chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She received a Moderna booster dose (0.25 mL) instead of Pfizer as first dose of series.
Shivering, chills - 2 hours  Fever 100.8, body aches, headache - 24 hours
Inflammation and pain under the left armpit about the size of a tangerine. First noticed about 36 hours after the injection. Accompanied with fever (100,6), chills, body aches, GI distress and headache pain 8/10, Inflammation ongoing though 60 hours post-injection.
Dizziness, muscle pain. Muscle spasms to the point that I could not stand without assistance or walk more than 2 minutes at a time. 2 weeks and 1 day post second shot, still having muscle spasms that are temporarily debilitating. I cannot drive longer than 20 minutes. Tylenol and ibuprofen taken daily, seeking physical therapy.
4yo male vaccinated with DTap and HAV on 01/23/08 Right deltoid. Following day developed a large tender, red swelling of right upper arm 8cm x 10 cm. Right arm painful. No fever, no chills, no lymph node swelling. Physician diagnosis-Vaccine reaction. No antibiotics.
Pt sated I just don't feel well and thinks she just got worked up with everything Happening.  BP 166/77 HR 102. Said she didn't take meds  today. . She signed refusal.
I admisitered the Varicella vaccine via IM injection. This vaccine is to be administered via SQ. Client had no symptoms at time of vaccine or for 15 mins after. Called client 24 hours later, she states only some soreness when the injection site is touched. She denies any other adverse effects.
Full body hives, itching, swelling, irritation, and redness.  The hives persist after changing soap/diet/etc. Have seen my primary care provider at Clinic, he prescribed Zyrtec and hydroxyzine which stem the symptoms but after about 24hrs the rashes come back.
PAIN, REDNESS, WARM TO TOUCH, ITCHY. ICE PACK.
VACCINE TEMPERATURE DROPPED TO 1.4C; TEMPERATURE EXCURSION AND VACCINE GIVEN TO FIVE PATIENTS; This spontaneous report received from a health care professional concerned multiple patients.No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213b21a and expiry: UNKNOWN) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-NOV-2021, the patient experienced temperature excursion and vaccine given to five subjects. On an unspecified date, the patient experienced vaccine temperature dropped to 1.4c.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the temperature excursion and vaccine given to five patients and vaccine temperature dropped to 1.4c was not reported.This report was non-serious.
Information has been received from a registered nurse concerning a 4-year-old white female with no pre-existing allergies, birth defects or medical conditions who on 27-Apr-2007 was vaccinated subcutaneously at her current physician's office with a second dose PROQUAD (MSD).  There was no illness at the time of vaccination.  Previous vaccinations, that were done at another health providers office, included on 09-Mar-2004 a first dose of PROQUAD (MSD).  On 28-Oct-2007 the patient experienced a sore throat, a temperature of 101 and a rash on the trunk and arms.  She was seen at the physician's office on 30-Oct-2007 and diagnosed with probable chicken pox.  On 01-Nov-2007, the grandmother reported that the child was feeling better but continued to break out.  The patient recovered on 02-Nov-2007.  Additional information is not expected.
Information has been received from a 65 year old male nurse with hypertension and high cholesterol who on an unspecified date "more than five years ago" in approximately 2001 was vaccinated with a first dose of Pneumovax 23. No adverse symptoms were noted. On 06-DEC-2006, the nurse was vaccinated intramuscularly with a 0.5 mL second dose of Pneumovax 23 (lot 651399/0486F). The patient had a chest cold for the past 3 weeks at the time of vaccination. Concomitant therapy included atenolol, LIPITOR, DYAZIDE, DAYQUIL, and vitamins (unspecified). Later that day on 06-DEC-2006, the patient's arm was bruised and sore at the injection site, and he applied ice. The next morning on 07-DEC-2006, the side of his arm was also affected. The area was 5x3 inches and was red, warm, and tender. He took diphenhydramine HCl for the symptoms. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information received from a physician indicated that the physician did not order the vaccination, and did not observe or advise the patient on his experience. No additional information is expected.
