| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1289131 | 56 | F | MI | 05/05/2021 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 ER2613 |
Angiogram, Angiogram normal, Blood gases normal, Blood magnesium normal, Blood t...
Angiogram, Angiogram normal, Blood gases normal, Blood magnesium normal, Blood thyroid stimulating hormone normal; Calcium ionised normal, Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Full blood count normal; Gait disturbance, Metabolic function test normal, Paraesthesia, Thyroxine free normal, Troponin normal; Urine analysis normal; Balance disorder, Chills, Dizziness, Dysstasia, Ear disorder; Erythema, Eye disorder, Feeling of body temperature change, Hypoacusis, Hypoaesthesia; Influenza, Musculoskeletal stiffness, Nausea, Paraesthesia, Peripheral swelling; Presyncope, Rash, Sensory disturbance, Tinnitus, Vaginal haemorrhage; Vestibular disorder; Erythema, Peripheral swelling, Rash, Rash papular, Ultrasound Doppler normal; Angiogram, Angiogram normal, Blood gases normal, Blood magnesium normal, Blood thyroid stimulating hormone normal; Calcium ionised normal, Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Full blood count normal; Gait disturbance, Metabolic function test normal, Paraesthesia, Thyroxine free normal, Troponin normal; Urine analysis normal; Balance disorder, Chills, Dizziness, Dysstasia, Ear disorder; Erythema, Eye disorder, Feeling of body temperature change, Hypoacusis, Hypoaesthesia; Influenza, Musculoskeletal stiffness, Nausea, Paraesthesia, Peripheral swelling; Presyncope, Rash, Sensory disturbance, Tinnitus, Vaginal haemorrhage; Vestibular disorder; Erythema, Peripheral swelling, Rash, Rash papular, Ultrasound Doppler normal; Angiogram, Angiogram normal, Blood gases normal, Blood magnesium normal, Blood thyroid stimulating hormone normal; Calcium ionised normal, Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Full blood count normal; Gait disturbance, Metabolic function test normal, Paraesthesia, Thyroxine free normal, Troponin normal; Urine analysis normal; Balance disorder, Chills, Dizziness, Dysstasia, Ear disorder; Erythema, Eye disorder, Feeling of body temperature change, Hypoacusis, Hypoaesthesia; Influenza, Musculoskeletal stiffness, Nausea, Paraesthesia, Peripheral swelling; Presyncope, Rash, Sensory disturbance, Tinnitus, Vaginal haemorrhage; Vestibular disorder; Erythema, Peripheral swelling, Rash, Rash papular, Ultrasound Doppler normal; Balance disorder, Biopsy skin, Blood lactic acid, Computerised tomogram, Electromyogram; Hepatic steatosis, Hyperacusis, Joint swelling, Laboratory test, Limb injury; Magnetic resonance imaging, Memory impairment, Nausea, Neuropathy peripheral, Peripheral swelling; Rectal haemorrhage, Skin reaction, Small fibre neuropathy, Tinnitus, Ultrasound scan; Vaginal haemorrhage, Vestibular disorder; COVID-19, Drug ineffective
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3 days post, pt notified clinic of nausea, muscle aches, burning sensation in her arm, and dizziness...
3 days post, pt notified clinic of nausea, muscle aches, burning sensation in her arm, and dizziness. Symptoms improved Received 2nd dose on 4/14-now with dizziness, unsteady gait, tingling in all extremities
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| 2824059 | 25 | F | OR | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1780 |
Arthralgia
Arthralgia
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Patient reports left shoulder pain after receiving Covid-19 vaccine. The pain is constant, but worse...
Patient reports left shoulder pain after receiving Covid-19 vaccine. The pain is constant, but worsens with sleeping on the left side, reaching over head, applying pressure to the area, and weight-bearing.
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| 2824060 | 19 | F | CA | 01/31/2025 |
MNQ |
SANOFI PASTEUR |
|
Unevaluable event
Unevaluable event
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None
None
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| 2824061 | 79 | F | CO | 01/31/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5J959 |
Rash
Rash
|
The patient developed rash on both arms 3 days after receiving the vaccine that started to get bette...
