chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal issues day 1- 3. Tired and some weakness.  Day 4 severe weakness, felt like I was going to pass out. Left work and went to ER. Basic blood work, ekg was normal. Sent home to rest. Day 5 rest all day still weak. Day 6 felt better was able to do work around the house until about 8:30 in the  evening. It was like flipping a switch extremely weak all of a sudden. Day 7 (Sunday) felt ok until around 3 in the afternoon then felt like I was going to pass again.  At this point I?m not able to do much of anything but lay around. Day 8 was a holiday so again  not able to do much from being weak. Now notice I?m losing the ability to feel temperature  of anything I touch with feet and legs. Also beginning to feel like I?m burning on the inside in arms and legs. Day 9 went to work but couldn?t do much. To weak to do anything.  Got an appointment with my GP on day 10. She ran all sorts of blood work and again most everything is normal. Also forgot to add that  I can only sleep 3-5 hours per night since I got the shot.  Next day when eating dinner arms and legs went numb and weak. Same thing next day while eating lunch. So basically everyday I get weaker and can barely function fot the most part. Very weak, burning inside and sick on stomach a lot with some headaches.
Pt is 5 weeks pregnant. Does not know the estimate date of delivery, she just found out. Woke up around 2 a.m, body aches, arm pain, vomited, vertigo episode, kind of confused and difficulty getting out of bed. Today, she is having weakness and arm pain, low grade fever and stomach cramps.
no additional AEs; PROQUAD administered to 13 year old patient; PROQUAD and VARIVAX were both administered to 13 year old patient on 1/4/23; This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided. The patient had no vaccination record and vaccine dose history was unknown.  On 04-JAN-2023, the 13-year-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, once, lot #W005206 has been verified to be valid, expiration date was reported as 14-FEB-2024; and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status has been verified as recombinant human albumin (rHA), 0.5 ml, once, lot #W024548 has been verified to be valid, expiration date was reported as 31-JAN-2024, both administered for prophylaxis into same extremity (strengths, exact anatomical locations, and routes of administration were not provided) (product administered to patient of inappropriate age) (overdose).
muscle pain; low grade fever; flu like symptoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 60's received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6206) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of Injection: Arm, Route of administration: Intramuscular, Lot number: EN6201), administration date: 11Feb2021, for Covid-19 Immunization, reaction(s): "muscle pain", "low grade fever", "flu like symtoms", "tiredness", "COVID-19". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "flu like symptoms"; PYREXIA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "low grade fever"; MYALGIA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "muscle pain"; FATIGUE (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.  Additional information: Mild reaction to all covid vaccines including muscle pain, low grade fever, flu like symptoms, tiredness.
3/28/07 Per phone conversation w/reporter, patient developed hives within a few minutes of vaccine.  Treated in office and at home w/oral Benadryl.  Patient had complete recovery w/o difficulty.
Information has been received from a nurse practitioner concerning a 3 month old male who was vaccinated with a 2ml oral dose of Rotateq (No lot number was provided). The nurse practitioner reported within 3 weeks after vaccination the patient developed intussusception. Medical attention was sought and the patient was hospitalized and underwent surgery. Subsequently, the patient recovered. There was no product quality complaint. The event was also considered to be immediately life-threatening, disabling and an other important medical event (surgery) by the reporter. Additional information has been requested.   8/31/07 Received patient demographics from CDC.  9/4/07 Received vax record from pcp.  VAERS database updated w/same. 10/5/07 Reviewed hospital medical records which reveal patient experienced copious bilious drainage from NGT & dx w/ SBO.  Had previous surgery of ileocolic resection w/primary anastomosis for IS w/dead bowel.  Admitted 8/1-8/7/2007.  Operative findings on 8/3 was a very tough cord like adhesion going straight across the ileum about 4-5 cm prior to earlier anastamosis w/colon.  Adhesion was lysed & small bowel was functional & healthy.  Multiple other smaller adhesions were lysed as well.  Admitted to PICU for post op observation.   FINAL DX: No D/C summary included.  Recurrent intussusception, surgically reduced.  10/5/07 Received D/C summary.  Patient had bilious vomiting.  Laparotomy & lysis of adhesions as above.  FINAL DX: postoperative bowel obstruction, surgically reduced.  Records faxed to CDC.  10/29/07 Reviewed hospital medical records which reveal patient experienced bilious vomiting & lethargy x 1 day.  Admitted 6/20-6/25/2007.  Taken to OR for probable mid-gut volvulus & found to have incarcerated ileocolic IS w/necrotic ileum.  Right colon resection w/primary anastomosis was done.  Progressed well & d/c to home FINAL DX: Ileocolic intussusception, surgically reduced.  Records faxed to CDC.
