chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 2 days at (DTAP and HIB) over left thigh, it was pink and erythematous, not much tender but itchy. Within 24 hours, swelling over and around injection site (anterior/lateral thigh). Site of swelling about 3 1/2" X 2 1/2". No fluctuation, induration or much temperature. No blistering or papule formation over swelling area. No problem walking or limp; normal gait. Lymph nodes in area-WNL. Treat with calamine lotion; Atarax po and Keflex 250mg tid X 10 days.
My daughter received her second injection of GARDASIL on December 22, 2008.  On December 31, 2008 she had a sudden and severe hives reaction-  inner thighs of both legs and feet, blood red, swelled, very painful and itchy.  We went to the emergency room where she was treated unsuccessfully with BENADRYL and then was given steroids, which after 12 hours reduced the horrific hives.  Then on Friday, January 2, 2009 she started to complain about severe pain in her armpits.  By Sunday night the pain spread up her chest, neck, jaw and lips. We have an appointment at our Dr. this afternoon, but felt that since there was NO other reason - sickness, strange meal, etc. I should report this event immediately.4/14/09-records received-presented to ED 12/30/08- C/O rash on legs began morning of visit to ED. Pruritic. Has had similar rash in past. DX: urticaria. Subsequently developed aches in neck and axillae, legs. Assessment: viral syndrome. 1/12/09 C/O body aches and generalized weakness and low back pain and buring of hands. Now severe headache with photophobia and neck stiffness, slight nausea. 4/28/09-office visit 15/09-C/O musculoskeletal symptoms and rash. Previously seen in ED for allergice reaction. Now have aches in neck, axillae, legs. Impression: Viral syndrome. 1/7/09 continues to C/O leg pain and hand and arm pain. Impression: Myalgia. 1/12/09-second opinion for C/O jaw pain, muscle pain and headache. Light sensitive. Spots in eyes. Impression: Parent child concerns. 1/13/09-seen in ED for worst headache of her life.  Parent refuses LP.  Impression: headache. headache maybe migranoid with photophobia. Myalgia. 1/19/09-C/O blood in urine, fever and sore throat. 3 week history of evolving UTI and strep throat per parent.
Tiredness; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). On 29-Mar-2021, FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Immediately after injection complained of severe pain at site. Fell off table and fainted for approximately 10 - 15 seconds. Hyperventilated and cried progressing Chvostek's sign in hands and feet. Rebreathing into a bag progressing to clearing of symptoms. Complained of headache, blurry vision; Vision test was normal. Vomiting x 1 in parking lot and speech was momentarily inarticulate. Sent to ER. At ER neuro exam was normal except for word recall "coffee instead of coughing" "Sired instead of tired." Continued complaint of headache. Vomited x 2. All symptoms spontaneously cleared approximately 6 hours after incident. Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. No fluids were taken from 7/10/2006 PM until IV in ER. Anion gap noted on chemistries and concentration of urine obtained after several hours of hydration. Discharge diagnosis: Dehydration, Vasovagal syncope secondary to shot vs pain at injection site.  7/17/06 Medical records received from reporter/provider which included vax record, office note of 7/11 & neuro consult of 7/15 by MD who also saw her in the hospital on 7/11-12.  Neuro report indicates the CT scan of head was WNL & that dx is syncope probably precipitated by pain of vax injection along w/dehydration (no fluid intake since evening of 7/10 until IVF given in ER).  As of 7/15 patient continued to have throbbing HA when bending down & also c/o strong heart beats ocassionally.  PMH: dehydration requiring hospitalization at age 3 yo.  Also has hx of mild anxiety.  Family hx: patient's mother has Fuch's disease (genetic degenertive corneal disease which her mother also had) & patient's father has depression. There are no siblings.  It was noted that she had 3 episodes of emesis following vax along w/ sustaining mild concussion when fell from exam table which was characterized by brief episode of aphasia, slurred speech & possible right facial paresis noted only by patient's mother./ss 10/27/06 Received medical records from hospital which reveal patient seen in ER after LOC with head trauma.  Noted to have slurred speech, word finding difficulty, HA & emesis x 2 which resolved after several hours.  Admitted for overnight observation.  Given IVF & IV Toradol.  Head CT was WNL.  Neurology consult done which was essentially WNL with mild generalized weakness, speech intact & mental status clear.  Final dx: LOC with head trauma, vasovagal syncope.
pt recv vax 25OCT98 & pt noted induration,inc warmth, pain & swelling on 26OCT98 that is persistent w/worsening pain;
Approximately 8 days after the injection, my arm was red, itchy, and swollen from below injection site to shoulder.  It continues  a week later.
