chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within hours of vaccine developed local redness and swelling at site of injection. Next day presented to office with 3.5 x 5 cm area of tenderness redness and swelling no drainage, no regional adenopathy.
Severe ataxia resulting in fall with weakness - unable to get up for approximately 15 minutes; brain fog, fatigue.
From initial information received on 12Aug04 from a RN regarding an adverse event occurring, it was reported that an 18 year old female college student received a first dose of Menomune A/C/Y/W-135, lot number UE048AA, administered IM in the left deltoid on 20Jul04. That evening, the pt went to the ER after developing a fever of 103 degrees F, a severe headache and a stiff neck. She was administered IV fluids and was discharged home with prescribed antipyretics. The pt went to her physician's office on 21Jul04. At that time she still had a slight headache and fatigue. Blood work was ordered to rule out mononucleosis. The pt was diagnosed with serum sickness and recovered from these events on an unspecified date. From additional information received on 13Sep04 from the initial reporter, additional lab information was provided. It was also reported that this case was reviewed 10Sep04. Pt now back to normal. Please see final lab of 04Sep04. (Monocyte 9 (high, reference range 2-8%). No further information is anticipated, this case is considered closed.
My adverse reaction did not come for a few months, I ended up contracting Shingles and then as soon as the Shingles (May9th-22nd) ended, I ended up in Acute Afib and was sent to the hospital on June 6th, 2021
Patient developed Urticaria around upper arm and neck, reported feeling "a little woozy". We had her lay down and took vital signs which were within acceptable limits.   Pt denies shortness of breath or swelling of face, mouth, or throat.    Patient refused IM diphenhydramine and ambulance transport.   Patient states she will be transported by private vehicle to the local ER. Patient assisted to private vehicle with no worsening of symptoms or complaints.   Report called to ER nurse.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a child patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a Licensed Vocational Nurse (LVN). The age at vaccination was not reported. The batch number of FLUARIX QUADRIVALENT was unknown. The nurse reported that she was aware of two patients that experienced swelling and redness at their injection site. Limited information was provided by the nurse. No further information was available. This was 1 of the 2 cases reported by the same reporter.
Redness at injection site only. The area of redness was 4 inches by 5 inches at the largest point. The red area began to get smaller on 1/9/21. The patient did not report any other adverse reaction to the vaccine.
Patient reported a red rash that extended from the site of the vaccination approximately 3inches wide and 5 inches in length that extended from the flu shot site down towards the elbow. Rash was reddish and rough skin with itchiness, and small amount of pain when pressure was applied, felt slightly warm. This was noted in the morning of 10/8/2019 and was present for 3-4 days until it faded away over the course of a night. Patient took an antihistamine on the 2nd day which did not seem to help. Patient did not see his physician or seek medical assistance, reporting it to the nurse who provided the vaccine on 10/30/2019.
Time I got shot - within 2 hours; arm sore; body aches - by five hour mark I knew something wrong. Extremely fatigued. 7:00 Pm had a fever. Slept a long time - so much pain in body aches that I was crying into the 24th. "Like I want to die" body aches. I took Tylenol for pain and fever. Had these symptoms until I went to Dec 27 went to URGENT CARE. Had to take a COVID test  and Flu test - negative. Continued to have symptoms until New Year's Eve. Urgent care just said to keep taking Tylenol. Fatigue and weak still for 14 days. Was also getting Vertigo - 7 days into it and it lasted a week - off and on.
No additional AEs were reported; patient received on 12/15/2021 an expired dose of GARDASIL 9.; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 15-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter "once", lot #R029900 was confirmed to be valid, expiration date: 23-JUL-2021 for prophylaxis (anatomical location and route of administration were not provided) (expired product administered). No adverse effects were reported. .
Numbness, pain, tingling, loss of feeling at injection site, plus entire arm, write, hand, and shoulder. As of today, still no relief.
2056 pt had an extensive local reaction. Pt came back to doctors office and was seen by Dr at 13:30. Pt was given Benadryl 1/2 tsp PO. Pts mom was instructed to monitor patient for difficulty breathing, increased redness, swelling if this occurred to take pt to ER.
flu like symptoms, body ache, nausea, fatigue. Appeared about 12 hours after second dose and lasted about 24 hours before it resolved.  Arm pain at injection site, resolved 2-3 days after, aleve took away the pain.
