chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, who is the patient. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm in 2015 at a single dose and two doses of pneumococcal polysaccharide vaccine (manufacturer unknown) via unspecified routes of administration in 2003 and 2008 at single doses; all for immunization. Ongoing medical history included Stage 4 renal failure (diagnosed when she was 53-years-old), diabetes from 2008, and immunocompromised. Concomitant medications included ORENCIA at an unknown dose intravenously once a month from an unknown date for rheumatoid arthritis and Flu vaccine in Oct2017 via an unspecified route of administration at a single dose for immunization. The patient previously received the Flu vaccine every year since she was about 50-years-old for immunization and had gotten sick after each administration. The patient experienced pneumonia twice last fall in Sep2017 and Oct2017, respectively. The clinical course was as follows: The first time she got pneumonia was in mid Sep2017. She ended up in the hospital on unknown dates for about 2 days. At that time, tests were performed because she had a severe chest spasm. The results were not provided but it was reported she was diagnosed with pneumonia. She stated that the pain was excruciating. The second time she developed pneumonia was in late Oct2017. She had her abatacept infusion on a Friday. The following Wednesday she got a influenza vaccine. She started feeling bad about 24 hours after getting the flu shot. She was diagnosed with pneumonia the following Monday. She was never hospitalized the second time she had pneumonia, but had to go to the physician's office to get antibiotics, which she was on for quite a while. She had fevers for 2-3 weeks. She had more asthma type problems since having pneumonia and got wheezy faster. The clinical outcome of the pneumonia twice last fall in Sep2017 and Oct2017 was recovered with some lasting effects in late Nov2017 or maybe even early Dec2017. The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.
7APR93 pt had shot @ 2:45- @ 8:30 & started crying loud-cried till 10; lt ear was red on outside & inside; face looked swollen but could have been from crying, couldn't walk, leg hurt; acted stiff; next day seemed to favor leg; felt hot;
Severe pain in entire left side of body, headache, passing out, fever, nausea, vomiting, blurry vision, sweating, weakness that night. Next day, 3/27/2021 same side effects. 4/5/2021 still having tingling, trouble with general movement in the left arm, muscle weakness
ARM WAS STILL PURPLE; PAIN WAS UNBEARABLE FOR A WHOLE WEEK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced arm was still purple, and pain was unbearable for a whole week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was still purple, and the outcome of pain was unbearable for a whole week was not reported. This report was non-serious.
not feel well; pain; fatigue; chills; fever; sweaty; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis.   Previously administered products included HPV vaccine (received 2 doses without any problem) and Menveo.   On 24th July 2019 11:30, the patient received the 1st dose of Bexsero and the 3rd dose of HPV vaccine. On 24th July 2019, 1 days after receiving Bexsero and HPV vaccine, the patient experienced fever and sweating. On 24th July 2019 23:30, the patient experienced fatigue and chills. On 25th July 2019, the patient experienced pain. On 26th July 2019, the patient experienced feeling unwell. The patient was treated with ibuprofen (Motrin), paracetamol (Tylenol) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fatigue, chills, fever, pain and sweating were recovered/resolved and the outcome of the feeling unwell was not recovered/not resolved.   The reporter considered the fatigue, chills, fever, pain, sweating and feeling unwell to be related to Bexsero. It was unknown if the reporter considered the fatigue, chills, fever, pain, sweating and feeling unwell to be related to HPV vaccine.  Additional details were reported as follows: The patient's mother reported for the patient. The patient received the first Bexsero vaccine as part of his routine vaccination because he was attending college. The reporter clarified that he did receive the third part of HPV series at the same time and on the same arm where he got Bexsero vaccine. However, he did not have any reaction to the other two HPV vaccine that he received in the past; so at this point, they were only suspecting that the events are due to the Bexsero vaccine.  Later on the same day of receiving Bexsero vaccine, on that evening, the patient complained about unusual fatigue and around 11:30 PM at night he had the chills.  The patient had a fever of 101.6 degrees F at 3:30 AM. The reporter gave him Motrin 1,000 mg and called her health plan that has someone working 24/7 for advice. They told her to take him to emergency room if the temperature goes over 104 degrees F. The patient's temperatures escalated to 102 and again, it was 103 within 40 minutes after calling the health plan. The patient seemed to be in pain. The reporter got some compressed ice and took his temperature again. Within 15 or 20 minutes of making that phone call, his temperature were over 104 degrees. She took her son to the emergency room (ER). At the ER, her son had his temperature taken rectally and they were 102.8 degrees. He was given fluids and stayed for an hour at the ER. They discharged him on both Motrin and Tylenol staggered every 3 hours (alternating both medications every 3 hours). The patient was sweaty and had fever (of 99.8 degrees F) the entire day. The physician reported this event to the CDC.  The reporter consented for follow up.
