| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2804997 | 82 | M | IL | 11/04/2024 |
RSV RSV RSV RSV RSV FLUX RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER PFIZER\WYETH |
52R7B 52R7B 52R7B 52R7B 52R7B |
Abdominal X-ray, Asthenia, Blood alkaline phosphatase, Blood creatine phosphokin...
Abdominal X-ray, Asthenia, Blood alkaline phosphatase, Blood creatine phosphokinase, Blood gases; Blood glucose, Chest X-ray, Computerised tomogram head, Dyschezia, Dysphagia; Electrocardiogram, Endotracheal intubation, Full blood count, Guillain-Barre syndrome, Hypoaesthesia; Hypoxia, Intensive care, International normalised ratio, Magnetic resonance imaging spinal, Metabolic function test; Mobility decreased, Paraesthesia, Prothrombin time, Respiratory failure, Ultrasound Doppler; Death, Guillain-Barre syndrome; Death, Guillain-Barre syndrome
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Inflammatory demyelinating polyradiculoneuropathy (Guillain-Barre Syndrome). 11/2/2024 presentation ...
Inflammatory demyelinating polyradiculoneuropathy (Guillain-Barre Syndrome). 11/2/2024 presentation with weakness to ER, Patient also reported he was having difficulties with swallowing, and difficulties with bowel movement. Patient reported to nursing staff that he had numbness and tingling in his upper extremities. Currently, patient can only wiggle the toes, and has trace movement distally in the right upper extremities, he is able to flex the left upper extremity, but unable to abduct or adduct the left upper extremity. 11/4/2024 update, transferred to ICU with respiratory failure requiring intubation for hypoxemia.
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✓ | ✓ | ||||
| 1810484 | 74 | F | NV | 10/23/2021 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0191 EW0191 EW0191 |
Asthenia, Bedridden, Feeling abnormal, Hypersomnia, Pyrexia; Weight decreased; D...
Asthenia, Bedridden, Feeling abnormal, Hypersomnia, Pyrexia; Weight decreased; Drug ineffective, Post-acute COVID-19 syndrome
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She had a fever of 102 degrees Fahrenheit; She felt like hell.; Has lost a couple pounds; she had no...
She had a fever of 102 degrees Fahrenheit; She felt like hell.; Has lost a couple pounds; she had no energy; would sleep 5-6 hours after trips to the store; Felt very weak; Bedridden four weeks after vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) received from Pfizer-sponsored program. A 74-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiry date: Unknown), via an unspecified route of administration on 06Jun2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. Medical history included breast cancer from Dec1999 and ongoing carcinoma in situ Ductal carcinoma in situ, hysterectomy from an unknown date and unknown if ongoing and had surgery on Dec1999 to Dec1999. Description of complaint: Premarin: Caller said that she took Premarin that caused cancer 21 year back and will they probably take both breasts, she would have both removed. She said she had not had cancer in 21 years, they said they would take one and might need to take the other one if it would develop to cancer. Caller said she did something with the other lady, but she does not know if she did a report about Premarin, she thinks this stuff should be taken off market. Premarin NDC/LOT/EXP: Unknown. Caller said she took Premarin starting in 1985 after an emergency hysterectomy, it was recommended by a doctor because she was going nuts and wanted to kill herself, she never felt like that before she had the hysterectomy. She said she wanted to kill herself, she was rolled up in a ball, and her parents were screaming and having a fit and called the doctor. She said she started taking Premarin and in 3 days she was back to normal. She said she had a 25lb weight gain in a month, and she took Premarin from 1985-1999 without realizing it could cause breast cancer. She said she started getting breast cysts, and a surgeon went in and said something was wrong with her milk duct, it did not look right. She said they called 3 days later and said it came back as carcinoma in situ, but told her she won't have to do anything since her lymph nodes were clear. She said they did a biopsy and took a 2x2 chunk out of her breast, it was big, she was not sure if that was measured in inches or centimeters, she thinks inches, her breast dropped in size to AA, it was a scoop like an ice cream scoop. Premarin dosage unknown. She said she had beautiful thick hair before she took the Premarin. She said she took Tamoxifen for 5 years and did aggressive radiation for a month or two, maybe three months, and then she was off Premarin permanently. She said she was fine off Premarin, she did not take anything, she learned to live with the hot sweats. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from Jun1965 and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: AW0135) via an unspecified route of administration, administered in left arm on 16May2021 for covid-19 immunization. She reported that after her first dose she was ok, her arm was sore for two days then after that it was fine. She says she did no treatment for the soreness she just moved it around and went to. She says she didn't take Aleve. She says after her second dose in June she was bedridden. The patient previously took premarin for hysterectomy and experienced cancer, tamoxifen for chemotherapy and experienced aggressive radiation. On an unspecified date in Jun2021, the patient experienced felt very weak, bedridden four weeks after vaccine, has lost a couple pounds, she had no energy, would sleep 5-6 hours after trips to the store. On 07Jun2021 experienced, she had a fever of 102 degrees Fahrenheit, she felt like hell. The patient did not received any treatment for the events. It was further reported that, caller said that she got her first dose on 16 May 2021, and then her second dose on June 06th at. She said you take them a month or so apart. She provides LOT: AW0135 or AW0185 for her first dose and says that the way it was handwritten the numbers are smoothed together. She provides LOT: EW0191 for her second dose. She felt very weak and was bedridden four weeks after getting the vaccine. Caller said it was more like 9 weeks, she did get out of bed, after two weeks she was able to get up and walk, at around 9 weeks she was able to go to the store, clarified at 3 weeks she was going to store then coming back to bed and would sleep 5-6 hours after trips to the store. She said she still falls asleep if she were to be talking like this on the phone she would have to lay down. She