chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold sore on his lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; tired; fever; shivering; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix, the patient experienced fever, shivering and nausea. On 17th December 2020, the patient experienced tiredness. On 21st December 2020, the patient experienced cold sores lip, hives, pruritus facial and lip pruritus. On an unknown date, the outcome of the fever, shivering and nausea were recovered/resolved and the outcome of the tiredness, cold sores lip, hives, pruritus facial and lip pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, shivering, nausea, tiredness, cold sores lip, hives, pruritus facial and lip pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient reported that, same night after receiving the vaccine he had fever, shivering, and nausea and these have resolved.  On next day in the morning, the patient was tired, and this was still ongoing at the time of reporting.  5 days after receiving the Shingrix, he developed a cold sore on his lip, hives and itching around his left eye, hives and itching on the left side of his face from the eye down to the lip and these were all still ongoing at the time of reporting.  The patient reported he used a cold washcloth on his face and lip for the hives and itching. The reporter consented to follow up.
I received my second dose of the COVID-19 vaccine on 05/12/2021, two days prior to expected menstrual/period. I received my period as expected. HOWEVER, my next period was supposed to occur on 06/10/2021. I am 10 days late, and have been experiencing mentsrual cramps in my low abdomen and back pain for two weeks, with no period. My period has been late one other time in 27 years of life, and only by 5 days. I have never had such a late period, and I am not pregnant.
My throat was sore, I broke out in hives and it lasts less than 24 hours.  My upper left arm is swollen and pain in the entire arm.  Having a bad headache.
This is a spontaneous report from a contactable consumer reporting for himself. A 67-year-old male patient received the first single dose of PREVNAR 13 (lot N16562, expiry date 31Oct2017) on an unknown date in the morning in early Nov2016, in left arm, for immunisation. No other vaccines administered on the same date. Medical history included ongoing cholesterol diagnosed 10 or 12 years before the report (she was getting yearly or semi-yearly blood checks and everything was very good, nothing out of zone as far as his numbers for his cholesterol), they discovered a thyroid nodule and removed half of his thyroid in Dec2012 (he was seeing an endocrinologist for it), ongoing blood pressure abnormal diagnosed 10 years before the report, ongoing low testosterone diagnosed 3 years before the report, ongoing folliculitis with ongoing scalp itch (he had tried about a dozen different products, has had it for about five years), allergies to clindamycin phosphate (Manufacturer: Perrigo, topical solution, used the product Plangent to apply clindamycin phosphate, liquid in a swab, round thing about size of jar lid, NDC number: 45802-263-37, probable expiration date Feb2018, additional number near expiration date: 6CT0548) and to other unspecified medicines (he had ongoing breaks out for his allergies, sometimes he got a cream or salve and antibiotics; the break out cleared up and he broke out again; he had tried many different creams and antibiotics that stops itching and breakout rash but it comes back a month later). The patient previously took influenza vaccine in 1973, in right arm, for immunization; then he got about one a year in fall. He got for immunization also tetanus vaccine (last one was six to ten years before the report) that really hurt when getting it. Concomitant medications included oral atorvastatin 20 mg, 1 tablet/day, ongoing since about 10 years before the report or more, for cholesterol, oral L-THYROXINE ongoing at 88 ug, 1 tablet/day, for low thyroid levels because of removal of half of thyroid, oral DIOVAN 80 mg, 1 tablet/day, ongoing since about 10 years before the report, for blood pressure, topical ANDROGEL (strength 20.25 mg) in shoulder and upper arm, 3 pumps of gel per day (explained as a 75 g pump 1.62%), ongoing for low testosterone and montelukast from 13May2017. The patient experienced arm pain (where he received the suspect vaccine) in Nov2016 and limitation of arm movement (moderate) on an unspecified date. He was able to move arm above shoulder but not above head as he had pain when raising the arm above the head. Reaching down and stretching arm to pick something up could send a real sharp pain at point of injection. In the last two months the limitation of movement in his arm had got more bothersome. He went to the doctor for another check-up issue and asked his doctor about his arm. It was like "when you get a sore and hurts for a little while and it gets infected and start to notice it". Right now it felt like "he had the shot yesterday or this morning", he had a constant sore arm. The pain took 1 to 2 minutes to subside. Events had not yet resolved at the time of report.
Pt received Tdap and varicella and passed out. Hit forehead on wall and recieved a lacaration steri strips were applied Pt c/o dizziness and pain. Pt stayed in office 20 to 30 min and was ok to leave per Dr. After pt had no complaint of dizziness or pain. Mom is a nurse an made a f/u phone call the next day to report child is fine.
Arm two times it size. High fever. Aches, very red. BENADRYL and aspirin.
