, patient had previously received dose of Prevnar 20 on 3/19/25. Initial dose wa...
Administration error, patient had previously received dose of Prevnar 20 on 3/19/25. Initial dose was not on state registry.
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| 2850721 | 9 | M | CA | 07/22/2025 |
HPV9 |
MERCK & CO. INC. |
Z005055 |
Injection site mass, Injection site pain, Injection site paraesthesia, Paraesthe...
Injection site mass, Injection site pain, Injection site paraesthesia, Paraesthesia
More
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Patient received a HPV #2 vaccine in office on 5/27/25. Administered in the left deltoid muscle. Mom...
Patient received a HPV #2 vaccine in office on 5/27/25. Administered in the left deltoid muscle. Mom called our office on 7/10/25 due to a lump that developed under the tissue at the injection site along with a tingling sensation in patient's arm. The lump was sensitive to touch and when palpated, patient would feel a tingling sensation down his arm to his hand. Otherwise, no pain or trouble moving his arm or hand. Upon collecting history, mom states that the lump developed immediately post vaccination on the same day. Mom also confirms that patient experienced mild arm soreness for 1-2 weeks post vaccination. Patient iced the deltoid muscle which improved the arm soreness but did not improve the lump at the injection site or tingling sensation. During the phone discussion with mom, it was recommended for patient to try a warm compress for 10-15min with massage. Instructed to do this twice daily for the next several days. Mother was instructed to make a follow up appointment that following Monday 7/14/25 if there was no improvement. Attempted to follow up with parent on 7/14/25 but unsuccessful; voicemail was left at 11:42am. Successfully able to follow up with mom on 7/18/25. Mom states that patient is doing much better. Explains that the warm compress and massage greatly improved the lump that was at the injection site and the tingling sensation has fully resolved.
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| 2850722 | 1 | F | TX | 07/22/2025 |
HEPA MMR PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
l4ea4 y013171 mf0416 z003883 |
Injection site rash, Rash, Rash erythematous; Injection site rash, Rash, Rash er...
Injection site rash, Rash, Rash erythematous; Injection site rash, Rash, Rash erythematous; Injection site rash, Rash, Rash erythematous; Injection site rash, Rash, Rash erythematous
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Episode started Thursday, 07/17/2025. The affected locations include the neck, chest, left arm, left...
Episode started Thursday, 07/17/2025. The affected locations include the neck, chest, left arm, left lower leg, and right lower leg. The rash is characterized by redness. Mother was told to monitor the baby and a call was made on 7/22/2025 at 11:50AM to follow up on the patient, dad answered and stated that the child no longer has a rash.
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| 2850723 | 58 | F | FL | 07/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Injection site pain, Musculoskeletal pain, Paraesthesia, Vaccination site mass
Injection site pain, Musculoskeletal pain, Paraesthesia, Vaccination site mass
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Lump in your left arm at the vaccine site , noted feeling like my arm is going to sleep. Site is ten...
Lump in your left arm at the vaccine site , noted feeling like my arm is going to sleep. Site is tender, pain in the shoulder blade and a deep ache, " feel like it is on the inside
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| 2850724 | 1 | F | TX | 07/22/2025 |
HEPA MMR PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
l4ea4 y013171 mf0416 z003883 |
Injection site rash, Rash; Injection site rash, Rash; Injection site rash, Rash;...
Injection site rash, Rash; Injection site rash, Rash; Injection site rash, Rash; Injection site rash, Rash
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Episode started Thursday, 07/17/2025. The affected locations include the neck, chest, left arm, left...
Episode started Thursday, 07/17/2025. The affected locations include the neck, chest, left arm, left lower leg, and right lower leg. The rash is characterized by redness. Mother was told to monitor the baby and a call was made on 7/22/2025 at 11:50AM to follow up on the patient, dad answered and stated that the child no longer has a rash.
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| 2850725 | 1 | F | PA | 07/22/2025 |
PNC21 |
MERCK & CO. INC. |
z05472 |
Crying, Immediate post-injection reaction, Pyrexia
Crying, Immediate post-injection reaction, Pyrexia
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Patient crying immediately after vaccine given and parent then noted that hives developed several mi...
Patient crying immediately after vaccine given and parent then noted that hives developed several minutes after given vaccine. Hives noted to forehead and one to upper back. Provider called to room several minutes later and examined patient. Normal vitals and hives self resolved within 15 minutes without any additional spread or other symptoms.
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| 2850726 | 77 | M | OK | 07/22/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
47n3Y 47n3Y |
Hyperhidrosis, Hypotension, Laboratory test, Musculoskeletal stiffness, Posture ...
Hyperhidrosis, Hypotension, Laboratory test, Musculoskeletal stiffness, Posture abnormal; Scan brain, Syncope, Unresponsive to stimuli
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Pt's wife stated stiffening up with head cocking to the side and ultimately dropping, sweating,...
