chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure/had shingles several times since the shot; shingles/had shingles several times since the shot; had Covid even with the shot; Received shingles shot at or below 45 years age; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 45-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, covid-19 and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles, covid-19 and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter was 51 years old, no shot had Covid in December. The patient (that's younger than the reporter) had shingles several times since she got the shot. The patient stated that never before.  The patient had Covid even with the shot. Additional supportive information: The patient received Shingles vaccine at inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, Covid-19 event was linked with Shingles shot as this was an interactive digital media case due to which no further clarification would raise.
arm is really hurting / complaining continuously about the pain in his arm; extreme sharp pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really hurting / complaining continuously about the pain in his arm) and VACCINATION SITE PAIN (extreme sharp pain at the injection site) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013A21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B12 AAA), VITAMIN-D (VITAMIN D AND ANALOGUES), DORZOLAMIDE, APIXABAN (ELIQUIS), HYDROCHLOROTHIAZIDE, INSULIN GLARGINE (LANTUS), METFORMIN, LEVOTHYROXINE, LOSARTAN, CELECOXIB (CELEBREX) and LEUPRORELIN ACETATE (LUPRON) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is really hurting / complaining continuously about the pain in his arm) and VACCINATION SITE PAIN (extreme sharp pain at the injection site). At the time of the report, PAIN IN EXTREMITY (arm is really hurting / complaining continuously about the pain in his arm) and VACCINATION SITE PAIN (extreme sharp pain at the injection site) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up received-regulatory authority
Patient felt SOB after vaccine.  No significant medical history, seen by EMS with no intervention needed.  Released to self care.
My mother died on February 19, 2021. She had her 2nd dose vaccine on 2/11, on 2/12 it was noted that she was not able to walk, on 2/13 she was walking at 30%, on 2/14 she was walking with difficulty, on Monday 2/15 she was throwing up violently and her blood pressure dropped, so she was sent to Clinic. My sister was told she was just constipated and she had A Fib (never reported before to us). My sister was then told on 2/16 early a.m. that she had a blood clot that destroyed her colon. Due to age surgery would likely not be successful. She then died on the Friday. We are reporting in the event that the Pfizer vaccine was somehow a contributing factor to the A fib or to the Clot. She has no history of A fib or clotting prior to this incident. She was 93, and did have dementia, but was able to eat normal foods prior to this. What was unusual was the challenge in walking the day after the shot. Other than that no difference was observed until the day she was admitted to the hospital emergency room. She was a resident at Assisted Living, Memory Care, and that is where she received the vaccine. The mailing address I provided is her mailing address prior to death.
Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had experienced headache since his/her shingles injection 3 days ago from the day of reporting. The reporter wanted to know if it was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
devel swelling of leg @ site of DTP w/fever 102-6-7 days later devel irritability, refused bottle & feeding; cry high pitch; PE neg;
developed a heart condition; missed work; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (developed a heart condition) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (developed a heart condition) (seriousness criterion life threatening) and IMPAIRED WORK ABILITY (missed work). At the time of the report, CARDIAC DISORDER (developed a heart condition) and IMPAIRED WORK ABILITY (missed work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported  Treatment medication not reported.   Reporter did not allow further contact; Sender's Comments: This case concerns a 57-year-old male with a serious unexpected event of cardiac disorder, and nonserious unexpected Impaired work ability. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
30hr p/vax pt devel severe pain, swelling & redness @ inj site;48hr pt was unable to tolerate pain;pt was seen @ walk in clinic;told arm infected;started on ATB;
pt recvd vax 2 hrs later lt hand little & ring finger started w/ a tingle & kind of numb; shakes it freq which seems to help the numbness;
rash the size / diameter of a grapefruit; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. In January 2020, 24 hrs after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in left deltoid. The patient developed a rash the size or diameter of a grapefruit, with no swelling on left side shoulder with 24 hours of receiving the 1st dose of Shingrix and events took a week to resolve. The reporter consented to follow up.
Patient came to ED with generalized weakness, shortness of breath, and productive cough.  Patient admitted to hospital with Covid.