said she talked to a lady who got Moderna who said that she has the same thing happen to her. No further details provided about the lady who took Moderna. She said the first day after she got her second dose she had a fever of 102 degrees Fahrenheit and she felt bad. She said the second day she called her doctor because she still felt bad, her fever was down to 100 degrees Fahrenheit. She said on the third day she was doing better. She says she did not take anything to treat the fever, she did not take Aleve or anything because it would interfere with the shot. Caller said it has gotten a little bit easier, she was finally back on her exercise bike for 40 minutes a day. She says she was and was fat, she has lost a couple pounds, she was not a cripple that was bedridden she had no energy. She says she couldn't go to the gym and couldn't get out of bed after she had the Pfizer shot. She says she can go out for little trips, and if she overexerts herself she goes back to bed for an hour or two. She said she went in a month ago for her annual mammogram, which they told her yesterday they found calcifications and said there were 15 calcifications there, those are microscopic, the radiologist said they were around where had she surgery, which might explain it, and the Clinic had said sometimes you could have calcifications after you are hit in your breast, have surgery, or have aggressive radiation. She said that this may have caused it after 21 years, but what she does not understand was since she has not touched any kind of estrogen. She said her doctor today said wait 6 months to see if it changes and if it did they would take the breast off, and she asked what about the other one, and he said they would recommend that come off too if she could get it in her other breast. She said that the doctor wanted to check it in 6 months and do a second mammogram in six months and an ultrasound and if it has grown they want to take it out, they suggested a total mastectomy. She said that it would be agony to wait 6 months since it won't grow enough to spread and show beyond, it was not an aggressive cancer. Caller said she also had a friend who died after taking Premarin, her cancer came back after she took Premarin again, she was dead in 6 months. She said that that Premarin causes cancer, this also happened to her surgeon's nurse, later clarified to being her surgeon's receptionist and the friend she mentioned that died. She said the receptionist had breast cancer after she took Premarin and then a year later she saw her when she was back to work with her hair grew in and the receptionist said she can not stand the hot flashes, and went back to taking Premarin and was dead within 6 months. Caller says she had her surgery in January 2000, and then her doctor's receptionist was bald then, the receptionist was wearing a headpiece, so she asked her what happened and the receptionist said she was getting chemo treatment. She said she thinks the receptionist had chemo for a year, and then when she came back to see the surgeon the receptionist looked much better, her colour was back and she looked really good. She said the receptionist told her she had gotten symptoms back and they were horrible and she went back on Premarin and it killed her, she heard about her death from her doctor, the month or year she died she does not remember. Caller said that she can not have soy or any estrogen derivative and she has to watch her sugar because cancer grows and feeds on sugar, and she loves sugar. Tamoxifen: Caller says she went on Tamoxifen: NDC/LOT/EXP: Unknown. She says this was a chemo therapy where you take pills. Tamoxifen dosage unknown. Caller says she gained another 25lbs on Tamoxifen, and had some hair loss, and she used something called Nioxin which works and put hair back on her head. Caller said that they had discontinued her Tamoxifen on and off for three weeks because she kept vomiting, and then she took it for 5 years. Caller said that she would like to tell Pfizer to please stop the cruelty with Premarin and testing, somehow in the lab they are not testing, they are giving horrible beatings to the horses and have them tied down to get the urine for hormones, it was made from horse urine. She said she never would have taken Premarin if she had known this, she would rather have had the shakes and stuff you have when you have a sudden hysterectomy. She says that the pictures she saw makes her stomach sick, Pfizer has to work on the cruelty to animals, and take the urine humanely. She says there was a big petition about this going on. She says she also hopes no more women die from this or lose their breasts. When they found the DCIS. Had surgery Dec1999. Now I have calcification and will know if they are cancerous in six months. I have been disfigured from the danger in Dec1999. No admission to hospital due to the event. The patient underwent lab tests and procedures which included biopsy: 2x2 chunk out of her breast her breast dropped in size to AA, mammogram: calcifications (15 calcifications there), weight: 25lb (weight gain in a month Caller says she gained another 25lbs on Tamoxifen) on an unknown date. body temperature: 102 fahrenheit on 07Jun2021, body temperature: 100 fahrenheit on Jun2021. The outcome of the event asthenia was reported as unknown while for the other events was reported as recovering. Follow-Up (08Oct2021): Follow-up attempts are completed. No further information is expected.
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| 2830003 | 65 | F | CA | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Lip blister
Lip blister
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Blister lip; This non-serious case was reported by a consumer via call center representative and des...
Blister lip; This non-serious case was reported by a consumer via call center representative and described the occurrence of lip blister in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety. Concomitant products included fluoxetine hydrochloride (Prozac). On 03-MAR-2025 15:00, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 04-MAR-2025, 1 days after receiving Shingrix, the patient experienced lip blister (Verbatim: Blister lip). The outcome of the lip blister was not resolved. It was unknown if the reporter considered the lip blister to be related to Shingrix. It was unknown if the company considered the lip blister to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 The patient received Shingrix vaccine and 18 hours later she woke up with a blister on her lower lip. The reporter did not know the lot number of the vaccine.
