chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 237c4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd January 2023, 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 Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments: Office manager reported that medical assistant administered an expired dose of kinrix on 23rd January 2023, whereas kinrix was expired on 13th January 2023. The reporter consented to follow up. Additional Supportive Information: the patient received vaccine, which was expired on 17th January 2023.
Post vax, the patient developed varicella. Unspecified medical attention was sought. It was reported that the patient's sister had a similar experience following exposure to varicella virus vaccine. Additional information has been requested. F/U 6/17/02: Information has been received from a physician and consumer concerning her 6 year old Caucasian son with no known allergies, asthma and a mild developmental delay who on 9/11/95 was vaccinated with a 1st dose of varicella (lot 609280/0429B). Concomitant vaccination that same day, included a 1st dose of MMRII (lot 615325/0787R) and a 4th dose of Hib (lot 6F61149). Concomitant therapy included albuterol nebulizer qid and fluticasone propionate (Flovent) MDI BID. There was no illness at the time of vaccination. The physician reported that on 2/1/01, that pt developed breakthrough varicella and it was reported to be a mild illness. The pt sought unspecified medical attention. There was no relevant diagnostic tests and lab data. The pt subsequently recovered. The date of recovery was unknown. It was reported that the pt's sisters (WAES01021600 and 01021601) had a similar experience following exposure to varicella virus vaccine live. No further info is expected.
(LD) red streaks, hot to touch, headache, fever, itching. Difficulty breathing 10-21-10 went to Clinic sent to ER tx with KEFLEX and inhaler.
Uncontrollable gasping on exertion (36 hrs after vaccine #2), VO2 max decreased significantly after vaccine #2, worsening chest pains and worsening fatigue in the months following
Recipient reported nausea, dizziness, and tingling sensation in his fingers 15 minutes after the vaccination.  Nurse placed him on a gurney and checked vital signs. His vital signs at 10:15 AM was: BP 117/79 (left arm lying), Pulse 72,  Pulse Ox 99%, Respiration 18.  Nurse offered him water; he drank it. He stayed in the gurney for another 15 minutes then said he felt well. He then sat in a chair until 10:45AM. He left on his own without difficulty.
Breakout in hives which started day after vaccine.  First on waist, then the entire arm,  neck - both arms, face and chest four days of hives and still ongoing with rash Treated with Allegra  and  aloe, witch hazel ,
Five days after 2nd dose of Moderna, I had some pain in bottom of right lung. By early the next morning, I had severe pain on the whole right side of my chest, particularly when trying to take a breath. Pain was worse when lying down. I went to ER 2 days later and was diagnosed with multiple pulmonary embolisms in both lungs and a pulmonary infarct in the lower lobe of the right lung. I was instructed to discontinue the birth control pills I was taking. Doctors could not say for certain if the vaccine was a factor in causing the clots. I'm now prescribed an anticoagulant medication. I now have a pulmonologist. Current status of clots unknown.
Patient is only 16 and she is here for her second dose of the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is only 16 and she is here for her second dose of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is only 16 and she is here for her second dose of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is only 16 and she is here for her second dose of the vaccine) 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.   No relevant concomitant medications were reported. No treatment information was provided.
25min p/vax pt stretched arms out as if to yawn but then arms stiffened & eyes rolled back-pt slumped over to the side as if in a faint-mom aroused by shaking-episode last 5-10seconds;pt fine afterwards-ate lunch, played;
No adverse event, patient was given adult dose of Hep A after already completing Pediatric Series.
Patient received her 2nd Menactra 2 years to early.   Patient had no symptom or signs of any adverse events.
Pt vaccinated at work on 25OCT2011.  Experienced bloody diarrhea from 10DEC2011 to 12DEC2011.  Received abx, had urticarial rash, abx d/c'd and steroids started 14DEC.  Diplopia noted 15DEC, worsened on 16DEC, went to ER.  Admitted with rapid worsening to absent gag and cough reflex, paralysis of upper and lower extremiies, intubated.  Received botulinum antitoxin but weakness progressed, EMG on 17DEC inconclusive, repeat EMG on 21DEC classic for Guillain-Barre.  Pt plasmapharesed five times between 21DEC and 29DEC with moderate improvement.  Received trach and peg and discharged to long-term care facility on 29DEC.
Pt. states that after receiving 2nd dose of Phizer 07/25/2021, started experiencing symptoms 07/26/2021 of excessive bleeding through menstrual (fibroids), ER visit 07/29/2021 Blood Work, Iron Low recommended follow-up with Primary. Still continuing to bleed.
Patient began to feel faint within 5 minutes of receiving his vaccines and standing. He was instructed to take a seat and continue to wait, at which time the patient expressed that he'd like to lie down and immediately became nauseous and trembling and began to vomit.
Body aches, chills, migraine, nausea, fatigue >48 hours.
