| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2822485 | 38 | F | DC | 01/23/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8735 EW0172 FJ5682 |
Exposure during pregnancy; Exposure during pregnancy; Exposure during pregnancy
Exposure during pregnancy; Exposure during pregnancy; Exposure during pregnancy
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I received the Pfizer vaccine during pregnancy and am concerned about its potential impact on babies...
I received the Pfizer vaccine during pregnancy and am concerned about its potential impact on babies. I had the vaccine during my third trimester, and my daughter has experienced afebrile seizures (which are not typical in either my or my husband?s family) and delays in speech development. SHE IS BORN
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✓ | |||||
| 2822486 | 69 | F | GA | 01/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient and her wife came in together and asked for an RSV vaccine because their adult daughter has ...
Patient and her wife came in together and asked for an RSV vaccine because their adult daughter has been severely ill with RSV for a month. They are under 75 years old, so I informed them that it was no longer indicated unless they had increased risk. They both said they were diabetic and in their late 60's so wanted to go ahead and get vaccinated. I asked if they had every gotten an RSV shot, both indicated that they had not, and our pharmacy software also did not show they had gotten it as far back as the profile shows. We administered the vaccine to each of them. The next day we were notified by our corporate that they both had already received this vaccine 10/5/23. I informed the patients. They did not realize they had ever received it. They were not upset, and they were not experiencing any adverse reaction. They are doing well but know to follow up if anything changes.
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| 2822487 | 11 | F | IN | 01/23/2025 |
HEPA MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
423NL X026597 |
Extra dose administered, Inappropriate schedule of product administration; Extra...
Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration
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Patient given 2nd dose Hep A on 1/22/2025 - first dose was 10/16/2024 - Given too early based on imm...
Patient given 2nd dose Hep A on 1/22/2025 - first dose was 10/16/2024 - Given too early based on immunization schedule. Patient given MMRV on 1/22/2025 - last two doses given 6/13/2015 and 10/16/2024 - MMR was not needed, patient should have only received Varicella
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| 2822488 | 69 | F | NC | 01/23/2025 |
RSV |
PFIZER\WYETH |
ln5496 |
Fatigue, Limb discomfort, Pain, Pain in extremity, Paraesthesia
Fatigue, Limb discomfort, Pain, Pain in extremity, Paraesthesia
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Patient is trying to get appointment with neurologist for next week. She states the next day after ...
Patient is trying to get appointment with neurologist for next week. She states the next day after the shot her muscles in right arm felt heavy when trying to lift. Some tingling in the fingers when holding things and pain from pinky finger all the way up the arm. The symptoms are worse when lifting something and then dull throughout the day with little pain but it is annoying. States it also feels like she has a knot in her arm but it is on the underside/backside of arm, not where the shot was given. It also feels like she has a knot in the back of her shoulder. States she also had ghost pain in the same spot in her other arm that lasted for a few days but then went away. Patient stated she had a similar issue years ago so she is not sure if this is from the shot or not or if the shot irritated the nerve pain. She had to do physical therapy years ago due to nerve pain/damage in her arm from leaning on it and long commutes. Patient also stated she has chronic nerve pain she is being treated for. After the shot she went shopping and used her right arm where the shot was given to lift a bag of oranges and that may have been the start of it. Patient also had fatigue for about 5 days after that vaccine.
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| 2822489 | 52 | F | VT | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Periarthritis
Periarthritis
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Adhesive capsulitis
Adhesive capsulitis
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| 2822490 | 62 | F | VA | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N547S |
Pain in extremity
Pain in extremity
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pain in the right arm
pain in the right arm
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| 2822491 | 1.5 | F | MA | 01/23/2025 |
DTAPIPVHIB HEP PNC20 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
UK109AA 4D333 LC5483 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Patient was given a dose of Hep B, Pentacel and PCV20 erroneously. She was given the same vaccines a...
Patient was given a dose of Hep B, Pentacel and PCV20 erroneously. She was given the same vaccines at 15 months - due to a change in the well child visit schedule this was an oversight
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| 2822492 | 1.17 | M | PA | 01/23/2025 |
DTAP |
SANOFI PASTEUR |
2CA77C1 |
Rash, Urticaria
Rash, Urticaria
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Mom reported to this writer. Onset of generalized rash ~90 min after immunization. Hives starting on...
Mom reported to this writer. Onset of generalized rash ~90 min after immunization. Hives starting on trunk w/ spread to ears, chest, face. Gave OTC
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| 2822493 | 3 | F | PA | 01/23/2025 |
DTAP |
SANOFI PASTEUR |
2CA77C1 |
Peripheral swelling
Peripheral swelling
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Mom reports >24 hr after vaccination, child's arm swollen.
Mom reports >24 hr after vaccination, child's arm swollen.
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| 2822494 | 28 | M | NC | 01/23/2025 |
ANTH ANTH FLU3 FLU3 MNQ MNQ YF YF |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS SEQIRUS, INC. SEQIRUS, INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR SANOFI PASTEUR |
300211A 300211A AW1617A AW1617A AMVB056A AMVB056A UK118AA UK118AA |
Dizziness, Hypoaesthesia, Hypoaesthesia oral, Mouth swelling, Paraesthesia; Para...
Dizziness, Hypoaesthesia, Hypoaesthesia oral, Mouth swelling, Paraesthesia; Paraesthesia oral, Pharyngeal swelling, Vision blurred; Dizziness, Hypoaesthesia, Hypoaesthesia oral, Mouth swelling, Paraesthesia; Paraesthesia oral, Pharyngeal swelling, Vision blurred; Dizziness, Hypoaesthesia, Hypoaesthesia oral, Mouth swelling, Paraesthesia; Paraesthesia oral, Pharyngeal swelling, Vision blurred; Dizziness, Hypoaesthesia, Hypoaesthesia oral, Mouth swelling, Paraesthesia; Paraesthesia oral, Pharyngeal swelling, Vision blurred
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Approximately 15 minutes after receipt of these vaccines patient experienced dizziness and blurred v...