The patient developed rash on both arms 3 days after receiving the vaccine that started to get better a few days later.
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| 2824062 | 45 | F | MI | 01/31/2025 |
FLU3 FLU3 TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Bursitis, Injected limb mobility decreased, Injection site pain, Musculoskeletal...
Bursitis, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Product administered at inappropriate site; Rotator cuff syndrome, X-ray limb; Bursitis, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Product administered at inappropriate site; Rotator cuff syndrome, X-ray limb
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Received vaccines at my workplace clinic. The Tdap vaccine was administered very high on my right a...
Received vaccines at my workplace clinic. The Tdap vaccine was administered very high on my right arm, which I originally didn't think anything of. I experienced the usual 2-3 days of soreness in my upper arm. Then for the next 4 weeks, the pain worsened and also included limited range of motion and stiffness. I have no previous history of shoulder pain, injury, or surgery. I scheduled an appt at Orthopedic Clinic on 1/31/25 where I received x-rays and was diagnosed with subacromial bursitis with impingement syndrome and I received a subacromial cortisone joint injection to manage the pain and inflammation. Too soon to report treatment outcome.
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| 2824063 | 40 | F | MA | 01/31/2025 |
HPV9 |
MERCK & CO. INC. |
Y013712 |
Papule, Rash, Rash pruritic, Skin hyperpigmentation
Papule, Rash, Rash pruritic, Skin hyperpigmentation
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Pt reported onset of pruritic rash over her knees, ankles, and axilla a few days after her second Ga...
Pt reported onset of pruritic rash over her knees, ankles, and axilla a few days after her second Gardasil 9 vaccine. She did not seek care for it until two weeks after the vaccination, at which point she had some hyperpigmented, small papules on her ankles and knees that did not appear to be urticarial or related to Stephens Johnson syndrome.
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| 2824064 | 66 | F | MO | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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My arm was sore for a week or more, however, it continues to ache throughout the day and it has been...
My arm was sore for a week or more, however, it continues to ache throughout the day and it has been 3 months. At times I can't hardly lift it above my head because it hurts. Other times I can lift it with no problem. I can't identify any other reason why my arm aches other than taking the shingles shot. I am supposed to get a second vaccine within 6 months, however, I dread doing it if it will be a repeat of what I have put up with for the past 3 months.
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| 2824149 | 3 | M | MO | 01/31/2025 |
DTAPIPVHIB HEP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UK038AA 4D333 |
Erythema, Pyrexia, Seizure, Swelling, Tremor; Erythema, Pyrexia, Seizure, Swelli...
Erythema, Pyrexia, Seizure, Swelling, Tremor; Erythema, Pyrexia, Seizure, Swelling, Tremor
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mother said on phone Redness, swelling, shaking Seizure for 15-20 seconds Convulsion 1-2 seconds fev...
mother said on phone Redness, swelling, shaking Seizure for 15-20 seconds Convulsion 1-2 seconds fever
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| 2823605 | M | 01/30/2025 |
HPV9 |
MERCK & CO. INC. |
|
Skin papilloma
Skin papilloma
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his dermatologist recommended he get the vaccine because he is experiencing warts in his hands/pharm...
his dermatologist recommended he get the vaccine because he is experiencing warts in his hands/pharmacist refused to administer the vaccine to him because he was over the age of indicated use; No additional AE; This spontaneous report was received from a consumer and refers to a male patient over 50 years of age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Patient report that his dermatologist recommended, he get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection because he was experiencing warts in his hands. He was scheduled to receive the first dose of vaccine on 16-JAN-2025 (also reported as today) but the pharmacist refused to administer the vaccine to him because he was over the age of indicated use and the pharmacist was worried, she would be audited, even though his insurance agreed to pay for it ((Product prescribing issue). No additional adverse events were reported. Additional information is not expected. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-2501USA004808: US-009507513-2501USA004808:
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| 2823606 | U | 01/30/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Burning sensation, Herpes zoster, Malaise, Vaccination failure; Burning sensatio...
