chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. came into Immunization Clinic on Mon., 13 Mar 06 at 1340 to continue immunizations for himself and his family in preparation for their move in May 2006.  Patient had been given VIS handouts on Hepatitis B and Japanese Encephalitis. He denied any allergies to foods, drugs, latex or environment, denied being ill or running a fever of 100.4F for the last 5 days, denied taking any medications prescribed or over the counter on a daily basis, denied any reactions of any type to any previous immunizations, denied any surgical procedure within the last 4 weeks, denied being given any blood products in the last 90 days.  Pt denied any discomfort.  Pt. instructed on our local protocol of waiting a minimum of 30 min. and reporting any signs of dyspnea, itching, difficulty swallowing, "feeling funny", nausea or abd. pain after JEV was given.  Pt. given Hep B #2 and JEV #1 at 1344.  At 1408 complained of feeling anxious, "funny taste" in his mouth and difficulty swallowing.  Pt ambulated with assistance to Immunization treatment room-stable on feet-Alert Oriented X3, color pink, skin warm, moist, perspiring.  Anaphylaxis protocal started.  Dr called--VS BP 142/88 AP 110 reg. Resp 28 clear @ bases, equal no wheezing, rales or rhonchi noted SAo2 99% Temp 97.1F via ear probe  Epinepherine 1:1000 0.3 mgm given via epi-pen in rt. lateral thigh at 1409 by R.N. Oxygen via mask @ 8L/min. started. Pt head of bed elevated 45 degrees.  1410 Dr. here and examined patient. Benadryl 50 mgm IM in RIC per M.D. order by R.N.  Pt vital signs monitored every 5 min. X30 min, then every 15 min X 60 min.,then every 30 min x2. Vital Signs remained stable-SAo2 remained between 97% and 99%. Pt stated swallowing much better at 1430.  Color pink -skin warm and dry VS B.P. 140/76 AP 80 reg. Resp 24 clear at bases equal--no wheezing rales or rhonchi noted. Swallowing sips of water without difficulty SAo2 98% O2 discontinued. Solu-Medrol 125 mgm IM in LIC at 1440 per M.D. order by R.N.  1500--Pt stated he felt great but a little sleepy--Denied any dyspnea or dysphagia SAo2 remain at 97% to 98% on room air.  Pt playing game boy- Alert orient X3-Color pink- Skin warm and dry.  Pt monitored and observed until 1600.  Dr again examined patient at 1515 and gave patient and his wife discharge instructions on medications Benadryl 25 mgm by os every 6 hours x 11 days, Prednisone 20 mgm by mouth every 8 hours x 5 days.  Epi Pen 1:1000 0.3 mgm to be administered by patient if he has any dysphagia, dyspnea, rash hives and to get to hospital E.R. if these symptoms should occur.  Pt instructed on use of Epi-Pen with return demo. by patient by R.N.  Pt up to B.R. with assistance at 1555 steady gait-voided quantity sufficient without apparent difficulty VS T. 97.2F-B.P. 124/72, A.P. 64 reg., Resp 20 clear to ausculatation SAo2 98%.  Pt taking fluids without difficulty.  Pt has follow up appointment with M.D. Fri. 17 Mar 2006. Pt instucted on the importance of not taking JEV again. Talked with patient via phone on Wed. 15 Mar. 2006 and he stated he was feeling great-no problems.
This spontaneous report as received from a physician refers to a 12 year old male patient. On 14-JUL-2014, the patient was vaccinated with a dose of GARDASIL (Lot # J009788, expiration date 17-MAR-2016) (route not reported). The physician reported that on 18-JUL-2014 at 16:00, the patient's father called in behalf the son who was complaining on not having feelings in his legs. On 21-JUL-2014, the father called to state that the patient still was experiencing soreness in his leg and could not walk. The patient's father stated that he gave the patient MOTRIN and this relieved the symptoms but once the medication duration was completed the symptoms returned. On 24-JUL-2014, the father called back again to state that the soreness remained in the patient's legs. The physician recommended to the father to take the patient to the hospital. The outcome of could not walk and not having any feelings in his legs was unknown. The outcome of soreness in his legs was reported as not recovered. Additional information has been requested.