Approximately 15 minutes after receipt of these vaccines patient experienced dizziness and blurred vision. Approximately 1 hour after receipt patient experienced numbness/tingling to face and mouth and felt as if his mouth and throat were swelling. Symptoms improved following receipt of Benadryl 50mg IV x 1 and EpiPen 0.3mg IM x 1.
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| 2822495 | 1.25 | M | OH | 01/23/2025 |
DTAPIPVHIB VARCEL |
SANOFI PASTEUR MERCK & CO. INC. |
UK167AA Y013350 |
Pyrexia, Vomiting; Pyrexia, Vomiting
Pyrexia, Vomiting; Pyrexia, Vomiting
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fever tmax 104F temporal at home and vomiting
fever tmax 104F temporal at home and vomiting
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| 2822496 | 13 | M | KY | 01/23/2025 |
DTAPIPV HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
3RT93 Y005835 08370AA U8232AA |
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
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N/A
N/A
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| 2822497 | 75 | F | FL | 01/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Feeling abnormal, Hypersomnia, Malaise, Somnolence
Feeling abnormal, Hypersomnia, Malaise, Somnolence
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pt says after about 2 hours after getting the RSV vaccine she became very sleepy. She had malaise an...
pt says after about 2 hours after getting the RSV vaccine she became very sleepy. She had malaise and felt very ill with no upper respiratory issues. She took tylenol extended release and went to bed. She has slept alot and her symptoms are better but she has still not totally recovered. She has never felt so bad after getting vaccinated before.
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| 2822498 | 0.67 | M | VT | 01/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
DN273 |
Wrong product administered
Wrong product administered
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Patient was due for Hep B but was given Hep A
Patient was due for Hep B but was given Hep A
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| 2822499 | 1.25 | M | ID | 01/23/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
B532G |
Unevaluable event
Unevaluable event
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None
None
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| 2822500 | 75 | M | MN | 01/23/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
333SK CZ979 |
Asthenia, Chills, Hyperhidrosis, Vomiting projectile; Asthenia, Chills, Hyperhid...
Asthenia, Chills, Hyperhidrosis, Vomiting projectile; Asthenia, Chills, Hyperhidrosis, Vomiting projectile
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Patient reported severe chills, severe diaphoresis, projectile vomiting, the evening of the vaccinat...
Patient reported severe chills, severe diaphoresis, projectile vomiting, the evening of the vaccination day followed by extreme weakness lasting for 3 days. Patient did not notify us of these side effects until today (1/23/25) which was over 2 months past the date of vaccination.
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| 2822501 | 54 | F | OH | 01/23/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Injected limb mobility decreased, Injection site bruising, Injection site erythe...
Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule; Injection site swelling, Injection site warmth, Pain in extremity
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My left upper arm swelled up terribly, bruised, and developed a very hard egg-size knot beside the i...
My left upper arm swelled up terribly, bruised, and developed a very hard egg-size knot beside the injection site. Over the egg-size knot area, my skin was red & hot to touch. The circumference of the swelling initially was the size of a small grapefruit. I experienced & continue to experience severe pain and limited range of motion in my left arm. I keep icing the area and keeping an eye on the injury. I have never had a reaction like this before. It wasn't due to my Pharmacy immunizing tech, he did a wonderful job.
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| 2822502 | 54 | M | ND | 01/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4H79Y 4H79Y |
Chest pain, Heart rate increased, Hypoaesthesia oral, Pain in extremity, Paraest...
Chest pain, Heart rate increased, Hypoaesthesia oral, Pain in extremity, Paraesthesia; Rash
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HAD A SORE ARM FOR THE FIRST 3 DAYS. ON DAY 3 HE NOTICED A RASH ON HIS TORSO, WITH TINGLY HANDS AND ...
HAD A SORE ARM FOR THE FIRST 3 DAYS. ON DAY 3 HE NOTICED A RASH ON HIS TORSO, WITH TINGLY HANDS AND A NUMB UPPER LIP. THE PATIENT ALSO HAD MILD CHEST PAIN AND AN INCREASED HEART RATE. TODAY IS DAY 6 AND HE SAYS THAT HE STILL HAS THE SYMPTOMS BUT THEY ARE MILDER THAN WHAT THEY WERE BEFORE.
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| 2822503 | 61 | F | TX | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
334T3 |
Injection site bruising
Injection site bruising
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Injection Reaction. Started the same day. Large Bruise. As of 01/20/2025, bruise has not cleared.
Injection Reaction. Started the same day. Large Bruise. As of 01/20/2025, bruise has not cleared.
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| 2822504 | 48 | F | TX | 01/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8432AA |
Cough, Dry mouth, Hyperhidrosis, Respiratory tract congestion
Cough, Dry mouth, Hyperhidrosis, Respiratory tract congestion
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Sweating, dry mouth within 1 hour of receiving vaccine. Patient went into hospital. Had chest conges...
Sweating, dry mouth within 1 hour of receiving vaccine. Patient went into hospital. Had chest congestion and required antibiotics. Had cough.
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✓ | |||||
| 2822505 | 62 | F | MO | 01/23/2025 |
PNC20 PNC20 PNC20 PNC20 PNC20 VARZOS VARZOS VARZOS VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LC1281 LC1281 LC1281 LC1281 LC1281 94SE2 94SE2 94SE2 94SE2 94SE2 |
Arthralgia, Asthenia, Back pain, Chest pain, Ear pain; Facial pain, Inflammation...