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| 2830004 | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pyrexia
Pyrexia
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fever; This non-serious case was reported by a consumer via interactive digital media and described ...
fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever). The outcome of the fever was not reported. It was unknown if the reporter considered the fever to be related to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had 101 fever after first shot. There was a question that 'is a 101 fever normal after the first shot'. The follow-up could not be possible as no contact details were available.
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| 2830005 | 03/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered, Oral herpes
Expired product administered, Oral herpes
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fever blisters on my lips.; This non-serious case was reported by a consumer via interactive digital...
fever blisters on my lips.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: fever blisters on my lips.). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported that patient received the Hepatitis A vaccine which was expired 2 days ago, which led to expired vaccine used.
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| 2830006 | M | 03/06/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspeceted vaccination failure; My husband had the shot and still got shingles; This serious case wa...
Suspeceted vaccination failure; My husband had the shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My husband had the shot and still got shingles). 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: 28-FEB-2025 This case was reported by a patient's wife via interactive digital media. The patient had the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding 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 vaccine Shingles vaccine.
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| 2830007 | 03/06/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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arm hurts; This non-serious case was reported by a consumer via interactive digital media and descri...
arm hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 in arm (Verbatim: arm hurts). The outcome of the pain in arm was resolved (duration 1 week). It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-FEB-2025 The case was received from the patient via interactive digital media. The patient get the vax. The patient reported that your arm hurts for a week, so what.
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| 2830008 | M | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain
Pain
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hurt like hell for several days; This non-serious case was reported by a consumer via interactive di...
hurt like hell for several days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult male 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 pain (Verbatim: hurt like hell for several days). The outcome of the pain was resolved. The reporter considered the pain to be related to Shingrix. The company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 01-MAR-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via interactive digital media. The Shingrix vaccine hurt like hell for several days, and it required two doses. However, it was worth it.
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| 2830009 | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; receive shingles twice; This serious case was reported by a consumer ...
Suspected vaccination failure; receive shingles twice; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: receive shingles twice). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated he/she received/contracted shingles twice, even with a shingles shot (Shingrix). 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 vaccine Shingrix.
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| 2830010 | M | 03/06/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received twinrix 6 months ago and skipped the 2nd dose; This non-serious case was reported by a phar...
received twinrix 6 months ago and skipped the 2nd 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 elderly male patient who received HAB (Twinrix adult) for prophylaxis. Previously administered products included Twinrix adult (The patient received 1st dose on 05-SEP-2024 with batch number 4DS4N and expiry date 25-SEP-2026). On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: received twinrix 6 months ago and skipped the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-FEB-2025 The pharmacist called and reported a question regarding the Twinrix vaccine. The reporter had a patient who got his 1st dose in September and knew that Twinrix was 0,1 and 6 months. However after 6 months, the patient wanted to have the Second dose and in this case the reporter asked if they should give him 2 more doses or just give 1 dose. The reporter consented to follow up. The pharmacist stated that it was a couple of husband and wife that received twinrix 6 months ago and skipped the 2nd dose. Twinrix Second late dose. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025023093:Same reporter different patient
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| 2830011 | 4 | F | GA | 03/06/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
T343J |
Expired product administered
Expired product administered
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administered an expired dose of Kinrix expired; This non-serious case was reported by a nurse via ca...
administered an expired dose of Kinrix expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis. Previously administered products included Pediarix (1st dose of Pediarix received on 09th February 2022, with batch number 2AJ32 and expiry date 9 February 2022), Pediarix (2nd dose of Pediarix received on 04th August 2023, with batch number 2AJ32 and expiry date 4 August 2023), Pediarix (3rd dose of Pediarix received on 08-SEP-2021 with batch number 7P2Y3 and expiry date 4 August 2023) and Infanrix (1st dose of Infanrix received on 20-APR-2022, with batch number AK443 and expiry date 16th September 2023). On 25-FEB-2025, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Kinrix expired). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-FEB-2025 The licensed Practical Nurse explained that a Medical Assistant administered an expired dose of Kinrix on February 25th 2025, which led to expired vaccine used. Vaccine expired on January 25th 2025. It was the first Kinrix dose for the patient but they received 3 prior Pediarix vaccines on April 5th 2021, July 6th 2021, September 8th 2021 and 1 prior dose of Infanrix on April 20th 2022. Pediarix dose 1 of batch number 2AJ32 received on February 9th 2022, Pediarix dose 2 of batch number 7P2Y3 and expiry date was August 4th 2023, Pediarix dose 3 of batch number 7P2Y3 and expiry date was August 4th 2023. Infanrix dose 1 of batch number AK443 and expiry date was September 16th 2023. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2830012 | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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they never finish the series; This non-serious case was reported by a pharmacist via call center rep...
they never finish the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in the unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they never finish the series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported on 26-Feb-2025 if a patient had not finish the series and they did not had it in the last 3 to 5 years, could we restart the series or just get one more dose. The reporter mentioned that this situation was related to 4 to 5 patients, but they did not had any patients Personal Information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2830013 | NM | 03/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Extra dose administered
Extra dose administered
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two bexsero vaccines were given on the same day; This non-serious case was reported by a pharmacist ...
two bexsero vaccines were given on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced overdose (Verbatim: two bexsero vaccines were given on the same day). The outcome of the overdose 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: 26-FEB-2025 The pharmacist reported that two bexsero vaccines were given on the same day to an 11-year-old patient, which led to overdose.
