| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2800445 | 66 | F | VA | 10/19/2024 |
COVID19 COVID19 FLU3 FLU3 COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
LM2223 LM2223 388461 388461 |
Candida infection, Erythema, Fungal infection, Pruritus, Rash; Urticaria; Candid...
Candida infection, Erythema, Fungal infection, Pruritus, Rash; Urticaria; Candida infection, Erythema, Fungal infection, Pruritus, Rash; Urticaria; Alopecia, Body temperature, Chills, Headache, Pyrexia; Urticaria; Alopecia, Body temperature, Chills, Headache, Pyrexia; Urticaria
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Patient states that about two hours after vaccinations, she started to experience hives with itchi...
Patient states that about two hours after vaccinations, she started to experience hives with itching and redness on the inside of the right arm. She then noticed it on the left arm at a later time, and two days later the rash appeared on her chest. The rash comes and goes, and she is still having issues over five weeks later. Patient went to PCP and was initially treated with an 8 day course of Prednisone 10mg on 9-13-24. When the issue was not resolved as of 9-21-24, she was prescribed a Medrol Dose Pak and Triamcinolone 0.1% Cream at an urgent care clinic. Patient again saw PCP on 10-2-24, and was prescribed a course of Prednisone 10mg. As of 10-18-24, the patient now appears to have developed thrush, and is being treated with Nystatin suspension. Patient also mentioned that the rash/hives tend to flare up in the shower.
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| 2679669 | 72 | M | MD | 09/06/2023 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
HF7708 HF7708 |
Atrial fibrillation; Atrial fibrillation
Atrial fibrillation; Atrial fibrillation
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Patient received RSV (Abrysvo) vaccine on 9/2/23 at Pharmacy. Next day after receiving the vaccine...
Patient received RSV (Abrysvo) vaccine on 9/2/23 at Pharmacy. Next day after receiving the vaccine, patient called to report of potential Atrial Fibrillation the patient experienced based on the A fib sensor device reader the patient wears. Pharmacist advised patient should follow up with his doctor or go to the emergency room. Patients doctor advised patient to go to the emergency room, where the A Fib event the patient experienced was confirmed. Patient was treated at the emergency room and sent home. Patient is still concerned if he will have a repeat of the A Fib event. Pharmacy is reporting this event.
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| 2821616 | M | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Fatigue, Pyrexia, Rash
Fatigue, Pyrexia, Rash
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fever; rash; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A mal...
fever; rash; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; RASH (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown". Additional information: Patient received the second Pfizer COVID vaccine recently with side effects of fever, rash, and fatigue. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2821617 | F | 01/17/2025 |
PNC20 |
PFIZER\WYETH |
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Erythema, Fatigue, Mobility decreased, Pain in extremity, Skin warm
Erythema, Fatigue, Mobility decreased, Pain in extremity, Skin warm
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for three days her arm hurt quite a lot but then right now can move it but it is still; for three da...
for three days her arm hurt quite a lot but then right now can move it but it is still; for three days her arm hurt quite a lot but then right now can move it but it is still/arms movement back but at the site it flared up more; for three days her arm hurt quite a lot but then right now can move it but it is still/arms movement back but at the site it flared up more; redness went away but came back/4 inch round red mark and it is a little more warmer than the rest of the skin; felt tired; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "for three days her arm hurt quite a lot but then right now can move it but it is still"; MOVEMENT DISORDER (non-serious), MOBILITY DECREASED (non-serious), outcome "not recovered" and all described as "for three days her arm hurt quite a lot but then right now can move it but it is still/arms movement back but at the site it flared up more"; ERYTHEMA (non-serious), outcome "not recovered", described as "redness went away but came back/4 inch round red mark and it is a little more warmer than the rest of the skin"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Additional information: Patient noticed today maybe a 4 inch round red mark and it is a little more warmer than the rest of the skin. Originally it was red it seems to go away and patient noticed in the shower, when is feeling it now it is slightly warmer than the rest of arm. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2821618 | M | NY | 01/17/2025 |
COVID19 COVID19 |
JANSSEN PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test, Weight; COVID-19, Drug ineffective,...
COVID-19, Drug ineffective, SARS-CoV-2 test, Weight; COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
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I've had Covid three times; I've had Covid three times; This is a spontaneous report recei...