Arthralgia, Asthenia, Back pain, Chest pain, Ear pain; Facial pain, Inflammation, Magnetic resonance imaging abnormal, Muscle strain, Muscular weakness; Musculoskeletal pain, Myalgia, Neck pain, Nerve conduction studies abnormal, Neuralgia; Neuralgic amyotrophy, Osteoarthritis, Pain in extremity, Rash, Rash vesicular; Sleep disorder; Arthralgia, Asthenia, Back pain, Chest pain, Ear pain; Facial pain, Inflammation, Magnetic resonance imaging abnormal, Muscle strain, Muscular weakness; Musculoskeletal pain, Myalgia, Neck pain, Nerve conduction studies abnormal, Neuralgia; Neuralgic amyotrophy, Osteoarthritis, Pain in extremity, Rash, Rash vesicular; Sleep disorder
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December 10th: I began having left sided neck pain which progressed into left shoulder, chest and b...
December 10th: I began having left sided neck pain which progressed into left shoulder, chest and back pain over the next few days to the point I couldn?t sleep. December 14th: I called MD Live and completed a virtual visit for the left shoulder, arm, pectoral, and scapula pain. At that time I had full range of motion and no loss of strength in the left arm. I received and started a medrol dose pack that afternoon. I was taking Tylenol round the clock for pain with little relief and was also using Voltaren cream on the affected shoulder. The pain was excruciating and constant..December 16th: in the evening I began applying the Voltaren cream to my shoulder and felt what appeared to be a rash which covered my left shoulder, ran across the top of the left side of my back and down past my antecubital area on my left arm. I also began to lose muscle strength in my left arm and the pain extended into the left side of my face and external left ear. December 17th: I came to the office and saw Dr who confirmed the muscle weakness in the left arm and indicated the rash looked liked shingles. She sent me to the ER for further evaluation and MRI. The MRI confirmed Parsonage Turner syndrome. I was started on Acyclovir for the shingles, pain and sleeping meds. The rash subsided over the course of the next 2 weeks but the pain and weakness persisted. January 8: I saw the Neurologist and had a nerve conduction test performed which confirmed the upper brachial plexus was ?75%? gone but also indicated the nerves were already beginning to regenerate. She prescribed Amyltriptiline for the nerve pain and physical therapy. She recommended I return in 6 weeks. January 14: I began having some relief from the nerve pain January 20: Most of the pain has subsided, continue to have weakness but feel like I?m regaining some strength in the left arm.
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| 2822506 | 69 | F | GA | 01/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient and her wife came in together and asked for an RSV vaccine because their adult daughter has ...
Patient and her wife came in together and asked for an RSV vaccine because their adult daughter has been severely ill with RSV for a month. They are under 75 years old, so I informed them that it was no longer indicated unless they had increased risk. They both said they were diabetic and in their late 60's so wanted to go ahead and get vaccinated. I asked if they had ever gotten an RSV shot, both indicated that they had not, and our pharmacy software also did not show that they had gotten it as far back as our profiles show. We administered the vaccine to each of them. The next day, we were informed by our corporate that they both had already received this vaccine on 10/7/23. I informed the patients. They did not realize they had ever received it. They were not upset, and they were not experiencing any adverse reactions. They are doing well but know to follow up if anything changes.
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| 2822507 | 47 | F | AK | 01/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
Hypoaesthesia, Pain in extremity, Product administered at inappropriate site
Hypoaesthesia, Pain in extremity, Product administered at inappropriate site
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Patient expressed concern after the immunization that it was provided too high (provided by a techni...
Patient expressed concern after the immunization that it was provided too high (provided by a technician under RPH guidance). On 1/22/25 patient reported to us that she had significant arm pain beginning the next day along with numbness from the shoulder to the fingers.
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| 2822563 | 0.33 | U | CT | 01/23/2025 |
RV5 |
MERCK & CO. INC. |
2032353 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No additional AE; an infant received their first dose of ROTATEQ at 19 weeks of age instead of the r...
No additional AE; an infant received their first dose of ROTATEQ at 19 weeks of age instead of the recommended 6-12 weeks; This spontaneous report was received from a nurse and refers to a 19-week-old (also reported as 5-month-old) patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-DEC-2024, at 19 weeks of age instead of the recommended 6-12 weeks as outlined in the prescribing information, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml / series, administered orally for prophylaxis (lot #2032353, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 21-OCT-2025; strength was not provided) (Inappropriate schedule of product administration). No symptomatic events were reported. No additional information was provided. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
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| 2822564 | 26 | F | IN | 01/23/2025 |
HPV4 HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Anxiety, Arthralgia, Arthritis, Autoimmune disorder, Autonomic neuropathy; Brain...
Anxiety, Arthralgia, Arthritis, Autoimmune disorder, Autonomic neuropathy; Brain fog, Condition aggravated, Depression, Dyspnoea, Fatigue; Fibromyalgia, Headache, Hypersomnia, Impaired driving ability, Impaired work ability; Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal stiffness, Neck pain, Somnolence
More
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Autonomic injuries; autoimmune injury/Gardasil-induced autoimmune disorder; fibromyalgia/fatigue, jo...