My shoulder joints and back of neck felt sore about 30 mins after the vaccine. About 2 hours after the vaccine I felt exhausted.  I tried to ignore it but could not concentrate on my work and ended up going to bed and falling asleep for 3 hours.  Got up briefly and then slept through the night. The next day I was completely exhausted and couldn't work so I gave up and went to bed.  I had mild chills but no fever (67.3). Basically stayed in bed all day. The next day I woke up feeling completely fine, except for a sore arm at the injection site.  I had no treatment.  I still have days when I feel exhausted. Since most get these symptoms after the 2nd shot I'm a bit concerned that my 2nd may be worse.
throat cancer; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT CANCER (medically significant), outcome "unknown". Event took place after use of product. Patient, who is also a cardiologist, said the covid-19 vaccine gave him throat cancer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and known product profile, the causal relationship of the reported events and the use of  Comirnaty is cannot be fully excluded. There is limited information available to make a meaningful assessment. The case will be assessed further once new information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Swelling, redness & pain at injection site & armpit Low grade fever, chills,headache,muscle pain, tiredness, lost of taste buds
Pain and swelling in the left knee and couldn't walk due to the pain and swelling.  Has appt with her orthopedic physician on 11/23/09 at 2 PM.
Muscle fatigue; Muscle cramps; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), MUSCLE SPASMS (Muscle cramps) and ARTHRALGIA (Joint ache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019821A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), MUSCLE SPASMS (Muscle cramps) and ARTHRALGIA (Joint ache). At the time of the report, MUSCLE FATIGUE (Muscle fatigue), MUSCLE SPASMS (Muscle cramps) and ARTHRALGIA (Joint ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.  After the first dose of vaccination, the patient had severe muscle cramps which seemed to be like broken rib. On an unknown date, the x-ray was performed but nothing was noticed for cramping. The joint was hurting with fatigued muscle.   This case was linked to MOD-2021-331113.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up include updated reporter details. updated patient demographics. updated suspect product details. updated events outcome.
Information has been received from a physician concerning a 20 year old female who was vaccinated with her first dose of GARDASIL intramuscularly. There was no concomitant medication. The physician reported that the patient received her first dose of GARDASIL and had a pretty bad case of hives that took several weeks to clear up and two visits to the emergency room. The patient recovered and no further information was provided. Additional information has been requested. Additional informtion has been requested.
Subsequent to receiving varicella virus vaccine live on 08/18/98, the pt developed 8-10 lesions on neck with several on arms and chest on 08/25/99. It was noted that the pt has not been exposed to chickenpox or shingles. Additionally the pt had a fever of 99.7. Follow up information from a registered nurse reported that the pt recovered.
Entire body hurt,Weak, lathlathergic,  stomach bloated, slept through only got up to use bathroom, drink tea and water.  Next day awake 6 hours had 1 meal, cup tea and water. Slept 2 hours up til 10:30 back to sleep.
administrated an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number pp9l5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows; On 22nd October 2021, the patient received Kinrix, which was already expired on 16th October 2021. No further events were reported. The reporter agreed to be contacted for follow-up. The reporter consented to follow-up.
