chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). The consumer mentioned that a friend of hers, whose daughter experienced aphonia described as the patient could no longer speak after getting GARDASIL shot (onset date was not specified). Upon internal review aphonia was considered medically significant. Additional information is not expected as no reporter details were provided.
Pt said left arm was just sore Fri & Sat. Sunday Pt states she developed redness/welt on Sunday night. It was warm to the touch. Monday she noticed bruising on arm. Pt did state she on that side and doesnt know that contributed to brusisng. Pt stated today (Tuesday 2/15) that redness is going down & it is still warm to the touch but a lot better Pt states she takes Tylenol & Ibuprofen daily
Migraine headache 7:00 AM - Noon; dry heaves twice in morning. Rash (little bumps started same day, more all over most of body by 10/07/2012. Lightheaded in a.m., slight fever and chills in afternoon and evening.
On 5/9/2021, I developed a diffuse urticarial rash and lip swelling. I went to the ER and received epinephrine and prednisone. The urticaria rash resolved on 5/15/2021. On this day, I did receive the 2nd Pzifer Vaccine.
Information has been received from a physician concerning a 37 year old female healthcare worker who "a couple of weeks ago", in approximately July 2008, was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently, the patient developed a tender "knot" at the injection site. At the time of this report, the patient was recovering. Additional information has been requested.
A vibrating, pulsing sensation off and on near her lower trunk; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not having any allergies to medications, food, or other products. Concomitant medication was not reported. On 05Mar2021 at 04:30, the day after shot, and every day since, she had a vibrating, pulsing sensation off and on near her lower trunk. It doesnt hurt, but was concerned as she never had it before. She cannot control it whatsoever. At first, she thought she was feeling a small earthquake, then thought that might be her phone in purse was vibrating, but it was her. She was very scared to take second shot. The clinical outcome of vibrating, pulsing sensation off and on near her lower trunk was not recovered.  No follow-up attempts are needed. No further information is expected.
erythema 2 1/2 x 2 1/2 in diameter 48hr p/vax;instructed mom to apply cold compress & given APAP as needed for pain;reddened indurated;redness is localized 2 1/2 x 2 1/4;
Patient received Pfizer COVID vaccine on 3/2/21 (lot # EN6198), 3/30/21 (lot # ER8732), 10/23/21 (lot # GG3527), and Pfizer Bivalent COVID booster vaccine on 11/11/22 (lot # GJ6738). On 12/29/22, patient tested positive for COVID. On 1/2/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID-19 pneumonia, and hypoglycemia. Patient discharged home on 1/5/23.
Inflammation from middle of the neck (upper part) until inside of mouth at level of wisdom molar limited opening, pain, purple color back of the throat same symptoms, bleeding sore gums.
I recevied the vaccine at 3:00 4:30 I started to itch  5:15 I got home and I noticed that my neck and chest was red and I noticed a rash .. The rash was across  my neck, shoulder and breast area Took Benadryl which helped a little Later that evening I had a rapid heart rate that lasted an hour .. Hot flashes , I was very nauseas. I could not sleep the next day the rash was still there but no itching  I discovered the knots on my lymph nodes they were swollen and red.. I noticed sharp  pain in my neck as well.
Follow-up was received from a healthcare provider (nurse) on August 2013. The additional information provided includes patient identifiers for two cases. This case now pertains to one of the thirteen patients. Information for the other patients is captured in case number 2013-08317 and 2013-06998. This case involved one of a cluster of thirteen unidentified patients who had received intramuscular injections of IMOVAX Rabies, lot number D1177-1. This 24 year old female patient was vaccinated intramuscularly three times with IMOVAX Rabies Lot # D1177-1 into the right deltoid. Dates of administration were not reported for this patient. Titers were checked on 14 May 2013 and 15 May 2013 and were low. Laboratory test results were not reported. The patient's other medications were reported as SPRINTEC, EPIDUO and BACTRIM. Dose, route, dates and indication were not reported. The patients pre-existing allergies and medical conditions were reported as no known drug allergies, reported as NKDA. No further information was available at the time of this report. The patient outcome was reported as unknown. Document held by sender: None.