I've had Covid three times; I've had Covid three times; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "Covid", start date: 2020 (unspecified if ongoing), notes: first one is before the vaccine; "lost twenty pounds" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've had Covid three times". The event "i've had covid three times" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: lost twenty pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for covid and got a prescription of Paxlovid. The patient had covid 3 times; the first time was before the vaccine. The second time he had it, the patient went to urgent care, and he got Paxlovid for free. The patient felt a lot better than he did the first time he had Covid when he had pneumonia and lost twenty pounds. The patient had covid after Paxlovid. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2821619 | M | FL | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Guillain-Barre syndrome
Guillain-Barre syndrome
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contracted Guillain Barre Syndrome after a Covid Shot; This is a spontaneous report received from a ...
contracted Guillain Barre Syndrome after a Covid Shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "contracted Guillain Barre Syndrome after a Covid Shot". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2821620 | 60 | F | 01/17/2025 |
COVID19 FLU3 TDAP |
UNKNOWN MANUFACTURER SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
602MF013 UT8506KA 5YB5G |
Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Se...
Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Sepsis
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Abscess limb; Acute kidney injury; Sepsis; Initial information received on 06-Jan-2025 regarding an ...
Abscess limb; Acute kidney injury; Sepsis; Initial information received on 06-Jan-2025 regarding an unsolicited valid serious Courtesy case received from a consumer/non-healthcare professional. This case involves a 60 years old female patient who said to experienced abscess limb, acute kidney injury and sepsis after receiving Influenza USP trival A-B subvirion no preservative vaccine [Fluzone], Boostrix, Novavax Covid-19 vaccine. The patient's past medical history included Asthma, Tobacco user, Hypertension, Bipolar disorder and Drug hypersensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing bacterial rhinosinusitis and Fungal skin infection. Concomitant medications included Fluticasone propionate, Salmeterol xinafoate (Advair); Salbutamol (Albuterol); Azelastine, Buprenorphine, Mirtazapine (Mirtazepine Teva); Olanzapine, Oxybutynin, Propranolol and Venlafaxine. On 29-Oct-2024, the patient received a dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot UT8506KA via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for drug used for unknown indication and received a dose of suspect novavax covid-19 vaccine injection not produced by Sanofi Pasteur lot 602MF013 via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for drug used for unknown indication and received a dose 1 of suspect Boostrix not produced by Sanofi Pasteur lot 5YB5G via intramuscular route in unknown administration site (strength and expiration date: not provided) for drug used for unknown indication. On 06-Nov-2024 the patient developed abscess limb, acute kidney injury and sepsis (latency- 8 days). These events was assessed as medically significant and life-threatening and the patient was hospitalized for these events. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events.; Sender's Comments: Sanofi Company Comment dated 17-Jan-2025: This case involves a 60 years old female patient who said to experienced abscess limb, acute kidney injury and sepsis after receiving Influenza USP trival A-B subvirion no preservative vaccine [Fluzone], Boostrix, Novavax Covid-19 vaccine, with latency of 8 days following vaccination. Further information regarding previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, concomitant use of multiple vaccines remains as confounding factor and the role of individual suspect vaccine cannot be assessed.
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| 2821639 | 87 | F | PA | 01/17/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
75F74 |
Extra dose administered
Extra dose administered
|
received 2nd dose of Arexvy; This non-serious case was reported by a pharmacist via call center repr...
received 2nd dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75F74, expiry date 31-OCT-2025) for prophylaxis. Previously administered products included Arexvy (received 1st dose on 12-JAN-2024 from batch number PS2CK with expiry date 10-JUL-2025). On 19-DEC-2024, the patient received the 2nd dose of Arexvy. On 19-DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received 2nd dose of Arexvy). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 19-DEC-2024 Pharmacist reported that patient received a dose of Arexvy and then was administered with an extra dose of Arexvy, which led to an extra dose administered. The vaccine administration facility was the same as primary reporter.
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| 2821640 | U | 01/17/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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Sudden death
Sudden death
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Sudden death; This is a spontaneous report received from a Consumer or other non HCP from License Pa...
Sudden death; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA369389 (Sanofi), AE-017381 (BioNTech SE). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN DEATH (death, medically significant), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.; Reported Cause(s) of Death: Unknown cause of death
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| 2821641 | 32 | M | IL | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0170 |
Anxiety, Dust allergy, Illness
Anxiety, Dust allergy, Illness
|
Same initial onset of symptoms after vaccine, my anxiety keeps amplifying with symptoms; Very sensit...
