chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EPILEPSY W STATUS EPILEPTICUS ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA
Patient had onset of nausea, vomiting, and diarrhea approximately 4 hours after immunization.  He reports having multiple episodes (>10) diarrhea with yellow-brown, loose stool without melena or hematochezia and multiple (>10) episodes emesis that was nonbloody and nonbillious.  Denied fevers, chills, body aches, or other symptoms.  He was treated symptomatically with antiemetics and oral rehydration solution.
Redness, swelling, mild itching, soreness  below vaccination site of right deltoid. Received vaccine 11/13/2020, noticed above symptoms on 11/15/20, Recommended ice, pain medication, Benadryl as needed
Signed consent and center enrolment form obtained. VIS provided, student denies any allergies, and No past medical history.  At 11:00am IZs IPV, HBV, Tdap, MCV, MMR and Varicella administered, student stated that she is having difficulty of breathing.  Assessed student.  At 11:10 student c/o difficulty breathing, B/P 85/57, HR 83, RR 26, O2 Sat 96% alert, oriented to time, place, and person. Pupils equal, round, and reactive to light, Lungs clear bilaterally, Student continue complaining of SOB, lower lip pale, fingers bilaterally pale. Mild Diaphysis   11:23am Epinephrine, (Auto-injectors) 0.3 mg administered by NP. Student started shaking, difficulty to verbalize, facial expression were symmetrical, strong grips bilaterally, and strong bilateral extremities movements.      11:30am normal skin color BP 96/65 HR 80 O2 sat 100%, student stated her breathing is improved. Alert and oriented, School administers, student?s guardian notified, EMS call initiated, student?s guardian notified.  EMT arrived brief report given, student transferred to Hospital.
Vaccine administered 3/20/14 at school-based Tdap clinic. Small fine pustular-like rash noted at injection site morning of 3/22/14. By evening of 3/22/14 the lesions/rash had increased down upper arm from inj site. Itchiness associated with rash, some discomfort, no other symptoms. Mother reports the area of the rash increased further on 3/23/14 and 3/24/14 but remained confined to upper arm. Rash with unusual pattern of concentric arcs at distal point. (Prior to appearance of rash on 3/22/14, pt had usual local reaction of discomfort and swelling.) On 3/26/14 mother reports child was seen by PCP on 3/25/14; physician stated an unusual reaction following vaccination is likely to occur due to child's compromised immune status.
Janssen given on 3/12/2022. Patient verbally consented/confirmed, he had not received previous COVID-19 vaccination. After vaccination, discovered patient received a dose of Moderna on 2/15/2022 at a different pharmacy.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient received covid vaccine and was sitting in the chair outside the pharmacy waiting 15 minutes for observation. She suddenly fell out of chair and remainded unconscious momentarily on the ground. We responded immediately and patient came to. The ambulance was called and responded. They allowed her to stay at the pharmacy to be monitored further an she left with boyfriend after another 30 minutes. No further follow up with ambulance.
Throat wheezing with cough/chest tightness, swollen, watery eyes -took Benadryl and Sudafed for symptoms. After 8:00 pm had body aches, chills and low-grade fever took Motrin for symptoms.
EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for an unspecified indication. No concomitant medications were reported. On MAR-2021, the subject experienced exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure via breast milk was not reported. This report was non-serious.  Version created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Event of Maternal exposure during breast feeding was changed to Exposure via breast milk.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Redness and warmth at injection site patient described 2 inch rash. Pain resolved, rash still apparent at 8pm 9/18.
Havrix administration after freezing exposure; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced incorrect storage of drug (Verbatim: Havrix administration after freezing exposure). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Jul-2023 The reporter consented to follow-up. The patient received a Havrix dose exposed at 28 degree Fahrenheit, which led to incorrect storage of drug.
