chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unknown number of patient. On an unknown date the patient was vaccinated with VARIVAX (dose, route and frequency were not reported, lot# reported as M028459, EXP 07-JUN-2018). The nurse reported the vaccine was exposure at 4.5 Celsius for 3 hours and 15 minutes and then 5 Celsius for 4 hours and 5 minutes before administration. No adverse effect was reported. This is one of the reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001370: US-009507513-1612USA008061: US-009507513-1612USA008060.
Initial unsolicited report received from a consumer on 11 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of Meningococcal vaccine (batch number, dose, route, cycle in series and site of administration was not reported, manufacturer unknown) on an unspecified date (when patient's son was 3 months old). It was reported that the patient received all vaccines in past. It was reported that the patient had a stroke a few years ago. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient almost died, and he had a lot of painful side effects. It was reported that "I was told you can NEVER get it again, but I have read people saying they did". Patient reports that patient had stroke (unspecified) a few years ago and also suspects to have had it again. Lab data and corrective treatments were not reported. Outcome of events was not reported. This case considered serious due to life threatening event: stroke. List of documents held by sender: none.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0191) at the age of 64 years for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Relevant Medical History and Concurrent Conditions (not including reaction / event):, Comments: High blood pressure. Concomitant medication(s) included: METOPROLOL SUCCINATE taken for hypertension. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches all the time"; SMOKE SENSITIVITY (non-serious), outcome "unknown", described as "when I am at work it make this worse 'smoke' and now my body feels like it heats up"; FEELING HOT (non-serious), outcome "unknown", described as "when I am at work it make this worse 'smoke' and now my body feels like it heats up and in end I just have to take the smoke and everything just like get out of it and 'quit' the smoke because it feels like I am too hot"; MALAISE (non-serious), outcome "unknown", described as "I didn't feel right".
Patient is seeing a speech pathologist as part of cleft palate therapy. She received the MMR vaccine on 4/1/10 around 3:15 pm in the afternoon. Had 100.3 degree fever that night; given TYLENOL; acting normally. Slept through the night, but started stammering when she awoke. Has continued to stammer the past couple of weeks, but now it occurs only rarely. Says that patient's weakest area is oral motor so contacted the speech therapist who thought that the stammering may be associated with the vaccine. I advised  that she should bring patient in to be seen. Appt booked for Wed 4/21/10 at 10:00 am for f/u. Also explained to her that out office can complete the vaccine adverse reaction form and submit it to the state program for review. She acknowledged.
Redness at injection site; Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 13th September 2019, the patient received Shingrix. On 17th September 2019, 4 days after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient had redness and pain at injection site following Shingrix vaccination. The reporter did not consent to follow up.
Low grade headache, Injection site soreness, log grade body aches, moderate fatigue.
SEVERE RASH WIDESPREAD OVER BODY, ITCHING, PUSTULES, BENADRYL GIVEN, IV PREDNISONE STARTED.
Left shoulder pain on raising arm overhead. Continues and getting worse on day 12 after vaccine. Is now hurting on minor movements. On day 13 have taken 1 aspirin and 1 Neurontin.
Extreme pain in (R) upper arm for 4 days - fever x 2 days.
Pt developed generalized body rash. As of report date, pt still had some rash on torso and legs but it looked old in nature.
Tested COVID-19 positive after receiving her Pfizer-BioNTech COVID-19 vaccination; Tested COVID-19 positive after receiving her Pfizer-BioNTech COVID-19 vaccination; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0140; Expiration Date: 31Mar2021), via an unspecified route of administration, administered in arm on 27Jan2021 (Age at the vaccination: 56-year-old) as dose 2, single and also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0140; Expiration Date: 31Mar2021), via an unspecified route of administration on 06Jan2021 (Age at the vaccination: 56-year-old) as dose 1, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took her daily medications but declined to provide that information at the time of reporting. Patient stated she was advised by her husband who was a Pfizer employee, to report to Pfizer that she tested COVID-19 positive on 03Aug2021 after receiving her Pfizer BioNTech COVID-19 vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Aug2021. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL0140. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The outcome of events was unknown.   Lot/ batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a physician's assistant concerning a female who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot # unknown).  On an unspecified date the patient was administered PNEUMOVAX 23 upon discharge from the hospital for an unspecified illness.  The patient subsequently developed severe swelling at the injection site.  Medical attention was sought in the office.  No further details were available.  Additional information has been requested.
redness 4x6cm @ inj site & tenderness 12 days p/vax given;came to office 25NOV97 to have it checked;MD gave erythromycin to r/o cellulitis & DPH for discomfort;
Vomiting-resolved Double vision in am for 7 days-resolved  Balance issues-ongoing
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-370033 (Patient Link).
Sick to stomach, unsteady on feet, difficulty swallowing, arm felt limp, pain on shoulder. Has nausea but only gagging, has not thrown up yet. Feels weak, dizzy like if did not eat in last 5 days but has been eating.
moderate rash to left arm, mild to right arm. Also rash to trunk and legs. Benadryl was taken
Fatigue and body aches. Lasted for about 3 weeks. Finally went to urgent care.