Burning sensation, Herpes zoster, Malaise, Vaccination failure; Burning sensation, Herpes zoster, Malaise, Vaccination failure
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Suspected vaccination failure; it burns /sick/ frequent outbreaks; This serious case was reported by...
Suspected vaccination failure; it burns /sick/ frequent outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: it burns /sick/ frequent outbreaks). 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 and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that it burned and reported not to get fooled by the vaccine. Both injections made patient sick as a dog and the patient had more frequent outbreaks. This case was considered as suspected vaccination failure as details regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2823607 | U | MI | 01/30/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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administered only the lyophilized hib component of pentacel and used sterile water to dilute it with...
administered only the lyophilized hib component of pentacel and used sterile water to dilute it with no reported adverse event; Initial information received on 23-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age / gender patient who was administered only the lyophilized HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and used sterile water to dilute it with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Jan-2025, the patient received an unknown dose of lyophilized HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site and used sterile water to dilute it with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, they wanted to know if the HIB dose counted as a dose. They had a follow up question with what they should do about the DTaP-IPV component. Information on the batch number was requested corresponding to the one at time of event occurrence. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823608 | F | NC | 01/30/2025 |
RAB |
SANOFI PASTEUR |
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Incomplete course of vaccination
Incomplete course of vaccination
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patient had their pre-exposure in 1999 but the patient only had 1 dose with no reported adverse even...
patient had their pre-exposure in 1999 but the patient only had 1 dose with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who had her pre-exposure in 1999 but the patient only had 1 dose of rabies (HDC) vaccine [Imovax Rabies] with no reported adverse event . The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient had their pre-exposure in 1999 but the patient only had 1 dose with an unknown dose of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization with no reported adverse event (routine immunisation schedule incomplete) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, patient received the vaccine from a different brand which the she could not remember. Patient told the specialist that her titers dropped and she would need a booster so she was asking on the number of shots that she should receive for the booster dose of Rabavert This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2823623 | 47 | F | NY | 01/30/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
|
Biopsy kidney, Biopsy lung, Dialysis, End stage renal disease, Goodpasture'...
Biopsy kidney, Biopsy lung, Dialysis, End stage renal disease, Goodpasture's syndrome; Transfusion; Biopsy kidney, Biopsy lung, Dialysis, End stage renal disease, Goodpasture's syndrome; Transfusion
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I was diagnosed with a rare autoimmune disease anti gbm good pasture now a proven side effect of cov...
I was diagnosed with a rare autoimmune disease anti gbm good pasture now a proven side effect of covid vaccine. There are other proven cases. I have end stage renal disease and am on dialysis.
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โ | โ | โ | |||
| 2823626 | F | MD | 01/30/2025 |
HPV4 |
MERCK & CO. INC. |
|
Inability to afford medication, Off label use, Product prescribing issue
Inability to afford medication, Off label use, Product prescribing issue
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My doctor has prescribed me the Gardasil vaccine, however, I am outside of the normal recommended ag...
My doctor has prescribed me the Gardasil vaccine, however, I am outside of the normal recommended age to receive it. She has seen a great benefit to older women with my condition who have gotten Gardasil.; inability to afford medication; No additional AE; This spontaneous report was received from a consumer regarding herself, a female patient of unspecified age (reported as outside of the normal recommended age to receive Quadrivalent Human Papillomavirus [Types 6,11,16,18] Recomb. Vaccine [GARDASIL]). The patient's medical history, historical drugs, known drug allergies, and concomitant therapies were not reported. Her concurrent conditions included an unspecified condition. On an unknown date, the physician prescribed her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, outside of the normal recommended age to receive this vaccine, as she had seen a great benefit to older women with her condition who have gotten it (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) (Off label use). The physician was willing to give it her at her office, but her insurance would not pay for it. Local pharmacies won't even give her the vaccine. She had been told it was well over $500 dollars for each vaccine and there were three of them. That was very costly for her at this time. She had checked out the company's patient assistance programs but her income was over the limits. So she asked if there was anything the company could do to provide some assistance to lower the cost of the vaccine for her, as she would have to decide to not to get the vaccines if she was unable to receive some assistance, stating it was very troubling when decisions about her health had to come down to price (Inability to afford medication). No additional events were reported. Lot # is being requested and will be submitted if received.