Same initial onset of symptoms after vaccine, my anxiety keeps amplifying with symptoms; Very sensitive to dust/inhale any amount of dust, get severely sick; Very sensitive to dust/inhale any amount of dust, get severely sick; This is a spontaneous report received from a Consumer or other non HCP. A 33-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0170) at the age of 32 years for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the first administration of BNT162B2. The patient's relevant medical history included: "Gerd" (ongoing); "Sleep apnea" (ongoing); "heart attack/heart issues" (ongoing); "heart attack/heart issues" (ongoing); "Pneumonia" (ongoing). The patient is not allergic to any previous vaccination, medications, food all other products. There were no concomitant medications. The patient was not taking any other medications within 2 weeks prior to the event onset. The following information was reported: ANXIETY (hospitalization), outcome "not recovered", described as "Same initial onset of symptoms after vaccine, my anxiety keeps amplifying with symptoms"; DUST ALLERGY (non-serious), ILLNESS (non-serious), outcome "not recovered" and all described as "Very sensitive to dust/inhale any amount of dust, get severely sick". The event "very sensitive to dust/inhale any amount of dust, get severely sick" required physician office visit. Therapeutic measures were taken as a result of dust allergy, illness. Clinical course: After the vaccine, the patient was very sensitive to dust. If he inhales any amount of dust, he gets severely sick. This resulted to multi-doctor/multi-lung specialists visits and the patient was prescribed with an inhaler (ongoing use). It was also reported that the patient has same initial onset of symptoms after vaccine, his anxiety keeps amplifying with symptoms. The patient's anxiety resulted to hospitalization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400329270 same reporter/patient/suspect vaccine; different dose/event;
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| 2821642 | F | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Autoimmune disorder, Dermatitis, Post-acute COVID-19 syndrome, Urticaria
Autoimmune disorder, Dermatitis, Post-acute COVID-19 syndrome, Urticaria
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hyper auto immune system; dermatitis; hives burning, itchy in the body; long term Covid; This is a s...
hyper auto immune system; dermatitis; hives burning, itchy in the body; long term Covid; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2), in 2023 as dsoe number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "hyper auto immune system"; DERMATITIS (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "hives burning, itchy in the body"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long term Covid". The event "long term covid" required physician office visit. Clinical course: Caller wanted to report a reaction after vaccines and long term Covid which has been to many doctors they told her she had dermatitis and hyper auto immune system with hives burning, itchy in the body after Covid vaccine 2 years ago. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2821643 | 58 | F | NJ | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2212 |
Arthralgia, Neck pain, Peripheral swelling, Product administered at inappropriat...
Arthralgia, Neck pain, Peripheral swelling, Product administered at inappropriate site, Ultrasound scan
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Patient states she had arm swelling, neck and shoulder pain and had to see a doctor. She said they c...
Patient states she had arm swelling, neck and shoulder pain and had to see a doctor. She said they completed an ultrasound and the vaccine was administered too high and too forward in the arm. Patient was prescriber cyclobenzaprine for the pain. The pain finally just went away after 3 months.
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| 2821644 | 56 | F | OR | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
2935465-05780 |
Fatigue, Influenza like illness, Nasal congestion, Nasopharyngitis, Pain
Fatigue, Influenza like illness, Nasal congestion, Nasopharyngitis, Pain
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Cold and flu-like symptoms such as stuffy nose, headache, body aches, fatigue, excessively tired, th...
Cold and flu-like symptoms such as stuffy nose, headache, body aches, fatigue, excessively tired, that has, so far, lasted 8 days (and counting).
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| 2821645 | 24 | F | WA | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Urticaria
Urticaria
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I experienced, and am still experiencing chronic hives from the vaccine.
I experienced, and am still experiencing chronic hives from the vaccine.
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| 2821646 | 11 | M | CA | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Incorrect dose administered
Incorrect dose administered
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Patient received covid vaccines pfizer for 12 yrs + instead of 5yr-11yrs
Patient received covid vaccines pfizer for 12 yrs + instead of 5yr-11yrs
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| 2821647 | 12 | M | WA | 01/17/2025 |
HPV9 MMR MNQ VARCEL |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
X024650 X008385 U8361AA Y011017 |
No adverse event; No adverse event; No adverse event; No adverse event
No adverse event; No adverse event; No adverse event; No adverse event
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No signs or symptoms of adverse reaction, no treatment required
No signs or symptoms of adverse reaction, no treatment required
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| 2821648 | 45 | M | 01/17/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
020B21A 020B21A |
Condition aggravated, Fatigue, Headache, Immune-mediated arthritis, Joint swelli...
Condition aggravated, Fatigue, Headache, Immune-mediated arthritis, Joint swelling; Malaise, Neuropathy peripheral, Respiratory tract congestion, Rhinitis
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Since receiving the moderna covid vacccine, my neuropathic symptoms associated with my right ankle (...
