chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She seemed off since being exposed. Kept her at home and away from others while she got better. She was a text book study. Pink eye, fever, sore throat, photophobia, rash... The rash showed up about a week later. Severe photophobia. Her fever got up to 105 for only 30 minutes and then went down after we gave her a bath to bring the fever down and gave her homeopathic remedy to bring it down. It did. We almost went to the hospital but called again and they said as long as it was going down and she was functioning, eating and drinking, just to keep an eye on her. It took a few weeks to get over. Gave her homeopathic remedy Euphrasia 30x and it helped alleive the pain of photophobia during that time. Then homeopathic remedy Belladonna 30x for the high fever, which she responded to very quickly any time her fever came on. And to get the rash to go away Sulphuricum Acidicum homeopathic remedy 30x. She wasn't itchy.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that doses of GARDASIL (lot number, expiry date, dose and route unspecified) were exposed to 80 degrees Fahrenheit for one day and above 46 degrees Fahrenheit for unspecified amounts of time from 01-OCT-2013 to 31-OCT-2013 which was not supported. It was unsure if any doses were administered. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Patient recieved Pneumovax and influenza in left arm. Reports significant pain and hives of left arm x 1 week. History of influenza vaccine without incident.
Left thigh upper leg with large reddened welt covering entire upper muscle - right lower leg - outer aspect with large welt - temperature 101.1 at this time.
Patient is a 81-year-old male was admitted with complaints of ankle pain.  Patient was attempting to move from 1 chair to the other he hit his ankle he did not lose consciousness.  Because of the pain he brought to the ER when he came to the ER patient vitals have been stable. Trauma work-up done including left foot x-ray no acute process. Right foot x-ray diffuse soft tissue edema chronic deformity of mid right fibula compatible with healed fracture left ankle x-ray diffuse soft tissue edema. He was found to have AKI, rhabdo. Asymptomatic Covid 19 on routine screening for discharge at the request for SAR. He was kept on Ativan, Haldol and Thorazine for agitation.  He was certified by the psychiatrist.  Currently awaiting placement.  Incidentally, patient was noted to have swabbed positive for COVID-19.  He is currently admitted as psych facility will not take him till he is off COVID precautions.  He does not have any upper respiratory symptoms at this time.  No fevers or chills.  No chest pain or shortness of breath.  He mentions to have received 2 doses of the vaccine in 2021.  When I examined the patient, he did not want to go into details of why he was having homicidal and suicidal ideations. Pt medically cleared for discharged via EMS transportation. DCP coordinated and arranged by psych. No other needs.
After my vaccination I went home and in about two hours afterwards, I started to feel dizziness and fatigue. I also started to feel muscle pain. I had to lay down for the rest of the day. The next day I could not move and my body was very painful and stiff. It was so bad that I could not clean myself. I then went to the emergency room and after bloodwork I was prescribed Prednisone and a muscle relaxant. I was also instructed to talk to a rheumatologist due to the inflammation that I was suffering from. The Prednisone helped a bit but not a lot. The rheumatologist that I visited took a lot of blood, and diagnosed me with Polymyalgia Rheumatica.  I had been given a steroid to help with preventing me from having a stroke or going blind. They did a biopsy and showed negative for PMR however the blood work still showed I was in parameters for PMR. Actemra injection was suggested however the Prednisone was keeping my symptoms controlled. Today I am only taking the Prednisone when I have a flare up. I am still receiving infusions of Actemra every month.
Approximately after one week of my second dose I began having heart palpitations. Over the course of the next month the palpitations increased from 1-2 a day to 4-5 in a day. I recently visited my primary care physician and refered myself to a cardiologist which I am waiting at this point to see. (July 16 2021 today). As of the last week I have actually been feeling better and have only had minor episodes but will still see the cardiologist. But there is no doubt that this was brought on by the second shot.
Employee reporting disturbed sleep at night secondary to pain at injection site.  She is reporting that she experiences some numbness from shoulder to elbow at night.  States upon questioning that she has full range of motion to left arm during daily activities.  Primary concern voiced by employee is numbness and disturbed sleep.  States she takes Ibuprofen on a regular basis, and this has not had any effect on the nightime discomfort.  Advised to follow-up with her primary care physician.
MOC boyfriend was babysitting;child was shaking & turning purple;boyfriend called 911 & amb came for child;tx in ER w/shot;child had T104 in ER;MOC told inc fever caused by ear infect not immun;
On 6/25/99, the pt developed a red, itchy spot on right arm. On 7/18, she had developed numerous spots on extremities; easy to bruise. On 8/5, her left leg was swollen. On 8/24, she was dx with leukocytoplastic vasculitis. Treated with oral antibiotics.