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| 2823627 | U | GA | 01/30/2025 |
VARCEL |
MERCK & CO. INC. |
Y011019 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; patient who was administered improperly stored VARIVAX following a TE; This sponta...
No additional AE; patient who was administered improperly stored VARIVAX following a TE; This spontaneous report was received from an other reporter referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On 28-JAN-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # Y011019, expiration date: 18-JUN-2026; strength, dose, anatomical location and route of administration were not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of 11 degree Fahrenheit (F)/ 6F to 14F (the time frame was 30 Minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).
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| 2823628 | U | 01/30/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Allergy to vaccine
Allergy to vaccine
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Allergic to vaccine; This non-serious case was reported by a consumer via interactive digital media ...
Allergic to vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine 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 allergy to vaccine (Verbatim: Allergic to vaccine). The outcome of the allergy to vaccine was not reported. It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine. It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine. Additional Information: GSK receipt Date: 31-DEC-2024 This case was reported by a patient via interactive digital media. The Patient was allergic to vaccine.
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| 2823629 | U | 01/30/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise, Vaccine positive rechallenge
Malaise, Vaccine positive rechallenge
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sick; This non-serious case was reported by a consumer via interactive digital media and described t...
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine with an associated reaction of illness (received 1st dose of Shingles vaccine on an unknown date, refer linked case US2025AMR004636). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR004636 Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. Patient got two of the shots and they both made him/her sick.; Sender's Comments: US-GSK-US2025AMR004636:same patient
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| 2823630 | 7 | M | TN | 01/30/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
47Y5M |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Inappropriate age; This non-serious case was reported by a other health professional via call center...
Inappropriate age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis. On 02-JAN-2025, the patient received Infanrix. On 02-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the inappropriate age at vaccine administration 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 The health care professional reported that a seven years and ten months old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
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| 2823634 | 63 | M | NY | 01/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2YC74 |
Hypoaesthesia
Hypoaesthesia
|
Numbness starting upper arm travels down to hand Numbness happens many times a day
Numbness starting upper arm travels down to hand Numbness happens many times a day
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| 2823635 | 4 | U | CA | 01/30/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U7838AA Y012342 |
Erythema, Injection site vesicles, Peripheral swelling, Skin warm; Erythema, Inj...
Erythema, Injection site vesicles, Peripheral swelling, Skin warm; Erythema, Injection site vesicles, Peripheral swelling, Skin warm
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Mother has pictures. Seen 1/21/25 for 4 year old well child care, got DTap/IPV and MMR/Varicella. He...
Mother has pictures. Seen 1/21/25 for 4 year old well child care, got DTap/IPV and MMR/Varicella. Her arm got swollen and red, it was warm to the touch no fevers. Then developed a little blister at the injection site. Left arm No interventions, redness is better but still present. Has scab
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| 2823636 | 86 | F | IL | 01/30/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
A9KR2 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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I received RSV "AREXVY" vaccination in my left arm, Tuesday 12-10-2024 at 4:30 pm at pharm...
I received RSV "AREXVY" vaccination in my left arm, Tuesday 12-10-2024 at 4:30 pm at pharmacy. I did not feel the needle shot when it was given to me. I asked the lady if I needed to stay after the shot. She said, no. I walked to the car. I then felt a stinging in my left arm shot area. But it soon went away. So I drove home.--about 20 miles. The next day the arm was sore when I rubbed it. At bedtime I noticed the arm was also red with fever in the upper arm area-- about a 3 inch area and slightly swelled. I took 1/2 Tylenol pill when I went to bed. I was able to sleep at night. (I took my temperature by mouth when I had the reaction to RSV vaccination and my body temperature was around 97.7 degrees. I did not have a fever other than the 3 inch area at the site of the vaccination.) Thursday at 3:30 am, I woke up and went to the bathroom. The arm was still sore and red and had fever in the same area. I then took 1/2 Tylenol pill and went back to bed and back to sleep. Thursday morning I was concerned that I should be doing something about the reaction since it was no better--still about the same. I called Medical Group where my family doctor, is located at 8:49 am. I left a mesage for the nurse to call me back.