The patient received her first dose of the Pfizer vaccine and was waiting in observation when she momentarily loss consciousness. No other serious medical problem or injury occurred while on site.
Vaccination was administered outside of best use time window.  Approximately 1.5 hours outside of the best use time window.
Pt developed cellulitis at site of injection per ER, Tender, red, and swelling 24 hours after vaccinations. Temperature of 101 F at home per Mom, but afebrile in ER. Treated with Keflex. Cellulitis developed at the MMR site.
33 y.o. female with history of asthma, SVT, sickle cell trait, eosinophilic esophagitis, asthma, preeclampsia presenting to ER today with scratchy throat after Covid vaccine.  Patient was observed for a total of 45 minutes, and brought to the emergency room for provider evaluation.  She denies difficulty breathing, difficulty swallowing, throat swelling, drooling or pain.  She denies URI complaints, fevers, chills, lightheadedness, dizziness, nausea or vomiting.   ED Update: She was given famotidine and Benadryl here in the emergency room.  She has no demonstration of hives, rash, induration, or swelling at the injection site.  Differential diagnoses for this patient include allergic reaction, however this is most likely related to anxiety.   Patient had improvement after medications, was able tolerate p.o. without difficulty.  She is no longer complaining of scratchiness in her throat.  She states she has Benadryl at home, recommended she can also take Zyrtec daily.  Discussed worsening symptoms and when to seek immediate care in the emergency room.  Patient verbalized understanding of teaching, feel that she is stable for discharge as she is able to verbalize red flag symptoms.  She is able to ambulate out of ER with steady gait.
Approx 4 hrs following vax pt had onset of vomiting which continued on the average of 15 mins for about 6 hrs; pt also had temp 101 & high pitched whining cry; no hx of adverse rxn following prev vax;
Started 10-10-13 PM and pain in arm, then 10-11-13 AM noticed arm bruising, which progressed then to different colors. Saw gyn doctor 10-14-13 who told her to check in with us - bruise measures 14cm length x 8cm width arm circumference 25.5 cm 6cm down from injection site.
Around 0400 pt was up to the BR and her heart was racing.  At 0800 when she went to get up her legs gave way. She called her family and family indicated her speech was garbled and difficult to understand. Patient was transported to ER on 12/04/2023 by ambulance at 0846. CTA Head/Neck completed on 12-04-2022 IMPRESSION: 1. No significant stenosis or occlusion of vertebrobasilar or internal carotid arteries. 2. Compression of the medulla by hypertrophied atlantoaxial extraaxial joint capsule where there are degenerative changes.  Suggest correlation with MRI.  CT Head on 12/04/2022: 1. Age related changes                                               2. Chronic ischemic disease                                               3. No bleeding   MRI 12/05/2022 : 1.Recent small ischemic infarct n the left sylvian lobe and adjacent parietal lobe.                                   2. Atrophy and moderated chronic small vessel ischemic white matter change.                                  Course by ER MD on 12/05/22 at 1700 -The patient was seen and examined. Speech and neuro exam non focal at discharge.  Pt completed f/u with PCP in a week for a Holter monitor,  BP monitor, and adjustment of hypertensive medications.   Pt had a two week f/u with cardiology on 12/21/2022.  Transthoracic ECHO was ordered by Cardiologist.  01-20-2023- I received a call from the patient on 01/20/2023.  She call the health department to let us know that she had a stroke on 12-04-2022 subsequent to receiving a Moderna Bivalent Booster on 11/29/2022. After questioning the patient as to whether any of the HCP's completed a VAERS form, she indicated they had not.  Her daughter is a PA and thought the patient should call us and let us know.  I instructed the patient the health department would complete the VAERS form and submit it for reporting the incident.  I also instructed the patient that someone from the VAERS system may call her for additional information.
I received the vaccine 10 days ago and the only side effect I had was injection site soreness for a couple of days. Then, yesterday, I noticed a large, circular, reddish, raised, slightly hardened & warm to the touch area on my left arm near the injection site. Today, it has become slightly bigger and redder and there are 2 smaller circles that seem to trail off of it as well.