16JAN97 w/severe itching of head;by 12noon was covered w/red welts;by PM 16JAN the bottom of feet hurt & was covered w/rash;17JAN97 could not walk w/o pain;went to MD;throat & glands around throat swollen;pain in joints;swollen ankle
sore; slight bruising; swelling of the lymph node underneath the arm pit of the vaccination site; nauseous; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (sore), CONTUSION (slight bruising), NAUSEA (nauseous) and LYMPHADENOPATHY (swelling of the lymph node underneath the arm pit of the vaccination site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (tree pollen allergy) and Epinephrine. Concomitant products included FAMOTIDINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced NAUSEA (nauseous). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling of the lymph node underneath the arm pit of the vaccination site). On 23-Apr-2021, the patient experienced PAIN (sore) and CONTUSION (slight bruising). At the time of the report, PAIN (sore), CONTUSION (slight bruising), NAUSEA (nauseous) and LYMPHADENOPATHY (swelling of the lymph node underneath the arm pit of the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included maintanence inhaler for seasonal tree pollen allergy.  Patient reports waiting 30 minutes after receiving the vaccine due to an undiagnosed connective tissue autoimmune disease. Patient stated that in the past she had experienced body chills, feeling really hot, bad periods from autoimmune disease.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' relevant medical history and concomitant medication were not reported. On an unknown date in 2015 (reported as since 14-MAY-2015, which was the date the exucrsion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from an other healthcare professional (PVX2019-144) on 16-Jan-2019. The report describes a 65-year-old elderly female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif (lot number: 3003214) for an unknown indication.   It was reported that the consumer picked up Vivotif on 08-Jan-2019 and never refrigerate them. She took the unrefrigerated doses on 09-Jan-2019, 11-Jan-2019, and 13-Jan-2019 respectively.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 13:00 as dose number unknown (booster), single (Lot number: GL0447), in right arm and on 14Jun2023 at 13:00 as dose number unknown (booster), single (Lot number: GJ6743) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound Covid19; initial symptoms gone by 15Jul2023, returned 18Jul2023. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Itching all over his body; This is a spontaneous case, reported by other health professional (medical assistant - MA) to agency (reference numbers: SEQ19-07308) on 09-Dec-2019, concerning a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date in November 2019, the patient was administered Afluria Quadrivalent [Influenza Vaccine, bath number reported as 4F42909 (Seqirus batch umber: YF42909), dose, route of administration, anatomical location and expiry date: not reported] for prevention of seasonal influenza in the hospital .  On the same day, after receiving the vaccine, the patient developed severe itching all over his body. The corrective treatment for itching was not provided.  At the time of this report, the outcome of the event was not reported.  The reporter did not provide the causality assessment to Afluria Quadrivalent.  The reporter did not give permission to be contacted for follow up.  Company comment: The event of itching all over was assesses as related to Afluria Quadrivalent.; Sender's Comments: The event of itching all over was assesses as related to Afluria Quadrivalent.
Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on 01/06/21 reports extreme fatigue and continued sore arm at injection site. 1000 started having chills and generalized muscle aches. Temperature elevated to 101.2 at 1545, took Tylenol and temp went down to normal range with 1-2 hours back to 100.0 at 1815. Reports dizziness during that time as well.
Pt developed redness, swelling and hives on arm. He also had lethargy and loss of appetite. Parent was instructed to give Benadryl and Tylenol with good relief reported, 48 hours, post vax. No further adverse problems. Mother concludes 3-4 X family history of tetanus allergy.
Patient was content up until 3 hours after vaccination.  at 3 hours post vaccinations, she was screaming out in pain.  The uncontrollable crying lasted for 1 hour at which point we called the doctor.  We were told to administer tylenol.  after doing so, the patient continued to cry in pain for 45 minutes.  after 45 minutes the crying stopped.
Client reports had some discomfort 1-2 days after vaccine receipt which was similar to pain with first dose. First dose pain resolved after day 2. With dose 2 vaccine, client reports continued shoulder pain at joint with movement of shoulder above 90 degrees, also reports sporadic nerve pain "pins and needles" from shoulder to pinky on right arm. Denies redness or swelling at site.
Redness, swelling (baseball size) hot to touch, red lines at injection site.  Sent to ER.
High fever, which lasted for about 4 days. Extreme irritability lasting for about 10 days from the date of vaccination. Fever was highest (104 degrees) on 12/17, vomiting occured on that day as well. On 12/19 rash of pink spots appeared all over his trunk. Called the nurse help line at the medical group and were told this sounds like "normal" reactions to one of the five vaccines he was given on 12/9/09 (the MMR one).