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| 2823637 | 56 | F | 01/30/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Blood test, Injection site bruising, Product administered at inappropriate site
Blood test, Injection site bruising, Product administered at inappropriate site
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The adverse reaction to my forearm is that it was bruised dark purple and deep blue color for 3wks. ...
The adverse reaction to my forearm is that it was bruised dark purple and deep blue color for 3wks. at clinic under doctor requests for blood work. Therefore, no pneumonia or shingle shot was ever given upon my request but flu shot. Right -forearm
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โ | ||||||
| 2823682 | 80 | M | IA | 01/30/2025 |
COVID19 |
MODERNA |
3043159 |
Death
Death
|
Death
Death
|
โ | |||||
| 2823683 | 66 | F | PA | 01/30/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
388496 388496 |
Dizziness, Dry mouth, Dysphonia, Feeling hot, Feeling jittery; Nausea, Paraesthe...
Dizziness, Dry mouth, Dysphonia, Feeling hot, Feeling jittery; Nausea, Paraesthesia oral, Pharyngeal paraesthesia
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Vaccine given at approximately 3:15 PM. By 3:20 PM, patient reported dry mouth and warm, tingling se...
Vaccine given at approximately 3:15 PM. By 3:20 PM, patient reported dry mouth and warm, tingling sensation in mouth/throat, with some nausea. Denied swelling, shortness of breath, itching, redness, hives, or difficulty swallowing. Offered Pt some water. At 3:30 PM, patient reported also feeling jittery/dizzy; no other new symptoms. Pt declined offer to call ambulance but ate a cookie. Vitals normal for patient, as noted below. By 3:35 PM, noted that jitteriness, nausea, and tingling were gone. Still denied swelling or SOB. (Called patient's PCP at 3:39 PM and discussed reaction with receptionist; was transferred to nurse line voicemail. Attempted to call back to discuss live at 3:42 PM but again was unable to connect with nurse at this time, so left voicemail with my and the patient's cell numbers.) Patient noted feeling better at check-ins at 3:55 PM and 4:03 PM, with just some remaining warmth and some voice change. Still denied swelling and shortness of breath. Pt was comfortable leaving pharmacist care at 4:15 PM--only warmth in mouth remaining. Counseled to call 911 immediately if SOB, swelling, or dizziness developed. Pt noted she has medical alert pendant at home and cell phone with her. Called patient to follow-up at 5:47 PM; reported only having warm tongue at this point; did not have diphenhydramine available at home. Reinforced when to call 911 and advised to contact PCP if symptoms remained by next morning. Staff from PCP office called back when she received message at 8:47 AM on 1/30/25. I provided an update on the course of events since the initial voicemail; she planned to call the patient to check-in today and notify the physician.
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| 2823684 | 77 | F | NC | 01/30/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
929pn jb27a |
Extra dose administered, Fatigue, Oropharyngeal pain, Pain in extremity; Extra d...
Extra dose administered, Fatigue, Oropharyngeal pain, Pain in extremity; Extra dose administered, Fatigue, Oropharyngeal pain, Pain in extremity
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Patient received an extra dose by mistake of Arexvy. First dose was received 12/15/23 and second dos...
Patient received an extra dose by mistake of Arexvy. First dose was received 12/15/23 and second dose was received 1/29/25. Patient has a sore arm, some fatigue and slight sore throat. No other adverse effects reported by patient. Called patient to discuss incident at 10:20am on 1/30/25
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| 2823685 | 76 | M | 01/30/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8081561 u8521aa |
Body temperature fluctuation, Fatigue, Headache, Heart rate increased, Tremor; B...