2 yr old was administered Kinrix; Kinrix as 3rd dose of DTaP and IPV; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) 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 Pentacel (The first dose was received on an unknown date) and Pediarix (The second dose was received on an unknown date).   On 15th November 2022, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 28-NOV-2022. Reporter's comment: The medical assistant (MA) had reported that, a child patient was administered with Kinrix. The Healthcare Professional (HCP) had also reported that patient had received Pentacel as their first dose and Pediarix as their second, so the Kinrix was their third dose of DTaP and IPV vaccine schedule. The reporter had consented to follow-up. Additional supportive information: The patient who had received Kinrix as their third dose was younger than 4 years, which had led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Moderna vaccine was administered outside of office - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/16/2022 ACUTE EXACERBATION OF COPD J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 7/16/2022 ACUTE EXACERBATION OF COPD J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/28/2022 ACUTE EXACERBATION OF COPD R09.02 HYPOXIA 6/22/2022 ACUTE EXACERBATION OF COPD J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/16/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 7/16/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/28/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXIA 6/22/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/16/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 7/16/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/28/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXIA 6/22/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/16/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 7/16/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/28/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 6/22/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/16/2022 ACUTE EXACERBATION OF COPD J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 7/16/2022 ACUTE EXACERBATION OF COPD J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/28/2022 ACUTE EXACERBATION OF COPD R09.02 HYPOXIA 6/22/2022 ACUTE EXACERBATION OF COPD
Patient initially was sent over from the clinic by his PCP for SOB, low oxygen sats, and hypotension.  The patient reportedly had Bps in the 70's systolic with multiple manual readings. His oxygen was in low 90's on RA.  The clinic put some nasal o2 on and wheeled him to the ED.  He was able to get onto the cot by himself.  He notes that he started feeling like he 'couldn't get a good deep breath' last Sunday 9/19/2021. He had been outside 'cutting down ragweed' which he has a history of allergy to.  He thought that 'he just got a good dose of ragweed' at that time, but the SOB was worsening and he has started to have fatigue that started about 2 days ago.  He had a small amount of diarrhea this morning with his normal BM, but no nausea or vomiting.  He denies fever, ear pain, rhinorrhea, or cold-like symptoms. He has a cough, but it is dry and seems 'baseline'. He has had an altered sense of smell, with the predominant smell of aluminum over other smells.  He believes his taste is intact. He has no history of covid infection and he was vaccinated with two doses of the pfizer covid vaccine in the spring of this year. He has no known exposure to covid.  Diagnoses   Upper respiratory tract infection due to COVID-19 virus  Acute kidney injury - Patient transferred to hospital for developing pneumonia, covid positive, hypoxia, and AKI.
Patient had slight upper arm swelling, itching, chills and left sided nerve pain along ribcage. Some redness around immunization site. Swelling ran along back of (L) arm.
Post COVID vaccination (received on 12/14) Had MULTIPLE episodes of palpitations lasting several minutes. These palpitations started the evening of 12/14 and continued throughout 12/15/2020
Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) in an elderly male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml).    No concomitant medications were provided by the reporter. The patient was administered 0.25 ml instead of 0.50 ml of the bivalent vaccine. No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-642993 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642993:1st patient case
Sharp stabbing stomach pain without nausea or diarrhea. Burning, achy joint pain followed by chills, fever ,headache and general weakness. Lack of appetite due to stomach pain. Continued for 48 hours. Slow improvement on 4/4. Still having  moderate, intermittent stomach pain and now diarrhea. Poor appetite, feel flushed, without fever. Still headache,weakness and fatigue
First issue is full on bronchitis 2 weeks of antibiotics 2 days after 2nd dose.    However, my menstrual cycle is spot on 28 days for the last 11 years.  After dose 1 my period came 5 days early with heavy bleeding.  2nd period was 4 days early and when I tell you the bleeding was GOD AWFUL I mean I have never bled so much in my life during my period.  Tampons wouldn't hold it and let' just say my bedding needs replacing.  Absolutely god awful bleeding.