Since receiving the moderna covid vacccine, my neuropathic symptoms associated with my right ankle (post surgical neuropathy 2016) progressively worsened and ultimately spread bilaterally to my lower back and left foot. These symptoms were accompanied by fatigue, malaise, and persistent joint swelling, headaches, congestion, and rhinitis. i was recently diagnosed with immune related arthritis in those areas and other major joints. None of these neurologic and immune related conditions are conventional and only arose/worsened following the covid vaccination
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| 2821649 | 56 | F | IL | 01/17/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FJ917 |
Infection, Local reaction, Musculoskeletal chest pain, Swelling
Infection, Local reaction, Musculoskeletal chest pain, Swelling
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PT HAD A LOCAL REACTION . SWELLING ABD UT GOT INFECTED, PT ALSO SAID HER RIBS WERE HURTIN
PT HAD A LOCAL REACTION . SWELLING ABD UT GOT INFECTED, PT ALSO SAID HER RIBS WERE HURTIN
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| 2821655 | 57 | M | NC | 01/17/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013009 Y013009 |
Blood test, Headache, Injection site pain, Nausea, Pyrexia; Vomiting
Blood test, Headache, Injection site pain, Nausea, Pyrexia; Vomiting
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patient had pain in injection site, headache starting night after vaccination, fever and nausea and ...
patient had pain in injection site, headache starting night after vaccination, fever and nausea and vomiting starting that evening.
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| 2821656 | 2 | M | WA | 01/17/2025 |
HIBV PNC20 |
MERCK & CO. INC. PFIZER\WYETH |
X022982 HR3650 |
Injection site erythema, Injection site swelling, Injection site warmth, Letharg...
Injection site erythema, Injection site swelling, Injection site warmth, Lethargy, Weight bearing difficulty; Injection site erythema, Injection site swelling, Injection site warmth, Lethargy, Weight bearing difficulty
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Per mother: lethargic, unable to bear weight, swelling and redness at both injection sites, warmth a...
Per mother: lethargic, unable to bear weight, swelling and redness at both injection sites, warmth at R thigh.
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| 2821657 | 69 | F | NH | 01/17/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
Y013009 |
Feeling hot, Injection site paraesthesia, Injection site pruritus, Injection sit...
Feeling hot, Injection site paraesthesia, Injection site pruritus, Injection site warmth, Paraesthesia; Feeling hot, Injection site paraesthesia, Injection site pruritus, Injection site warmth, Paraesthesia
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patient had a reaction to the capvaxive vaccine, came back a few minutes (maybe 5) after the vaccine...
patient had a reaction to the capvaxive vaccine, came back a few minutes (maybe 5) after the vaccine and said her arm that she got the capvaxive in started itching at the injection site and getting warm/tingling, then that feeling traveled down her arm, across her chest and to her entire body. She waited by the pharmacy for about a half an hour before she left, she said when she left she did still have the feeling but it was getting better. A few hours later her side effects subsided completely
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| 2821658 | 87 | M | GA | 01/17/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient previously vaccinated with Arexvy 10/25/2023, and he should not have been vaccinated again. ...
Patient previously vaccinated with Arexvy 10/25/2023, and he should not have been vaccinated again. He has experienced no adverse reactions.
More
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| 2821659 | 76 | M | AR | 01/17/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site pain
Injection site pain
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Extreme continuous pain in exact area where injection of vaccine was given. Never had this type of ...
Extreme continuous pain in exact area where injection of vaccine was given. Never had this type of problem with any other vaccine ever!
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| 2821660 | 54 | M | NM | 01/17/2025 |
HPV9 |
MERCK & CO. INC. |
y013712 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient received a Gardasil vaccine that he did not request. No adverse reaction.
Patient received a Gardasil vaccine that he did not request. No adverse reaction.
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| 2821661 | 0.5 | F | WA | 01/17/2025 |
RV5 |
MERCK & CO. INC. |
2051974 |
Enema administration, Frequent bowel movements, Haematochezia, Vaccine positive ...
Enema administration, Frequent bowel movements, Haematochezia, Vaccine positive rechallenge
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Presented with blood in stool on 1/2. 9 days after getting her 3rd rotavirus vaccine. Parents report...
Presented with blood in stool on 1/2. 9 days after getting her 3rd rotavirus vaccine. Parents report they noted change in her stools with increased frequency following the vaccine. This occurred with prior immunization of rotavirus as well. Pt admitted to hospital after 4 attempts at air enema, ultimately successful.