Body temperature fluctuation, Fatigue, Headache, Heart rate increased, Tremor; Body temperature fluctuation, Fatigue, Headache, Heart rate increased, Tremor
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shakes, lack of temperature control, headache, fatigue, increased heart rate - lasting for about 6 h...
shakes, lack of temperature control, headache, fatigue, increased heart rate - lasting for about 6 hours, eventually subsided, did not result in hospital/ER visit. Pt used tylenol, rested and increased fluid intake
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| 2823686 | 74 | F | MO | 01/30/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM2221 u8515ca |
Burning sensation, Muscle spasms; Burning sensation, Muscle spasms
Burning sensation, Muscle spasms; Burning sensation, Muscle spasms
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States she took a diphenhydramine 25 mg pill on 01/29/2025 at 2:30 pm and then took a nap. States th...
States she took a diphenhydramine 25 mg pill on 01/29/2025 at 2:30 pm and then took a nap. States that at about 4:30 pm on same day she woke up with a burning sensation at her left upper thigh and right leg "muscle spasms" in her calf and foot. States lasted about 15 minutes and then went away with no reoccurrence since that time. Stated she just wanted to report it as she had received vaccines on 01/27/2025 and had never had anything like that happen before.
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| 2823687 | 60 | F | WI | 01/30/2025 |
UNK |
UNKNOWN MANUFACTURER |
275NJ |
Arthralgia, Magnetic resonance imaging joint, Rotator cuff syndrome, X-ray limb
Arthralgia, Magnetic resonance imaging joint, Rotator cuff syndrome, X-ray limb
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Teammate received the Flu vaccine at the Pharmacy on 12/3/24 and has had left shoulder pain since. H...
Teammate received the Flu vaccine at the Pharmacy on 12/3/24 and has had left shoulder pain since. Had physical therapy x 3 with no improvement. Saw Occ Health doctor who ordered MRI and X- ray and referred pt to Orthopedic doctor. Teammate stated MRI showed rotator cuff damage. Teammate stated orthopedic doctor recommended surgery.
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| 2823688 | 76 | F | SC | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
Lm2224 |
Pain in extremity
Pain in extremity
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Patient has had arm pain since shot was given.
Patient has had arm pain since shot was given.
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| 2823689 | 28 | M | NC | 01/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
42B22 |
Extra dose administered
Extra dose administered
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None
None
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| 2823690 | 66 | F | NY | 01/30/2025 |
COVID19 |
MODERNA |
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Conjunctivitis
Conjunctivitis
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pinkeye
pinkeye
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| 2823691 | 51 | F | MD | 01/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
74NC9 |
Abdominal pain upper, Chills, Feeling abnormal, Headache, Immediate post-injecti...
Abdominal pain upper, Chills, Feeling abnormal, Headache, Immediate post-injection reaction
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Starting immediately, after the 2nd dose, patient has been experiencing severe headaches, cold chill...
Starting immediately, after the 2nd dose, patient has been experiencing severe headaches, cold chills, and stomach cramps. These are intermittent and come and go. Patient says she has never felt like this before and does not feel like herself. She has been take Aleve to combat these effects, but it's not working.
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| 2823692 | 66 | M | FL | 01/30/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
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duplicate Immunization of Arexvy - previously vaccinated 12/18/2023
duplicate Immunization of Arexvy - previously vaccinated 12/18/2023
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| 2823693 | 15 | M | OR | 01/30/2025 |
HPV9 HPV9 MNQ MNQ |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y007991 Y007991 U8375AA U8375AA |
Dizziness postural, Eye movement disorder, Hyperhidrosis, Loss of consciousness,...
Dizziness postural, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Pallor; Posture abnormal; Dizziness postural, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Pallor; Posture abnormal
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Patient received 2 IM vaccines in left deltoid at 0805. Patient stood up without issue and went and ...
