chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 69 yo female with a history of hypothyroidism who presents to clinic for evaluation and recommendations of a local site reaction after vaccine receipt. The patient reports she received IIV at clinic (GSK lot# 25N22). She noted mild pruritus at the site several hours later. By afternoon it was erythematic, warm to touch and mildly tender, and continued to enlarge in affected area. She developed induration and mild edema. It reached a nadir on Wednesday and they contacted us due to concern for adverse reaction. There was no burning, streaking or dermatitis of papules, vesicles, pustules or erosions. She did not treat it with anything. She has normal ROM, no numbness or tingling. Her arthritis to her hands may be a little worse. She had mild malaise initially which resolved without treatment. She had no fever, chills, headache, cough, chest pain, nausea, emesis or diarrhea. She had no immediate symptoms at the vaccine receipt of urticaria, pruritus, shortness of breath, oral/tongue/facial swelling, conjunctivitis, rhinorrhea, chest pain, wheezing or nausea.
I started to have tunnel vision and dizzy spells. I felt like I was losing focus and had bad headaches. I went to the ER. I had a CT and blood work done. I had a lumbar puncture and the opening pressure was 29, which was above normal. I needed a blood patch four days later because I had a migraine that would not cease. On June 1st, I got another Lumbar puncture because I was having the same symptoms.
Headache BOCY ACHES, CHEST PAIN X 2 DAYS Narrative:
2nd day right arm where shot given, paralyzed partially betweeen elbow and shoulder, bright red, low grade fever-101f. Told by nurse this is normal. 3rd day fever of 102.5 arm now black and blue and red with pickly heat or scaretina signs. Went to Dr. Given keflex antibiotic, and told to take ibuprofen as needed to treat fever. Patient not fully recovered until following Monday 12/24. Update 12/03/02 Arm still slightly weak, and itchy once in a while at site of injection. Continuing prescribed antibiotics. Fever gone.
Information has been received from a medical technician concerning her 18 month old female daughter, with no pertinent medical history and no drug reactions/allergies, who on 16-JUL-2008 was vaccinated with VARIVAX (Merck). There was no concomitant medication. During the administration the child moved, the needle came out of the arm, it was reinserted, the child moved again and about half of the vaccine spilled on the skin. The site was not cleansed but was covered with a band-aid. The following day, on 17-JUL-2008, the patient experienced slight diarrhea with slight diaper rash and was irritable. On 18-JUL-2008, symptoms have resolved. The child is scheduled to have dose at 2 years old. The patient sought medical attention, in office. There was no product quality complaint. No further information is available.
unconsolable crying for 5 hrs p/vax; pt recovered; uneventfully
MEDICATION ERROR; PATIENT RECEIVED VACCINE OUT OF  THE RECOMMENDED TEMPERATURE  RANGE; This spontaneous report received from a pharmacist concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and  expiry: 13-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced medication error. On 03-MAY-2021, the subject experienced subject received vaccine out of the recommended temperature range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and patient received vaccine out of the recommended temperature range was not reported. This report was non-serious.
Patient developed fever/ swelling to face & neck the day after her 3rd HPV9 vaccine. Also had fever/chills, fatigue, & rapid heart rate. In office the next day c/o sore throat & congestion.
Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking 1000 mg of acetaminophen the shaking resolved in 30 minutes. That same day around 10 AM patient had muscle soreness in neck and shoulders and a mild headache.
1-3 days after the booster shot ringing in the right ear started on and off for several days until it became constant ringing (tinnitus) on 15.01.2022. ENT did an audiogram and diagnosed tinnitus in the right ear as well as mild hearing loss in both ears (right ear more dominant hearing loss than left ear). ENT prescribed pentoxyfillin and ginkgo. After 7 days no improvement. Another ENT prescribed 3 high dose steroid infusions. On day 3 of infusions the audiogram showed a slight improvement. Up until now, the tinnitus sound improved (got more quite) but is still there at the moment.