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| 2821662 | 82 | M | GA | 01/17/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Erythema, Extra dose administered
Erythema, Extra dose administered
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patient got AREXY 2023 - the system didn't upload it to vaccine registry. In 2025 he asked for ...
patient got AREXY 2023 - the system didn't upload it to vaccine registry. In 2025 he asked for AREXVY, vaccine registry was checked and wasn't on there so patient was given a second dose. He did not have any adverse events , just some redness on his arm.
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| 2821663 | 0.83 | M | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
No adverse event, Product preparation error
No adverse event, Product preparation error
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Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride...
Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
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| 2821664 | 2 | M | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride...
Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
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| 2821665 | 3 | F | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
No adverse event, Product preparation error
No adverse event, Product preparation error
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Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride...
Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
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| 2821666 | 2 | M | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
No adverse event, Product preparation error
No adverse event, Product preparation error
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Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride...
Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
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| 2821667 | 59 | F | 01/17/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0171 |
Fatigue, Pyrexia, Tinnitus
Fatigue, Pyrexia, Tinnitus
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FEVERS, FATIGUE - WITHIN 1 DAY - NOTABLE LEFT SIDED TINNITUS THAT HAS NOT RESOLVED NEARLY 4 YEARS LA...
FEVERS, FATIGUE - WITHIN 1 DAY - NOTABLE LEFT SIDED TINNITUS THAT HAS NOT RESOLVED NEARLY 4 YEARS LATER.
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| 2821668 | 37 | F | OH | 01/17/2025 |
HPV9 |
MERCK & CO. INC. |
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Fatigue, Headache, Myalgia, Pyrexia
Fatigue, Headache, Myalgia, Pyrexia
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Low grade fever, muscle aches, headache, and fatigue last 5 hours
Low grade fever, muscle aches, headache, and fatigue last 5 hours
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| 2821669 | 77 | F | GA | 01/17/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Received a 2nd dose on 01/14/2025. First dose was on 01/09/2024. Patient has not had any adverse eff...
Received a 2nd dose on 01/14/2025. First dose was on 01/09/2024. Patient has not had any adverse effects.
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| 2821670 | 12 | M | PA | 01/17/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Dizziness, Fall, Head injury, Headache, Hypoaesthesia; Loss of consciousness, Pa...
Dizziness, Fall, Head injury, Headache, Hypoaesthesia; Loss of consciousness, Paraesthesia, Sensory disturbance
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Patient said he couldn?t feel his arm. It felt numb. But he wanted to go home. He started walking to...
Patient said he couldn?t feel his arm. It felt numb. But he wanted to go home. He started walking to the front of the office, felt dizzy and passed out almost immediately. He fell and hit his head. His head hurts but no other lasting symptoms. Afterwards he said before he felt dizzy his legs felt tingly, he felt like he was shrinking, and he felt like he was being pushed down.
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| 2821160 | F | 01/16/2025 |
COVID19 FLU3 TDAP |
UNKNOWN MANUFACTURER SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
602MF013 UT8506KA 5YB5G |
Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Se...
Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Sepsis
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Sepsis; Abscess limb; Acute kidney injury; This serious case was reported by a consumer via other ma...