Rash and burning sensation on head and neck an hour after the shot was administered and continued through the night. Sore throat also experienced. Both arms felt pain the next morning.
Two days after ZOSTAVAX subq injection, patient has a slightly red 2" circle around site 2" above elbow - slightly warm to touch.
On 6/2/99, the pt slept for most of the day which was reportedly unusual. On 6/3/99 she woke up with 10 pustules on her back and stomach. It was noted that she developed a total of 32 pustules. On 6/5/99, the pt was diagnosed with chicken pox. The pt has recovered. No further information is available.
really strong allergic reaction; Rash; almost like hives; This is a spontaneous report from a Pfizer sponsored program via a contactable Other HCP. A 66-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included lot allergies and thyroid condition. The patient's concomitant medications were not reported. The patient historical vaccine included received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and she was fine with the first dose. On an unspecified date, the patient experienced really strong allergic reaction, rash for three weeks almost like hives. The outcome of the events was unknown.  Additional information: She stated caller was a HCP and caller wanted to know if a patient has bursitis in her elbow was it safe for her to receive the Pfizer COVID vaccine? Caller stated to her that she was a medical social worker (LCSW). Caller stated that she works in hospitals and with doctors and a patient was not getting a clear answer from her doctor and doctor would not call us so she was trying to get information for the patient. The caller stated her sister had the Pfizer COVID vaccine and did fine with the first dose but after the second dose she had a really strong allergic reaction where she had a rash for three weeks almost like hives. Caller states her sister reported this reaction to DSU already. Caller also stated that her sister has a lot allergies and a thyroid condition. Caller did not provide any other details for her sister. Informed caller that Pfizer cannot provide medical advice or treatment recommendations for individuals patients that it will be up to the HCP to provide recommendations based off patient's medical history as they will have access to their information. Caller enquired if it was common to have a rash for three weeks after the second dose and according to PI Section Adverse Reactions in Post Authorization Experience Rash is listed as a side effect that has been reported. Informed caller that PI does not state the duration that the rash can last.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Brief fainting spell 15 minutes after administration, cold & sweaty, dizziness & lightheaded. Patient recovered after 40 minutes.
Bell?s Palsy to the left side of my face. Woke up Wednesday morning with symptoms.
number of friends that had pink arm for a week or two that went away; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 06-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (number of friends that had pink arm for a week or two that went away) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (number of friends that had pink arm for a week or two that went away). At the time of the report, ERYTHEMA (number of friends that had pink arm for a week or two that went away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include general medications. No treatment information was provided.
Wasn't able to get second dose; A spontaneous report was received from a consumer concerning her mother(M-S) who is 88 year old female, who received her first dose of Moderna Covid -19 vaccine and couldn't take the 2nd dose as scheduled.  The consumer's medical history was not provided except she had a pelvic fracture. Her relevant concomitant medications were not provided. No information on allergies.   On 15-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. She couldn't take her 2nd dose due to hospitalization. She is being hospitalized for a pelvic break prior to her first dose of vaccine and been admitted in rehab facility since then. She is unable to receive her 2nd dose as scheduled.  Action taken with 2nd dose of Moderna Covid-19 vaccine was unknown.  The outcome of the event inappropriate schedule of vaccination is unknown at the time of report.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Mildly sore arm after the first and second shot; This is a spontaneous report from a contactable consumer. A contactable consumer (patient) reported for a himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced mildly sore arm after the first and second shot on an unspecified date. No medical questions about side effects at this time. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Pain and swelling in left armpit, followed by chills and trouble sleeping on the first day. Fever of 101.5, extreme fatigue, chills, headache, multiple swollen lymph nodes, aches all over body, for the following 4 days and continuing presently.