Extreme pain! All over. Severe. The intensity so great I took way to much ibuprofen and spent night in bed crying on and off.
Fever of approx 100.5, chills and body aches lasting for  12 hours. Additionally, 5/10 pain in the armpit/lymph node area and tenderness to the touch last 36+ hours.
The day after the shot her arm was quite red and became very sore. Over a week the redness went away but she continued to have soreness all through the upper arm. She also developed significant weakness in the arm. She couldn't open a sliding glass door with her R hand. She is right-handed. She couldn't lift her arm above horizontal either forward or to the side. She especially has pain and weakness with internal rotation behind her back.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/1/2022 Discharge Date: Jun 4, 2022  PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1] Acute respiratory failure due to COVID-19 [U07.1, J96.00]   HOSPITAL COURSE: Patient is a 59 yo female with PMH of mild intermittent asthma, POTS, essential HTN, NIDDM2, chronic neck pain, migraines an fibromyalgia who presented to the ED with dyspnea, sore throat and nausea. She was initially seen at the UC (5/28) where she was diagnosed with COVID-19 and prescribed Ivermectin of which she took 2 doses. She was subsequently prescribed Pavlovid after seeing her primary on 5/30 and took 4 doses prior to presentation.    In the ED she was noted to be hypoxic and initially placed on 15 liter non-rebreather before being weaned to 4 liters NC. She was given a dose of Decadron and had a CTA thorax obtained in the ED without evidence of PE or acute process. She was admitted to the medicine service for COVID-19.   # Acute Hypoxic Respiratory Failure (Resolved) Secondary to COVID-19 She reported being vaccinated against COVID-19 with booster having been obtained 8/2021. Pro-calcitonin was obtained which was unremarkable and given lack of any PNA on CT, she was not prescribed antibiotics. She was treated with oral Decdron and Remdesivir and was quickly able to wean to room air. She did not demonstrate any hypoxia with ambulation prior to discharge and therefore given her history of diabetes and no further oxygen requirements she was discharged home without steroids. She was recommended to follow-up with her PCP. She was discharged in stable condition and discharge instructions provided.
This spontaneous report as received from the patient's mother refers to her 13 months old daughter. The patient did not have any concomitant medication, pertinent medical history, known drug reactions or allergies. In November 2012, the patient was vaccinated with her first dose of M-M-R II, 1 shot, subcutaneously (albumin status, lot # and expiration date were not reported). The patient's mother reported that within 24 hours after receiving the M-M-R II, the patient was no longer able to talk (disability). The patient was taken to autism and speech specialists who conducted blood testing (results were not provided), and stated that the event was not a result of the vaccination with M-M-R II. She had been in speech therapy for 18 months and at the time of the report (reported as "now") was able to communicate, but the mother did not elaborate on the patient's speech capabilities. The outcome of the event was reported as recovering. It was also reported that therapy with M-M-R II was discontinued and was not reintroduced. The patient's mother stated she was looking for monovalent vaccines for measles, mumps, and rubella due to the event. The patient's mother did not assess the causal relationship between the event and M-M-R II. The patient's speech loss was considered to be disabling event. Additional information has been requested.
chills, shaking, h/a, diaphoresis, t98.4;APAP
Received Fu shot 1-2 months prior. Next day pain on right hip started. Felt like it was going through the bone. Pain was intense. 2nd day became very fearful, emotional, fears took over mind like night terrors. Couldn't sleep for 10 days.