Patient experienced Nausea, Fatigue, and soreness to the arm, In 24 hours a rash began and started heading down towards her elbow. She saw her primary physician today and was counseled that she has seen similar reactions with other 2 dose vaccinations. But if the rash does not clear up in a week or if it gets worse she needs to have it rechecked for cellulitis.
neck pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: The patient received both doses and started experiencing side effects such as neck pain and nausea. The pain started increasing lately and she wanted to know if that's normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Penicillian allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Date and time adverse event started:   3/10  went away then  started again  3/18/21 area on arm is itchy and hard  using witch hazel; recommended hydrocortisone cream for itching
This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 61-year-old female patient who received SHINGRIX (batch number EK279, expiry date March 2020). On 11th march 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, several weeks after receiving SHINGRIX, the patient experienced blistery rash (serious criteria other: as per reporter), influenza-like symptoms (serious criteria other: as per reporter), chills (serious criteria other: as per reporter), sores mouth (serious criteria other: as per reporter) and fever (serious criteria other: as per reporter). The patient was treated with acyclovir. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the sores mouth was unknown. It was unknown if the reporter considered the blistery rash and sores mouth to be related to SHINGRIX. The reporter considered the influenza-like symptoms, chills and fever to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional was a retail pharmacist. The patient received SHINGRIX vaccine on the left arm. The healthcare professional (HCP) stated that the patient was due for 2nd dose. The HCP stated that the patient reported of having fever, chills, and flu like symptoms developed within a few days of 1st dose and recovered within a few days of onset. The HCP stated that the patient reported around 25th March 2018. The patient was unsure when the events occurred and had a gradual onset started to develop a blistered chest rash, sores in and around her mouth. The HCP stated that the patient went to on primary care doctor on 30th March 2018 and received Acyclovir to treat blister rash and sores. The HCP reported that all symptoms had resolved except for small chest rash. The only treatment was physician visit and Acyclovir and the patient had returned to normal daily activities.
had kinrix at 5 year old / Now 8 with low pertussis titers.; Which vaccine for pertussis can I give/ Had 4 previous ones. 2, 6, 15 months and 5 years / kinrix at 5 year old; This case was reported by a physician via call center representative and described the occurrence of therapeutic response decreased in a 8-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included pertussis vaccine (received at 2, 6, 15 months and 5 years).   On an unknown date, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, more than 2 years after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced therapeutic response decreased and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the therapeutic response decreased and inappropriate schedule of vaccine administered were 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 provided as follows: The patient received 4th dose of kinrix at 5 year's of age and at 8 year's of age he/she had low pertussis titers, which led to therapeutic response decreased and inappropriate schedule of vaccine administered. The reporter asked if which vaccine for pertussis could be given to patient. The reporter did not consent to follow-up.
Throat felt tight, hx of allergy to shellfish-has epi-pen at home.       This feels similar to his prior anaphylaxis.   Pt. and mom agreed to epi and EMS transport.   R. thigh epi administered and care was turned over to onsite EMS.  Blood sugar was 210.   Pt. has type 1 diabetes and uses insulin pump.
Bell's Palsy- treated with prednisone and acyclovir. Some residual still left. Numbness to right arm and leg. Severe headache.
Left arm red, swollen, not tender, but itchy, gave patient Zyrtec and Benadryl.
Dry hacking cough, headache, 100.2 fever lasting 10-12 hrs
pt recvd vax; swelling approx 4" in diam w/ raised the size of an egg; swelling started to diminish some w/in 2 days but most of swelling & discoloration was there x 7 days; many flu shots in the past;
The patient developed back pain one month after the first injection on February 24 she was diagnosed with pericardial effusion?s and 750 mL was drained from the pericardium. The work up is on going but it seems to be Pericarditis  which occurred after the vaccination
Sterile water was used to reconstitute the lyophilized powder; Sterile water was used to reconstitute the lyophilized powder; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that sterile water was used to reconstitute the lyophilized powder of Shingrix, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up.
Substantial Hair loss, burning scalp, itchiness .  It worsens after each vaccine dose and booster
Information has been received from a pharmacist concerning a 60 year old female patient who on 30-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (route not reported) (lot number 669260/0152AA, Exp. 01-MAY-2012). On 30-MAR-2011, the patient developed "on and off tingling in the arm from the elbow to the fingers" soon after. The patient called pharmacy to seek medical attention. There was no treatment given for the event. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Evening of shot, itching all over starting lower leg and moving up the body-had to take dentures out-blisters on gums.
Review of ED notes show she received IV infusion of normal saline, and IV push of benadryl and compazine after going to the ER for severe headache on 04/17/2021. She first noticed pain when streching the arm shortly after the IV infusion but didn't pay attention to it, then 5 day later she noticed localized swelling and redness.  Patient was sent for US doppler which left cephalic vein thrombus detected on duplex US. Was treated with aspirin and had follow up doppler of UE for follow up on LUE cephalic vein thrombosis-negative 5/13/21.