8/23/08 PT. EXHIBITED REDNESS, SWELLING, HEAT OF L UPPER ARM. 8/29/08 C/O DIFFICULTY BREATHING FOR 5 DAYS.  SYMPTOMS HAVE RESOLVED.
Three days after receiving the first injection I began experiencing tingling in my hands and feet, occasionally random on my legs and arms. This was not continuous, but sporadic throughout the day. There are days when it seems to subside but I continue to have tingling and sometimes pain in my hands, fingers and feet. I did receive a second dose on 1/29/2021. That injection was painful and my arm was sore for 2 days. On 1/30/2021 I experienced chills and ran a temp of 100 for most of the day. I took acetaminophen to reduce the fever.
CHILLS; BRONCHOSPASM; This spontaneous report received from a patient concerned an 80 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included slight cough. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bronchospasm. Laboratory data included: Chest X-ray (NR: not provided) Clear lungs. On 10-APR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and the outcome of bronchospasm was not reported. This report was non-serious.
Patient was administered an expired vaccine; vaccine had expired on 12/16/2022. No adverse reaction to vaccine.
Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA824A, expiry date February 2025) for prophylaxis.   On 1st March 2023, the patient received Menveo. On 1st March 2023, 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 Information: GSK receipt date: 02-MAR-2023 Reporter comment: The reporter reported that, the male patient received only the diluent component of Menveo (2 vials presentation) without being properly reconstituted. The health care practitioner declined to provide patient´s details. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up Additional Supportive Information: The patient received only the diluent component of Menveo (2 vials presentation) without being properly reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Developed itch bump 1 week after 1st injection. Skin became crusty and peeled.  Unsure if it just exacerbated my Skin condition
death R65.10 - SIRS (systemic inflammatory response syndrome) N17.9 - AKI (acute kidney injury)
3 hours after receiving the second dose of the Pfizer vaccine, patient broke out into diffuse, erythematous and pruritic rash although by exam not consistent with hives. I saw the patient 4 days later and her symptoms were persistent and she was fearful to seek care because she thought steroids might blunt her immune reaction to the virus. She has had multiple similar rashes when she has taken new drugs, specifically antibiotics and antiestrogen therapy for history of breast cancer. She has required oral steroids before for similar rashes.
Information has been received from a medical receptionist concerning a 76 year old female with no pertinent medical history and no drug reactions/allergies who on 13-JAN-2009 was vaccinated IM with PNEUMOVAX 23 0.5ml (LOT# 658449/0989U). Concomitant therapy included alendronate sodium (MSD), NAPROSYN, hydrochlorothiazide (manufacturer unknown) and EVISTA. On 13-JAN-2009 the patient developed a "knot" at the injection site that is red, hot and bruised. The physician had ordered warm compresses and AUGMENTIN and unspecified labs. At the time of reporting, the patient was recovering from the adverse event. It was reported that the patient sought medical attention: office visit. Follow up information was received from a medical receptionist concerning the 65 year old female patient with no known allergies who on 13-JAN-2009 (at 11:30 am) was vaccinated in the left arm with a dose of PNEUMOVAX 23 (lot# 658449/0989U) in physician's office. Concomitant therapy included DYAZIDE, alendronate sodium (MSD) and EVISTA. There was no illness at the time of vaccination. On 15-JAN-2009 the patient experienced left arm warm to touch, red swollen knot (3 inches x 1 inch), body aches and "could hardly get out of bed". Laboratory tests were performed (CBC, BNP, TSH), but no results were provided. The patient was placed on AUGMENTIN, 875 mg, twice a day, for 20 days to treatment the adverse effect. The patient recovered on 28-APR-2009. The reporter considered the adverse events to be other important medical events as they required medical/surgical intervention. No further information is available.
02/14/2021: Presented to the emergency department with shortness of breath and lower extremity edema. Imaging showed pulmonary edema, and patient was admitted for inpatient hemodialysis (ESRD on HD prior to arrival) and monitoring.
Patient recieved vaccination at 1300 hours, at 1900 hours had edema and erythema in area, took 50 mg Benadryl, at 1300 hours pt awoke with worsening edema and erythema up neck and down arm.
woke up Sunday after receiving the 2nd dose on Wednesday with hive clusters all over my body with extreme itching and throat tightness. i sought emergency medical treatment at Er. The shot being the only thing to change in my routine in the course of a few weeks. i was treated with IV solution, Benedryl, Reglin, Pepcid and steriod. I was sent home with oral steriods. A day later the hives have gone away but still have some itching.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 70-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 14-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804108 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Shortly after vaccination, patient began developing low grade fevers, sore throat/throat discomfort, as well as worsening substernal chest pain that was worse with inspiration by post-vaccine day 2.