Information has been received from a physician's assistant concerning a 20 year old female patient with no pertinent medical history or drug reactions/allergies who on 02-MAY-2012 was vaccinated IM with the first 0.5 mL dose of GARDASIL in her left deltoid (lot # 672653/1860AA, expiration date on 30-SEP-2012). There was no concomitant medication. The physician assistant reported that on 04-MAY-2012, the patient developed a severely swollen labia. The patient was treated with prednisone EMLA cream, PENICILLIN VK, BENADRYL and TYLENOL with codeine #3. No laboratory tests were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Follow up information has been received from physician assistant, refers to a 20 year old female patient with none illness at the time of vaccination and none drug allergies who on 02-MAY-2012 at 13:07 was vaccinated intramuscularly with a first dose of GARDASIL (dose not reported) Lot # 672653/1860AA. On 04-MAY-2012 the patient experienced severe vulvar pain and severe vulvar swelling worsening over 5 days and mild macular allergic appearing rash on arm and upper back. The outcome was not reported. Reported terms "severe vulvar pain, severe vulvar swelling and mild, macular allergic appearing rash" were considered as disability/incapacity. Additional information has been requested.
a red, raised welp on forehead with a complaint of headache. Patient also complained of being dizzy and had fatigue for the next 24 hours. Took tylenol and Benadryl
Heavy menstrual period about two weeks after first vaccine dose. It was a continuous period until 7 months later, doctor prescribed megace 40mg to stop menstrual period. Still ongoing treatment and not sure if issue is resolved at this time.
I was extremely dizzy when I woke up.  I've had vertigo 20 years ago, but this was much worse. The room was spinning and I could feel my eye movements trying to follow the spin.  I tried to do eplys, but that made me vomit, which wasn't the case previously.  I was worried about driving since I couldn't tell when next dizzy spell would happen.  I rested and seemed to get better.  I went to work the next day, but left after a few hours when I could feel the dizziness start up again.  I made a phone appointment with my doctor and spoke with an doctor in her practice.  He suggested I keep doing the eplys for a few more days.  It's been working, I haven't vomited again and dizziness is very slight and not very frequent.
Fever   Chills Shivering uncontrollably Severe body aches Nauseous  Severe pain at injection site Swelling and discoloration at injection site Still sore at injection site after 10 days
Son had 2 grand mal seizures 7 days after H1N1 vaccination. Stomach ache night before event. Started to vomit 2:30 AM. Vomited 3-4 times. First seizure at 10:30 AM, duration 40 seconds. Second seizure at 6:50 PM, duration over a minute. Increase anti-seizure med. and change. Bit tongue during second seizure. Increased DILANTIN.   12/04/08 Consult for DOS 08/11/09: seizures. Pt developed seizures, dehydration, nausea, vomiting and as a result of sz dislocated shoulder.  Pt was seen by a specialist and started on Dilantin.     12/04/09 Consult received for DOS 11/11/09 DX: seizures. Pt presented for a follow up visit for seizures. Pt stopped Dilantin and to start Lamictal brand name to tolerate better sedation effect, and to lower the incidence of epileptic relapses.     12/08/09 ED notes for DOS 11/07/09; DX: seizures. Pt presented with 2 sz episodes and slightly febrile. Neuro exam: wnl; Pt to follow up with specialist.
Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder & neck); soreness/stiffness in left hip; soreness/stiffness in left hip; fatigue; This is a spontaneous report from a contactable pharmacist, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1284) solution for injection intramuscular in the left arm on 31Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01Jan2021, the patient experienced slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. No treatment was provided for the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. The outcome of the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
covid vaccine breakthrough case  dose 1 Moderna 2/3/21  038K20A dose 2 Moderna 3/3/21  030A21A
Pt was seen in ER for redness and swelling in right thigh.  Patient notified practice after ER visit.
PT DEVELOPED FLU LIKE SYMPTOMS THE DAY AFTER FLU SHOT.
@ 3/25/2021 The injection LT Arm Reversed to RT ARM. The moderate day time -Severe nite Throb Like on Last Nerve Persisted. All across Shoulder and up RT Neck. Not where injection was. 600mg ibuprofen subsided. I won't allow 2nd dose.  Apparently my religious course in prayer, vegan diet, exercise and over 50 years megadose vitamin supplement especially Ester C will be sufficient. Added more yogurt green tea. Always filtered water.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:51, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
Symptoms started with a low grade fever on the day of the MMR vaccine. A couple of days later he started complaining about his stomach hurting and of major headaches. A few days after that a rash started in his stomach and then spread all across his body. He started having loose stool. The rash eventually went a way but the headache, stomach pain and diarrhea persisted. He also had decreased appetite. After about 15 days of these symptoms, He eventually even started having accidents - he couldn't hold his pee or the diarrhea. This also resulted in him emotionally feeling angry and withdrawing a lot. After about a month the symptoms started to subside and he eventually retuned to being normal.