Approx. 5 hours after vaccine an arrhythmia began + lasted through next day. UpoN waking + standing, I experienced multiple near - syncopal episodes throughout the day. Arrhythmia continued with decreased blood pressure. No fever, vomiting or diarrhea.
5 days after receiving vaccines, mother noticed hives starting on L thigh around the injection sites - pt was taken to medical center & was treated there.
Information has been received from a physician concerning a 15 year old female patient who on 01-AUG-1996 and 15-OCT-1998 was vaccinated with the first and the second dose of MMR II. On 02-JAN-2010 the patient experienced mumps. The patient has no fever. The parotitis was on the right side. The parotitis count was 98. The date diagnosed was 12-NOV-2009. It was unknown if the patient had sought medical attention. The lab diagnostic tests performed: on 12-NOV-2009 IgM was negative, IgG was 4.6 and serum amylase was 195. At the time of report the patient's status was unknown. Follow-up information has been received from a physician concerning a 14 year old female patient on 29-DEC-2009 experienced mumps. The date diagnosed was 31-DEC-2009. The lab diagnostic tests performed: on 31-DEC-2009 IgM was <1:10, IgG was 5.65. Additional information has been requested.
pt recv vax 25JUL96 & 28JUL96 pt broke out w/8-10 chicken pox on belly, under arm & in diaper area, w/fever of 101-102;pt also had URI sx described as wheezing;pt also teething but otherwise healthy;
I got a severe headache and began to ache all over my body. I just wanted to be in bed. The next day still had headaches, chills, aching all over. I had no appetite. I developed a fever on 01/22/2023 in the evening. I tested myself on 01/23/2023. My O2 stats never got below 92. I could not think while I was at work. I have recovered from my symptoms.
pt presented to ofc c/o severe h/a, & fever; PE reveals nuchal rigidity & photophobia; pt admitted to hosp for eval
I have fibromyalgia and follow the injection the nerves started firing like crazy. After they calmed down I felt severely drained like post seizure? I was in bed with body aches everywhere I have been injured for 3 days.
Slight soreness at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 26Feb2021 at 14:45 (at the age of 51-years old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 27Feb2021 at 08:00, the patient experienced slight soreness at injection site the following day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight soreness at injection site the following day was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; sore left arm; This is a spontaneous report from a contactable consumer (patient's husband). A 79-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 79-years-old, via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP6955) as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. No Additional vaccines administered on same date. No Prior vaccinations within 4 weeks. Repoeter stating that he and his wife had shot number one, 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm on 27Mar2021. Sore left arm, same arm as shot. Arm was sore for the day. Treatment was none. Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe. Was prescribed pain medicine for a week but did not take because it makes her feel funny. Is one of those powerful medications, can't remember the name. No AEs require a visit to Emergency Room or Physician's office. Event outcome of sore arm was recovered on 27Mar2021, of broken right arm was recovering, of the remaining was unknown.  No follow-up attempts are needed. No further information is expected.
Dizziness Narrative: After 15mins observation ended, pt stood up and felt light headed; VS taken, BP 152/68, HR 71, O2Sat 100%; pt observed for another few mins and at 1130, she said she's feeling fine and ready to leave; declined to go to ED.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion,; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    No concomitant medication was provided.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 1 Aug 2022 and individual vials were put in the refrigerator on the day of use.  Treatment medication was not provided by the reporter.   This case contains information for the 75th patient out of 104 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
COVID arm, rash, itchy  Treatment - None Outcome - slowly dissipate (redness) but still itchy
(R) arm where BOOSTRIX given has 5 x 4 cms/oval cellulitis area. Treated with warm compress & IM ROCEPHIN 1 gm - plus PO AUGMENTIN 600 PO BID X 10 day.
Started with pain behind the head and the next day I had a Facial Paralysis on the right side of my head
Severe soreness at injection site. Fatigue  Stomach cramps Joint and muscle aches Bad headache Diarrhea High fever chills severe sweating Dizziness
On the morning of December 24, 2021 I woke up with red, swollen eyelids that were painful to the touch.  My eyelids continue to be pink in color two days later (though less swollen) and are still a bit painful to the touch.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Raised red rash at injection site. Bump under the skin about the size of a golf ball. Skin is warm to the touch. Pain in arm radiating out from injection site.
Pain to upper arm. limited ROM. Hurts to raise arm. No improvement or worsened status since shot date.