Sepsis; Abscess limb; Acute kidney injury; This serious case was reported by a consumer via other manufacturer and described the occurrence of sepsis in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G) for prophylaxis. Co-suspect products included Influenza vaccine (Fluzone) (batch number UT8506KA) for prophylaxis and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 602MF013) for prophylaxis. The patient's past medical history included asthma, smoker, hypertension and bipolar disorder. Concurrent medical conditions included sinusitis bacterial, fungal dermatitis and drug allergy (BUPROPRION drug allergy). Concomitant products included fluticasone propionate;salmeterol xinafoate (Advair), salbutamol (Albuterol), azelastine, buprenorphine, mirtazapine (Mirtazepine Teva), oxybutynin, propranolol, venlafaxine and olanzapine. On 29-OCT-2024, the patient received the 1st dose of Boostrix (intramuscular), Fluzone (intramuscular) and Novavax COVID-19 Vaccine (intramuscular). On 06-NOV-2024, 8 days after receiving Boostrix and Fluzone, the patient experienced sepsis (Verbatim: Sepsis) (serious criteria hospitalization, GSK medically significant, life threatening and other: serious as per reporter), abscess limb (Verbatim: Abscess limb) (serious criteria hospitalization, life threatening and other: serious as per reporter) and acute kidney injury (Verbatim: Acute kidney injury) (serious criteria hospitalization, GSK medically significant, life threatening and other: serious as per reporter). The outcome of the sepsis, abscess limb and acute kidney injury were resolved. It was unknown if the reporter considered the sepsis, abscess limb and acute kidney injury to be related to Boostrix. The company considered the sepsis, abscess limb and acute kidney injury to be unrelated to Boostrix. Additional Information: GSK Receipt Date: 13-JAN-2025 Patient was received by Novavax on 06-Jan-2025. A 60 year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (LOT: 602MF013) on 29-Oct-2024. The following secondary suspect medications were reported: FLUZONE [INFLUENZA VACCINE](influenza vaccine) and BOOSTRIX(tetanus vaccine toxoid). The following medical history was reported: ASTHMA, SMOKER, HTN, BIOPOLAR D/O, BUPROPRION, BACTERIAL RHINOSINUSITIS and YEAST DERMATITIS. The following concomitant medications were reported: ADVAIR(fluticasone propionate), ALBUTEROL [SALBUTAMOL](salbutamol), AZELASTINE(azelastine), BUPRENORPHINE(buprenorphine), MIRTAZAPINE(mirtazapine), OLANZAPINE(olanzapine), OXYBUTYNIN(oxybutynin), PROPRANOLOL(propranolol) and VENLAFAXINE(venlafaxine). On 06-Nov-2024, on 9 day after vaccination the patient experienced ABSCESS LIMB(Abscess limb)(Serious: Life Threatening and Caused/Prolonged Hospitalization), ACUTE KIDNEY INJURY(Acute kidney injury)(Serious: Life Threatening, Caused/Prolonged Hospitalization and Other Medically Important Condition), SEPSIS(Sepsis)(Serious: Life Threatening, Caused/Prolonged Hospitalization and Other Medically Important Condition). At the time of reporting, the event outcome of Abscess limb was Recovered/Resolved, Acute kidney injury was Recovered/Resolved and Sepsis was Recovered/Resolved.; Sender's Comments: Sepsis, Abscess limb and Acute kidney injury are unlisted events which are considered unrelated to GSK vaccine Boostrix.
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| 2821161 | 30 | M | MI | 01/16/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
55M72 |
Expired product administered
Expired product administered
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Expired drug used; This non-serious case was reported by a other health professional via call center...
Expired drug used; 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 30-year-old male patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis. On 06-JAN-2025, the patient received Havrix (right arm). On 06-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). 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: 06-JAN-2025. The medical assistant stated that a patient received an expire dose Havrix on the day of reporting in right arm, which led to expired vaccine used. No reactions to report but reporter had questions on how to proceed. The medical information, phone number and transfer was provided.
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| 2821179 | 50 | F | AZ | 01/16/2025 |
COVID19 COVID19 VARZOS VARZOS |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Bursitis, Electromyogram, Eye irritation, Hypoaesthesia, Magnetic resonance imag...
Bursitis, Electromyogram, Eye irritation, Hypoaesthesia, Magnetic resonance imaging; Pain, Paraesthesia, Scan with contrast, Temperature intolerance, Tenosynovitis; Bursitis, Electromyogram, Eye irritation, Hypoaesthesia, Magnetic resonance imaging; Pain, Paraesthesia, Scan with contrast, Temperature intolerance, Tenosynovitis
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Tingling all limbs, mostly RUE. especially digits 1-3 volar Temp sensitivity now. Numbness develop...
Tingling all limbs, mostly RUE. especially digits 1-3 volar Temp sensitivity now. Numbness developing. Stinging burning. Tx GABA mg b complex diclofenac oral. Methocarb. Tenosynovitis. Mass. Bursitis.
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| 2821183 | U | NY | 01/16/2025 |
PNC15 |
MERCK & CO. INC. |
X011735 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE/PQC reported.; HCP stated that the VAXNUEVANCE vaccine expired on 01/10/2025 and wa...
No additional AE/PQC reported.; HCP stated that the VAXNUEVANCE vaccine expired on 01/10/2025 and was administered to a patient on 01/14/2025.; This spontaneous report was received from a nurse and refers to a patient with unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-JAN-2025, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X011735, expiration date: 10-JAN-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). It was stated that the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) vaccine did not have any previous temperature excursions. No additional adverse event (AE) reported (No adverse event). Lot# is being requested and will be submitted if received.
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| 2821184 | M | WV | 01/16/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
445TK |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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Shingrix third dose; late second dose of Shingrix; This non-serious case was reported by a pharmacis...