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| 2830014 | M | MI | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
BP74J |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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received the second dose of Shingrix 12 days after the first dose; This non-serious case was reporte...
received the second dose of Shingrix 12 days after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 26-FEB-2025, the patient received the 2nd dose of Shingrix. On 26-FEB-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received the second dose of Shingrix 12 days after the first dose). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 27-FEB-2025 A pharmacist reported that a patient received the second dose of Shingrix 12 days after the first dose, which led to shortening of vaccine schedule. The reporter asked that the second dose considered was valid.
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| 2830015 | F | GA | 03/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
YA344 |
Injection site nodule, Injection site swelling
Injection site nodule, Injection site swelling
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nodule at the injection site that is still present; patient has a swelling that it has not gone away...
nodule at the injection site that is still present; patient has a swelling that it has not gone away since then; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number YA344, expiry date 31-JAN-2026) for prophylaxis. On 17-MAY-2024, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site nodule (Verbatim: nodule at the injection site that is still present) and swelling (Verbatim: patient has a swelling that it has not gone away since then). The outcome of the injection site nodule and swelling were not resolved. It was unknown if the reporter considered the injection site nodule and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site nodule and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 27-FEB-2025 The medical assistant report that a patient received a dose of Bexsero and had a nodule at the injection site that was still present, patient had a swelling that it had not gone away since she received the dose. The health care professional wanted clinical advice, what they could did.
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| 2830016 | 4 | M | MT | 03/06/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
T343J |
Expired product administered
Expired product administered
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expired dose administration of Kinrix; This non-serious case was reported by a nurse via call center...
expired dose administration of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis. On 27-FEB-2025, the patient received Kinrix. On 27-FEB-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose administration of Kinrix). 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: 28-FEB-2025 The Vaccine Administration Facility is the same as Primary Reporter. The registered nurse reported an expired dose administration of Kinrix which led to expired vaccine used. The Health Care Provider mentioned that they received three expired doses of Kinrix from another clinic and they were doing an investigation. Only reported one expired dose administration.
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| 2830017 | M | GA | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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has not yet received the 2nd one; This non-serious case was reported by a pharmacist via call center...
has not yet received the 2nd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in July 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the 2nd one). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 28-FEB-2025 The pharmacist reported that the patient had not yet received the 2nd one. The vaccine administration facility was the same as primary reporter. The reporter stated follow-up via postal. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
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| 2830018 | 21 | F | WA | 03/06/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9JG23 |
Expired product administered
Expired product administered
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expired vaccine used; This non-serious case was reported by a pharmacist via call center representat...
expired vaccine used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis. On 01-MAR-2025, the patient received the 1st dose of Engerix B. On 01-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired vaccine used). 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: 03-MAR-2025 Reporter had question regarding a vaccine, the hepatitis B vaccine, Engerix-B, they had a patient that received an expired vaccine, it had expired on February Tenth and the vaccine was given on March First. The patient received expired vaccine, which led to expired vaccine used.
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| 2830019 | 64 | F | CT | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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never completed the series; This non-serious case was reported by a nurse via call center representa...
never completed the series; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose on 28-DEC-2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never completed the series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-MAR-2025 Patient received her last Shingrix vaccine in 2020 and she never completed the series. Reporter asked if they can we give that to her now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2830020 | 03/06/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Anxiety, Chills, Hypokinesia, Illness, Pyrexia; Speech disorder, Tremor
Anxiety, Chills, Hypokinesia, Illness, Pyrexia; Speech disorder, Tremor
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could barely move; temors; fever; chills; could barely talk; patient felt like they were dying; The ...
could barely move; temors; fever; chills; could barely talk; patient felt like they were dying; The Vaccine was the sickest I have ever felt in my life.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. This is reported via JnJ mediated social media site The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's past medical history included: covid-19 infection. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. dose number series 1. The batch number was not reported. The company is unable to perform follow-up to request for batch or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced could barely move, temors, fever, chills, could barely talk, patient felt like they were dying, and the vaccine was the sickest i have ever felt in my life..(dose number series 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of could barely move, temors, fever, chills, could barely talk, patient felt like they were dying and the vaccine was the sickest i have ever felt in my life. was not reported. This report was non-serious.
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| 2830021 | 51 | F | 03/06/2025 |
COVID19 COVID19 PNC21 PNC21 |
MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. |
3043836 3043836 Y011819 Y011819 |
Chills, Erythema, Pain in extremity, Pyrexia, Skin abrasion; Vaccination site wa...
Chills, Erythema, Pain in extremity, Pyrexia, Skin abrasion; Vaccination site warmth; Chills, Erythema, Pain in extremity, Pyrexia, Skin abrasion; Vaccination site warmth
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Distal patch with excoriation started day after receiving vaccine; Warmth to site; Chills; Fever; Er...
Distal patch with excoriation started day after receiving vaccine; Warmth to site; Chills; Fever; Erythematic patches on left arm; Left arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever) and ERYTHEMA (Erythematic patches on left arm) in a 51-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043836) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. The patient's past medical history included Palpitations, Pain in hip (Bilateral chronic hip pain), Hiatal hernia and Esophageal spasm (Esophageal spasms). Previously administered products included for Drug use for unknown indication: Celebrex. Past adverse reactions to the above products included Allergy with Celebrex. Concurrent medical conditions included Schizoaffective disorder, Obesity, Tobacco user, Insomnia, GERD, Adrenal adenoma, Dyslipidemia and Allergy to NSAIDs (Celebrex allergy). Concomitant products included Bupropion hydrochloride (Wellbutrin), Hydroxyzine hydrochloride (Atarax), Omeprazole (Prilosec), Ziprasidone hydrochloride (Geodon) and Hyoscyamine sulfate (Anaspaz) for an unknown indication. On 19-Dec-2024, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and first dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Dec-2024, the patient experienced SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain). At the time of the report, SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. It was reported that after the day of vaccination, patient experienced reported events. Lad data was reported as vital signs were recorded. Current illness was reported as unknown. Patient was started on antibiotics on day 4 post vaccination after patient went to clinic again.