Autonomic injuries; autoimmune injury/Gardasil-induced autoimmune disorder; fibromyalgia/fatigue, joint pain, neck stiffness, neck pain, brain fog, shortness of breath, headaches; exacerbation of pre-existing anxiety; exacerbation of pre-existing depression; idiopathic hypersomnia/neurological injuries; falling asleep while driving, falling asleep while talking; excessive daytime sleepiness; joint inflammation/decreased range of motion; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt). Prior to receiving quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was able to work longer hours, go to school, and stay engaged in family and social relationships. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 09-SEP-2019, at the age of 26 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On 25-OCT-2019, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On unspecified dates, after receiving the first and second vaccinations, the pt began experiencing fatigue, falling asleep while driving, falling asleep while talking, excessive daytime sleepiness, and exacerbation of pre-existing anxiety. On 12-JUN-2020, the pt received her third dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On unspecified dates, after receiving the third vaccination, the pt's symptoms worsened and she began experiencing joint pain, joint inflammation, neck stiffness, neck pain, decreased range of motion, brain fog, shortness of breath, exacerbation of pre-existing depression and headaches, and exacerbation of fatigue, falling asleep while driving, falling asleep while talking, and excessive daytime sleepiness. As a result of her post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. Her fatigue and sleep issues overwhelm her life. She falls asleep at work and even while driving. Her joint pain makes it difficult to complete daily personal and professional responsibilities. On unknown dates, based upon her chronic and severe post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, idiopathic hypersomnia and fibromyalgia. The pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop and exacerbate serious and debilitating autoimmune, autonomic, and neurological injuries and resulting sequelae, including but not limited to idiopathic hypersomnia and fibromyalgia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The pt has suffered at the time of report and continued to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. She also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt had suffered and at the time of report continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events of autonomic neuropathy, autoimmune disorder, idiopathic hypersomnia, fibromyalgia, exacerbation of anxiety, arthritis and depression aggravated was considered to be not recovered. The lawyer considered the events of autonomic neuropathy, autoimmune disorder, idiopathic hypersomnia, fibromyalgia, exacerbation of anxiety, arthritis and depression aggravated to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Upon internal review, the events of autonomic neuropathy and autoimmune disorder was determined to be medically significant. The events of autonomic neuropathy, autoimmune disorder, idiopathic hypersomnia, fibromyalgia, exacerbation of anxiety, arthritis and depression aggravated was considered to be disabling.
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✓ | |||||
| 2822565 | M | 01/23/2025 |
COVID19 COVID19 FLU4 FLU4 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK |
Infection, Loss of personal independence in daily activities, Pain, Rash, Rash v...
Infection, Loss of personal independence in daily activities, Pain, Rash, Rash vesicular; Skin ulcer, Wound; Infection, Loss of personal independence in daily activities, Pain, Rash, Rash vesicular; Skin ulcer, Wound
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very painful; sores; prone to infection; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; Rash ves...
very painful; sores; prone to infection; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; Rash vesicular/Blistery rash; rash; WOUND; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of loss of personal independence in daily activities in a 33-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) for prophylaxis. Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for prophylaxis. The patient's past medical history included generalized anxiety disorder, post-traumatic stress disorder, post-acute covid-19 syndrome and major depressive disorder. Concurrent medical conditions included drug allergy (allergy to cehlore, gabapentin, propanalol). Concomitant products included bupropion, lamotrigine (Lamictal), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall) and formoterol fumarate, mometasone furoate (Dulera). On 22-OCT-2024, the patient received the 1st dose of FluLaval Quadrivalent 2024-2025 season (intramuscular) and the 1st dose of Novavax COVID-19 Vaccine (intramuscular). On 02-NOV-2024, 11 days after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced loss of personal independence in daily activities (Verbatim: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES), vesicular rash (Verbatim: Rash vesicular/Blistery rash), rash (Verbatim: rash) and wound (Verbatim: WOUND). On an unknown date, the patient experienced pain (Verbatim: very painful), skin ulcer (Verbatim: sores) and infection (Verbatim: prone to infection). The outcome of the loss of personal independence in daily activities, vesicular rash, rash and wound were not resolved and the outcome of the pain, skin ulcer and infection were not reported. It was unknown if the reporter considered the loss of personal independence in daily activities, vesicular rash, rash, wound, pain, skin ulcer and infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. It was unknown if the company considered the loss of personal independence in daily activities, vesicular rash, rash, wound, pain, skin ulcer and infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra 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: 26-DEC-2024 The patient experienced loss of personal independence in daily activities, rash, rash vesicular and wound after receiving Flulaval and Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 12 Day. Experienced blistering rash that spread throughout right armpit and left open sores on torso, in armpit and up the inside of right bicept. The sores were very painful, prone to infection and significantly adversely impacted ability to function normally. The causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and events loss of personal independence in daily activities, rash, rash vesicular and wound was considered possible.
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| 2822566 | U | NC | 01/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
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dose of expired Engerix-B was administered to the pateint; This non-serious case was reported by a o...
dose of expired Engerix-B was administered to the pateint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (expiry date 01-AUG-2024) for prophylaxis. On 26-DEC-2024, the patient received Engerix B. On 26-DEC-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: dose of expired Engerix-B was administered to the pateint). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 30-DEC-2024 The manager of an urgent care reported that a dose of Engerix-B was expired, and a medical assistant administered it to a patient which led to, expired vaccine used.
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| 2822567 | U | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Had a shingrix 2019 and last in 2024.; This non-serious case was reported by a consumer via interact...
Had a shingrix 2019 and last in 2024.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Had a shingrix 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Had a shingrix 2019 and last in 2024.). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter had a Shingrix 2019 and last in 2024. The reporter asked does he/she still need a third shot. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
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| 2822568 | U | MA | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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Only dministered the shingrix vaccine as solution with no powder; Only dministered the shingrix vacc...
Only dministered the shingrix vaccine as solution with no powder; Only dministered the shingrix vaccine as solution with no powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only dministered the shingrix vaccine as solution with no powder) and inappropriate dose of vaccine administered (Verbatim: Only dministered the shingrix vaccine as solution with no powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The reporter had visited with the patient and went to administer the Shingrix but only administered the solution with no powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter said that it was a general question as however when asking if a patient was administered and she was defensive when asking for safety data. No further data was collected.