Pt's wife stated stiffening up with head cocking to the side and ultimately dropping, sweating, low blood pressure and being unresponsive for up to 5 minutes while at the breakfast table the morning following vaccine. Pt was responsive by time ambulance arrived and was coming around. Was taken to Medical Center. They ran tests, including a brain scan, and concluded he had syncope. Pt's wife believed it was a seizure.
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| 2850727 | 32 | M | TX | 07/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KR75K |
Erythema, Feeling hot, Malaise, Pain, Swelling
Erythema, Feeling hot, Malaise, Pain, Swelling
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Severe pain, Swelling, Heat, Redness, General Malaise
Severe pain, Swelling, Heat, Redness, General Malaise
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| 2850728 | 71 | M | KS | 07/22/2025 |
RSV |
PFIZER\WYETH |
LN8482 |
Expired product administered
Expired product administered
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Vaccine was completed by technician, the correct product was taken out of fridge before vaccine was ...
Vaccine was completed by technician, the correct product was taken out of fridge before vaccine was given to the patient. After the vaccine was given, the technician came to the pharmacist and saw that he had mistyped the expiration date in database and had given an expired product. Patient was left a voicemail to call us back. Patient called back and was told he was given an expired vaccine. He was notified that it was recommended that he could talk with his provider about repeating the dose, or the recommendation is to repeat the dose. He said he would contact his provider.
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| 2850729 | 6 | M | CO | 07/22/2025 |
YF |
SANOFI PASTEUR |
uk218aa |
Contraindication to vaccination, Rash erythematous, Throat irritation
Contraindication to vaccination, Rash erythematous, Throat irritation
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I administered the Yellow Fever vaccine to and patient on Friday afternoon 07/18/2025. Patient, 6 ...
I administered the Yellow Fever vaccine to and patient on Friday afternoon 07/18/2025. Patient, 6 years old, had an allergic reaction to the YF vaccine and complained to mom of irritated throat and a redness/rash. Symptoms presented 5 minutes after the injection. Mom gave the patient liquid Benadryl, which she had on hand. Patient felt better after Benadryl was given to him by mom. There wasn't a need for us to implement emergency treatment at the pharmacy. Dad later reviewed to me patient is allergic to eggs , which is a contraindication to the Yellow Fever vaccine. Parents were aware of it and had discussed with a specialist prior to consulting travel health. The specialist had approved patient to get the vaccine despite the egg allergy. However, that when they filled out the live consent form, parents did not list egg as an allergy for patient. I followed up with patient that night and next day . Per dad, patient is fine, no concerns stated.
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| 2850730 | 16 | M | FL | 07/22/2025 |
MNP |
PFIZER\WYETH |
LX5014 |
Arthralgia, Fatigue, Injection site pain
Arthralgia, Fatigue, Injection site pain
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joint pain, fatigue, pain at injection site
joint pain, fatigue, pain at injection site
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| 2850731 | 62 | M | NH | 07/22/2025 |
PNC21 |
MERCK & CO. INC. |
Z004302 |
Fatigue
Fatigue
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Fatigue onset 5 hours after vaccine administration. Fatigue persists, but is improving.
Fatigue onset 5 hours after vaccine administration. Fatigue persists, but is improving.
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| 2850732 | 18 | F | TX | 07/22/2025 |
MNQ |
SANOFI PASTEUR |
U8375AA |
Dizziness, Nausea, Pallor, Syncope, Vomiting
Dizziness, Nausea, Pallor, Syncope, Vomiting
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After administration of the TB test and MenQuadfi (MCV4) vaccine, the patient reported feeling dizzy...
After administration of the TB test and MenQuadfi (MCV4) vaccine, the patient reported feeling dizzy, appeared pale, and experienced a brief syncopal episode lasting approximately 30 seconds while seated in a chair with armrests down. The nurse immediately called for assistance and initiated assessment and supportive care. The patient was provided with juice, which she tolerated well. She reported feeling slightly better. Shortly afterward, the patient experienced nausea and was provided with an emesis bag. One episode of emesis occurred, estimated at approximately 100 mL of fluid. Initial vital signs were as follows: Blood Pressure: 89/50 mmHg Pulse: 68 bpm The patient reported feeling improved. A second set of vital signs was taken: Blood Pressure: 90/57 mmHg Pulse: 70 bpm A snack was offered twice but declined; the patient accepted a bottle of water and continued to drink both juice and water. She reported feeling significantly better. Final set of vital signs prior to discharge: Blood Pressure: 95/60 mmHg Pulse: 71 bpm The nurse accompanied the patient and her partner to their vehicle. A steady gait was observed with no signs of instability upon standing or walking. The patient s partner confirmed he would be driving the patient home. Discharge instructions were provided, including advice to eat a meal as soon as possible and to seek immediate medical attention at the nearest emergency clinic if any further symptoms arise. The patient verbalized understanding.