Rash on majority of stomach and inner right arm,  itching  -took Benadryl 25mg 5/5/2021 10pm
Approx. 17 hours post vaccination, the pt noted numbness in right arm down to middle of right thumb. This increased to include occasional coldness and numbness of whole thumb, occasional tingles of right arm. Saw a physician on 11/05/2001 and was given muscle relaxer. On 11/08/2001 he felt numbness had decreased slightly.
Aches in my arms and shoulders began a few days before the second vaccination in the series.  After receiving the second vaccination, the aches progressed to full upper body aches.  They have since progressed to full body aches.  I also had major chills 2 nights ago.
Moderate aches and pains morning after shot, unable to go to work. Increase in pain daily over subsequent 5 days. Extreme fatigue/exhaustion, brain fog, and intense nerve pain throughout body, constant. Pain in joints, mobility difficult, pain increases when movement is minimal. Pain preventing sleeping.  Pain is strongest around trapezius, scapula, and triceps on both sides. Tingling and numbness below elbows. Migraine-level headache. Joint stiffness ongoing. Chiropractic adjustments 12/8/21. Ibuprofen, aspirin, and acetaminophen 12/2 - present (12/9)
Round, red, raised, tender area about 6" around area of inflammation was found at injection site.  Notified MD and was seen next day on May 31, 2003.  MD determined this was an adverse reaction to Whooping cough vaccine and not cellulitis.
My menstrual cycle has been very messed up and I have been bleeding almost every 2 weeks since the middle of February. I am still taking my birth control as I was prior to the vaccine and nothing else has changed with my medication or health. I have an appointment scheduled with my OB to discuss the issue.
soreness in right arm, numbness in right hand, having a hard time with opening and closing right hand and nausea
24 hrs p/DTP/inactivated polio vax, pt exp a raised red, hive-like rash; tx w/DPH; reaction lasted 1 wk;
Abdominal and kidney pain Narrative: Patient received J&J COVID vaccine on 4/7/2021. No adverse event experienced in the immediate post-monitoring period. Patient called after J&J notice received. Patient reports that day after vaccination experienced severe abdominal pain and headache that had not subsided. After phone call on 4/13 patient went to emergency room. I do not have records from that visit at this time, however patient reports that she was diagnosed with kidney stones. No treatment was provided, but patient was referred to urology.
flu like symtoms; discomfort from injection site; headache; This case was reported by a lawyer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for shingles.   On an unknown date, the patient received Shingrix (injection). On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms, injection site discomfort and headache. The action taken with Shingrix was unknown. On an unknown date, the outcome of the influenza-like symptoms, injection site discomfort and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site discomfort and headache to be related to Shingrix.  Additional details: The patient ingested shingrix on 19 November 2019. This medication was administered by two separate injections. the patient received the first injection without complications. However, within a few hours of receiving the second. injection she experienced flu like symptoms and discomfort at the injection site. She soon developed a bad headache which typical over-the-counter medications did not alleviate.
Fatigue; Fever (Not Measured); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Fever (Not Measured)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Fever (Not Measured)). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Fever (Not Measured)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt seen in office 3/27/15 for other reason and asked to have left injection site checked-slight redness at site and approx baseball sized area around site. By Sunday 3/29/15 entire arm (posterior) from shoulder to elbow red and warm to touch. Instructed to use BENADRYL 25mg Q 4 hours and ice to area. On 3/30/15 seen in office and given script for cephalexin 500 3x/d for 10 days.
Narrative:   Other Relevant Hx:  Symptoms:  Headache Treatment:  ACETAMINOPHEN 325 MG ONCE
12 hours after receiving my vaccine, I had a fever, chills, body aches, shortness of breath, fatigue, weakness, and a sore arm
Patient was administer 0.3 mL of undiluted Pfizer Vaccine.  Pt. offered MD exam to include EKG and troponin levels with follow up.  Pt complains of fatigue, headache, and muscle aches while all are improving.