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| 2822569 | F | CA | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received the first dose of Shingrix 2 years ago/ Can she get the second dose now; This non-serious c...
received the first dose of Shingrix 2 years ago/ Can she get the second dose now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 2 years ago on an unknown date). On an unknown date, the did not patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix 2 years ago/ Can she get the second dose now). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The pharmacist called to ask if a patient could get the second dose of Shingrix, if the first dose was 2 years ago. The reporter wanted to know did patient needs to repeat the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
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| 2822570 | 59 | F | FL | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Dizziness, Injection site swelling, Pain in extremity, Peripheral swelling, Vert...
Dizziness, Injection site swelling, Pain in extremity, Peripheral swelling, Vertigo
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Bump where the injection was given; Swollen arm; Very painful arm, arm is a little sore; Spinning; D...
Bump where the injection was given; Swollen arm; Very painful arm, arm is a little sore; Spinning; Dizziness/when she would lie down and close her eyes, the dizziness did not stop; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received Zostavax on an unknown date ). Concurrent medical conditions included herpes zoster. On 21-DEC-2024, the patient received the 1st dose of Shingrix (right arm). In DEC-2024, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Bump where the injection was given), swelling arm (Verbatim: Swollen arm), pain in arm (Verbatim: Very painful arm, arm is a little sore), spinning sensation (Verbatim: Spinning) and dizziness (Verbatim: Dizziness/when she would lie down and close her eyes, the dizziness did not stop). The outcome of the injection site swelling, swelling arm and pain in arm were not resolved and the outcome of the spinning sensation and dizziness were resolved. It was unknown if the reporter considered the injection site swelling, swelling arm, pain in arm, spinning sensation and dizziness to be related to Shingrix. It was unknown if the company considered the injection site swelling, swelling arm, pain in arm, spinning sensation and dizziness to be related to Shingrix. Additional Information: GSK receipt date: 30-DEC-2024 The patient received the first dose of Shingrix and experienced a very painful arm, swollen arm, and a bump where the injection was given. On this day, the patient stated the arm was a little sore, a little swollen, and a little bump where the injection was given. About 3 to 4 days after the vaccine was given, that patient experienced dizziness, and spinning, night time was worse. Even when she would lie down and close her eyes, the dizziness does not stop and the dizziness had since resolved.
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| 2822571 | 0.5 | M | WV | 01/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Z27PB |
Incorrect dose administered
Incorrect dose administered
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6 month old patient received an adult dose of Havrix; 6 month old patient received an adult dose of ...
6 month old patient received an adult dose of Havrix; 6 month old patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HAV (Havrix) (batch number Z27PB, expiry date 27-AUG-2026) for prophylaxis. On 27-DEC-2024, the patient received Havrix. On 27-DEC-2024, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 6 month old patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 6 month old patient received an adult dose of Havrix). The outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-JAN-2025 The nurse reported a 6 month old patient received an adult dose of Havrix which led to adult product administered to child and overdose. The vaccine administration facility was the same as primary reporter.
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| 2822572 | 67 | F | TN | 01/23/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
7gf79 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Menveo 1 vial was administered to a patient over 55years of age; This non-serious case was reported...
Menveo 1 vial was administered to a patient over 55years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 67-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 7gf79, expiry date 31-DEC-2025) for prophylaxis. On 15-NOV-2024, the patient received Menveo. On 15-NOV-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo 1 vial was administered to a patient over 55years of age). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist called reporting Menveo 1 vial was administered to a patient over 55 years of age. The patient received it because she was going to be starting on a complement inhibitor. The pharmacist did not know if patient started treatment with this medication as she was waiting on the vaccines.
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| 2822573 | 74 | M | NY | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Headache, Injection site pain, Pain
Chills, Headache, Injection site pain, Pain
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pin in left arm injection site; shivering; achiness; headache; This non-serious case was reported by...
pin in left arm injection site; shivering; achiness; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 14-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 15-JAN-2025, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pin in left arm injection site), shivering (Verbatim: shivering), pain (Verbatim: achiness) and headache (Verbatim: headache). The outcome of the injection site pain, shivering, pain and headache were not resolved. It was unknown if the reporter considered the injection site pain, shivering, pain and headache to be related to Shingrix. It was unknown if the company considered the injection site pain, shivering, pain and headache to be related to Shingrix. Linked case(s) involving the same patient: US2022174220 Additional Information: GSK Receipt Date: 15-JAN-2025 Patient received his second Shingrix vaccine on 14-JAN-2025 and experienced symptoms 24 hours later of shivering, achiness, headache and left arm painful. These symptoms were not resolved. For tolerance of first dose refer case US2022174220.; Sender's Comments: US-GSK-US2022174220:Same patient
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| 2822574 | F | NY | 01/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Autoimmune disorder, Interstitial lung disease; Autoimmune disorder, Interstitia...
Autoimmune disorder, Interstitial lung disease; Autoimmune disorder, Interstitial lung disease
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autoimmune disease; autoimmune disease with interstitial lung disease; This serious case was reporte...
autoimmune disease; autoimmune disease with interstitial lung disease; This serious case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced autoimmune disorder (Verbatim: autoimmune disease) (serious criteria GSK medically significant) and interstitial lung disease (Verbatim: autoimmune disease with interstitial lung disease) (serious criteria GSK medically significant). The patient was treated with rituximab (Rituxan). The outcome of the autoimmune disorder and interstitial lung disease were unknown. It was unknown if the reporter considered the autoimmune disorder and interstitial lung disease to be related to Shingrix and Shingrix. The company considered the autoimmune disorder and interstitial lung disease to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Pharmacist stated she had a patient that completed Shingrix series in 2020. The patient had an autoimmune disease with interstitial lung disease and was receiving Rituxin infusions. Pharmacist stated she really was not sure if the autoimmune disease was present before Shingrix series was administered, but she thought it was a newer development as the Rituxin was new for the patient. The pharmacist could no longer recall the name of the patient, so she was unable to look in the patient's records to locate the exact date of Shingrix doses. The only patient specific information the pharmacist could provide was that this was a female patient in her 80s. The patient decided to not receive any further Shingrix dosing. The pharmacist was inquiring about recommendations on repeating the series in patients receiving Rituxin, as the patient's physician had mentioned finding guidelines that advised repeating. Following an internal meeting on 15-January-2025, it was realized that clarification was needed to determine if the autoimmune condition with interstitial lung disease was pre-existing, or occurred after the Shingrix series, so an outbound call was placed back to the pharmacist on 15- January -2025. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Autoimmune disorder and Interstitial lung disease are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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| 2822575 | U | NY | 01/23/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Cerumen impaction, Deafness neurosensory, Fatigue, Headache, Injection site pain...