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| 2830023 | FL | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature...
SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s). An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Linked Report(s): US-PFIZER INC-PV202500025503 Same article/event and different patient;
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| 2830024 | FL | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature...
SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s). An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Linked Report(s) : US-PFIZER INC-PV202500025503 Same article/event and different patient;
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| 2830025 | 62 | M | AR | 03/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
301308A 301308A |
Anxiety, Blood test, Dyspnoea, Dysuria, Investigation; Visual impairment
Anxiety, Blood test, Dyspnoea, Dysuria, Investigation; Visual impairment
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he went that night because he could not pee; his vision comes and goes; anxiety got 10 times worse; ...
he went that night because he could not pee; his vision comes and goes; anxiety got 10 times worse; out breath suddenly; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Lot number: 301308A) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety", start date: 2005 (ongoing), notes: Anxiety diagnosed about 20 years ago after his father died; "COPD" (unspecified if ongoing), notes: a lot of years ago; "double pneumonia" (unspecified if ongoing), notes: a lot of years ago. Concomitant medication(s) included: CLONAZEPAM taken for anxiety (ongoing). Vaccination history included: pfizer COVID19 vaccine (Lot number: EW0172), administration date: 06Aug2021, for Covid-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxiety got 10 times worse"; DYSURIA (non-serious) with onset 2021, outcome "unknown", described as "he went that night because he could not pee"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "his vision comes and goes"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "out breath suddenly". The events "he went that night because he could not pee", "his vision comes and goes", "anxiety got 10 times worse" and "out breath suddenly" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.
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| 2830026 | M | NJ | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Brain fog, Muscle fatigue, Pain
Brain fog, Muscle fatigue, Pain
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body aches; muscle fatigue; brain fog; The initial case was missing the following minimum criteria: ...
body aches; muscle fatigue; brain fog; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 04Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 56-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, 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: PAIN (non-serious), outcome "unknown", described as "body aches"; MUSCLE FATIGUE (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown". Additional information: The patient reported in 2021 a whole slew of things like 13 or 15 days of adverse effects, that included muscle fatigue, brain fog, and body aches, he did not recall any reference number and since he unfortunately suffered from brain fog and if they ask him what he did 8 minutes ago he did not remember much, less about 4 years ago. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2830027 | F | MI | 03/06/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Dry skin, Dyspnoea, Ear pain, Erythema, Feeling abnormal; Feeling hot, Pain, Pru...
Dry skin, Dyspnoea, Ear pain, Erythema, Feeling abnormal; Feeling hot, Pain, Pruritus, Rash, Rash vesicular
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My body is hot; Not able to breathe; Rashes in my whole body; had itches all over in pain; it became...
My body is hot; Not able to breathe; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Ear was in pain; Toe was really like a dry; looks like I have shingles; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Medical history: Consumer stated, No, I do not have any other medical condition. The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (medically significant), outcome "unknown", described as "My body is hot"; DYSPNOEA (medically significant), outcome "unknown", described as "Not able to breathe"; RASH (medically significant), PAIN (medically significant), outcome "not recovered" and all described as "Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet"; ERYTHEMA (medically significant), PRURITUS (medically significant), outcome "unknown" and all described as "Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet"; EAR PAIN (non-serious), outcome "unknown", described as "Ear was in pain"; DRY SKIN (non-serious), outcome "unknown", described as "Toe was really like a dry"; HERPES ZOSTER (non-serious), outcome "unknown", described as "looks like I have shingles". Therapeutic measures were taken as a result of feeling hot, rash, pruritus, pain, dry skin. Additional information: The consumer stated, "I need to report side effect of the vaccine, the Pfizer vaccine I take the Prevnar 20. The consumer stated, After two hours I did take the Prevnar 20 and got severe like a rashes in my whole body. My body is hot and then I had itches all over in pain. So, I took like I needed to go to the hospital and they gave me some shot for steroids (Suspect captured as Unspecified Steroid shot) or whatever and that didn't mean not a little bit the side effects so I went to sleep after that and then I wake up my body was normal but the yesterday starting like a 07:30 PM. I start eat again and I have bed time it became worse because then it was more redness all over and then attack you know my ear was in pain and then my toe was really like a dry and I start like not able to breathe and I needed to rush to the emergency room. Now they gave me more like a medication they gave me Prednisolone and the guy told me that this should be okay to take and I was 5 until like around 2 PM today and I assume getting worse and worse. I need to go to the emergency room again because neither the shot neither the medication nothing is helping and I can't feel right now, my body is becoming rash in my hands, in my feet and I am in pain and it is not resolving my problem and I don't know at this point what to do? The consumer further stated, This is like, is that attacking me looks like I have shingles and nobody told me that these vaccines shot have sort of side effects because if they will tell me I will not take it and for now on I am not taking any Pfizer vaccine or any vaccine at all because I am done with vaccine because after these side effect I can not deal with it no more. It is very painful and I am comfortable costly you know I am not able to wanted that yesterday today and even to take off of what because I am in pain." 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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| 2830028 | M | WA | 03/06/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Fall; COVID-19, Drug ineffective; COVID-19, Drug ine...