4-5 hrs p/vax began high-pitched screaming x 1 hr; afterward, cont w/crying;
This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a patient who received Influenza vaccine Quadrivalent unspecified. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified, the patient experienced injection site joint pain. On an unknown date, the outcome of the injection site joint pain was unknown. It was unknown if the reporter considered the injection site joint pain to be related to Influenza vaccine Quadrivalent unspecified. Additional details were received as follows: The reporter stated that she needed to get the Flu shot but had experienced chronic shoulder pain where the previous Flu shot was administered. The reporter asked whether she could receive the Flu shot in thigh. No other information was known, including whether chatter was a health care professional or not, contact information, or the brand of vaccine.
Large red splotch size of baseball. Thick red ring around splotch. Hot, raised, itchy.
Pt. seen in office 9/22/15 for 15 mo WCE and immunizations. Per mom, pt became fussy and began refusing to bear wt/walk next eve. No fever. Seen at pediatric office 9/24/15 -> no edema, redness at hip/knee joints - or - vaccine site. Likely secondary to muscle soreness. Rec -> ibuprofen and observation at time of report.
The following day after receiving the vaccine (March 25th) the patient experienced broadly dispersed hives in the front, side and back of the torso. Most were itchy. One was painful upon scratching it. The patient's mother reached out to the pharmacy a week later on March 31st to report the symptoms and stated that her daughter still had the hives. She gave her daughter Benadryl the evening of the 31st and then reported the next day (April 1st) that the rash had gotten a bit worse. The patient's physician was contacted by the mother shortly after the appearance of the rash and the physician recommended she contact the pharmacy where she received the vaccine as to what to do. After receiving the call from the mother on the 31st the pharmacy attempted a contact with the patient's physician, but made contact on April 1st. The physician's assistant was asked if the physician had seen the patient to evaluate the nature of the rash to possibly rule out any other causes and at that point the assistant recommended that the patient call in to schedule a visit. The mother was subsequently called to let her know what the physician's office had recommended and they will be following up with a visit to the physician.
1 day after vaccination child developed red bumps on chest, back, feet and forehead. Fever x 24 hours, vomiting, no diarrhea. 10/10 father called pediatrician stated probably had something to do with clothes, soap and maybe carpet.
Moderna Dose 1 3/9/21 (003A21A) Moderna Dose 2 4/13/21 (026B21A) COVID Positive 1/16/22  1/17/22: 81-year-old male with history of TIA, seizure with Todd's paralysis, AAA, hypertension, hyperlipidemia and right internal carotid artery stenosis presented with generalized weakness.  Patient reports symptoms started about 3 days ago with generalized weakness, poor appetite and unsteady gait.  Patient reports symptoms have been getting progressively worse as he became increasingly weak having difficulty walking, denies any loss of sensation in his extremities, no facial droop or speech abnormalities. No back pain no recent trauma no abdominal pain, nausea or vomiting.  Denies any UTI symptoms.  Patient is a febrile and hemodynamically stable.  Unremarkable CMP, troponin less than 0.01, WBC 14.6 with hemoglobin of 13.7.  Chest x-ray is unremarkable for acute abnormalities.  Head CT is unremarkable for acute abnormalities.  Urinalysis and COVID-19 PCR pending.  1/20/22: P.o. vitamin-C, vitamin-D and zinc sulfate  P.o. aspirin 81 mg daily  Resume home Keppra 1000 mg b.i.d.  Hemodynamically stable for discharge  Will discharge home with services  Patient and wife agree with plan of care  Follow-up with PCP in 3-5 days
given just a menveo solution not the powder; given just a menveo solution not the powder; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received just a Menveo solution not the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked what to do with it. The reporter consented to follow up. This case has been linked with case US2021AMR170497, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170497:Same reporter
I  started having an reaction after about 6 hours from injection and ended up in the ER. I saw the doctor the same or next morning after dose two with swelling of my left side of neck and shoulder area with headache and nausea. Some heart palpitations.  I went to see the doctor who reviewed the CT neck and chest and it showed swollen nodes from injection site to neck to left upper chest and under left axillary in chain like appearance. . The symptoms remained for several weeks with on and off headaches. He finally prescribe medication for headache and recently repeat CT scans. I also had to get an US and Mammogram to see if it went into my breast tissue. I had to see the Cardiologist who has done two stress tests thus far and now as of today has notice a new heart murmur and is setting me up for an Echo.  No previous history of any heart murmur.