EVENT* A week after my shot I noticed a hive 4-5 inches in (diameter measurements). It was very red and warm to touch and it was located where my injection was given. It was a very uncomfortable feeling especially at night if I accidently rolled over on the arm in question. It lasted for 24 hours and left then came back exactly seven days later. This happened for a three week time period. My arm was very weak and sore most of the time. Medications- Motrin* I took 600milgrams in a 24 hour period and I was still in pain.  Dates* The dates in February are as followed 13, 21 and 28
red. with a lump/ welt, warm and itchy at injection site; injection site pain; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE URTICARIA (red. with a lump/ welt, warm and itchy at injection site) and INJECTION SITE PAIN (injection site pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), GABAPENTIN, METFORMIN and VITAMIN B12 [VITAMIN B12 NOS] (VITAMIN B12) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021 at 8:00 AM, the patient experienced INJECTION SITE URTICARIA (red. with a lump/ welt, warm and itchy at injection site) and INJECTION SITE PAIN (injection site pain). At the time of the report, INJECTION SITE URTICARIA (red. with a lump/ welt, warm and itchy at injection site) and INJECTION SITE PAIN (injection site pain) had 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.
Symptoms: Seizures, head twitching, inconsolable crying, high pitched screaming, loss of eye contact, zoning out, stopped talking, babbling, smiling, laughing, complete personality change. Though months of detoxing, child is finally regaining ability to do acts mentioned above.
Immediately follow administration of Td, pt became lightheaded and unresponsive after about 30-60 seconds. He quickly aroused with no sequelae.
Patient states she had a sudden onset of chills and severe quivering. Contacted 911 from fear of serious health issue. Temperature was 96.8 F, blood pressure was 100/100
Narrative:  Patient reported that she developed chronic muscle and joint pain in the whole body and particularly knees after the 2 shots of Pfizer Covid-19 vaccine received in Jan 2021. Patient was completing physical therapy for pain management.
Hives on her chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her chest) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (Hives on her chest). On 08-Feb-2021, URTICARIA (Hives on her chest) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown dates, the patients' were vaccinated with an improperly stored dose of VAQTA (strength, dose and route of administration were not provided) (lot # L036300 expiration date 11-APR-2016 and lot # M003011 expiration date 15-NOV-2017). The registered nurse stated that VAQTA was exposed to the following temperature conditions: 34 degree F for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Major swelling of arm, severe pain, and unable to use arm.  Symptoms progressed to swelling-double the size of my arm, and cellulitis of the right forearm.
Diagnosed on 7/21/2021 with nerve damage caused by the vaccine. Caused inflammation and severe burning in upper GI area, tingling in right arm and hand, right lower back, hip and buttocks inflammation and severe pain and burning. Probable  lung inflammation   Treatment plan has yet to be determined.  Experiencing constant nerve pain and burning.
Patient got Moderna as dose 1, inadvertently given Pfizer for dose 2.
Itchy, red palms and itchy, red soles of feet. Blister rash spreading down back of both legs from buttocks to knees.
DTaP/IPV administered right arm 10/20/2004. 10/21 dad noted bruising. 10/22 noted 4 inch circumference redness and swelling. Itchy. Dad gave Tylenol for discomfort and called office for recommendations. RN recommended some amount 0.1% hydrocortisone to area ID, Benadryl and 1-tsp q 6 hours prn itchying, Tylenol/ Motrin as directed per discomfort.
Neck pain on the side, both sides of neck. Starting at 6 am after immunization. 72 hours pain was going. IBU did not help.
Started with a migraine lasting 2 days. Then for 3 weeks had severe fatigue, chronic headache, nausea, loss of appetite, vision change, balance issues, tingling, pins and needles, burning (in feet; hands; face; tongue) and weakness in limbs. Neuropathy systems have persisted and continue currently. I have been seen by primary care and neurologist multiple times since January, 2021. I had multiple labs, lumbar puncture, brain MRI and spinal MRI. Brain MRI showed white matter changes. The symptoms I have been experiencing are life-changing and life-limiting. I have not been able to workout as usual prior to vaccine. I have had to miss work at times and needed accommodations.
Pt recieved 2nd dose of Moderna 1 week early. 1st dose received on 5/26/21 so second dose should have been given on or after 6/23/2021
Patient received COVID vaccine on 12/30/2020. She had the following symptoms for 36 hours: severe headache, chill and fever (24 hours) body ache, fatigue  and joint pain
I noticed that I am not sable to workout out or do strenuous activities like I used to. The hand swelling has not improved and I am experiencing new adverse reactions to medications. There is no evidence that I had COVID but my symptoms are consistent with Long Haul COVID.
Left arm has large swollen area noted by grandmother.  Sore to touch, denies redness, or warmth.  No fever or rash.