my left shoulder and arm started hurting; My left shoulder and arm started hurting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8734), at the age of 40 years old, in left arm on 10Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient had no known allergies. Medical history included asthma and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine in four weeks of vaccination. Concomitant medications included amlodipine (strength: 5 mg) at 5 mg; montelukast sodium (MONTELUCAST, strength: 10 mg) at 10 mg. The patient previously received the first dose of BNT162B2 (lot number: EP6915), at the age of 40 years old, in left arm on 20Mar2021 at 11:00 at single dose for COVID-19 immunisation. The patient experienced left shoulder and arm started hurting on 17May2021. It was not a constant pain. The pain start worst on 06Jun2021. The pain was constant. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included COVID PCR test: negative (Nasal swab) on 29Apr2021, COVID PCR test: negative (Nasal swab) on 06May2021. Therapeutic measures were taken as a result of left shoulder and arm started hurting and included treatment with prednisone 20mg twice a day for five days. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Not sure if coincidental or causal.  Booster shot was painless.  That evening started developing soreness in arm injected.  Over the following days left shoulder/arm (length of shoulder down arm to bicep/tricep and occasionally elbow/top of forearm) became increasingly sore and painful with a very limited range of motion.  Condition has not improved.  I have had previous issues with that shoulder and am currently experiencing similar but less serious issues with my right shoulder resulting from a strain weightlifting.  However, there was no obvious trigger for the left shoulder issue other than the booster shot.  I had assumed the problem was a coincidence but was told by my massage therapist last week that she has two other clients experiencing a similar problem after receiving the booster shot.
Right anterior shoulder with edema, mild puffiness and warm and maculopapular, itching and color changes. Give Benadryl, ice, ibuprofen. monitor. Return to clinic of worse.
Fever, headache, itching, hives appearing, and swelling of the eyes. Almost all lasted about a day. The hives and itching lasted about 3 days.  I took some ibuprofen and it did not do much to help. The best remedy was getting lots of rest.
Td given in right deltoid IM. Pt came in 9/2/04 stating pain, swelling, redness and decreased ROM in right arm x three days around 6 inch area of erythema, induration, heat and swelling distal to right deltoid region. Ice pack and ibuprofen 800 mg TID. To see clinic doctor on 9/3/04.
Rash to Left torso spreading to midline of abdomen and to left side of back.  Observing for past 30 hours.  Slightly itching and internal hot flashes occasionally
Patient with 2 COVID Moderna vaccinations who admitted after a fall who incidentally tested detected for COVID during routine admission testing.  No hypoxia during stay per provider.  D/C summary note below:  "the patient had ground level fall resulting in left hip fracture had orif, uneventful. Pain controlled, ambulated well, able to dc home with home care and family support. Incidentally covid positive without hypoxia"
The patient was sitting after the vaccine in the waiting area and about 15 minutes after he said he had cotton mouth. At that time I observed him and had him drink water. Another 10 minutes passed and he said he still had cotton mouth. I had him take his mask off and noticed his lower lip looked slightly swollen, I had him take a Zyrtec 10mg (he didn't want benadryl at the time due to drowsiness). He agreed his lip was slightly swollen, he sat down again and we observed him. His blood pressure, pulse and temperature was taken. His bp was elevated 139/98, pulse 90, temp 98. He sat for a few minutes and then checked his bp on our machine it was 144/85 pulse 90. He did not complain of shortness of breath, he did not have trouble breathing, no dizziness. He said his lip seemed about the same maybe a little better. I advised him that it might be best for him to go to urgent care to be evaluated. He agreed and was taken to urgent care. He was seen at urgent care where they decided he did have an allergic reaction/anaphylactic due to swollen lip. His bp and pulse went down according to patient while at urgent care  where he was given benadry. They released him with prescriptions for medrol dose pack, hydroxyzine and epipen. He saw Dr at the Urgent Care.
On Sunday May 9th, I experienced a fever, chills, body ache, nausea, and headache from about 8am through 8pm.   Then on Monday May 10th my left armpit (arm of both shots) was swollen and very painful.  The pain has subsided a  bit but is still uncomfortable today (5/12/2021).  I read online it can take 4 weeks for swollen lymph nodes to fully recover.
Developed itching during the night, about  40 hours after vaccination.  Found itchy red elevated welts on upper legs, hips, upper arm, upon waking, about 44 hours after vaccination.   Symptoms are not debilitating, self treated with topical antihistamine (Benadryl).
Fever 101.7, chills, migraine  What I was worried about was my hearing diminished by about 50% for about 12 hours and ringing and echo in my ears. Echo started about 2pm on 2/3 day after shot. Today the ringing in my right  ear is still ongoing.  Fever and headache are gone.