Cerumen impaction, Deafness neurosensory, Fatigue, Headache, Injection site pain; Myalgia, Presbyacusis, Pyrexia, Temporomandibular pain and dysfunction syndrome, Vertigo positional
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sensorineural hearing loss; Benign paroxysmal positional vertigo; Cerumen impaction; Temporomandibul...
sensorineural hearing loss; Benign paroxysmal positional vertigo; Cerumen impaction; Temporomandibular joint DISORDER; Presbycusis; INJECTION SITE PAIN; FEVER; FATIGUE; MYALGIA; HEADACHE; This solicited report received from a physician by COV19VAC-NONCOMP: Jansen COVID 19 Non Company Solicited Study. This report was referenced in literature: and concerned a patient of unspecified age and sex (subject number and site number were not reported). The patients height and weight were not reported. Age at time of vaccination was unknown. Aim- Anecdotal reports of sudden sensorineural hearing loss (SSNHL) following COVID-19 vaccination have emerged in the otolaryngology community. Studies have demonstrated no association between COVID-19 vaccination and SSNHL. We aim to characterize the spectrum of otologic symptoms following COVID-19 vaccination. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patients received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. Methods- Patients presenting to the otology clinic at a tertiary care, urban medical center between May and July 2021 were screened with a short questionnaire for development of otologic symptoms following COVID-19 vaccination. Patients were inquired about previous COVID-19 infection, method and date of diagnosis if previously infected, COVID- 19 vaccination status, and vaccine brand and dates if vaccinated. Screened symptoms included hearing loss, tinnitus, ear drainage, dizziness, vertigo, imbalance, facial nerve palsy, smell change, and taste change; patients were specifically asked if such symptoms appeared during active COVID-19 infection or within 4 weeks of any dose of COVID-19 vaccination. Additionally, demographic data, including age and gender, were obtained. All above uses of patient data were approved by the Regulatory Authority. For patients reporting any otologic symptoms, a retrospective chart review was performed to collect audiometric data and final diagnoses. Audiometric data from the initial presentation were gathered and notes written by the primary otologist were reviewed for relevant medical history, diagnoses, and treatments. Pearson's chi-square test was used to evaluate for significant differences in vaccination proportions. On an unspecified date, the patients experienced sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia, and headache. Dose series 1. Results- Between May and July 2021, 500 patients were screened. Median age was 56.6 years old, with 59.4 % female and 40.2 % male. 420 patients (84.0 %) were vaccinated, with 58.4 % receiving Pfizer, 29.1 % receiving Moderna, and 3.8 % receiving Johnson & Johnson. 61 patients (14.5 %) reported one or more otologic symptoms within 4 weeks of vaccination, including 21 (5.0 %) with hearing loss, 26 (6.2 %) with tinnitus, 33 (7.9 %) with dizziness, and 19 (4.5 %) with vertigo. Of the 16 patients (3.2 %) reporting tinnitus with no associated hearing loss, 8 were diagnosed with subjective tinnitus and 4 were diagnosed with temporomandibular joint syndrome. Of the 18 patients reporting hearing loss, 11 had exacerbations of underlying pathologies (e.g. Meniere's disease, presbycusis) and 7 were newly diagnosed with SSNHL (1.4 %). The action taken with janssen covid-19 vaccine was not applicable. The outcome of sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia and headache was not reported. The reporter considered the causality between janssen covid-19 vaccine and sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia, and headache as not reported. Company causality between janssen covid-19 vaccine and Vertigo positional, Cerumen impaction, Temporomandibular pain and dysfunction syndrome, Presbyacusis, sensorineural hearing loss, injection site pain, fever, fatigue, myalgia, and headache was not related. Conclusion- Patients reporting otologic symptoms following COVID-19 vaccination received various diagnoses of uncertain etiology. The incidence of SSNHL in these patients is comparable to the general otology patient population. Additional studies are required to determine the incidence of specific diagnoses following vaccination. This report was serious (other medically important condition).; Sender's Comments: V0-Deafness neurosensory, Vertigo positional, Cerumen impaction, Temporomandibular pain and dysfunction syndromePresbyacusis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
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| 2822576 | F | MA | 01/23/2025 |
COVID19 |
MODERNA |
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Pyrexia
Pyrexia
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fever/ started fever within one hour and could not break it; This spontaneous case was reported by a...
fever/ started fever within one hour and could not break it; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever/ started fever within one hour and could not break it) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/ started fever within one hour and could not break it) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever/ started fever within one hour and could not break it) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had no medical history, concomitant disease or risk factor. Reporter causality was not reported. The patient did not experience any additional symptoms or events. There were no lab data or results available. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2025: Live significant follow-up information received contains reporter's state, event verbatim and event seriousness criteria added as medically significant, and additional references were added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2822577 | F | LA | 01/23/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Syringe issue
Syringe issue
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the glass tip broke so they were not able to draw it from the vial; The initial case was missing the...