Weakness in legs, pale, fatigue, diarrhea then constipation. Patient was admitted to hospital for evaluation. The assessment could find no cause for sxs so attributed to shot.
Patient reported headache in sinus area, chills, fatigue, and arm soreness. Measured temperature of 101.5.
Immediate onset of intense muscle cramps in upper arm because the nurse giving the injection inserted the needle deep into the muscle and in between two major arm muscles near top of arm.  After 6 hours, the pain had traveled up my arm nerve pathway into my shoulders and neck.  Lifting or movement of my shoulders and arms above the chest was excruciating.  On a scale of 1 to 10,  I was at 7.5 by 11 p.m that evening.  Within 24 hours, a noticeable hematoma had appeared with swelling and large areas of rash and itching roughly 5 inches in diameter a few inches down from the injection site. Within 24 hours I experienced a low fever and difficulty swallowing and breathing.  I used my asthma inhaler to mitigate breathing symptoms and took Advil at 400mg every 4 hours to mitigate pain, swelling, and fever, as well as 24-hr Claritin to provide antihistamine relief. By Tuesday and Wednesday - 4 and 5 days out from the injection, swelling, rash, itch and massive hematoma in that arm continues to swell, creating a severe numbing sensation arm and hand and general discomfort.  I saw a Dr. at the same facility I received the Pneumonia shot, and was treated for an upper respiratory infection with Allegra-D and Ceprozil, 500MG.  As of Wednesday, Oct 28 (5 days after Pneumonia vaccine injection), the allergic reaction is still very much problematic with continued discomfort in left arm due to swelling and itching near injection site as well as overall discomfort common with a severe allergic reaction.  Currently considering an Emergency room visit to request steriod shot to calm things down, but due to Hypothyroid issue, this may not be best course of action.
Pt recvd 3 doses of Engerix-B on 22MAY90, 02JUL90 & 4MAR90 (1991?) for antibody protection against Hep B; 8APR91 HBSAB RIA resulted as neg; Dose 4 & 5 of Engerix-B given on 12APR91 & 17MAY91; 17JUL91 HBSAB RIA was positive;
I day post vaccinations Right arm hurt so badly that pt was unable to lift it/use it functionally and I started to have chills. By evening, pt stated she was under two blankets, shivering. hands were extremely cold as if they were in ice water. This lasted ~ 24 hours with another 24 hours to follow feeling fatigued with lack of left upper extremity usage
Hives, facial swelling, throat discomfort treated with Benadryl 12.5 mg and 0.3 Epi Pen sent to ER.
pt devel hives on face 5min p/vax;given DPH w/relief observed in ofc for 1/2hr;no airway compromise;no epi needed;
completion of a GARDASIL 9 series for a 36 year old whose last dose was on 03/2022; No additional AE details or PQC.; This spontaneous report was received from a medical assistant and refers to a 36-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in March 2022, the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, and route of administration were not provided) as prophylaxis. The reporter informed that the patient would complete the vaccination scheme in more than a year (Inappropriate schedule of product administration). No adverse event was reported.
Fatigue, headache, severe pain at injection site, chills, elevated heart rate (especially at night), difficulty sleeping,, chest tightness. Symptoms lasted about 1 week post-vaccination.  Also, Period came 1 week early, lasted 10 days and was very light. Very unusual
Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine.  Other symptoms include dizziness, fatigue, difficulty concentrating at times.  The tinnitus has been constant.  I saw my PCP, an ENT specialist, and an Audiologist.   There is no treatment for the tinnitus and it may be permanent.
I was fine until around five or three or five hours later and I was in bed like with the flu and aches all over my body and I had stay in bed, this lasted for two full days on the third day I felt better.
