chrisvoncsefalvay/vaers-outcomes huggingface dataset:
74-year-old patient received two doses of FLUZONE HIGH-DOSE QUADRIVALENT, one was on 9/13/2021 and 2 month apart second on 11/18/2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Physician via the Regulatory Authority (Reference number- 00864734) and transmitted to Sanofi on 18-Nov-2021.  This case involves a 74-year-old female patient who vaccinated with a 0.7 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date not reported) via intramuscular route in the left deltoid on 13-Sep-2021 and 2 months apart received another 0.7 mL (once) dose of the same vaccine (lot UJ774AA, expiry date 30-Jun-2022) via intramuscular route in the left deltoid on 18-Nov-2021 for prophylactic vaccination (extra dose administered).  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication reported no other vaccines at the time of vaccination.  It was a case of actual medication error due to extra dose administered (latency was on same day as per second dose).  It was reported "The caller wanted to know if there is any concern if a patient was administer 2 doses of Fluzone High dose, 2 month apart. The patient received two dose of Fluzone HD Quad. One was on 9/13/2021, the second was 11/18/2021."  At the time of report, no adverse event reported.  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.
Myalgia CHILLS, SORE RIGHT ARM Narrative:  Other Relevant History:
Information has been received from a physician concerning an "about 16 year" old female who on 10-JUL-2009, around 4:00 pm was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number not reported). Later that same day, at around 8:30 PM, the patient called the office and reported that she felt tired and lightheaded. No lab diagnostic studies were performed. It was noted that the patient had no adverse experiences after the first and second doses of GARDASIL. At the time of the report, the patient's status was unknown. Additional information has been requested.
10/17 lethargy and T=99F.  Runny nose, upper resp. congestion, cough. Then T=102F. Vomited X2. Eyes Burning, Ears congested with decreased taste and hearing.No difficulty breathing. Did not return to normal function for one week.
multiple Hives over entire body; Shortness of breathe; acute asthma attack(s); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 17:30 (Lot number: 32D308N) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vascular Ehlers-Danlos disease" (unspecified if ongoing); "hypermobility Ehlers danlos disease" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Cardiac syncopy" (unspecified if ongoing); "Bilat renal cell carcinoma" (unspecified if ongoing); "Lesions to skull bones" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; METOPROLOL; HYDROCHLOROTHIAZIDE. The following information was reported: ANGIOEDEMA (medically significant, life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "multiple Hives over entire body"; DYSPNOEA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "Shortness of breathe"; ASTHMA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "acute asthma attack(s)". The events "multiple hives over entire body", "shortness of breathe" and "acute asthma attack(s)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of angioedema, dyspnoea, asthma. Clinical Course: The patient did not receive any other vaccine in four weeks. The patient had not Covid prior vaccination. The patient had Covid tested post vaccination. The patient had healthcare providers not to receive the vaccine due to co morbidities but was forced to by employer or lose job. The patient had known allergies. The patient received treatment for adverse event. The physicians appt multiple inhalation thereapies.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Angioedema, Dyspnoea, Asthma and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a clinical trial coordinator concerning a female health care worker (age not reported) at a study site.  On 04-DEC-2006, the patient was vaccinated in the left deltoid with the first dose of HPV vaccine (yeast) outside of the study.  Subsequently, the patient developed discoloration. A band aid was placed over the injection site.  As of 12-JAN-2007, there was still obvious discoloration to the area with visible outline of the band aid.  The patient stated that she had never had this happen with a band aid before.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Pfizer Dose 1 4/8/21 (EW0161) Pfizer Dose 2 4/30/21 (EW0161) COVID Positive 12/25/2021  12/25/21: This is a 54 yo female patient who presented to the ED this evening because of fatigue  Patient has a history of COPD, chronic diastolic heart failure, end-stage renal disease on peritoneal dialysis, depression  She is currently dependent on oxygen, wears 2 L of oxygen at home  She reports intermittent shortness of breath but currently is breathing comfortably on her home dose of oxygen requirement  She reports diarrhea and decreased appetite. She denies chest pain, abdominal pain. She reports being vaccinated against COVID with Pfizer however is not sure if she received her booster as of yet because she does not know where to go to receive this  States all family members are positive for COVID-19  Chest x-ray in the emergency department shows patterns consistent with COVID-19 pneumonia  She was given IV antibiotics in the emergency department  1/5/22: 59-year-old female admitted for COVID pneumonia complicated by acute hypoxemic respiratory failure, unresponsive episode requiring Code Blue, cardiopulmonary arrest status post CPR with successful ROSC. She was intubated and sedated and spent time in the ICU from 12/26 to 12/29. She was started on IV steroids, antibiotics and antivirals. Patient was placed on hemodialysis instead of regular PD so she could receive IV remdesivir.  However, remdesivir was discontinued due to elevated liver enzymes. She has underlying poorly controlled hypertension and COPD chronically on 2 L oxygen at home, ESRD with PD dependence, chronic pain disorder on methadone protocol initiated opiate dependence.  Patient improved and is no longer requiring any supplemental oxygen.  Nephrology has plans to switch the patient back to peritoneal dialysis, hemodialysis catheter was removed.