My right shoulder joint on the side of the shot started to hurt within a week of getting of the shot. It was very painful, and I had problems moving my arm and carrying my tools. I went to Urgent care and I have been referred to an Orthopedic specialist. I have lost the range of motion in that arm and I can?t lay down on my side. I have never had any problems since I injured that shoulder 20 years ago as a kid. I take an Aleve or Tylenol  if I need to but it does not really help with the pain.
This child received a Hep B shot in the nurses office at school based clinic. He returned to class and was sitting in the class and fainted. The patient was taken back to the nurses room for observation for 20 minutes. No complications, he was released back to the class. No further problems noted.
I got the injection on my left arm and that evening I had a fever of 100.3 and the next morning I was perfectly fine. My arm was sore and took Tylenol and 11/18/2021 I started with a cough and the next day I decided to go get tested because my granddaughter is pregnant. I had a rapid COVID-19 test and it came back positive. 2 days later I was asked to take another COVID-19 test and it came back negative, in the meantime the doctor prescribed me Mucinex and by thanksgiving I was feeling much better.
Information has been received from a consumer concerning her 16 year old daughter with no pertinent medical history, no drug reactions or allergies reported, who in June 2009 and in August 2009, was vaccinated with the first and second doses of GARDASIL (route and lot # unknown) respectively. There was no concomitant medication. On an unspecified date, the patient experienced swelling and pain in her knee after receiving the second dose of GARDASIL. No lab diagnostic studies were performed. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Follow-up information was received from the physician who reported that on 18-JUN-2009, the patient received the first dose of GARDASIL (lot # 662300/0100Y) and on 24-AUG-2009, the patient received the second dose of GARDASIL (lot # 662404/0312Y). There were no concomitant vaccines given. The physician reported that the patient experienced "gradual" swelling and pain in her knee after days to weeks from the second dose of GARDASIL. There was no serious criteria. The physician stated that the patient was very active in sports. No further information is available.
chills, fatigue, body ache, arm soreness Narrative:  employee states: similar to her first dose she gradually  noticed arm soreness which progressed as the evening passed. Around 1am she woke up with  chills, full body aches and she was unable to sleep after that. She does not  remember a fever of N?V?D
Fever, Chills, Heart Palpitations - Heart rate was 126 Joint Pain Pain in Chest when taking Breaths More Pain when lying down, cant turn on the side Eye Pain with Headaches
I have had an ear infection since around 9/6. Have taken a full round of antibiotics (started 9/12 - ended 9/19): 300 mg capsules of cefdinir. None of my symptoms have resolved.
A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 49 year old female patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered) on 13-Nov-2020 (batch number: 11/25/1970 and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: 4 days).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 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.
Pain at injection site lasted over 48 hours. Hand on same arm had some inflammation, which started 36 hours after injection and is diminishing at 72 hours. Painful lymph node behind jaw on same side of body. Vomited 32 hours after injection, then had stomach pain and cramps with loose stool for several hours.  Fatigue started after 24 hours and is continuing  at 72 hours after injection.
Approximately 21:30, developed wheezing, touble breathing, hives all over body and felt like throat was closing. Fever at 22:30 was 102, axillary. Was given 3 doses of liquid Benadryl and was better at 23:00. Hives did not return. Had enchiladas and strawberry shortcake for dinner. Has had strawberries since then and had no problems. No known allergies.
I noticed flakiness on my shelf and I thought it was dandruff. I tried using head and shoulders, but it didn't help. I went to my doctor and was told that I have scalp Psoriasis and was prescribed Ensillar which is a shampoo for my Psoriasis. I used it for two weeks and it helped and two weeks later it started to flare up again. I did another treatment for a week and then it cleared up. I had a follow up appointment and she said that it looked good. If I had another flare up, I would just do another treatment.
redness, swelling, and pain from injection sight down through elbow area and spreading into lymph tissue in crook of armpit
Cutaneous hypersensitivity.  A large red lesion around the injection site roughly 3 inches in diameter.  Very sensitive to the touch the first 3 days.  Skin felt hot and became progressively itchy on day 2 and 3.  Redness is starting to fade a little on day 4.