PATIENT REPORTED SWEATS, ACHING JOINTS, SHAKING AND HAD TO GO TO THE RESTROOM MULTIPLES DURING THE NIGHT.
Report body aches and severe back pain. Treatment: Tylenol. Outcome: Back pain and body aches remains unchanged day post vaccination. Scheduled an appointment to see doctor. Does not Interfere with ADLs.
At the site of injection sub cut, 5 cm x 4 cm induration, erythema, edema, tender to palpation.
Severe sore throat, right side headache with sharp pain, congestion through the nose, coughing. I was in bed from Sat - Tuesday sleeping all the time. I had all over body aches, a lot of pressure on in my ribcage when I coughed. A little fever in the beginning 99.9 then it stopped. On Thursday I got up and started feeling a little better but was having difficulty keeping my breath and couldn't breathe through my nose. I went to urgent care on Friday and was still very tired and weak. I received prednisone and albuterol spray, and an antiviral medication for 5 days. This week I've been able to continue with my workout activities but still a little congested in my chest.
Heavy clotting and menstrual bleeding began the day after the vaccine and has been going on for 12 days.  This is abnormal for me as I was premenopausal.   I do hear this is a common side affect so I'm not to worried.  I think this should be reported as an adverse affect to warn women that may be experiencing the same issues and as a precaution and strictly as information about potential side effects.
I got the vaccine on Friday. The next day I started getting swelling in my lymph nodes underneath my right arm and neck. I did not think much of it because I thought it was a normal reaction to the vaccine. I kept getting pain underneath my right arm and into my breast. It has been an intermittent thing. In the last month or maybe longer I have been experiencing weird things. I noticed it about my lower left quadrant. I started feeling really poorly a week ago till the point where I felt I needed medical care. I went to the doctor and they did a CT scan because they thought it was diverticulitis. The diagnosis was chronic pancreatitis, which is weird because I do not drink or smoke. I take good care of myself.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of syncope in a 21-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included typhoid vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 5 December 2013. Concurrent medications included Yellow fever vaccines (Non-GSK). On 5 December 2013 the subject received 1st dose of BOOSTRIX (unknown, left arm). On 5 December 2013, immediately after vaccination with BOOSTRIX, the subject experienced syncope. On 5 December 2013, the syncope was resolved.
Petechiae on face; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (Petechiae on face), PYREXIA (Low grade fever) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Low grade fever) and HEADACHE (Headache). On 05-Apr-2021, the patient experienced PETECHIAE (Petechiae on face). At the time of the report, PETECHIAE (Petechiae on face), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information in response to events was not provided.
1112 - Arrived to triage area reporting dizziness/light headedness. Hands moderately cyanotic and generally pale in appearance. Of note, reports drinking alcohol last night. BP 158/131, HR 145, RR 18  1114 - MD at bedside directing care. Trendelenburg performed, ice pack applied to forehead. Analogue pleth suspicious for SVT-like arrhythmia, but no telemetry available on-site. BP 173/86, HR 157, RR 20  1119 - BP 163/86, HR 136, RR 22  1125 - Called 911. BP 179/88, HR 138, RR 20  1127 - Called on-site EMS  1129 - Started L. AC PIV 20ga and initiated NS infusion. BP 174/88, HR 131, RR 20, SpO2 99  1133 - BP 175/82, HR 144, RR 18, SpO2 100%  1138 - BP 168/92, HR 131, RR 18, SpO2 100%  1143 - Gave 50 mg IV Benadryl. BP 167/84, HR 147, RR 22, SpO2 100%.  1144 - EMS arrived on-site and assumed care of patient. ECG shows "probable sinus tachycardia" and "ST junctional depression is nonspecific".  1149 - Transported to hospital by EMS.
generalized rash; This is a spontaneous report from a contactable Physician. This Physician reported for 74-year-old non-pregnant female patient who received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD and lactose allergy. The patient's concomitant medications included colecalciferol (Vitamin D) taken at unknown dose. It was unknown if any other vaccine in four weeks and if patient was tested for covid post vaccination. The patient did not have covid prior vaccination. On 05Mar2021, the patient experienced generalized rash. The patient required healthcare professional office/clinic visit. The patient received treatment with Methylprednisolone. The patient was recovering.  No follow-up attempts were possible; information about lot/batch no could not be obtained.