No adverse event; The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine (All previous vaccinations were Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 12-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported.  The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 and supposed to receive the new Moderna COVID-19 bivalent vaccine, but ended up receiving the 6 to 11 year dose that can be used as a booster dose for 18 years and older. The patient had not experienced any adverse reactions so far. The patient did not had vaccination records available at this time.  No treatment medications was reported.
have experienced muscle soreness that radiate through the neck.; This is a spontaneous report from a contactable pharmacist. A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included shoulder injury from an unknown date and unknown if ongoing, shoulder operation from an unknown date and unknown if ongoing (Operation of the injured arm). The patient's concomitant medications were not reported. The pharmacist reported that after their 1st dose, the patient experienced muscle soreness that radiate through the neck on May2021. The reporter mentioned that they are not certain if the adverse event was due to the vaccine administered or a shoulder injury. The reporter would like to know if they can administer the vaccine on the same arm where the 1st dose was given. It was also reported that patient was about to receive second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Breakthrough case admission after 2 vaccines Pfizer 2/10/21 Lot# EL9267;  Pfizer 3/3/21 Lot# EN6205
knot, rash, itching, redness @ site of inject began w/in 1-2 days p/inject; referred to MD 6 days p/inject;
Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 05-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid) was resolving.            No Concomitant product use was reported.  It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient experienced rebound of symptoms on 13-May-2022 12 PM, 2 days after treatment with Paxlovid.  The device date reported as 19-May-2022.  Company Comment: This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred on an unknown date after receiving mRNA-1273 Vaccine as fourth dose in the COVID-19 vaccination series.  Patient experienced rebound of COVID-19 symptoms 2 days after completion of COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid).  No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred on an unknown date after receiving mRNA-1273 Vaccine as fourth dose in the COVID-19 vaccination series.  Patient experienced rebound of COVID-19 symptoms 2 days after completion of COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid).  No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Information has been received from a registered nurse concerning a 21 year old female patient who on 07-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659182/1757U) 0.5ml intramuscularly. On 14-JUL-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 660389/1968U) 0.5ml intramuscularly. Concomitant therapy included YAZ. The nurse reported that the patient developed dizziness, nausea, some shortness of breath and heaviness in her chest after the first two doses of HPV vaccine. The nurse reported that the symptoms were worse after the second dose. The patient was observed in the office for 20 minutes after the vaccination and then was discharged home when all symptoms resolved. At the time of the report, the patient had recovered. The patient sought medical attention. Additional information has been requested. This is in follow-up to report (s) perviously submitted on 8/14/2008. No futher information is available.
Patient presented to clinic for COVID-19 booster vaccine. Vaccine was not diluted and given to the patient. Patient received just under 0.3ml of non-diluted vaccine. Patient was monitored for 20 mins before patient decided they wanted to leave and they were fine. Were instructed to seek medical attention  if an adverse event started to occur.
After pt was administered the vaccine pt. Returned to work area upon returning the pt proceeded to eat breakfast it was at that time the pt began to feel clammy and hot and very short of breath and tightness in the airway.
This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (exact dose and route of administration were not reported; lot # N012492 with the expiration date of 17-MAR-2018), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered dose of ZOSTAVAX experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 28 hours and 14 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported.
After 1st dose:  rash at the injection site; about a 4 inch oval and then spreading down to my elbow; some itching; some swelling, very sore After second dose:  8 hours after the injection  - chills; 10 hours after the injection - severe vomiting for 6 hours (I had 10 episodes of vomiting, mostly painful dry heaves)
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 48 years old female patient who received expired 0.5 ml dose of vaccine IMOVAX RABIES (lot number not reported) via intramuscular route in unknown administration site on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitant vaccines were given. It was a case of actual medication error due to expired vaccine used. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
In December 2022 I had a mild sore throat and began to lose sense of smell and taste.  I tested positive for COVID-19 on December 10, 2022.  I drank fluids and rested.  On December 15th I went to the emergency department because there was blood in my urine.  I was referred to a urologist.  On December 17th I went back to the emergency department in an ambulance because my wife said I was confused, disoriented and still blood in my urine.  I was diagnosed with sepsis.