Initial report received from healthcare professional on 26 November 2013. A 48-year-old female patient whose medical history and concomitant medications were not reported, received influenza vaccine (lot number and expiration date unknown) on 07 November 2013. The patient reported that she received influenza vaccine while in the hospital for her multiple sclerosis. On 08 November 2013, she has cold symptoms the next day but those are the same symptoms she has with her multiple sclerosis (MS) and stated did not think symptoms were related to flu vaccine. She stated that her resolved and she was fine now. The patient also reported that after she got home from hospitalization she had taken DAYQUIL and experienced dizziness after taking the DAYQUIL which had never happened before when she took DAYQUIL and stated that she had also been taking new information for her multiple sclerosis which probably didn't go with taking the DAYQUIL. As of this report, the patient was recovered from the event. Documents held by sender: none.
Patient received a pfizer covid-19 bivalent booster on 09/12/2022 and the patient was vaccinated again on 10/26/2022 with another pfizer covid-19 bivalent booster on 10/26/2022.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Developed delayed chronic urticaria 2 weeks after booster. Hives were all over rather than limited to injection site and were severe for about 2 weeks then tapering off and still present 3 months later. Treated with prednisone and antihistamines.
pt recvd vax;p/dose 1 exp small rash;p/dose 2,rash worsened & exp urticarial pruritic nodules on thighs & feet;Torso,face,upper extremities were not involved;tx w/ dph & decadron LA inject;unresolved
Pt states he had flu like symptoms; fever, chills, body aches with nausea.
Child received vaccines and sat for a minute or so then stood up and passed out, falling to the floor. Child assisted to a sitting position as soon as she came around. sat for 10 minutes before attempting to get up. No known injuries at this time
This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Subsequent to receiving second dose of Lymerix, the pt developed Lyme disease. As of 08/31/2000 the outcome of the event is unspecified.
He started with stomach pain two weeks after getting the vaccine. He had nausea, vomiting and diarrhea for about 2-3 times a week. It caused him to missed a lot of school because of this.  Sometimes he can't sleep because of his stomach be hurting and he be in a lot of pain a lot of the time. It hurts me to see my son hurting. Before the vaccine my son was a healthy child. The doctor prescribe him some Banophen 25mg x2 every 6 hours.
Patient was administered expired dose of MENACTRA not realizing it was expired on 30-Jul-2021 with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (Reference number- 00710629) and transmitted to Sanofi on 04-Aug-2021.  This case involves a 18 year old female patient who experienced patient was administered expired dose of menactra not realizing it was expired on 30-Jul-2021 (expired product administered) while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient past medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 04-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6641AB and expiry date: 30-Jul-2021] via an intramuscular route in the right arm for prophylactic vaccination.  It was case of actual medication error due to expired product administered. (Latency: on the same day).  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1st Dose:  headache, arm pain 2nd Dose:  Diarrhea, fever, chills, muscle pain, joint pain,  headache:  Lasting about 28 Hrs.  Then weakness and fatigue for about 30 hrs. Unable to work due to fatigue with little amounts of effort.
I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respiratory rate was 40+ and I couldn?t lower it),  shaking uncontrollably (felt increasingly cold, though my temp was normal; my skin was cold to the touch but I felt like it was burning off), tachycardic (heart rate was 140bpm and I normally am at 60-80 at rest). My throat felt like it was closing and my face was swollen. I should have gone to the ER, but I wasn?t thinking clearly and didn?t know what to do with my small children.  It took 2 hours until I stopped shaking, my heart rate returned to normal, and my breathing was under control.  Since then I have mainly been fatigued, taking Tylenol for overall aches, and have not been able to tolerate much activity (can only stand for about 5 minutes at a time).
Itching and redness at right deltoid injection site spreading to right arm neck and face within 5 minutes. Tongue described as feeling "thick and numb" at apx 10 minutes post vaccination injection. VS 142/99 HR 76 O2sat 98% RR 17. 50mg Benadryl IM administered at 2:20PM.