On 5/31/21, patient's husband described that the patient fainted and experienced  seizure-like activity. She reported nausea and dizziness before and after the episode. It took approximately 2 minutes for her to regain consciousness and she didn't have any recollection of what had happened. On 6/1/21, patient's daughter contacted nurse triage after she experienced forgetfulness and word-finding trouble, performed a FAST exam, and patient was admitted.  Work-up pending.
4 month old received the kinrix instead of Pentacel; 4 month old received the kinrix instead of Pentacel; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 11-OCT-2023, the patient received Kinrix. On 11-OCT-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 4 month old received the kinrix instead of Pentacel) and inappropriate age at vaccine administration (Verbatim: 4 month old received the kinrix instead of Pentacel). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 Information: GSK receipt date: 11-OCT-2023 A health care professional (HCP) reported that a 4 month old received the Kinrix instead of Pentacel, which led to wrong vaccine administered and inappropriate age at vaccine administration. No reactions reported. The reporter consented to follow up.
Started with rash from neck and shoulder down back on left side. Severe pain, fever, chills. Symptoms ongoing, skin feels like it is burning and spasms. Three weeks later not resolved. Trying an increase in gabapentin dosing for pain. Valcyclovir given as well.
pt recv vax 3PM & @ 4PM began crying;mom felt it was a strange cry w/burping noises;called amb @ 410PM;t100, adm to hosp & put on IV fluids x 3 days;redness around inj site;mom states pt fussy in hosp;inj site red, & tender w/inc temp;
Information has been received from a physician concerning a 5 year old female who was vaccinated with MMR II. Suspect therapy included VARIVAX (Merck). It was only known that they received MMR II and VARIVAX (Merck). It was not certain if they were administered concomitantly or in what order. Subsequently, the patient experienced rash and fever of 101 degrees F. This is one of several reports from the same source. Additional information has been requested.
Hospitalization for suicidal ideation, cellulitis, COVID-19 positive on dates 1/20/2023-1/23/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
On 15 Nov 2021, I received my Moderna Covid-19 booster.  I have concerns about how the vaccine was administered and its potential lack if efficacy.   The first thing that raised my concern during the vaccination was how slowly the vaccine administrator was pressing the syringe into my arm.  Second, after getting through my skin layer, the administrator had to apply additional force (while still pressing slowly) to get the needle into the muscle tissue.  Third, she slowly pressed the plunger to inject the vaccine into my arm.  Fourth, and most significant, when she pulled the needle from my arm, a significant amount of the vaccine was flowing down my arm from the injection site.  The injection  was one of (if not the most) uncomfortable injections I recall ever receiving.  Being concerned about the slow technique, I commented to vaccine administrator that I never recall having an injection done that slowly.  Her response was that her slow technique prevents or minimizes pain.    In the days following the booster injection, I did not experience the usual soreness around the injection site.  Prior to this booster during the 2021 calendar year, I received Moderna shots #1 and #2, shingles shots #1 and #2, and a flu shot.   All of them resulted in my arm being sore for a few days at the injection site.     Having seen much of the medication leak out when the needle was removed, I believe that the lack of soreness following the Moderna injection is evidence that an insufficient amount of the vaccine made it into my arm.    The most significant concern is that I do not believe that I received enough of the booster for it to do its job.   Given the possibly of not having received a sufficient amount, is it reasonably safe to simply repeat the booster to boost both my immunity and confidence?
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 10-FEB-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
This patient had urticaria, lip swelling, hand and feet swelling, approximately 1 hour after administration of her vaccinations.
arm was very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was very sore".  Additional Information: The patient wanted to know if the vaccine causes glucose levels to rise or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
03/07/2021, 03/08/2021; 03/09/2021; all 3-days, Headaches, body aches, hot/cold within body (no fever), pressure on chest, coughing up phlegm,   Advil to relieve headaches.