COVID-19, Drug ineffective, Fall; COVID-19, Drug ineffective; COVID-19, Drug ineffective, Fall; COVID-19, Drug ineffective
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fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was s...
fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was so freakin weak. I couldn't even get off the floor; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 76-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 included: "Covid", start date: Aug2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer shots for covid (Dose number unknown (had all the shots and all the boosters)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "COVID"; FALL (hospitalization, medically significant) with onset 2025, outcome "recovered", described as "fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was so freakin weak. I couldn't even get off the floor". The patient was hospitalized for fall (discharge date: 03Mar2025). The event "fell down on the front porch floor because i was so dizzy from being sick/ fell down because i was so freakin weak. i couldn't even get off the floor" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19, fall. Clinical course: the patient came back from (withheld) and got sick, he ended up going to urgent care the next day, they prescribed Paxlovid. "I was dying". They put him in the hospital for a few days, he came home yesterday evening (03Mar2025), he started taking Paxlovid this morning (04Mar2025). He went to get the prescription yesterday, and when he was told how much it was, he was so sick just said he need something, and he was really sick, and when he got home, he got out truck and fell down on the front porch floor because he was so dizzy from being sick, he fell down because he was so freakin weak, couldn't even get off the floor...he was not a small weak guy, and it just knocked the crap out of him, and they had to take him by ambulance to the emergency room, and once they got the IV in him and got him straightened out, he was able to come back to normal. And they gave him a different type of drug, but it's compatible with Paxlovid, and he had a prescription at home, he hadn't opened it. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2830029 | F | OH | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Incorrect dose administered, Pulmonary embolism
Incorrect dose administered, Pulmonary embolism
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pulmonary embolism (PE); she was accidentally given 2 doses; This is a spontaneous report received f...
pulmonary embolism (PE); she was accidentally given 2 doses; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization), 2 months after the suspect product(s) administration, outcome "unknown", described as "pulmonary embolism (PE)"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "she was accidentally given 2 doses". A patient had an adverse event to the BNT162b2 omicron (kp.2) immunization (she was accidentally given 2 doses by the pharmacist and subsequently (2 months later) developed PE/hospitalization. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2830030 | M | FL | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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diagnosed with COVID yesterday; diagnosed with COVID yesterday; This is a spontaneous report receive...
diagnosed with COVID yesterday; diagnosed with COVID yesterday; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Mar2025, outcome "unknown" and all described as "diagnosed with COVID yesterday". The patient stated that he was up to date on his shots and everything. So, he didn't know how this happened. They all went on a road trip, his whole family and they all came down with Covid. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2830031 | F | FL | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Prog...
have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old female 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 included: "can't see" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 6, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 7, single; Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID". The patient had COVID. She was too sick and all by herself. When offered an online enrollment, she stated that "when you get old, you can't see". She can't even spell her name anymore when she's sick. The patient has never been this sick in her life and she had eight COVID shots. Her neighbor had to go to pick up her stuff. She couldn't go as she was too sick.
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| 2830032 | M | TX | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Immunology test
COVID-19, Drug ineffective, Immunology test
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I've got COVID also.; I've got COVID also.; This is a spontaneous report received from a C...
I've got COVID also.; I've got COVID also.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "all kinds of heart problems" (unspecified if ongoing), notes: and this is not doing my constitution a bit of good. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Sep2024 as dose number unknown, single; RSV VACCINE taken for immunisation, in Sep2024 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "not recovered" and all described as "I've got COVID also.". The patient underwent the following laboratory tests and procedures: Immunology test: better immuned. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2830034 | MD | 03/06/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Incomplete course of vaccination; Incomplete course of vaccination
Incomplete course of vaccination; Incomplete course of vaccination
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HCP reported an adult patient missed their 3rd scheduled dose of GARDASIL9. HCP stated the 2nd dose ...
HCP reported an adult patient missed their 3rd scheduled dose of GARDASIL9. HCP stated the 2nd dose was received over a year ago. Specific date of administration was not provided. Patient demographics were not provided. No additional information was; No additional AE; This spontaneous report was received from a Nurse regarding an Adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection. On an unknown date in 2024 (also reported as over a year ago), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection; both doses were administered as prophylaxis (exact dose, route of administration, anatomical site of injection, lot number and expiration date were not reported for any of the mentioned vaccines). On an unknown date, the patient missed their 3rd schedule dose of the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccine (Inappropriate schedule of product administration). No additional adverse event was reported for the patient.
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| 2830035 | F | TX | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I've got COVID also. I just don't have it as severe as my wife has got it.; I've got ...
I've got COVID also. I just don't have it as severe as my wife has got it.; I've got COVID also. I just don't have it as severe as my wife has got it.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had an attack", start date: 23Sep2024 (unspecified if ongoing), notes: in the hospital on23Sep of this year; "passed out", start date: 23Sep2024 (unspecified if ongoing), notes: in the hospital; "wasn't breathing", start date: 23Sep2024 (unspecified if ongoing), notes: in the hospital; "blood pressure was down", start date: 23Sep2024 (unspecified if ongoing), notes: down to 51; "autoimmune disorder" (ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: Sep2024, stop date: Sep2024; RSV VACCINE taken for immunisation, start date: Sep2024, stop date: Sep2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "not recovered" and all described as "I've got COVID also. I just don't have it as severe as my wife has got it.". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2830036 | 83 | F | FL | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Fatigue, Vaccination site erythema, Vaccination site swelling, Vaccination site ...