Breath holding spells with a fainting spell followed by a brief anoxic seizure single episode triggered by crying fit. 7/29/08-records received for DOS 07/29-07/30/07-Life threatening event.  This is first seizure related to cyanotic breath holding spells. In ED had another spell when IV insertion took place. No spells that are unprovoked. PE:WNL. Assessment:breath holding spells with a fainting spell and brief anoxic seizure.
Information has been received from a RN concerning a female employee who was vaccinated with two or more doses of MMRII. Subsequently the pt had an equivocal measles titer.  It was noted that the pt was not pregnant.  Medical attention was sought. No additional information was provided.  It was also noted that the same source reported another employee with a negative measles titer following vaccination with two or more doses of MMRII (WAES 0308USA01010).  No further information is available. The physician may not be contacted.
Recieved injection on morning of Aug. 7th and was given tylenol and ibuprofen alternating every 2 hours.  On Aug. 8th, mom was feeding child and felt he was really hot.  At 0925 he began to have a seizure for about 30 seconds.  Mom called clinic and brought him in.  No temp at that time.  Was post dictal.
Pt states swelling and pain in upper arm at injection site. Primary doctor put patient on KEFLEX 25mg 1 capsule every 6 hours x6 days.
01/01/2021 - pt developed R arm pain, fever up to 102+ on 01/02/2021  seen in MedXpress - neg covid & rapd covid. Developed significant  redness in L upper arm that spread. Fever continued but  controlled with tylenol & ibuprofen. Redness, temp & pain improving on visit 01/04/2021.
Oct. 13, 2010 patient came into the flu shot clinic complaining of intensely severe pain in her entire left arm. She had received the flu shot approximately 20 min earlier in the left deltoid. Patient stated the injection stung a lot, but the sensation was greatly diminished shortly after. She had returned independently to her apartment, however, the pain began shortly after reaching her apartment and intensified to the point she could not tolerate it. Pain involved the entire arm and hand, making hand feel numb and as though a "shooting poker of some kind was going down the arm from the injection site to her fingers". No markings of any kind seen at the injection site; no abnormality palpable at the site. BP was taken and was approximately 100/60-70, Pulse regular, approximately high 80's (rescue squad took recording sheet with them so am uncertain of exact reading). No respiratory distress. Skin warm and dry, color pink. A student nurse was sent out to the ambulance to request one of the paramedic/EMT staff return to the clinic. Rescue squad came in and checked patient over then called a back up squad to come and take over so the other person experiencing the adverse reaction could be transported to the ER. Rescue squad worked to calm patient, used ice on her deltoid area, and continued assessment for approximately 30 minutes. She was feeling better, though pain was not completely gone and she did not want transport, so was left in my care for an additional 30 minutes until she felt strong on her feet and returned independently to her apartment. Pain was not completely relieved when she left the clinic; she was steady on her feet and mentally clear and coherent. Teaching was done by rescue squad and reinforced by me that she should see primary MD if pain is not gone tomorrow, or to go to ER if arm pain again worsens. I instructed to watch for signs of redness, swelling, increased pain and if occurs to see primary MD. She verbalized good understanding of all the teaching. 10-15-10 Called patient yesterday leaving a message to call me regarding her status. 10-16-10 Called patient again today; had not returned my call. Arm pain is gone but has developed "pebbly" lesions around the injection site that "itch like crazy". No other symptoms. Has not been seen in health care setting for the arm.
Patient took her Allegra every day after the Moderna vaccine, but skipped Jan 22, 2021, the symptoms presented Jan 23, 2021-swelling, warmth, and erythema at injection site. On Jan 23, 2021 she took her  Allegra
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     No medical history was provided.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications listed.  Patient taking muscle relaxants for treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-101893 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101893:case for wife(dose1)
I just wanted to report that, after receiving the Covid vaccine, I got the Bell's palsy so, that was the reaction I received.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included Cancer. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as single dose for covid-19 immunisation. On 03Jul2021, the after the vaccination, the patient experienced bell's palsy. Patient just wanted to report that, after receiving the Covid vaccine, patient got the Bell's palsy so, that was the reaction received. Patient stated just wanted to report that, after receiving the Covid vaccine, patient got the Bell's palsy so, that was the reaction received. The patient did not receive treatment for the event. It was reported that the patient has to take medications after the vaccine because of the side effect (Not further clarify). The patient underwent lab tests and procedures which included unknown investigation with unknown results on an unspecified date in 2021. It was reported that the patient was basically being treated by the doctor. The outcome of the event was unknown at the time of this report.
It wasnt until around 11pm that I started feeling bad. I was getting hot, confused a little uncomfortable or agitated, then I went to bed. I woke in the middle of the night in a crying fit because I thought I was going to die I felt soooo bad ! It was worse than any flu Id ever had! My joints hurt, my head wanted to explode , fever of 101.3 , breathing issues , exhaustion, thirsty...this lasted 2 to 3 days. Ive had a couple of days here in beginning of april til now of waking up feeling sick again. It doesnt last all day. Sometimes it just before bedtime. I guess I just feel a bit sick, but that could also be the cancer that ive had since july 2020 that hasnt been treated by a health care system I have?