Shortly after receiving gardasil vaccine (<5 minutes), patient was walking to the front of the office to checkout when she became presyncopal. Unclear whether she fully lost consciousness but she became confused, unable to support herself, and limp. Medical professionals were nearby and we were able to lower her to the ground and move her back into an exam room. She was laid on the floor initially, vital signs were taken and stable, and she quickly regained consciousness. She was then moved to the exam table where she remained for 15-20 minutes for further monitoring. All symptoms resolved and she was able to walk out of the office independently.
The patient arrived at Medical Center on 09/23/2021 for AMS x 1 week, and a temp of 102.  In the ED, covid positive, cxray indicated both diffuse interstitial and airspace infiltrates.  CT scan of the thorax without contrast confirmed at least moderate possible severe diffuse ground-glass and interstitial infiltrates consistent with COVID.  US of RLE showed chronic occluded distal vessels with collateral follow.  Patient sent to dialysis, his blood pressure was running low and was lethargic and weak, Oxygen saturations dropped.  Patient then had a rapid response, he was unresponsive with an unobtainable blood pressure.  He then went into a PEA cardiac arrest.  Patient expired on 9/24/2021.
2/19/13 23:24 Pt brought in by ambulance in cardiac arrest, "mother states pt has been having cough & URI symptoms since 5 days - seen by doctor 2/19/13 & given 4 vaccines. Pt sleeping & crying - suddenly pt turned white & was not breathing - 911 called & intubated. Doctor states he was not aware of any illness & child's DILANTIN level was 1.0. No lab found in medical record child revived & transfer to another hospital where child died on 2/20/13.
1/21/22  78 yr old female, presented to the ED  with altered mental status, ill appearance , lethargy, smelling of urine, fever, tachycardic, redness and wounds on both lower extremity, pressure sore on coccyx.  Hypoxic Patient is a lethargic, nonverbal, open her eyes is slightly to the verbal stimuli.  Unable to get any detailed history from the patient. Patient was evaluated at the ER, BP was low 80 x 50, high fever 103.3, heart rate 210.  Presently sao2 92 on 4 L. patient received IV fluids 2 L at the ER.  Patient blood pressure is not improved after the IV fluids.  COVID swab was taken at the ER. Review of Systems: Constitutional:   fever and chills Eyes:  Denies change in visual acuity  HENT:  Denies nasal congestion or sore throat  Respiratory:  ?cough and exertional shortness of breath.  Tachypnea Cardiovascular:  Denies chest pain, palpitations.  Swelling on both lower extremities GI:  Denies abdominal pain, nausea, vomiting, bloody stools or diarrhea  GU:  Denies dysuria  Musculoskeletal:  Denies back pain or joint pain  Integument: Redness swelling on lower extremity, pressure sore on coccyx Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies swollen glands  Psychiatric: Lethargy, advanced dementia  Plan: Septic shock , severe sepsis, complicated UTI, metabolic encephalopathy, lactic acidosis hypotension, nonverbal, lethargy,  -Admitted to ICU -ICU core measures -Suspected sepsis standing orders -IV fluid received at the ER - Patient is heart failurehistory -Pressors to start for low blood pressure, norepinephrine -Consulted to the intensivist for ICU management -IV Zosyn - Procalcitonin - creactive protein - vanco dosing   1/23/22 Hospital Course: She is a 78 year old that was admitted for septic shock secondary to UTI, LLE cellulitis and found to be covid positive. She was started on IV antibiotics and pulmonary was consulted. Her BP did not improve with IVF and she ultimately required 3 vasopressors. She was intubated secondary to respiratory failure. She had acute renal failure requiring nephrology consultation. Family did not want to do dialysis. Her condition overall continued to worsen with a very poor prognosis. Palliative care was consulted and family decided to proceed with comfort measures. Time of death 1830.