Patient received 2 IM vaccines in left deltoid at 0805. Patient stood up without issue and went and sat in another chair. Do dizziness with standing. 3 minutes later patient states he felt dizzy. Eyes rolled back and his head fell to the side. Patient was pale and sweaty. His mother was standing next to him and supported his head. Patient regained consciousness within 30 seconds. No nausea or vomiting. Elevated patient's feet and had him sit for 15 minutes. He then was able to stand without issue afterwards and reported no dizziness or nausea. was able to ambulate out of clinic without issue
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| 2823695 | 0.58 | M | MI | 01/30/2025 |
COVID19 |
MODERNA |
3043023 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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BUD 1/21/2025 vaccine given 1/27/2025
BUD 1/21/2025 vaccine given 1/27/2025
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| 2823696 | 11 | F | MI | 01/30/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
77KAS |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Pt given incorrect vaccine at time of visit, Pt needed Boosterix and received Bexsero from misread e...
Pt given incorrect vaccine at time of visit, Pt needed Boosterix and received Bexsero from misread error on vaccine order. No adverse side effects reported.
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| 2823697 | 56 | M | FL | 01/30/2025 |
COVID19 |
MODERNA |
010A21A |
Vitiligo
Vitiligo
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I developed vitiligo which is not present amongst 7 siblings with no history of vitiligo
I developed vitiligo which is not present amongst 7 siblings with no history of vitiligo
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โ | |||||
| 2823698 | 53 | F | ME | 01/30/2025 |
COVID19 COVID19 VARZOS VARZOS |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
204g23a 204g23a h37ca h37ca |
Blood test normal, Coagulation test normal, Epistaxis, Generalised oedema, Haema...
Blood test normal, Coagulation test normal, Epistaxis, Generalised oedema, Haematoma; Inflammation, Magnetic resonance imaging abnormal; Blood test normal, Coagulation test normal, Epistaxis, Generalised oedema, Haematoma; Inflammation, Magnetic resonance imaging abnormal
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Medically significant 30 minute nose bleed on 12/07/04. Multiple spontaneous hematomas and vascular...
Medically significant 30 minute nose bleed on 12/07/04. Multiple spontaneous hematomas and vascular inflammation in lower extremities verified via MRI Generalizes swelling on left side of body. No injection site reaction
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| 2823699 | 84 | F | MN | 01/30/2025 |
RSV |
PFIZER\WYETH |
KD0161 |
Pain in extremity
Pain in extremity
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Patient came to pharmacy on 1/28/25 reporting severe arm pain in the vaccinated arm. Controlled by ...
Patient came to pharmacy on 1/28/25 reporting severe arm pain in the vaccinated arm. Controlled by frequent doses of 600mg ibuprofen. She did not say when the issue initially started, just that is was after she had the vaccine. I recommended that she continue with the ibuprofen at 600mg up to 4 times a day and that she also report this issue to her doctor to see if additional follow up is necessary. Patient did state that she has bursitis issues in that arm already.
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| 2823700 | 48 | F | FL | 01/30/2025 |
HEP IPV TDAP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. |
dvx945659 PMCX1C891M skb235d2 msdy006523 |
Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pruritus; Pruritu...
Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pruritus; Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pruritus; Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pruritus; Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pruritus
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Patient reporting itching on left arm ,under left arm, neck and under left back side the day of the...
Patient reporting itching on left arm ,under left arm, neck and under left back side the day of the vaccination 01/27/2025, low fever (38 degree) and taking parasetamol unknown dose, 01/28/2025 patient taking benadryl 20 mg for itching and redness at side of the vaccination.
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| 2823701 | 5 | F | TX | 01/30/2025 |
MMRV |
MERCK & CO. INC. |
Y011215 |
Dermatitis bullous, Injection site erythema, Injection site vesicles
Dermatitis bullous, Injection site erythema, Injection site vesicles
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Pt was given the MMR/VAR vaccine on 1/28/25. Remarkable PE shows a cluster of bullous rash surround...
Pt was given the MMR/VAR vaccine on 1/28/25. Remarkable PE shows a cluster of bullous rash surrounded by erythema on her right thigh.
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| 2823702 | 33 | F | CA | 01/30/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
O27L21A O27L21A FC3182 FC3182 FF2588 FF2588 |
Electrocardiogram ambulatory, Electrocardiogram normal, Hypoaesthesia, Malaise, ...