Shingrix third dose; late second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 445TK, expiry date 09-AUG-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in NOV-2023). Concurrent medical conditions included stem cell transplant and immunosuppression. On 20-DEC-2024, the patient received the 3rd dose of Shingrix. In OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose of Shingrix). On 20-DEC-2024, the patient experienced extra dose administered (Verbatim: Shingrix third dose). The outcome of the drug dose administration interval too long and extra dose administered were unknown. Additional Information: GSK Receipt Date: 20-DEC-2024 and 23-DEC-2024 The pharmacist reported that a patient received third dose of Shingrix, which led to extra dose administered. At the moment of call patient was fine and no reactions. The vaccine administration facility was the same as primary reporter. The patient received an initial dose in November 2023 that facility was unaware of that as it was administered at different facility, after that they administered a second dose in October 2024, which led to drug dose administration interval too long. Health care professional mentioned during the conversation that patient was taking immunosuppressive medication for hematopoietic stem cell transplantation.
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| 2821187 | 70 | F | NC | 01/16/2025 |
FLU3 |
SEQIRUS, INC. |
388487 |
Injected limb mobility decreased
Injected limb mobility decreased
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Patient called in January and stated since one week after receiving flu vaccine right arm she has pr...
Patient called in January and stated since one week after receiving flu vaccine right arm she has problems with movement in that arm. She is visitng doctor for followup and treatment.
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| 2821188 | 0.5 | F | MA | 01/16/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7907AA HR3650 2037482 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Pt. was given vaccines to early. No adverse reactions. (Vaccine administration error)
Pt. was given vaccines to early. No adverse reactions. (Vaccine administration error)
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| 2821189 | 61 | F | OH | 01/16/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y7R27 Y7R27 |
Apathy, Arthralgia, Fatigue, Immediate post-injection reaction, Injection site d...
Apathy, Arthralgia, Fatigue, Immediate post-injection reaction, Injection site discomfort; Nausea
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Patient received the vaccine on 12/9 and immediately started feeling some discomfort as the medicati...
Patient received the vaccine on 12/9 and immediately started feeling some discomfort as the medication was entering her arm. Patient did not think anything of it because she has had vaccines before, and she has some mild discomfort from it but this 1 did feel little different on the administration of the shingles vaccine. As the day progressed, she started feeling tiredness and nausea and had a little bit of reduced motivation to do her day-to-day tasks because of how she felt. She started experiencing left shoulder tenderness at the site of injection by the time she got home about 30 minutes later.
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| 2821190 | F | MN | 01/16/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Blood pressure increased, Bradycardia, COVID-19, Dizziness, Electrocardiogram ab...
Blood pressure increased, Bradycardia, COVID-19, Dizziness, Electrocardiogram abnormal; Headache, Heart rate decreased, SARS-CoV-2 test positive, Serum ferritin increased, Transferrin saturation increased
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Experienced Bradycardia following the administration of Paxlovid for treatment of Covid-19. Began ta...
Experienced Bradycardia following the administration of Paxlovid for treatment of Covid-19. Began taking Paxlovid within 1 day of symptoms and testing positive for Covid-19. I am NOT current on Covid-19 vaccine because I had severe allergic reaction to the booster (3rd dose) and mild reaction after 1st and second doses). The booster caused swelling and hives and blood test results showed elevated levels of iron saturation, and ferritin levels indicating possible hemochromatosis. So, its advised by a healthcare professional that I avoid receiving the Covid-19 vaccine, On day 4 of taking Paxlovid, HR dropped below 39 bpm and experienced dizziness, headache, and lightheadedness, which are still occurring after medication administered was completed on 5. Made an appointment with primary care provider and was given an EKG and it was determined that Bradycardia is present. Blood present was in the hypertension range (150/96) and was told to monitor at home for the next few days as BP is typically in the normal range. If symptoms do not improve within 48 hours, will need ton return to PCP for follow up.
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| 2821191 | 70 | F | CO | 01/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
BP74J |
Condition aggravated, Generalised tonic-clonic seizure
Condition aggravated, Generalised tonic-clonic seizure
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Patient received 2nd Shingrix vaccine in the afternoon. Patient is on seizure medications but a clon...
Patient received 2nd Shingrix vaccine in the afternoon. Patient is on seizure medications but a clonic-tonic seizure had been triggered by the afternoon. Patient knows that this was caused by the vaccine as she experienced a more serious clonic-tonic seizure after receiving the Moderna's COVID-19 vaccine 03/22/2021.