1130 SHOTS ADMINISTERED. 1255 MOTHER CALLED QUESTIONING AN ALLERGIC REACTION, INSTRUCTED MOTHER TO RETURN TO CLINIC. 1305 MOTHER RETURNED WITH DAUGHTER: PUFFY EYES, SOB, TAKE TO ROOM, BENADRYL 12.5MG GIVEN PO, EPIPEN JR .15MG ADMINISTERED RT THIGH. ALBUTEROL NEBULIZER TREATMENT ADMINISTERED.PULSE OX PRIOR TO NEB 91 PERCENT, POST NEB TREATMENT 95 PERCENT. PULSE 1305 WAS 130, PULSE AT 1330 141, PULSE OX 95 PERCENT.  MR received revealing a 6 yr. old with reported nomal growth and development at her well child check, who had an anaphylactic reaction 1-1 1/2 hours after Proquad and MMRV vax.   Child developed swollen eyes (nearly shut), wheezing, increased work of breathing, and hives.  Returned to MD's office where she was treated with Benadryl, Albuterol, and Epinephrine.  Wheezing abated and breathing easier however eyes remained swollen. Home on benadryl and albuterol nebs PRN. Assessment:  Anaphylaxis due to vaccines.
Initial serious report received from a non-health care professional on 05 December 2013. A 62-year-old female patient had received a Flu shot (Lot number, site of vaccination and route not reported) on an unspecified date. It was reported that the patient was involved in bad car wreck in 1995 and had received EFFEXOR that caused her to have diabetes. The patient has high blood pressure, diabetes, fibromyalgia and trouble in her feet. It was reported that the patient catches flu even though she gets flu shot. Laboratory details and corrective treatment was not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
Patient stated he had a total of Anthrax vaccine x6, with the last one being in March 2000.  He was preparing to deploy next month and was told he needed another anthrax shot.  He stated he did not want to receive it because he was worried that it would cause his anger to return.  He spoke to his pcm who then contacted the healthcare center.  Patient received Anthrax vaccine #1 on 16 Sep 98 and he denied any problems with that vaccine.  He received #2 on 30 Sep 98 and again denied any pain, redness, swelling and discomfort.  He only noticed that at the beginning of Oct he was experiencing bad dreams in which he was fighting with others.  Prior to Anthrax #3 on 14 Oct 98 he stated he got into a fight in which he grabbed a guy by the throat and threw him against the wall and that he wanted to hurt him.  He did not mention the dreams or the fight when he received the 3rd shot.  These bad dreams continued to occur and he stated he was attacking people and having homicidal thoughts.  He got into his second fight towards the end of Oct and it felt like he was 'outside' his body looking back at himself attacking another person but he stated he remembers that he wanted to hurt this person very badly.  He stated he reported this to sick call (unsure when) and he was told it was not a symptom from the anthrax shot.  He did not attack anyone else until spring of 99, however he does not recall it if was before or after Anthrax #4 on 9 March 99.  He stated he had one other episode of attacking someone before he left in Jul 99 but he does not recall the date.  He received Anthrax #5 on 16 Sep 99 and later that fall he attacked 2 people.  He has had no major episodes of attacking people since that episode but he did continue to experience anger problems, in which he felt it was difficult to control his anger and he would have frequent outbursts.  He did not recall any changes in his ability to control his anger and outbreaks around the time of his Anthrax #6 on 9 Mar 00.  He stated he would have problems with anger management until he sought help early in 2001.  He stated he went to classes and saw psychiatry for a couple of months and since that time he has been able to control his anger and feelings of heightened aggression.  He currently denies homicidal or suicidal thoughts and is wanting to deploy next month with his unit.  His only concern is that if he resumes Anthrax his violent outbreaks will return.
Within a few minutes of receiving the vaccine the patient started convulsing and her tongue began to protrude from her mouth and was visibly swollen and she was struggling to breathe. Administered epinephrine and benadryl per standard anaphylaxis protocol and symptoms started to resolve but then resumed, repeated dose approx 5 minutes later and EMS system activated. Pt transported to the hospital and was monitored for approx 2 hours and given lorazepam and discharged home.