Fatigue, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
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Patient received a second dose of Prevnar 20, when not indicated. Patient already received Prevnar 2...
Patient received a second dose of Prevnar 20, when not indicated. Patient already received Prevnar 20 in July 2024, but it was not recorded in the immunization state registry. Patient stated experiencing redness, swelling, and warmth at vaccination site. Patient states arm is sore and experienced fatigue the following day.
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| 2830037 | 80 | M | FL | 03/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
HY1813 |
Unevaluable event
Unevaluable event
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Pt received a dose in 12/2023 and then a second dose on 03/05/2025
Pt received a dose in 12/2023 and then a second dose on 03/05/2025
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| 2830053 | 17 | M | CA | 03/06/2025 |
DTAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9kb9g x449y |
Mobility decreased; Mobility decreased
Mobility decreased; Mobility decreased
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Per patient, unable to lift
Per patient, unable to lift
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| 2830055 | 12 | F | OR | 03/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
A3X2K |
Circumstance or information capable of leading to medication error, Scratch
Circumstance or information capable of leading to medication error, Scratch
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12 year old child here for Immunization VIS handed to patient/guardian. Hep A vaccine was administer...
12 year old child here for Immunization VIS handed to patient/guardian. Hep A vaccine was administered, but before MA pulled out needle patient moved and caused the MA to scratch patient with the needle. Mother was there and witnessed, MA asked mother if it was ok to continue administering varicella and she stated that it was ok. Mother stood next to patient and provided comfort for the administration of the varicella vaccine. Patient was advised to stay in clinic 15 minutes after vaccine was administered in case of adverse reaction to vaccine.
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| 2830056 | 12 | M | OR | 03/06/2025 |
HPV9 |
MERCK & CO. INC. |
Y015180 |
Dizziness, Heart rate increased, Pallor, Pruritus, Urticaria
Dizziness, Heart rate increased, Pallor, Pruritus, Urticaria
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hive on lip, pale, feeling faint, increased heart rate, itching
hive on lip, pale, feeling faint, increased heart rate, itching
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| 2830057 | 67 | F | TX | 03/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
7L3ST |
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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PATIENT STATES SHE HAS HAD SEVERE PAIN IN HER ARM SINCE RECEIVING THE SHOT. SHE HAS TROUBLE LIFTING ...
PATIENT STATES SHE HAS HAD SEVERE PAIN IN HER ARM SINCE RECEIVING THE SHOT. SHE HAS TROUBLE LIFTING HER ARM OVER HER HEAD OR REACHING ACROSS HER BODY TO BUCKLE HER SEAT BELT. SHE HAS TRIED EXERCISING IT, AND MASSAGING IT AND THE PAIN WONT GO AWAY
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| 2830058 | 1.33 | M | CA | 03/06/2025 |
DTAP FLU3 HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
9KB9G UT8468LA T5727 X026330 Y013350 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered
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Wrong Vaccines (MMR and Varicella) administered. Treatment was 5mL of Ibuprofen
Wrong Vaccines (MMR and Varicella) administered. Treatment was 5mL of Ibuprofen
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| 2830059 | 66 | F | FL | 03/06/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
lx494 |
Arthralgia
Arthralgia
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pt complaining from shoulder pain
pt complaining from shoulder pain
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| 2830060 | 70 | M | NM | 03/06/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
93KK4 93KK4 93KK4 93KK4 93KK4 UNK UNK UNK UNK UNK |
Decreased appetite, Dehydration, Feeling abnormal, Gait disturbance, Pyrexia; Ac...
Decreased appetite, Dehydration, Feeling abnormal, Gait disturbance, Pyrexia; Acute kidney injury, Asthenia, Balance disorder, Condition aggravated, Death; Delirium, Diabetes mellitus, Diabetes mellitus inadequate control, Hypertransaminasaemia, Lethargy; Loss of personal independence in daily activities, Mental status changes, Organ failure, Pneumonitis, Pyrexia; Rhabdomyolysis, Sepsis, Urinary tract infection; Decreased appetite, Dehydration, Feeling abnormal, Gait disturbance, Pyrexia; Acute kidney injury, Asthenia, Balance disorder, Condition aggravated, Death; Delirium, Diabetes mellitus, Diabetes mellitus inadequate control, Hypertransaminasaemia, Lethargy; Loss of personal independence in daily activities, Mental status changes, Organ failure, Pneumonitis, Pyrexia; Rhabdomyolysis, Sepsis, Urinary tract infection
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Patient woke up on Sunday morning feeling poorly. He was having fever, up to 102, no appetite and ...
Patient woke up on Sunday morning feeling poorly. He was having fever, up to 102, no appetite and was having issues with walking without assistance. He was taken to the ER on Wednesday and he was given fluids due to the dehydration and the lack of appetite.
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| 2830061 | 2 | M | NY | 03/06/2025 |
VARCEL |
MERCK & CO. INC. |
y015558 |
Muscle twitching
Muscle twitching
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Patient having unilateral facial twitching.
Patient having unilateral facial twitching.