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| 2821192 | 44 | F | OH | 01/16/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
MC7HK |
Injection site erythema, Injection site pain, Injection site swelling, Pain, Pai...
Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
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Employee (patient) states later that evening noticed increased swelling of left upper arm (smaller t...
Employee (patient) states later that evening noticed increased swelling of left upper arm (smaller than the size of a golf ball. Pain and red streaks near injectin site and radiating down to left lower arm. Employee applied ice that evening, took ibuprofen, Benadryl and Zyrtec. Employee reported reaction on 1/16/25 to Nursing supervisor when she returned to work. Employee was sent to Employee Health (per her request for further examination). She does report her Left arm is improving, swelling has decreased and decreased pain. No red streaks noticed going down her left arm, states improved.
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| 2821193 | 51 | F | OH | 01/16/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
74NC9 74NC9 |
Arthralgia, Axillary pain, Mobility decreased, Pain in extremity, Shoulder injur...
Arthralgia, Axillary pain, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration; Asthenia, Mobility decreased, Nervous system disorder; Arthralgia, Axillary pain, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration; Asthenia, Mobility decreased, Nervous system disorder
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Pain in arm, shoulder, armpit and elblow. Unable to lift arm above head or straighten elblow out. S...
Pain in arm, shoulder, armpit and elblow. Unable to lift arm above head or straighten elblow out. SIRVA
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| 2821194 | 68 | M | CA | 01/16/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
N/A N/A |
Cardioversion, Resuscitation, Sudden death, Syncope; Cardioversion, Resuscitatio...
Cardioversion, Resuscitation, Sudden death, Syncope; Cardioversion, Resuscitation, Sudden death, Syncope
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Sudden death of male likely 67 to 68 at time of his initial inoculations. On 10/29/23 victim collaps...
Sudden death of male likely 67 to 68 at time of his initial inoculations. On 10/29/23 victim collapsed while dancing. Ambulance arrived at the scene. He worked in music. I believe he met the criteria of "fully vaccinated" because state mandated these inoculations by August 2021 to attend music events. IMO he was inoculated at clinic. Can't obtain dates, lot, maunfacturer et website DOB-address obtained via online website There is also another report that states different as his DOB.
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| 2821195 | 49 | F | PA | 01/16/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Asthenia, Chills, Respiratory disorder, Sudden death; Asthenia, Chills, Respirat...
Asthenia, Chills, Respiratory disorder, Sudden death; Asthenia, Chills, Respiratory disorder, Sudden death
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Online report of sudden death in female EUA recipient that was weeks away from her birthday. At that...
Online report of sudden death in female EUA recipient that was weeks away from her birthday. At that time of inoculations victim was 49-years-old. DOSE#1 Date 03/11/2021 LOT# ? DOSE#2 Date 04/08/2021 Lot# ?. Victim on 04/21/21 made a social media post-that described post Inoculation (of dose#2) adverse events taking place after day 5 fasting until day 13. She stated her adverse events as chills, temp, weakness and breathing. Despite being active on social medica her last post was on 10/11/21. Victim died in her residence according to obituary. There is conflicting data on city-ounty of victim at time of death, social media profile states as home. Online obituary states another location as place of residence. Estimated DOSE#2 date arrived by subtracting 13 days from 04/21/21 as per victims social media post.
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| 2821249 | 32 | F | PR | 01/16/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FA7484 FA7484 FF2588 FF2588 |
Anaemia, Condition aggravated, Haemoglobin decreased, Heavy menstrual bleeding, ...
Anaemia, Condition aggravated, Haemoglobin decreased, Heavy menstrual bleeding, Hysterectomy; Transfusion, Visual impairment, Vitreous haemorrhage; Anaemia, Condition aggravated, Haemoglobin decreased, Heavy menstrual bleeding, Hysterectomy; Transfusion, Visual impairment, Vitreous haemorrhage
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ANEMIA / LOW HGB / LONG PERIODS WITH LOT OF BLOOD / LOST OF VISION PARTIALLY / HEMORRATIAL VITRIUS
ANEMIA / LOW HGB / LONG PERIODS WITH LOT OF BLOOD / LOST OF VISION PARTIALLY / HEMORRATIAL VITRIUS
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| 2821250 | 61 | F | IN | 01/16/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3J994 3J994 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth; Rash
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Injection site became red, hot, sore, itchy, and swollen. A large rash lasted for over a week. I use...
Injection site became red, hot, sore, itchy, and swollen. A large rash lasted for over a week. I used an ice pack to help with pain; I also took Tylenol.
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