Resident had tested positive for covid-19 on 12/9/2020.   She had received the Pfizer vaccinations on 1/3/2021 and 1/23/2021.  She has tested positive again on 8/9/2021
Site of injection became red, swollen & patient reported itchiness within 5 minutes of administration of vaccine
contacted covid 19 with severe symptoms 4 months after finishing his vaccine; contacted covid 19 with severe symptoms 4 months after finishing his vaccine; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications in two weeks. The patient did not have COVID prior vaccination. The patient reported that he contacted covid 19 with severe symptoms 4 months after finishing his vaccine, on 30Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included Covid test post vaccination nasal swab, result: inconclusive on 30Apr2021. The patient received apixaban (ELIQUIS) as treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.
Headache-persistent  Weakness x 48 hours Fatigue x48 hours  Body aches x48 hours Arm pain swelling and redness persistent
While waiting 15 minutes after the injection, I begin to feel my heart bounding. I checked my heart rate on my Apple watch, it was 165. The heart rate slowly came down  to the 120's after approximately 30 seconds and remained their for thirty minutes. I felt better  and left the vaccination location. Shortly after, while driving home my heartrate went up to 152 for approximately the same amount of time  so I drove to my doctors office and explained what happen. They told me to go to the emergency room. By then my heartrate was 109 and I was feeling better. I did not feel the need to go to the emergency room, which I live less than a mile from the nearest hospital. Eventually my heartrate settled at 70-80's nearly 4 hours after the event.
Developed cough and throat tightness, difficulty breathing, inability to talk.  Seen at local emergency department and treated for anaphylaxis
This case was reported by a nurse and described the occurrence of injection site necrosis in a 4 month old female patient who had received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined injection for prophylaxis. In 2/04 the patient received the first dose of Pediarix at a dose of 0.5mL administered in an unknown leg. At an unknown time after receiving Pediarix, in February 2004, the patient developed an indentation of the muscle mass at the injection site which was a little smaller than the diameter of a dime. The examining physician referred to the reaction as muscle necrosis. The events were unresolved. The nurse considered the events were possibly related to vaccination with Pediarix. The case was assessed to be medically serious (OMIC). Follow up on 05/21/04 states: "These events were not reported to the vaccine provider until 04/07/04.  Upon follow up the nurse stated that it was fatty necrosis secondary to vaccination with Pediarix. No information regarding treatment was provided by the reporter. The events were unresolved. The nurse considered the events were possibly related to vaccination with Pediarix. The nurse stated that the pt belatedly received the second dose of Pediarix on 04/23/04 without incident. Injection site atrophy was assessed by manufacturer to be medically serious (OMIC)."
So my arm hurt for 9 weeks after the  first covid vaccine and I finally decided to go to ortho to get a checked out. They ordered an MRI and it showed so much inflammation in my shoulder that the NP thought I had severe trauma to my shoulder. I am a nurse and I believe the person that gave me the vaccine gave it to high up in my arm.  Improper vaccine administration  vs an actual Covid vaccine side effect that caused the inflammation??  I?m currently still in therapy and was recommended a cortisone shot.  This incident may lead to permanent damage/disability- only time will tell. We did take two weeks off of therapy to see how I would do without it and my range of motion has by 15 degrees in that time.
Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 08-MAY-2012, the patient was inoculated at a medical center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-SEP-2013, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages. and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses. and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient age and gender unknown.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  The nurse reported that the patient received the third dose of GARDASIL 9, (route and lot # unknown) for prophylaxis on 29-NOV-2016 which was earlier then recommended.  No adverse event was reported.  The outcome of the event was unknown. Additional information has been requested.
she reports that no adverse events were reported by the patient; Patient under 19 was given the adult dose; Product administered to patient of inappropriate age; This spontaneous report was received from a physician assistant and refers to a 18-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-JUL-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) 1 mL (dose for adult patient instead of pediatric dose) (product administered to patient of inappropriate age) administered in his left arm, lot # T017179, expiration date 26-OCT-2021 (route of administration and anatomical location were not reported) for prophylaxis (inappropriate dose of vaccine administered). No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T017179; expirationdate: 26-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 4th September 2018, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced product administration error. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and product administration error were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient reported that that she had her dose of SHINGRIX vaccine in her left shoulder area with the flu vaccine, which led to product administration error. It was sore as she expected but it was okay. For tolerance of 2nd dose refer case US2018223354.