Diagnosed with shingles 2/11/2022. I started itching and getting lesions/rash on my scalp 2/4/2022. I saw a dermatologist a week later 2/11/2022. I was prescribed acyclovir. After about 10 days shingles subsided.
Has a bright red rash on arm where injection was administered. Rash is warm to the touch and itches
Headache, Myalgia, Pain/swelling at injection site, chills, fatigue Narrative:
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, LIPITOR, NORVASC and hydrochlorothiazide. On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 20 hrs after receiving SHINGRIX, the patient experienced white blood cell count increased and C-reactive protein increased. On 16th April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the white blood cell count increased and C-reactive protein increased were unknown. The reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the white blood cell count increased and C-reactive protein increased to be possibly related to SHINGRIX. Additional details were provided as follows: The reporting physician was himself the patient. It was reported that immediately after vaccination the patient experienced pain at injection site (right arm) that he described as mild to moderate local pain. The pain had gotten better and arm was still sore now 3 days later. The patient had blood labs drawn approximately 20 hours after the injection for his annual physical and noted C-reactive protein elevated and slightly elevated white blood cell count. The patient was responsible prescriber for his own SHINGRIX prescription.
Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assiatant stated that, the patient received dose of Flulaval quadrivalent 2019-2020 season either on 18th October 2019, or within the week afterwards. The patient experienced vomiting and fever either the day of vaccination, or the day after vaccination. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and  sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and  sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 22-Sep-2022 at 1:28 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022 at 1:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    Concomitant product use was not provided by the reporter.  Dose 4 anatomical site was reported as deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.  Refrigeration excursions were identified, vaccine was housed in the units. There were excursions noted. Manufactures were notified and was made aware of the situation.  No adverse reactions were reported for patient at the time of the report.  Treatment information was not provided.
ZOSTAVAX was administered in left deltoid of the arm instead of in sub Q fat of arm. Pt. did not experience any adverse event.
became very ill; had diarrhea; throwing up; This is a spontaneous report received from a contactable consumer (patient) via a  sponsored program. This female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Mar2021 the patient became very ill, had diarrhea and was throwing up. She inquired if that could be from the vaccine. The clinical outcomes of became very ill, had diarrhea, and throwing up were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient presented to Observation check in area (@ 6:38 PM) complaining of being very anxious. Patient appeared Shaky and Sweaty. She was assisted back to treatment area where she was assisted again onto the cot to lay down. Patient history was obtained while he was inside treatment area. Pt stated she has Sulfa and Latex Allergies as well as Amlopidine.  Past Medical History stated above and Patient stated she was very anxious about getting the vaccine. Patient was given time to relax while laying down on the Cot and water to drink. Patient stated she felt fine after her 30 minute wait and that  she wanted to and was ready to leave at 7:08 PM.
next day he noticed redness and rash and hive like bumps near vaccine site.  was about 3 inches around the whole site
Pt playing & suddenly went limp, fell down eyes rolled back. called 911. To ER. Pt crying & irritable upon admit, t99.2 R; lab tests & spinal tap done;
no longer had the antibodies for varicella/still did not have the antibodies; booster shot/another booster shot; This spontaneous report was received from a consumer (patient's mother) and refers to an adult female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On an unknown date, when she was a child, the patient received her first and second doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported).  On an unknown date, as an adult, she discovered she no longer had the antibodies for varicella. This resulted in her receiving a first booster dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Extra dose administered).  On an unknown date, a few years later, it was discovered she still did not have the antibodies for varicella, which resulted in her receiving second booster dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Extra dose administered).  At the time of reporting, the outcome of the event no longer had the antibodies for varicella/still did not have the antibodies was unknown.  The causal relationship between no longer had the antibodies for varicella/still did not have the antibodies and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
About 3 to 5 minutes after receiving the Moderna 1st dose, my ears started feeling warm, than I felt light headed, ringing in my ears started. That lead to dizzyness, the inability to see or walk properly. I was helped, by two people holding me up by each arm, to the medical room that was set up. They helped me lie down. I think about 5 to 10 minutes later, it's a blur, so I don't officially know how long this lasted, I was able to tack some water they offered. The vertigo seemed to have left, but I was still wobbly and weak. After about 25 or 30 minutes I started sitting up. After 40, I felt ok enough to drive home, though still a bit unsettled on my stomach and weak. This feeling lasted a couple of hours. I started to feel better at that point, and then mostly felt a bit tired and sore at the injection site.