This case was reported by a consumer and described the occurrence of anemia in a 56-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was previously healthy. Concurrent medications included Hydroxyurea. On 27 December 2012 the subject received 1st dose of ENGERIX B (1.0 ml, unknown route, unknown arm) and one dose of an unspecified vaccine (unknown route, unknown arm). The subject had no information on this vaccine. In March 2014, 15 months after vaccination with ENGERIX B and unspecified vaccine, the subject experienced gastric problems. She went to emergency room and a whole series of tests was done on 20 March 2014. The results showed that she has no antibodies for hepatitis A and B and she has no immunity to Hep B virus. The subject also reported that she developed anemia 2 months after these vaccinations. At the time of reporting, her stomach problems were unresolved and her anemia was getting worse. The subject did not think there was a quality issue with the vaccine but she couldn't trust her doctor; she was never told that she had to receive additional doses for hep B. Follow up information received on 5 May 2014 from the consumer: The subject had no relevant medical history or allergy. On 27 December 2012, her blood pressure was 138/98 mmHg, her pulse was 64 bpm. On 27 December 2012, her physical examination was normal and she received 1st dose of hepatitis A vaccine in one arm and 1st dose of ENGERIX B in the other arm. She was never told that she had to receive a complete series of vaccination and she never received the following dose of vaccines. The consumer reported that 12 weeks after these vaccinations, she developed anemia. On 12 March 2014, a blood test showed that she had no antibodies for hepatitis A and B.
After the first couple hours I received pain in my left arm near the injection site throughout my entire shoulder. The next day I was exhausted I felt like I had the flu. This lasted for 3 days. I just took Tylenol and rested.
5 small red papules appeared on her back with small/slight vesicles on most of them. She complained of itching. Symptoms resolved in 3 days. She also had a large red area at the site of her Varivax injection 10 days after the injection. It resolved in 3-4 days.
This literature report (initial receipt: 16-Apr-2013) concerns a 31-year-old healthy male patient. On an unknown date the patient received an influenza vaccine (brand name, manufacturer and lot number were not reported). Two months (8 weeks) after influenza vaccine, the patient developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG (myelin-associated glycoprotein) antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction studies showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 32 degrees C. Two grams per kilogram of IVIG (intravenous immunoglobulin) was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. Reporter's comment: Vaccine-associated DADS-I (idiopathic distal acquired demyelinating symmetric neuropathy) may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, we suspect vaccination in our patient triggered an immune response against currently unrecognized antigens and manifested as restricted CIDP in the form of DADS-I. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS-I neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
NA Septic shock Aspiration pneumonia Acute encephalopathy Pancytopenia Seizure
(R)arm itching, redness, & swelling. ? cellulitis, warm to touch  Started on antibiotics
52 year old male with liver failure was admitted for hepatic encephalopathy and severe ascites. He was also in renal failure. He was treated with diuretics and paracentesis. He received blood transfusion. He will be discharged home today in stable condition. Patient educated on appropriate level of care post-discharge. No treatment for COVID-19.
Patient tested positive for COVID-19 and is fully vaccinated. Patient is hospitalized due to COVID.
thought that was going to die; tremendous body ache/awful body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEAR OF DEATH (thought that was going to die) and MYALGIA (tremendous body ache/awful body ache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included OMEPRAZOLE and BACLOFEN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEAR OF DEATH (thought that was going to die) and MYALGIA (tremendous body ache/awful body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEAR OF DEATH (thought that was going to die) and MYALGIA (tremendous body ache/awful body ache) outcome was unknown.
Student was given Twinrix and Hep B instead of Hep A and Hep B. Extra Hep B dose given.
Sore and itchy arm and red rash still remain.  Never had this reaction before with Covid or flu shots
headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous report from a contactable health professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1685), via an unspecified route of administration on 18Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified multivitamin, as well as levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fish oil/tocopheryl acetate (OMEGA 3). The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020 (at the age of 49-years-old) for COVID-19 immunization. On 19Jan2021, the patient experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills was resolved on an unspecified date in Jan2021.   No follow-up attempts are possible. No further information is expected.
Pain at injection site; Low grade fever; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 56-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 26th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fever to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the Practice Manager. The patient received dose of Fluarix Quadrivalent 2019-2020 season in left arm. The reporter stated that, after vaccination, the patient had injection site pain and low grade fever. The health care professional reported that the injection site pain and low grade fever resolved in 24 hours. The reporter denied consent to be followed up.
soreness in my arm from the [Pfizer COVID-19] shots; 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), as dose 1, single (Batch/Lot number: unknown), in arm 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 "soreness in my arm from the [Pfizer COVID-19] shots".  Additional information: Patient remember the soreness in his arm from the [Pfizer COVID-19] shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341130 Same patient/vaccine/event, different vaccine dose;
Approximately four hours after shot, patient had pain and was unable to lift arm.  No redness or swelling was noted. Patient took pain meds and has been taking anti-inflammatories. No swelling or bruising at time of reporting (midday on 11-17) and patient reports it is "85%" better.