Patient received the flu shot & pneumovax vaccine on Monday 09/28/20.  The following day patient stated she was in extreme pain. The patient went to the ER that day due to the pain.  She was diagnosed with cellulitis by the ER doctor.  The patient stated she lost arm mobility for 4 days and continues to struggle to get her strength back.
pt recv vax 21APR96 & 27APR96 pt devel gen lesions across chest & buttocks;pt was totally asymptomatic;
side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effect). At the time of the report, ADVERSE EVENT (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications are provided.   Reporter did not allow further contact
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL 0.5 ml (lot#unknown) intramuscular in June-2012 and received her second and dose of GARDASIL in November 2012, received her third dose of GARDASIL on 08-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No adverse effect reported. The action taken was not provided. Additional information has been requested.
blew his back out; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. 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: BACK DISORDER (non-serious), outcome "unknown", described as "blew his back out".  Additional Information: The reported age of patient was 66 with unknown unit. He got his first shot back on the 5th (unspecified date). He was supposed to get the second one on the 26th (unspecified date) but blew his back out and he had to reschedule. He was asking how far apart they can be given and if the second dose can be rescheduled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High fever (38.5C) started at mid-night.  Shivering started at 0:30AM following onset of high fever.  Very sever headache started at 1:00AM following onset of shivering.  Next morning, fever went down to 37.5C.  Sever headache continued.  By 9:00 PM, headache became less sever.
Information regarding Haemophilus Influenza B vaccine (manufacturer unknown) was received from mother regarding her 9 year old son, who, as an infant, developed shaking of his one arm and one leg, and was diagnosed with hemi-hypertrophy. At 1 month of age, the patient received his first dose on 01/15/1995.
1 day after shot, the injection site was swollen and I experienced soreness for the next 3 days. At day 5, redness turned into bruising. At day 5, redness/bruising and swelling went away. At day 7, redness and swelling came back along with itchiness and is still present. No pain so far.
My husband and I  received our 2nd Covid vaccines and 6-1/2 days later he died.   He had no heart issues and was tall, slim, healthy and very active.   He had 2 heart attacks before the ambulance came and 3 more in the ambulance on the way to the Hospital.   The next attack was as they were unloading him in the ER and he died.    I have the ambulance report, the ER report and his last blood work and checkup reports and there is no doubt the vaccine caused his death.   I showed his reports to a heart doctor that I know and he agreed that it has killed some people.   I know of 2 other people that live in my town that had the same thing happen to them.
very very swollen; every day more red, more red, more red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (very very swollen) and VACCINATION SITE ERYTHEMA (every day more red, more red, more red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021 at 6:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (very very swollen) and VACCINATION SITE ERYTHEMA (every day more red, more red, more red). At the time of the report, VACCINATION SITE SWELLING (very very swollen) and VACCINATION SITE ERYTHEMA (every day more red, more red, more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication list was not provided. No treatment medications were reported.
Patient states that as of 11/13/12 (19 days post-vaccination) she is still having signficant arm pain and stiffness at injection site.
6/26/11 Developed body aches & tenderness at site. No redness 6/27/11 had nausea, diarrhea. Cont with nausea, 6/28/11 notice lg lump in (L) axilla area a (R) side facial swelling and body aches.
High fever & rash initially around inject site 24 hrs p/inject; Rash later spread to entire body; Mom advised to use APAP, cool bath, see if necessary; Went to ER MD felt it was rash rather than cellulitis;
Information has been received from a registered nurse concerning a 78 year old female who in December 1998 was vaccinated with the first dose of Pneumovax 23. On 07-NOV-2006, the patient was vaccinated with the second dose of Pneumovax 23 (Lot# 651399/0486F). On an unspecified date, the patient developed injection arm erythema which extended to the elbow and also to the axillary and the chest area. At the time of this report, the outcome of the event was unknown. The registered nurse was requesting a lot check for Pneumovax 23 (Lot# 651399/0486F). The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory authority. Additional information has been requested.
I was on the golf course in August after playing 15 holes.  I had been sweating but I was drinking plenty of water.  I got to box 16 and fell to all fours.  I was sweating profusely.  I asked to be helped back to the car so I could get into the air condition.  When we got to my car I realized I was confused.  I sat down on the ground for a minute.  I lost control of my bowels.  I cleaned up and got into the car and cooled off and drove home.  I got more Gatorade and something to eat and I felt fine.  I got home.  A few hours later I had another bowel movement that was all blood.  Another two hours went by and I went to bathroom again and it was all blood again.  I went the ER and the pain was so bad I was on all fours.  It was abdominal cramps.  I had a CT scan and blood work.  One doctor told me I had diverticulosis.  I was given Fentanyl for pain.  Went home and then I rested for a few hours and then I had more abdominal pain and blood.  I went back to ER and was admitted.  I had another scan and they found clots around my colon.  They also saw a clot in a vein from my heart  to my liver.  I have been a jogger all my life..  They put me on Eliquis to prevent clots.  I've been fine ever since.  I've been to several doctors and no one can tell me what caused the clots.  I also saw a gastroenterologist.  I have an appointment with  a vascular doctor in a week or so as well as a hematologist.  I also saw an internal doctor at the hospital.