chickenpox like scabs / chicken pox like bumps; itchy, chickenpox like scabs / one itchy, scab on her back; big red rash; chickenpox like scabs appeared on her upper right arm; blisters on her right arm; her lungs felt like they were closing-up / her lungs were caving; itchy rash on her left arm near injection site; This case was reported by a consumer and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchiectasis (diagnosed about 1 year ago).   On 7th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th December 2020, 8 hrs after receiving Shingrix, the patient experienced rash. On 10th December 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced varicella-like rash, pruritus, red rash, scab and blister. On 8th January 2021, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the difficulty breathing and pruritus were recovered/resolved and the outcome of the varicella-like rash was not recovered/not resolved and the outcome of the red rash, scab and blister were unknown.   It was unknown if the reporter considered the rash, difficulty breathing, varicella-like rash, pruritus, red rash, scab and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had itchy rash on her left arm near injection site that appeared the night of the injection.  The rash completely faded about 1 and 1/2 weeks after the Shingrix injection. After 3 days of Shingrix shot, her lungs felt like they were closing up. The health care provider gave her a CAT (computerized tomogram) scan that was negative.  After 2 weeks of vaccination, the patient had itchy, chickenpox like scabs appeared on her upper right arm and there were only a few and the scabs came and went.  The patient had chicken pox like bumps and blisters on her right arm. The patient also reported one itchy, scab on her back. The patient experienced a big red rash and also felt like her lungs were caving. The patient was inquiring about if this had anything to did with her Shingrix vaccine The reporter did not consent to follow up and no permission to contact health care provider and did not want GSK to call her for any reason and would not give address. The caller did not provide a phone number or mailing address and did not provide consent to contact her health care provider. Discrepancy note:In SD TTO is provided but for code 805 we do not have cheatsheet code, probably it is 8 hrs, so we kept TTO as 8hrs for rash and pruritus.
Patient came in 8/20/21 to get her first dose of Moderna vaccine. Consent form was verified and screening questions were asked. Patient was waiting the required 15 minutes post vaccination and within 5-7 minutes of the post vaccination wait time, patient stated that she was feeling light headed and was going to faint. The pharmacy staff alerted store management and called for medical attention. After stating that she wasn't feeling well, the patient laid down on the floor and fainted for few seconds (5-10 seconds), brief convulsions observed. The patient was alert within a few seconds, able to talk to the pharmacist/ answer questions. The patient called family members while waiting for medical attention to arrive. The patient was continuously being fanned, given an ice-pack and water. The emergency services arrived within 10 minutes as well as the family members. EMS checked patient's vitals and all vitals were within range. The patient went with emergency services to get a complete check up at the hospital.
sore throat & chest congestion, sore arm for a few days;sneezing, runny nose, no fever;
Rash on feet and body, itching July 17-21, 2008 rash spreading by July 23, 2008 Pt saw nurse practitioner in July 23, 2008 adn was excused from work until July 28, 2008
Patient started having  generalized body weakness and fatigue few hours after vaccination on 05/22/2021. He subsequently developed chest pain on 05/23/2021 which progressively worsened and resulted in his presentation at the emergency room on 05/25/2021. While in the ED, Troponin was elevated at 17.22. EKG done had revealed ST elevations with PR depression. Cardiac MRI done showed myocardial edema involving the mid/apical lateral wall suggestive of acute myocarditis/inflammation. Patient received a loading dose of Colchicine and Ibuprofen as anti-inflammatory agents. Troponin was trended and peaked at 23.60 and slowly down-trended to 1.84 on 5/28/21 and he was subsequently discharged to follow up as outpatient.
Mild angioedema - swelling, itching, redness of ears, mild rash on upper chest. Resolved with 50mg Benadryl, 10 mg of singulair, 20mg of Zyrtec
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe
The morning of February 21, 2021, I started having severe burning in my chest and in my back. It prevented me from sleeping without sitting up. I did not report to work for 3 days. I thought it was gastrointestinal since I already had covid in November 2020. After having another covid test on March 1, 2021, after being fully vaccinated, I tested positive for covid again. That prevented me from having a scheduled colonoscopy. I eventually had my routine colonoscopy on  April 2, 2021 at the Clinic.
Local swelling, induration and erythema, next day. URI sx next day with low grade fever (100.4). Treated for possible cellulitis in ER 2 days after. Improving when I saw 4 days after.