C/O slight tingling of the roof of the mouth a few minutes after receiving varivax, which quickly subsided. Was kept in office 20 minutes with no further symptoms developing. Called office 3 days later (next open office day after weekend)to inform us that an hour she again had tingling and also developed numbness and tingling in hands and legs and weakness in her legs. Took Benadryl on her own with relief. Did not see a physician for treatment or follow-up.
Area of redness, tenderness at injection site started 1-2 days after injection; symptoms reported to office on 11/02/2015.  Pt examined by physician on 11/02/2015, Dx: Papule.  Rx: Cephalexin.  Advised to return if sx worsen or don't improve.  Follow-up call to pt done 11/09/2015: sx improved, pt did not take antibiotic.
Dose 1 was in my right arm. Dose 2 I got in my left arm because I was still suffering from "COVID arm" when I went in for my second dose.  I'm now 90 days out from my SECOND dose and I'm still experiencing painful lymph nodes in both my armpits. It's typically mild to moderate 5-6 days per week. Today it is serious pain on both sides to the point that I was unable to perform some typical exercises I do 4x per week and was in tears because of the pain. My primary care Dr. and my OB are both aware and have suggested Advil or Benadryl for the pain. Advil doesn't really help. Benadryl knocks me out and is not a sustainable solution.   I was hopeful the pain would go away a few weeks after the vaccine, but it seems to be sustaining itself and getting worse.
arm still hurt; Initial information received on 30-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age whose arm still hurt (vaccination site pain), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient whose arm still hurt (vaccination site pain), (latency: unknown) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Pt. tested positive on 8/18/2021; she was asymptomatic that day.  In afternoon of 8/19/2021 developed symptoms and called hotline and was swabbed on 8/20/2021- results pending. Covid positive after vaccination
An excruciating headache. Worst headache of patient?s life. Combined with moderate nausea and sensitivity to light. Patient does not have a history of migraines.
Generalised bullous cutaneous reaction; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED BULLOUS FIXED DRUG ERUPTION (Generalised bullous cutaneous reaction) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERALISED BULLOUS FIXED DRUG ERUPTION (Generalised bullous cutaneous reaction) (seriousness criterion medically significant). At the time of the report, GENERALISED BULLOUS FIXED DRUG ERUPTION (Generalised bullous cutaneous reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company Comment This spontaneous case concerns a patient of unknown age and gender with no medical history reported who experienced the seriousness criterion medically significant AESI of generalised bullous fixed drug eruption unknown days after a dose of mRNA-1273 vaccine. At the time of the report, the outcome of the event was unknown.  Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273 vaccine  is not affected by this report.   Reporter did not allow further contact
Dizzy, off-balance, nausea, low temp (95.9) followed later by high temp (100.3)  complete fatigue, unable to eat/keep food down..shaking, normal sleep/wake pattern turned upside down, pain and swelling at injection site, exhausted and weak.  Adverse events started 3-4 hours after shot. peaked between approx 36-48 hours post shot, slowly diminished and episode ended approx 72 hours after shot.
Started about 9:30pm day of shot Friday 19th of Feburary  and continued to get worse throughout the night, arm was very sore and painful and she was unable to move her arm, felt like her arm was paralyzed.  She could not lift it or move it.  Went to the MD the next day, was prescribed naproxen for her pain, 1 (500mg) tablet twice daily with food.  The medication did help, she is able to move her arm up to shoulder height after receiving this medication. Has not been back to md since initial visit.
Chest pain/heart palpitations with onset approximately 10 hours after second COVID-19 shot. Heaviness in chest, harder to breath, tightness in throat. Blood pressure normal, but heart rate increased. No fever or other symptomology. Symptoms worse reclining and trying to rest rather than upright.
Two shots 4 Y ago, then shingles again/Suspected vaccination failure; shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). 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 and Shingles vaccine.     Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that after his/her first shingles, he/she had two shots 4 years ago and found out that had shingles again. The patient thought the vaccine was 95 percent effective. The patient was on antiviral medication now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.