1/21 I noticed flu like symptoms with sinus congestion and joint pain. I did a home test and went to urgent care PCR and it returned positive. Quarantined until 01/27 and currently under mask up orders. During my visit to urgent care I also got a flu test (negative).
Patient left arm and shoulder, history of temperature and shortness of breath at home. 12x12 cm swelling left upper arm distal to injection site. Treated with 40mg triamcinolone, albuterol IM and ALLEGRA.
approx 2 hours after vaccines, pt became increasingly fussy, with poor feeding and progressive weakness 4/10 admitted to hospital. 4/11 intubated in ICU. Received botulism immune globulin. 5/27/08-records received for DOS 4/10-4/24/08-DC DX: Infantile botulism. Intubation and mechanical ventilation. NG. PE: generalized low tone, worsening hypotonia, whining. Admitted with C/O increasing fussiness and poor feeding. Inability to feed suck and swallow, unable to pick up head when prone. Treated with IVIG. Progressive return of tone and bulbar function. Cough, suck and gag are weak but improving.
Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0179, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 03May2021 at 10:15 (at the age of 31-year-old) as single dose for covid-19 immunization. The patient's medical history and known allergies were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO); vitamin D NOS [VITAMIN D] and vitamin B complex (VITAMIN B). The patient previously received first dose of BNT162B2 (Lot number: ER8731) via an unspecified route of administration, administered in left arm on 12Apr2021 at 10:15 for COVID-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 14May2021 at 20:00, the patient was diagnosed with Bell's Palsy. Treatment received for the adverse event included Steroid pills and antibiotics for 1 week. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event was resolving.  Device Date: 01Jun2021
This is a spontaneous report received from a non-contactable reporter.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.;
infant was given a Covid shot instead of flu vaccine with no reported adverse event; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory authority (under reference number - US-SA-SAC20211006000502).  This case involves infant patient (unknown gender) who was vaccinated with Covid shot  instead of the INFLUENZA VACCINE with no adverse event (Wrong product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of Covid shot produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination instead of INFLUENZA VACCINE.  It was reported Since this is a public post on the Sanofi campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Reporter some have received the wrong shot even a infant was given a Covid shot. I wouldn't trust anybody with a needle.  There were no laboratory data/results available.  It was case of an actual medication error due to Wrong vaccine administered (latency was on same day)  At the time of report, no adverse event was reported.  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.  There will be no information available on batch number for this case.
pt recvd vax;w/in 1 hr of dose 3,pt v;exp n,diarrhea,vertigo & puffiness at inject site;tx w/ donnatal 1 tab qid,antivert;not totally subsided;pt has a "punky feeling"; "everything not rt";
Seen at hospital ER 3/10/04-fever, abdominal bruising, abdominal distention.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JUN-2016 the patient received an improperly stored dose of VARIVAX (lot # L031066, expiry date: 13-JAN-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE ARM AT INJECTION SITE DAY 2, FATIGUE DAY 2, NAUSEA AND EASILY DEHYDRATED DAY 2-5 SWOLLEN LYMPH NODES DAY 8-10 ON RIGHT SIDE ONLY
Foster mother was still in WIC office when nurse noticed a red swollen area developing above the Band-Aid and above the injection site.  At it's largest area was quarter sized, red and warm to touch.  Foster mother called pediatrician from WIC office. Received instructions to have pt remain at WIC office for 30min.  If S/S worsen seek emergency medical tx.  Foster mother was given instruction by the pediatrician office to give the pt 1.25ml of Benadryl po once she gets home and to apply a cool cloth.  Foster mother remained at WIC office 1hr and 15min from time hive like area originally appeared. Hive like area had disappeared before she left and red area was disappearing.  Mother was back in Health Department office 8/15/2016.  Discussed follow up with her.  States she gave the Benadryl as instructed although the hive area was gone.  Child received DtaP 8/15/2016 without any problems.
Rash/ hives, throbbing arm pain, pins and needle feeling, tight chest, burning/ warm feeling in rash and arm, Nausea, ache in temples.