Received third dose of Rabies vaccine on 11/29/06. Returned to medical doctor on 11/30/2006 complained of rash for past 2-3 days and arthralgia of fingers for 1-2 days.  Treated with Prednisone and antihistamines. Symptoms resolved. Returned to medical doctor on 12/16/06. States that rash and arthralgia returned on 12/9/06. Medical doctor prescribed antihistamine and above.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with RECOMBIVAX (lot number 660951/0398X; expiration date 18-NOV-2010) on 21-MAR-2009. Other suspect therapies included VAQTA (lot number not provided). No concomitant medications were reported. On 21-MAR-2009 the patient was suppose to get a second dos eof VAQTA but instead received an adult dose of RECOMBIVAX HB. The patient did not experience any adverse events. Additional information has been requested.
Moderna COVID-19 Vaccine  Approximately 24 hours following the vaccination I began to feel light headed and extremely fatigued. I began to have a small rash around my hair-line that spread to my chest and arms. I self-medicated with diphenhydramine and recovered by the end of the day.
Patient stated that she felt ear ache and nauseous. Then she fainted in the bathroom and claims that she broke a rib. however, she said she did not go to the hospital. She contacted her primary physician on 10/17/16 to report this and then called the pharmacy.
PENTACEL given in error on 7/27/2012 error found 3/7/2013 should have been MENACTRA reported to CDC and Sanofi on 3/7/2013.
Within 5 minutes of MMR given, patient developed localized reaction 50x50mm redness and 25x25mm of induration.
10 cm x 8 cm, raised, hard, red, hot to the touch. Seen and treated for cellulitis on 12/19/18 at the clinic.
Allergic Reaction - red rash on arm, tingly face and jaw, headache, racing heart rate
Arm erythema, warmth, tenderness, edema with axillary lymph node tenderness consistent with cellulitis.
This report was received from a nurse concerning the occurrence of a rash in a male aged 34 years who was vaccinated with Havrix. On 4/14/00, the pt received his 1st vaccination with Havrix. After 6 days, 4/20/00, he experienced a full body rash. The most recent information received on 4/27/00, reported the symptoms resolved.
We did the at home test, and I tested positive on Feb 16th and was told by my doctor that if we wanted to be counted I had to call the board of health. I called them and they told me if I was still sick after 11 days to call my doctor. I did and they did a chest x-ray on me. I had a right pleural effusion.
With in five hours child developed fever, irritability, and diarrhea.  Gastrointestinal  symptoms and lethargy  lasted 5 days then resolved
Patient received a Pfizer COVID-19 vaccine after getting Moderna as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received a Pfizer COVID-19 vaccine after getting Moderna as a first dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a Pfizer COVID-19 vaccine after getting Moderna as a first dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received a Pfizer COVID-19 vaccine after getting Moderna as a first dose) outcome was unknown.        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.   It was reported that patient erroneously received a Pfizer COVID-19 vaccine as a second dose on 28May 2021 Lot #EW0187,expiration date 20Aug2021 on left arm intramuscularly. No Concomitant medications was reported. No Treatment medication was reported
Pt vax 6 doses & was non responder.  MD unsure which brand given.
The evening I received my vaccine, I started getting "low heart rate" notifications on my Apple Watch. I also received "Afib" notifications on 10/14/22 and 10/16/22. I am now 11 days post vaccine and my heart rate is still fluctuating between a normal rate (60-80) and a low rate (39-48). Cardiologist confirmed Afib readings.
CP, seen in ED 24 hrs after vaccine and ruled out for a MI. No hives, rash or injection site change. 12/8/2009 ED records, H&P for 12/1-12/2/2009 patient with c/o's chest pain and SOB, dx tests neg, Dc'd home, f/up with OP stress test DC Dx atypical chest pain 12/8/2009 PCP records for visits 11/30 and 12/7/2009 addressed recent ER visit, Nuclear stress done outpatient was normal and no further c/o's chest pain x 1 week.
left calf is twice the size of my right/ Left leg is so swelled up; foot on his left side gets really hot; arm was sore; This is a spontaneous report from a contactable consumer (reported for himself). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FAR484/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 07Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0189/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 17Jul2021as dose 1, single for covid-19 immunisation and tylenol experienced drug hypersensitivity. On an unspecified date in 2021, the patient experienced left calf is twice the size of my right/ left leg is so swelled up, foot on his left side gets really hot and arm was sore. The outcome of the events was unknown.  This follow-up is being submitted to notify theta the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.