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| 2850733 | 18 | F | AZ | 07/22/2025 |
HEPA HIBV HPV9 IPV MENB MNQ TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
42DM9, X025091 Y010802 Y1A212M 99G34 U8508AA 9JT4S Y017062 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Hib administered to 18 year old patient. Patient reports she is fine. Patient should return to clini...
Hib administered to 18 year old patient. Patient reports she is fine. Patient should return to clinic for Hep B once she discusses it with mother.
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| 2850734 | 4 | F | TN | 07/22/2025 |
MMR |
MERCK & CO. INC. |
X018902 |
Expired product administered
Expired product administered
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VACCINE WAS GIVEN 7/17/2025, EXPIRATION DATE WAS 7/12/2025 - GIVEN 5 DAYS PAST EXPIRATION DATE.
VACCINE WAS GIVEN 7/17/2025, EXPIRATION DATE WAS 7/12/2025 - GIVEN 5 DAYS PAST EXPIRATION DATE.
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| 2850735 | 0.75 | M | TN | 07/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Expired product administered
Expired product administered
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VACCINE GIVEN 7/11/2025, VACCINE EXPIRED 6/30/2025 - GIVEN 11 DAYS PAST EXPIRATION
VACCINE GIVEN 7/11/2025, VACCINE EXPIRED 6/30/2025 - GIVEN 11 DAYS PAST EXPIRATION
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| 2850736 | 30 | M | DC | 07/22/2025 |
HEPA SMALLMNK TDAP |
MERCK & CO. INC. BAVARIAN NORDIC GLAXOSMITHKLINE BIOLOGICALS |
YO17625 96868 9JT4S |
Incorrect route of product administration, No adverse event; Incorrect route of ...
Incorrect route of product administration, No adverse event; Incorrect route of product administration, No adverse event; Incorrect route of product administration, No adverse event
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Jynneos vaccination was incorrectly administered intramuscularly. Patient has not reported other adv...
Jynneos vaccination was incorrectly administered intramuscularly. Patient has not reported other adversely related effects yet.
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| 2850737 | 73 | M | MS | 07/22/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y019158 23AH3 |
Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling; Arthralgia, ...
Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling; Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
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Patient says that there was pain in both shoulders after vaccination. The right arm was swollen on t...
Patient says that there was pain in both shoulders after vaccination. The right arm was swollen on the following day (7/20/25) all the way down to the wrist and hand. Swelling has continued to today (7/22/25) patient says it is painful. Also says it could be a gout attack.
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| 2850738 | 51 | F | MI | 07/22/2025 |
HEP VARZOS |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
941589 93N4J |
Blood glucose normal, Dizziness; Blood glucose normal, Dizziness
Blood glucose normal, Dizziness; Blood glucose normal, Dizziness
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CLIENT STATES HAD AN EPISODE OF DIZZINESS STARTING BETWEEN 2:00PM-3:00PM ON 7/16/2025 AND WAS OFF AN...
CLIENT STATES HAD AN EPISODE OF DIZZINESS STARTING BETWEEN 2:00PM-3:00PM ON 7/16/2025 AND WAS OFF AND ON UNTIL 10:30PM. REPORTED BLOOD SUGAR OF 102. 7/17/2025 HAD AN EPISODE OF DIZZINESS THAT STARTED BETWEEN 3:00PM-3:15PM AND LASTED FOR 60-90 MINUTES. REPORTED BLOOD SUGAR IN AM 98
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| 2850739 | 15 | F | OR | 07/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Goitre, Menstruation irregular, Ovarian failure
Goitre, Menstruation irregular, Ovarian failure
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Goiter within a year of vaccination, and irregular period within two years and now POI at 17
Goiter within a year of vaccination, and irregular period within two years and now POI at 17
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| 2850740 | 1.67 | M | TX | 07/22/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y019171 Y015101 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Medication Error - MMRV ProQuad (Y019171) administered in combination with Varicella Merck (lot#Y015...
Medication Error - MMRV ProQuad (Y019171) administered in combination with Varicella Merck (lot#Y015101) on the same office visit on 07/07/2025. Medication error was found today 07/22/2025. Patient guardians have NOT contacted immunization office with any adverse reactions/side effects from injections.
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| 2850741 | 0.08 | F | ND | 07/22/2025 |
RV5 |
MERCK & CO. INC. |
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Diarrhoea, Infantile spitting up, Weight decreased
Diarrhoea, Infantile spitting up, Weight decreased
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Diarrhea and spitting up started after vaccination. It continued at least until today, 11 days later...
Diarrhea and spitting up started after vaccination. It continued at least until today, 11 days later, at the time of visit. Weight had also decreased by 50 g over those 11 days. Had at least 5-6 episodes of diarrhea, blow out diapers, for 2-3 days, and now is down to 2-3 per day. Many spit up events every day.
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