"Covid arm" , oval shaped red patch around injection site. Lasted 3 weeks plus, still mildly present at time of second dose, then more pronounced.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first shot of the COVID-19 vaccine on 04Jan2021 then tested positive for COVID-19 on 12Jan2021. Patient was concerned whether she should get the second shot of the COVID-19 vaccine as scheduled or should we wait. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between event "tested positive for Covid-19 " (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
1/98-warts on hands-still have them today many treatments tried, nothing helped, see medical record. 1/06-Type I diabetes-take insulin multiple times a day. Loss of vision. 1/98-Muscle and joint aches-constipation, diarrhea, fatigue, no treatment. 6/19/07 Received tag 2 report along w/clinical summary of medical records.  Will accept that as case complete.  Summary reveals patient received anthrax vax between 10 & 12, 1997 ( no documentation in military records) & had no immediate reaction.  Developed warts on hands/feet within about 2 weeks of vax.  Vax administered closest to current dx of IDDM was Hep A in 8/1998.  Patient had visual changes after Hep A vax.  Patient noted onset of polydipsia/polyuria in approx 10/06 along w/unexplained weight loss, fatigue, leg cramps.  Patient did not receive any medical care from 1998-2005.  Seen by MD & sent to ER 1/06 for elevated glucose & hospitalized for 3 days for IDDM management.  Currently is on insulin pump.  Currently under treatment for PTSD. FINAL DX: Type I diabetes mellitus, diagnosed 8 years s/p anthrax vax. 1/5/2010 Patient has type I diabetes.02/02/2010 Patient has Type1 DM and is on insulin pump.
Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided. No concomitant medication were provided. The vial  was first punctured on 04 MAY 2021 at 9:30AM.   This case was linked to MOD21-087072, MOD21-087071, MOD21-087063, MOD21-087013, MOD21-087012, MOD21-086959, MOD21-087011, US-MODERNATX, INC.-MOD-2021-106706 (E2B Linked Report).; Sender's Comments:  MOD21-087072: MOD21-087071: MOD21-087063: MOD21-087013: MOD21-087012: MOD21-086959: MOD21-087011: US-MODERNATX, INC.-MOD-2021-106706:
12 hours post vaccination, first symptom was nausea and fatigue.  At this time, heart rate elevated to 122 bpm while at rest, and oxygen saturation decreased to 92% while supine with head of bed elevated to 30 degrees.  The following morning, experienced general malaise, shortness of breath with stairs and household ambulation, and body aches/joint pain.  Symptoms resolved Sunday evening, however experiencing minimal shortness of breath, in comparison to day 1.
Initial report received from healthcare professional on 25 August 2014. A 9-year-old male patient, whose medical history and concomitant medications were not reported, had received 0.5 ml dose of FLUZONE QUADRIVALENT, batch number: U4990DA (dose number, route and anatomical site of administration were not reported) on 16 August 2014. It was reported that on an unspecified date, after couple of hours of receiving FLUZONE QUADRIVALENT Vaccine, the patient experienced hives all over his body. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil in one arm and then fainted while receiving a tetanus vaccine (manufacturer unknown) in the other arm. Medical attention was sought. No further information is available.
Im not sure what hep b was given, if i marked the correct one.   Event- 3-8-12 took him to his dr he was dx with URI.
Headaches, neck and shoulder pain, fatigue, body aches, started 12-14 hours after receiving second dose, used Tylenol as treatment, worked for 4-5 hours
Vaccinate at 2pm, by midnight I had fevers and intense chills. I was able to sleep from 2:30-3am. At 4:10am I started vomiting, emptying my stomach of all food, and again at 6:20am I started vomiting bile. I had a pounding headache from 4-10, when I had enough food back in my system to take ibuprofen.