Nausea, fever up to 103.6 while on tylenol and ibuprofen, chills, tingling hands and feet, terrible headache
autoimmune hepatitis; This serious case was reported by a consumer via sales rep and described the occurrence of autoimmune hepatitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced autoimmune hepatitis (Verbatim: autoimmune hepatitis) (serious criteria GSK medically significant). The outcome of the autoimmune hepatitis was not reported.   It was unknown if the reporter considered the autoimmune hepatitis to be related to Shingrix.     It was unknown if the company considered the autoimmune hepatitis to be related to Shingrix.   Additional Information: GSK Receipt date: 30-JUL-2023 The reporter self-reported that she been diagnosed with autoimmune hepatitis after first dose of Shingrix and she did not receive second dose of Shingrix.  The reporter agreed to follow up from GSK.
COVID-19 Vaccine EUA; Chills, Sweats, fever, Vomiting, headache, joint pain, muscle pain
Body aches; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Slight fever) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03212A, 039K20-2A and 071R21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Slight fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.  The patient had no adverse reactions after booster shot.   This case was linked to MOD-2022-467403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow-up information included no new information.
received first dose of the vaccine on 19Dec and tested positive on 30Dec; received first dose of the vaccine on 19Dec and tested positive on 30Dec; This is a spontaneous report from a contactable nurse reported for herself. A female patient on unknown age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not provided. On 30Dec2020 the patient experienced tested positive for COVID-19. It was reported that the patient is scheduled to have her 2nd dose on 09Jan2021however she's been getting roundabout information on what to do in her case. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.
7 months after receiving first dose of Pfizer mRNA injection on 03/07/2021 patient was diagnosed with Hepatocellular Carcinoma. Lesion measured 1.5 cm x 1.5 cm on October 11th, 2021. On November 30th lesion was removed by liver resection and measured 2.1 cm x 1.8 cm. The indicated growth rate of lesion puts disease start shortly after Pfizer injections. Prognosis uncertain, patient will be monitored with scan every 3 months.
injection site pain; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 22Feb2021 14:30 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No known allergies, no allergies to medications, food, or other products. On 23Feb2021, the patient experienced injection site pain next day. The patient did not receive any treatment for the event. The seriousness of the event was non-serious. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Mom states that she noticed last evening (1/13/10) that is right arm was swelling and a little red, pt was warm to touch as if low grade fever.  Mom states this morning (1/14/10) redness and swelling were much worse and pt was c/o pain at injection site.  Pt still has low grade fever.
Nerve sys disorder. Headaches, vertigo, lightheadedness, tiredness, nausea, short breathing.
Initial unsolicited report received from a non-healthcare professional on 20-Sep-2016. This case involves a (age and gender not reported) patient who was intramuscularly vaccinated with FLUZONE in 2015 and DAPTACEL in 2016 (batch number, expiry date, dose, dose in series and site of administration were not reported for both vaccines). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medication was not reported. On an unspecified date, following the vaccination patient had experienced cellulitis. Patient required emergency room/doctor visit. Laboratory investigation were not reported. Patient received antibiotics as corrective treatment. It was also reported that patient was scrub down the injection site with betadine prior to administration. Patient was recovered from the event on an unknown date. Upon internal review, case was considered as serious due to important medical event: cellulitis. List of the documents held by sender: none. Sender's Comments: Cellulitis is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but listed with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This is poorly documented case However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
4/9/2022 I was traveling back from spring break. Stops along the way at gas stations and was unmasked waiting in line to use the restroom. 4/10/2022 I woke up feeling like I was starting to get a cold, felt like I had a sinus infection, possibly allergies and itchy eyes, sore throat hard to swallow. Called in sick to school on Monday. Had a doctors appointment immediately on Monday. Had a fever. At the doctors appointment they use the laser thermometer which registered no temperature I insisted on a oral thermometer which registered at 99.8° temperature. I have had a temperature often on throughout this week until today  (4/19/2022). I was prescribed PAXLOVID, which I took the entire prescription. The first five days of being Covid positive I had severe muscle aches pains in all my joints, fever coughing with a productive cough, congestion, and due to my asthma had a difficult time breathing. I am still congested, coughing and having a hard time breathing! Due to your website not providing me enough time to enter all of my medication?s and giving me a warning of five minutes left, I had to rush through the rest of this and left three medication?s off.  I also take the following.: buProPion HCL XL 300mg 1XAM Pro air HFA inhaler at PRN Low-dose aspirin 81mg I have a call into my physician at this moment to see about getting something for my chronic cough that has turned into a bronchitis now and the schools will not let me return to work until I have a non-productive cough. I am sitting here without pay at this moment because no one will pay for Covid and I am out of sick days. So it is a very costly expense and no one will listen to the CDC no one will listen to any one with reason or scientific proof of what is happening. I hope this helps you!  As a healthcare provider, OT, I am praying this will help!