Fever, Chills, Headache, Very Weak, Diarrhea, Nausea
Client reported on 7/23/18 the following adverse reaction: She became tired and achy on Friday 7/13/18 at about 6PM. She woke up Sunday, 7/15/18 at 8:00 AM with (L) sided facial swelling and also some swelling of the right side. She has a picture of this on her cell phone. She denies numbness tingling of tongue or throat swelling. Her mom called a friend who is a nurse practitioner. The nurse practitioner prescribed prednisone on Sunday morning and they picked it up at noon. The client states it took 3-4 days for the facial swelling to go away. The achiness and the fatigue was gone by Sunday morning on 7/15/18. The client feels she is fully recovered now. The VAERS report was filled out on 8/10/18. 8/10/18 Client came in and filled out the VAERS and also a copy given to the client. 8/14/18 VAERS report faxed to the CDC.
Systemic: Body Aches Generalized-Severe, Additional Details: UPPER LEFT ARM PAIN STARTED 9/6. NOT IT HURS LIKE A POOLED MUSCLE SPREADING ACROSS THE RIGHT BACK AND SWALLEN. PAIN SEVERITY IS SEVERE. ADVISED TO CONTACT HER PRIMARY CARE PHYSICIAN TOMORROW.
Symptoms began 3/18/07 morning before church, took Alovert and then 1 hour later took Benadryl meltaway (unsure of mg), hives and swelling stopped, but didn't really improve.  That evening patient vomitted for 2 hours, didn't take last dose of oral typhoid vaccine.  3/19/07 AM:  patient felt better, but tired - after lunch started having trouble using right hand to grasp, joints began to swell - extremely painful to bend all joints - patient stated "feels like meat falling off my bones".  Patient's stomach also swollen, hard to move/walk, with a shuffle when walking, difficult to sleep.  On 3/20/07, AM - patient still in extreme pain, able to eat an egg, no difficulty using with elimination.  Patient called her private MD - unable to talk with him, patient taken to ER and admitted. 4/13/07 Received medical records from hospital which reveal patient experienced acute arthgias & joint swelling on 3/19/07 which worsened progressively over next 24 hours until seen in ER on 3/20 & admitted 3/20-3/28/07 w/arthralgias, abdominal pain, weakness, malaise, fever & diarrhea.  In ER had acute elevated LFTs & elevated CRP, significant synovitis & lacy diffuse rash.   Had received vax for mission trip to Peru.  Consults by endocrine & urology.  Synovitis & abdominal pain recurred w/steroid wean & steroids had to be increased & then weaned very slowly.  Upon d/c to home, continued oral antibiotics & steroid taper.   FINAL DX: acute serum sickness-type reaction suspected secondary to live typhus vax; hyperglycemia secondary to steroid use; novolin insulin injection site angioneurotic edema, possible insulin allergy; dilated right ureter, unable to exclude distal ureteral obstruction; prior 2 hospitalizations for drug intolerance/sensitivities.
Mild headache, hot flashes, soreness to arms, nasal drainage, persistent headache with photophobia.  Follow up on 06/05/2000: "Patient recovered from adverse event."
Patient is 17 years of age received a first dose of the Moderna vaccine in error at a different facility. Per CDC guidance he was provided a second dose of the Moderna vaccine today to complete the two dose series.
Approximately 10 minutes after patient received the vaccine, patient said she was not feeling well. Upon inspection, her skin was flushed red  and she said she had trouble breathing. When I asked patient if her throat felt like it was closing up, she said yes and that it was difficult for her to breathe. Patient was then treated with epipen and within seconds of receiving the epipen injection, patient's skin returned to its normal color and patient stated she was able to breathe normally again. Informed patient that we will call 911 however patient's parents refused 911 service and said they will go to urgent care and/or emergency room if condition worsens. Instructed patient to stay at pharmacy for at least another 30-45 mins for observation, which they did. Patient said she was feeling well and left the pharmacy with her parents after approximately an hour from time of the vaccine.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 7 year old patient who on 10/2/97 was vaccinated with a dose of varicella virus vaccine live. On 4/28/03, the patient developed chicken pox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chicken pox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Headache/stomach ache/back pain/arm pain/chest pain.  After noticing that stomach ache that had been lasting one week and pain increasing daily, went to urgent care clinic.  They gave me antacid for stomach pain and wanted to send me home.  I insisted something was wrong, so they took ct scan of abdomen.  They noted that there was some masses in abdomen and asked if I had cancerous tumors.  They immediately referred me to emergency room and local hospital for further tests and admission.