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| 2830062 | 28 | F | MI | 03/06/2025 |
RAB RAB |
SANOFI PASTEUR SANOFI PASTEUR |
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Asthenia, Chills, Fatigue, Headache, Nausea; Pyrexia
Asthenia, Chills, Fatigue, Headache, Nausea; Pyrexia
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I started feeling very tired and developed a headache around 7 pm, and around 10 pm I developed the ...
I started feeling very tired and developed a headache around 7 pm, and around 10 pm I developed the chills. Around 4 am I woke up feeling very feverish, nauseous, and weak. Around 7 am I took two Bayer's aspirin and symptoms improved considerably (no more chills or feeling feverish or nauseous). Symptoms disappeared by 1 pm.
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| 2830063 | 0.33 | M | TX | 03/06/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7295AA HE6174 2003177 |
Crying, Hypophagia, Pyrexia; Crying, Hypophagia, Pyrexia; Crying, Hypophagia, Py...
Crying, Hypophagia, Pyrexia; Crying, Hypophagia, Pyrexia; Crying, Hypophagia, Pyrexia
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2 hrs or so after vaccines started with low grade temps, incosolable - crying fits with parents havi...
2 hrs or so after vaccines started with low grade temps, incosolable - crying fits with parents having to hold constantly and then 3+ days of poor eating
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| 2830073 | 13 | M | OR | 03/06/2025 |
HEPA TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
DN273 3RE73 Y015100 |
Fatigue, Seizure, Vomiting; Fatigue, Seizure, Vomiting; Fatigue, Seizure, Vomiti...
Fatigue, Seizure, Vomiting; Fatigue, Seizure, Vomiting; Fatigue, Seizure, Vomiting
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Hep A, Varicella & Tdap on 2/19/25. Brief seizure ? & vomiting & fatigue a few days late...
Hep A, Varicella & Tdap on 2/19/25. Brief seizure ? & vomiting & fatigue a few days later. Placed neurology referral.
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| 2830077 | 75 | F | LA | 03/06/2025 |
FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Chills, Injection site pain, Malaise, Muscular weakness, Pain; X-ray
Chills, Injection site pain, Malaise, Muscular weakness, Pain; X-ray
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Pain in right upper arm, soreness & pain running down arm to elbow. Burning stinging just below ...
Pain in right upper arm, soreness & pain running down arm to elbow. Burning stinging just below the injection muscle aches still hurt. Right arm is weak, when writing it hurts, reaching for items it's painful. Right arm still sore & hurts it make me fell ill. I am experiencing chills & pain. No fever. Took Tylenol. Arm still hurt had x-ray done. No treatments.
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| 2829621 | F | PA | 03/05/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Immediate post-injection reaction, Seizure, Syncope; Seizure, Syncope; Immediate...
Immediate post-injection reaction, Seizure, Syncope; Seizure, Syncope; Immediate post-injection reaction, Seizure, Syncope; Seizure, Syncope
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Syncope; Seizures; This spontaneous report was received from Consumer and refers to her daughter a f...
Syncope; Seizures; This spontaneous report was received from Consumer and refers to her daughter a female patient of unknown age. The patient's medical history, concurrent conditions and Concomitant therapies were not reported. On 26-FEB-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Solution for injection, (lot # and expiration date were not reported) as Prophylaxis. On the same date, short afterward, the patient suffered an episode of syncope followed by two seizures. The reporter said that her daughter was in good health prior to receiving the vaccine. And the timing of the syncope and seizure immediately following the vaccination. At the reporting time, the outcome of Seizures and Syncope was unknown. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) was unknown/not reported/not provided. Upon internal review, the events of Seizures and Syncope were determined to be medically significant.
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| 2829622 | 69 | F | KY | 03/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Immunodeficiency, Red blood cell count decreased, Road traffic accident, White b...
Immunodeficiency, Red blood cell count decreased, Road traffic accident, White blood cell count increased
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Car accident; immunocompromised; This serious case was reported by a nurse via sales rep and describ...
Car accident; immunocompromised; This serious case was reported by a nurse via sales rep and described the occurrence of automobile accident in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-JUN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JUN-2024, less than a day after receiving Shingrix, the patient experienced automobile accident (Verbatim: Car accident) (serious criteria hospitalization and other: Serious as per reporter). On an unknown date, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant). The outcome of the automobile accident was resolved with sequelae and the outcome of the immunocompromised was not reported. The reporter considered the automobile accident and immunocompromised to be related to Shingrix. The company considered the automobile accident and immunocompromised to be unrelated to Shingrix. Additional Information: GSK receipt date: 25-FEB-2025 The patient had car accident. Patient was subsequently hospitalized and was referred to every specialist. It was determined that by doctors that the 2nd dose of Shingrix caused the patient to become immunocompromised. Patient was on Thyroid medicine at the time of reporting for unknown indication.; Sender's Comments: Road traffic accident and Immunodeficiency are unlisted events which are considered unrelated to GSK vaccine Shingrix.
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| 2829623 | 03/05/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Deafness unilateral
Deafness unilateral
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I lost hearing in my right ear from vaccine; This serious case was reported by a consumer via intera...
I lost hearing in my right ear from vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral 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 hearing loss unilateral (Verbatim: I lost hearing in my right ear from vaccine) (serious criteria GSK medically significant). The outcome of the hearing loss unilateral was not reported. It was unknown if the reporter considered the hearing loss unilateral to be related to Shingles vaccine. The company considered the hearing loss unilateral to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 26-FEB-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she lost hearing in his/her right ear from vaccine. Patient never had measles mumps or chickenpox.; Sender's Comments: Deafness unilateral is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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