the glass tip broke so they were not able to draw it from the vial; The initial case was missing the following minimum criteria: no adverse event (Product complaint only - the vaccine was not administered to the patient). Upon receipt of follow-up information on 10Jan2025, this case now contains all required information to be considered valid (reportability assessment received). This is a spontaneous report received from a Pharmacist from product quality group, Program ID. An 83-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), described as "the glass tip broke so they were not able to draw it from the vial". Additional information: A pharmacist reporter reported that he would like to get a replacement for an Abrysvo vaccine because when trying to administer it, the glass tip broke so they were not able to draw it from the vial and the patient was not able to get vaccinated because this was their only remaining dose. The presentation of this Abrysvo was the little sealed vacuum one with the vial and one cap and one syringe and it was not the pack of five. The reporter discarded the antigen vial, vial adaptor, diluent syringe and has no lots, expiry dates, NDC numbers or manufacturer names to provide from those components to provide; however, the reporter kept the box with the box lot number. The box was not damaged and was not squished. The complaint sample was not available to return. The reporter considered "the glass tip broke so they were not able to draw it from the vial" not related to rsv vaccine prot.subunit pref 2v. Causality for "the glass tip broke so they were not able to draw it from the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
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| 2822579 | 61 | F | OH | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
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Caller mentioned she has had Covid before and taken Paxlovid; Caller mentioned she has had Covid bef...
Caller mentioned she has had Covid before and taken Paxlovid; Caller mentioned she has had Covid before and taken Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 61-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0161) and on 03May2021 as dose 2, single (Lot number: EW0176) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (regular vitamins and hormone replacement therapy). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller mentioned she has had Covid before and taken Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2025) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
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| 2822580 | 65 | M | CA | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident, Chills, Computerised tomogram, Monoplegia, Somnolence
Cerebrovascular accident, Chills, Computerised tomogram, Monoplegia, Somnolence
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chills; falling asleep; tried to get up but had no function in left leg; strokes; This is a spontane...
chills; falling asleep; tried to get up but had no function in left leg; strokes; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 65-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure", start date: 2019 (ongoing). The patient's concomitant medications were not reported. The following information was reported: MONOPLEGIA (medically significant) with onset Jan2021, outcome "unknown", described as "tried to get up but had no function in left leg"; CHILLS (non-serious) with onset 26Jan2021, outcome "unknown"; SOMNOLENCE (non-serious) with onset 26Jan2021, outcome "unknown", described as "falling asleep"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "strokes". The events "tried to get up but had no function in left leg", "chills" and "falling asleep" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Feb2021) Two strokes. Clinical course: The patient was one of the first to get the shot, when they said it was safe to take. The patient had two strokes from the Pfizer COVID shot. It all started on 26Jan2021, the day after taking the first Pfizer COVID shot. The patient was sitting and started having chills and drove home. He was falling asleep and had chills driving home. It was freezing, so he put a blanket around. The patient didn't get up for three days, tried to get up but had no function in left leg. They missed the stokes when the patient went to emergency room, they were looking for Guillain-Barre, so they didn't catch a stroke. Patient's doctor sent him to neurologist,who did CT scan on the first week in Feb2021 and found two strokes. The lot number for BNT162b2, was not provided and will be requested during follow up.
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| 2822583 | F | IL | 01/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9PG49 |
Expired product administered
Expired product administered
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administering an expired Engerix-B vaccine to a patient; This non-serious case was reported by a oth...
administering an expired Engerix-B vaccine to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-day-old female patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis. On 03-JAN-2025, the patient received Engerix B pediatric. On 03-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: administering an expired Engerix-B vaccine to a patient). The outcome of the expired vaccine used was unknown. 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-JAN-2025 Reporter requested information and reported adverse events after administering an expired Engerix-B vaccine to a patient on 03-JAN-2025 which led to expired vaccine used.
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| 2822585 | F | MN | 01/23/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Arthralgia, Fatigue, Headache, Hypersensitivity, Myalgia; Pain in extremity; Art...
Arthralgia, Fatigue, Headache, Hypersensitivity, Myalgia; Pain in extremity; Arthralgia, Fatigue, Headache, Hypersensitivity, Myalgia; Pain in extremity
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Could be an allergic reaction; Tired; Headache; Muscle pain; Joint pain / Pain in shoulder; she was ...