Information has been received from a registered nurse concerning a 12 month old male patient with no medical history who on 1/5/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644722/0072N). Concomitant vaccine therapy administered on 1/5/04 at the same appointment included a dose of MMR and hepatitis B virus vaccine (+) HIB conjugate vaccine. On 1/26/04 the patient developed 50+ lesions all over his body, fever, and malaise. The physician prescribed diphenhydramine hydrochloride, calamine lotion and acetaminophen as treatment. It is unknown whether laboratory studies were performed. There was no product quality complaint reported. Additional information has been requested.  As per follow up report: the additional information included lab study results for varicella zoster virus antibody ICM which was reported high at 6.35 ISR, varicella zoster virus antibody IGG which was reported positive with a result of 1.72 EIA, and blood culture results which showed no growth after five days. It was noted that the patient recovered. There was no product quality complaint reported. No additional information has been requested.
Information has been received from a Registered Nurse concerning a female patient (age not reported) who on had received the 3rd dose series of RECOMBIVAX HB (dates, dose and site not reported) as routine vaccination. The Nurse reported that the patient "had titers drawn recently which showed a level of 5 which is not immune". No treatment was given. The patient was seen in the medical office. Relationship between Hepatitis B surface antibody negative and therapy with RECOMBIVAX HB was not reported. Additional information is not expected as no consent for follow up was obtained.
Mother stated late afternoon on 09/28/2017 she had noted a red spot on the left arm (Deltoid area) where her son received his vaccination. It appeared to be the size of a golf ball in diameter. It was warm to the touch but not painful no other symptoms where noted. Mother asked what she could do. I advised her to place a cold pack over site on a rotation of 30 minutes on and off. Children's TYLENOL or MOTRIN per label use as needed. If itching occurs can use Children's BENADRYL as needed. If she has more concerns she can contact her doctor or if after hours see a doctor at a local ER.
No treatment. Symptoms include arm pain, pain the radiates from shoulder down causing decrease usage, numbness.
Diagnosed with COVID; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). At the time of the report, COVID-19 (Diagnosed with COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Child administered Tdap vaccine. He became pale slumped to right side making a jerking movement with his legs and arms. His eyes rolled slightly back. This event lasted less than 2 seconds. His father and I talked to him. He stated he was scared. He complained of nausea, headache. He ambulated with assist to exam room & assisted up to exam table. He lied down for 15 minutes. BP 90/56 P 100. After 15min. increased 110/68 P 80. He felt normal.
sometimes I don't remember very well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "sometimes I don't remember very well".
got shingles but I had been vaccinated/suspected vaccination failure; shingles on right hand; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got shingles but she had been vaccinated so the patient did not know if the case had anything to do with that but only had it on right hand. It was not that bad. But the patient know how bad it was. That was the reason the patient got the vaccine in the first place. The patient's  hubby got it on his face and head. It was bad. The patient had go pick him up a prescription that when got her shot. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided. Note:Since narrative did not specify if the reporter's husband was vaccinated or not, only a single case was considered for the reporter themselves.
Pain in entire left arm extending into hand & fingers; left upper back pain; fever 101.5; body aches; extreme headache; nausea today 9/25/18.
Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Fever, chills, sore arm. Stuffy nose. All starting at around 2:30 am.
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-FEB-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician at a family practice for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Information has been received from a registered nurse concerning a 12 month old male fussy with decreased appetite and who on 05/24/2004 was vaccinated with a first dose of varicella virus vaccine live subcutaneously.  On 06/03/2004 the patient developed seven lesions, left cheek, right ankle, and left foot.  On 06/11/2004 the patient recovered.  Additional information has been requested.
I still have pain at injection site on my right shoulder. I have discomfort when raising or rotating right arm. The pain has not subsided or reduced since I have been administered the vaccine on 10/17/17. I have been taking OTC naproxen to alleviate some of the inflammation, however, it has not helped.
lower extremity cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (lower extremity cramps) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Jan-2021, the patient experienced MUSCLE SPASMS (lower extremity cramps). At the time of the report, MUSCLE SPASMS (lower extremity cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
In early January I was experiencing a rash with severe itching and bruising with loss of sleep due to symptoms which I thought was an exacerbation of my atopic dermatitis.  I completed a 10 day Prednisone tape on top of treatment with topical Triamcinilone, Atarax, Xyzal.  I was able to see a dermatologist on February 14th after continued issues without resolution of symptoms and was instead diagnosed with Urticaria.  Because this issue is different from my already diagnosed illness and realizing the timeframe in which it started I thought it should be reported just in case there is an association with my booster dose of Moderna Vaccine.  I am not being treated with Triamcinilone topical, Atarax, Triple doses of Cetirizine and a 21 day slow Prednisone taper.