Two days following injection, pt had local reaction which persisted several days, prompting office visit. Induration, itching, painful to touch.   No systemic symptoms. Already improving. No cellulitis. This form is only being completed since family requested f/u appt.
PATIENT EXPERIENCED LOCKING UP OF JAW ON RIGHT SIDE.  IT REMAINED LOCKED FOR  ABOUT ONE MINUTE. HE WORKED AT A CHEWING MOTION UNTIL IT FINALLY LOOSED UP FULLY.  HE WAS AT LUNCH AT THE TIME AND IT REAMINED PAINFUL AND UNCOMORTABLE THROUGH OUT THE MEAL. HE REPORTS THAT THE JAW REAIMED SORE FOR SERVEAL DAYS BEFORE RESOLVING.  NO MEDICAL TREATMENTS OR MEDICATIONS USED.  THE SAME REACTION OCCURRED AFTER THE 2ND DOSE ON 3/17/2023. THIS TIME IT WAS ABOUT A WEEK WEEK LATER WHEN THE SAME RIGHT SIDE OF JAW; SAME OUTCOME AND TREATMENT.
A week following the vaccine, I started my period a week early. This is odd as I am typically very on schedule. It was the worst period I have had in at least ten years. I threw up, couldn't leave my bed, and nearly blacked out when getting up. I also bled very heavily. I was scared and almost went to a clinic. It subsided after seven days. I had heard it was a potential side affect, but wanted to add my experience to the list. I am terrified for next month.
second dose of shingrix on april 2020 / 1st dose on 2018; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   In April 2020, the patient received the 2nd dose of Shingrix. In April 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
racing heart; shortness of breath; weakness in limbs; moments of dizziness; tiredness; nausea
Patient was given RSV vaccine in error, patient is of age and recommended group but didn't request.  Patient was not upset.
In the evening following the Vaccination I had chills, nightsweats, body aches, headache and sever arm pain. These symptoms continued the following day into the third day. I was bed ridden until late Sunday afternoon. The arm pain is now moderately painful with Tylenol but I am able to move it now and the other symptoms have lessened in severity as well.
Weakness, fever, chills. Skin rash that spread over body with some pustules. Also in pt. mouth.
It was reported that a 45 year old female received Fluzone SV '98-'99 USP on 10/26/98 and on 10/29/98, the pt experienced urticaria of hands and any body part exposed to cold. Symptoms reportedly started, post vax. From additional information received on 11/30/98, it was reported, "bee sting on 10/8/98 with slightly allergic reaction noted at the time, with swelling and itching."
Information has been received from a pharmacist concerning an approximately 40 years old female physician who was exposed to zoster vaccine live (Oka/Merck). It was reported that the physician was in close contact with the registered nurse who administered zoster vaccine live (Oka/Merck) and developed shingles. It was reported that the patient was originally thought to have shingles but was not diagnosed with it. The patient may have sumac poisoning. At the time of report the patient had not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. This one several reports received from the same source. Additional information has been requested.
Started to get mild headache and then chills.  As night progressed I was very cold with chills, had bad headache, face flushed and red.  By morning, had all the above plus face and lips were swollen, chest was heavy, left arm was almost frozen stiff and had to assist movement with other right hand. Nausea, no appetite, exhaustion.
Increasingly sore arm started within 2 minutes of vaccine. Treated with ibuprofen on 16Mar2021 and 17Mar2021. Sore arm resolved on 18Mar2021.  Migraine headache started 22Mar2021.  Treated with ibuprofen on 22Mar2021 and 23Mar2021 with no improvement. Migraine is ongoing as of 23Mar2021.
no adverse events or treatments.  HPV vaccine given outside of recommended age range.  Pt notified.
One minute post vax pt reported fluid filled vesicle near injection site; pt given diphenydramine; pt and vesicle were assessed; applied ice to injection site; reaction resolved.