Electrocardiogram ambulatory, Electrocardiogram normal, Hypoaesthesia, Malaise, Palpitations; Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test positive; Electrocardiogram ambulatory, Electrocardiogram normal, Hypoaesthesia, Malaise, Palpitations; Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test positive; Electrocardiogram ambulatory, Electrocardiogram normal, Hypoaesthesia, Malaise, Palpitations; Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test positive
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Have had L hand tingling and numbness in 3 fingers since the second vaccination in 2021. First exper...
Have had L hand tingling and numbness in 3 fingers since the second vaccination in 2021. First experienced palpitations after the Moderna vaccination in 2022. Had very mild COVID symptoms in July 2022. Saw PCP in August for continued palpitations and he recommended cardiology. Cardiology was seen, Holter monitor was placed, cannot recall dates but it was in 2023. After Holter monitor, Tilt table test was performed in June 2023. EKG in PCP office in August 2022 was normal. Subsequent EKGs from cardiology office have been abnormal ever since.
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| 2823703 | 25 | F | CA | 01/30/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
235D2 |
Exposure during pregnancy, Extra dose administered
Exposure during pregnancy, Extra dose administered
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A Boostrix vaccine was administered within a 14-day interval form the previous dose of Boostrix give...
A Boostrix vaccine was administered within a 14-day interval form the previous dose of Boostrix given on 01/14/2025 to a 25-year-old patient who is 30 weeks pregnant, with an estimated due date of 04/10/2025.
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| 2823704 | 79 | M | WV | 01/30/2025 |
COVID19 |
MODERNA |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Administered 51 days after last COVID-19 vaccination
Administered 51 days after last COVID-19 vaccination
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| 2823706 | 78 | F | GA | 01/30/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5W3H0W5EC2 5W3H0W5EC2 |
Extra dose administered, Fatigue, Injection site erythema, Injection site pain, ...
Extra dose administered, Fatigue, Injection site erythema, Injection site pain, Injection site reaction; Musculoskeletal stiffness
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The patient was given a second dose of RSV vaccine outside of CDC guidelines. The patient received t...
The patient was given a second dose of RSV vaccine outside of CDC guidelines. The patient received the vaccine for the first time on 11-19-2023. The patient reports adverse events of fatigue, redness, soreness, and stiffness in the arm where the vaccine was administered.
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| 2823707 | 60 | M | MS | 01/30/2025 |
FLU3 |
SEQIRUS, INC. |
P100715742 |
Laboratory test, Loss of personal independence in daily activities, Muscle spasm...
Laboratory test, Loss of personal independence in daily activities, Muscle spasms
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Within a week of getting the flu shot I began having severe muscle cramps all over my body. This is ...
Within a week of getting the flu shot I began having severe muscle cramps all over my body. This is unrelieved by Motrin. It required two ER visits. On the second ER visit i was unable to shower nor get dressed without my wifes help. These symptoms are still present. I am now on high dose steroids (Prednisone) with extreme difficulty weaning off the steroids. Several of my doctors are very suspicious of the flu shot triggering an autoimmune response. I am now under the care of Neurology, Rheumatology,Spine Doctor, and primary care doctor.
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| 2823708 | 49 | F | NY | 01/30/2025 |
TDAP |
SANOFI PASTEUR |
u8274AA |
Injection site erythema, Injection site pain, Injection site swelling, Lymphaden...
Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Ultrasound lymph nodes
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Patient had localized redness, swelling, pain at injection site and presumed regional lymphadenopath...
Patient had localized redness, swelling, pain at injection site and presumed regional lymphadenopathy although axillary ultrasound report was normal. This occurred 2 days after injection and resolved spontaneously within a week. No further concerns.
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| 2823709 | 2 | M | WI | 01/30/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN8272 4S5YG |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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none
none
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| 2823710 | 2 | M | WI | 01/30/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN8272 |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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none
none
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| 2823711 | 76 | F | OH | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2222 |
Pain in extremity
Pain in extremity
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Persistently sore arm (now 4+ months later).
Persistently sore arm (now 4+ months later).
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