Bumpy red rash on chest mainly right upper arm and some on left upper arm slight itch
I could feel tingling in my left arm and that my ears were still ringing. I told the nurse. I could feel the electrical tingling from elbow to wrist and it would stop at my wrist. I could feel though discomfort in the wrist like the first vaccine. Two days later, I started sweating. Doctor said the vaccine was working by having a fever. I had a low grade fever. I felt a little ill, I had a little diarrhea. No gassiness. I had headaches and I felt windblown and kind of foggy. And then about a week after the shot, my wrist actually started hurting (in September). I saw the doctor on the 21st, they couldn't see me until then. I told her I was in pain in the wrist. The dr. could see it was swollen. She is referring me to an Orthopedist and I will get an injection from that doctor to stop the pain, October 4th, some kind of cortisone with novacaine. What has gone away now are the chills and the low grade fever and body aches. I am still having the joint pain, left wrist is very tight and in the ring finger and middle knuckle of both fingers.
3rd dose of vaccine was given too early.  Dose # 1 was administered on 7/21/2022, 2nd dose was administered on 8/11/2022, 3rd dose administered on 9/15/2022.  Parent has not reported any adverse reactions.  Error was discovered when reviewing covid vaccine doses administered report.
Arm pain originating in the deltoid region spanning down length of arm. Patient reports limited range of motion, pain, weakness, and tingling in fingertips.
Swelling in left arm, redness, and "fever" present in arm. Slight to moderate soreness.
pt recvd vax 18OCT95;mom to clinic 24OCT95 stating pt devel rash around inj site;pt scratched rash 23OCT95;24OCT95 rash had spread to a large red area approx 1 1/2inches by 2 inches;warm to touch;referred to family MD;allerg pertussis
feeling nauseous after eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: NAUSEA (non-serious), outcome "unknown", described as "feeling nauseous after eating".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8 x 13cm area of erythema anterior thigh given Keflex and Benadryl.
Patient received the 1st dose of Moderna vaccine on 12/28/20.  The next day, on 12/29/20, she developed a fever >100, fatigue, chills, sore throat, new anosmia/dysgeusia, chest tightness, headache, GI symptoms, and nasal congestion.  When the symptoms did not resolve, she contacted her doctor on 1/2/21.  They referred her to get a COVID test and that test from 1/2/21 returned positive.  Follow-up on 1/4 showed symptoms stable.  No hospitalization required.  Treated with albuterol inhaler and pseudoephedrine.  Not believed to be related to vaccine, however reporting since my understanding is that VAERs is interested in reports of positive COVID cases following vaccination.
Sore throat, fever,  chills that started with the sore throat at 10pm on the same night as the shot and then the fever and chills came on over the night.
2AUg94 broke out in body rash; called MD who advised giving DPH; seen by MD that day since DPH did not help; pt had diarrhea 18AUG93 con to have some diarrhea now; fever 101;
Patient reported to a different pharmacist other than the immunizing pharmacist that she had received a Pfizer dose on 03/06/21. However, she the thought she was receiving her second dose of Moderna. She had received her first dose of Moderna on 01/26/2021 at a different location. She scheduled her appointment online. She was given a vaccine record card when she arrived that had Pfizer listed as being given for first dose, along with a PQCF form that listed Pfizer as the vaccine to be administered by a screener. She was advised by a technician that she was receiving the first dose of Pfizer. She was also advised by the pharmacist prior to being immunized that she was receiving her first dose of Pfizer.
RED BLOTCHY RASH ON FACE, STARTING ON ARMS AND RAPID HEART RATE. WHEN PATIENT ASSESSED WITHIN 1 HR OF ONSET STABLE VITAL SIGNS, NO RESPIRATORY DISTRESS; URTICARIA ON BOTH CHEEKS; NO SWELLING OF LIPS; NO STRIDOR  ADMINISTERED DIPHENYLHYDRAMINE 12.5MG PO AND OBSERVED OVER NEXT 1 HOUR
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive; (09Sep2022) Positive, notes: Rebound COVID, sxm restarted on 09Sep2022 and positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Aug2022 to 03Sep2022.  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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Patient stated was feeling dizziness, lightheadedness, tiredness, tingling in fingers and toes.  Patient was able to respond to verbal queues.  Patient experienced these symptoms for approximately 10 minutes and then symptoms improved.  Patient still complained of burning feeling in feet, however patient stated he thought it was due to his Baron Dupuytren's Disease.   Patient felt he could get up to walk out however I encouraged patient to stay for observation.  Approximately 25 minutes after shot patient begin to experience same symptoms however was complaining of chest tightness.  Called 911.  EMTs arrived and took over care of patient.