Could be an allergic reaction; Tired; Headache; Muscle pain; Joint pain / Pain in shoulder; she was having a problem with because that was the one starting aching; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Jan2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Jan2025 as dose number unknown, single), in arm for immunisation. The patient's relevant medical history included: "Diabetes" (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jan2025, outcome "unknown", described as "Could be an allergic reaction"; HEADACHE (non-serious) with onset Jan2025, outcome "unknown"; ARTHRALGIA (non-serious) with onset Jan2025, outcome "unknown", described as "Joint pain / Pain in shoulder"; MYALGIA (non-serious) with onset Jan2025, outcome "unknown", described as "Muscle pain"; FATIGUE (non-serious) with onset Jan2025, outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset Jan2025, outcome "unknown", described as "she was having a problem with because that was the one starting aching". Therapeutic measures were not taken as a result of hypersensitivity, fatigue, headache, myalgia, arthralgia, pain in extremity. Additional information: Reporter stated as, she just wanted to report some side effected that she had with a vaccine that she had with a COVID vaccine. She had a COVID vaccine this past Saturday (18Jan2025) at here in (PRIVACY) and it was not anything major. She mean, the fact that She had to cancel, she had to cancel her house keeper because she was not feeling that good but (Incomplete sentence). She mean, she had some side effects, it was not anything, like she said major and then she had to skip (redacted) and cancel her house keeper because she was not feeling too good but it was she, now it could be an allergic reaction where she had pain and then she tired and she had a headache and muscle pain and 'sores' and maybe some joint pain and she think that, that was about it, you know, that was about it. She mean, she know where she live (PRIVACY). Anyways and she just and she just did not feeling very good but she was feeling little bit better today (20Jan2025) but do you think. She was asking a question, that she could take some aspirin or pain reliever to relieve the pain and in her shoulder. She said, she should take some aspirin or pain, do she think she should take some kind aspirin or some kind of pain reliever like Tylenol whatever to relive the pain that was in her shoulder. Reporter stated, Tylenol, she was think of taking Tylenol. Reporter stated, like she said, she forgot her card on Saturday (18Jan2025). She just went to (PRIVACY) and she thought, now was the good time for her to began her vaccination. She got one. She got flu vaccination on her right arm and a COVID vaccination on her left arm and so, she do not really start to feel bad until yesterday (19Jan2025) around 7 o' clock in the morning when she was taking her shower and then she start, she was going to take a nap and she did not feel all that good. When clarified reporter also took the Flu vaccine on the same day (18Jan2025). Reporter stated, Yes. No, her right arm was just fine. It was just her left arm that she was having a problem with because that was the one starting aching and she needed that, not right then but she thought, maybe it had to do with that COVID vaccination because she knew that it was the COVID vaccination in her left arm because she knew the pharmacist, pharmacist given the flu vaccination in her right arm and given the COVID vaccination in her left arm. Reporter took the flu vaccination on the same day other than COVID vaccine. Reporter stated, she does not. She thinks it was flu vaccination but then she do not really know because she did not bring her card. Reporter also stated as, she took the Pfizer, she thinks she took the Pfizer COVID vaccination on Saturday (18Jan2025) in her right arm, yes. She took it in her right arm at. The patient does not really remember the exact time of vaccination. Reporter stated, well, she thinks it was just one shot. She was diabetic and because she was diabetic, she do take that medication. Reporter stated, no treatment received. No investigations reported.
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| 2822586 | F | ME | 01/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I have Covid; I have Covid; This is a spontaneous report received from a Consumer or other non HCP, ...
I have Covid; I have Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 53-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunisation; Bnt162b2 (DOSE 2), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid". Clinical course: The patient was requesting financial assistance to get PAXLOVID for Covid. She got Covid at work after she got 2 Pfizer shots and a booster. The lot number for BNT162b2 omicron (kp.2), was not provided and will be requested during follow up.
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| 2822587 | 54 | F | MI | 01/23/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
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Nausea, Vomiting; Nausea, Vomiting
Nausea, Vomiting; Nausea, Vomiting
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I have been nauseous and vomiting since the injection
I have been nauseous and vomiting since the injection
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| 2822588 | 0.58 | M | NJ | 01/23/2025 |
FLU3 FLU3 PNC20 PNC20 |
SEQIRUS, INC. SEQIRUS, INC. PFIZER\WYETH PFIZER\WYETH |
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Cough, Gastrooesophageal reflux disease, Pyrexia, Rhinorrhoea, Tremor; Vomiting;...
Cough, Gastrooesophageal reflux disease, Pyrexia, Rhinorrhoea, Tremor; Vomiting; Cough, Gastrooesophageal reflux disease, Pyrexia, Rhinorrhoea, Tremor; Vomiting
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This was for pneumococcal vaccine and flu booster.Vomiting, high fever (102), runny nose, coughing, ...
This was for pneumococcal vaccine and flu booster.Vomiting, high fever (102), runny nose, coughing, reflux and shaking
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| 2822589 | 2.17 | F | TX | 01/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
DN273 |
Abdominal pain, Decreased appetite, Extra dose administered
Abdominal pain, Decreased appetite, Extra dose administered
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New patient to clinic. Record ahowed one Hep A dose given on 11/10/23. Dose given 1/14/25. Upon rece...
New patient to clinic. Record ahowed one Hep A dose given on 11/10/23. Dose given 1/14/25. Upon receipt of vaccine record, patient already had second Hep A on 5/24/24. Discussed case with employee at Health Dept and she emailed literature for mother to review. Patient doing well although she had a decresed appetite and complained that she had occasional abdominal pain for 2-3 days. This report is to document that patient had a third Hep A vaccine.
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| 2822590 | 52 | M | NJ | 01/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Headache, Myalgia, Pain in extremity, Pyrexia, Rhinorrhoea
Headache, Myalgia, Pain in extremity, Pyrexia, Rhinorrhoea
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Pain at arm, pain at muscle at other parts of body, headache, fever, nasal discharge ,taking Tyle...
Pain at arm, pain at muscle at other parts of body, headache, fever, nasal discharge ,taking Tylenol 500mg two times so far, all symptoms still persistent at end of second day.
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| 2822591 | 62 | F | DE | 01/23/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
y013009 y013009 |
Chills, Erythema, Induration, Malaise, Pyrexia; Urticaria
Chills, Erythema, Induration, Malaise, Pyrexia; Urticaria
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pt states she had a fever/chills start at 2 am in the morning after vaccine. arm became red and hard...
pt states she had a fever/chills start at 2 am in the morning after vaccine. arm became red and hard. By Wednesday she developed hives all over her body , all over malaise for about 1 week. pt had virtual appoint with MD on 1/19/25. md dis not want to give pt steroids as to not interfere with immune response
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| 2822592 | 57 | M | MN | 01/23/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Patient was given dose IM, not SQ. No adverse reactions reported as of 4 hours after administration
Patient was given dose IM, not SQ. No adverse reactions reported as of 4 hours after administration
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| 2822593 | 80 | M | GA | 01/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient requested to receive an RSV vaccination. Pharmacist did not realize that patient had alread...
Patient requested to receive an RSV vaccination. Pharmacist did not realize that patient had already received an RSV shot (Arexvy on 11/25/2023). So patient has now received two RSV shots when only one is recommended. Patient has not reported any adverse events from either shot. Reporting because patient received two RSV shots when one is recommended.
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