chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son initially had side effects (tired, hot, sweaty) about 24 hours after receiving his first dose. About 58 hours after the first dose, he started having trouble breathing. He called me in a panic and asked me to come home because he couldn't breathe. It took me ~15 minutes, and by the time I arrived, he was having some trouble breathing so we took him to the emergency room. They did some tests and sent him home. By that point, the symptoms seemed to have resolved on their own. But then he had some labored breathing later that night.
No adverse event, gave a combo Hep A and Hep B instead of seperate vaccine Hep A and Hep B Vaccine given was not a VFC vaccine but a adult vaccine.
Localized redness in left thigh, no streaks (3x4 cm) non painful (itchy) area was demarcated
pt devel flu like sx including malaise, myalgia; sx had resolved by 9NOV93;
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 1/21/21, 2/13/21 and 8/18/21. Covid + at home on 7/14/22 - Tx'd w/paxlovid, doxycycline, and decadron w/o improvement. Presented to ED 8/2/21 tachypneic, hypooxic, and hypertensive. Admitted for acute resp fail w/hypoxia and hypercapnia. Glucose 222, BUN 99, Cr 3.13, CO2 16, Cal 7.1, CRP 156.8, Procal 0.50, INR 1.6, WBC 14.1, Hgb 8.6, Plt 112, CXR - bil PNA, COVID+ swab. BC x2 and UC pending. Pt was admitted to ICU and required intubation and prognosis cont'd to worsen. Transitioned to comfort care, expired on 8/9/22. Tx'd w/decadron, cefepime, and vancomycin.
The person giving the shot poked my arm and needle did not penatrate.. ..she pushed again really hard and told the people sitting next to us that she had a hard time getting the needle to go through...instantly neck and arm started to hurt ...I thought this was normal but the tingling in my arm down to my fingers really became bothersome..started to think I slept on my arm wrong that night.. then after another day I thought could I be having a mini stroke ..this numbness and tingling has Not stopped ...I started losing feeling in my left pinky and the finger next to the left pinky finger .... I have a hard time grasping things with the hand and to this very day I still have No feeling in those 2 fingers and my arm hurts if I left passed a certain point ...and today I have wierd rash spot that just developed on that arm very small but itchy and strange ..I recently reported to my doctor and he said we will wait and see what happens but my muscle in my arm is not feeling right and I feel something more needs to be looked into before I have no feelings left in this arm..
Muscle aches, headache, and slight fatigue beginning 20 Hours after vaccine administration.
edema & erythema extending from inject margin of lt deltoid to 3" below elbow, posterior aspect;
Appendicitis upgraded to Colonitis and Typhlitis resulting in appendectomy and right-hemicolectomy. Lab-inconclusive cause of inflammation.
Full hepB schedule; received Twinrix when supossed to receive Havrix; Full hepB schedule; received Twinrix when supossed to receive Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B (on an unknown date, the patient received full hepatitis B schedule).   On 11th April 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported The pharmacist reported patient with full hepatitis B schedule received Twinrix when patient was supposed to receive Havrix instead, which led to wrong vaccine administered and extra dose administered for hepatitis B. The Health Care Professional wanted to know how to proceed with schedule. The Health Care Professional provided limited information since she as not at the facility. No demographic details from patient could be collected neither lot number nor expiration date of Twinrix. The reporter did not consent to follow-up.
Administered past expiration. Moved from freezer to fridge 10/7/2021 with 30-day expiration on 11/6/2021. Verified no repeat dose needed with manufacturer.
Employee stated having rash on various parts of his body, weakness, some numbness to arms. The symptoms resolved 2 days  after vaccine administration. Employee has not had previous reactions to multiple flu vaccines in the past.
Information has been received from an emergency medical technician concerning a 32 month old male patient with no pertinent medical history and no drug reactions/allergies who in the same appointment 3 years ago "in August 2007" in another state, was vaccinated with a first dose of MMR II (Lot# not reported) and influenza virus vaccine (unspecified). Within 20 minutes the child had hives "head to toe", a fever and was very lethargic. He was treated with BENADRYL and other unnamed injections. Since then he had had skin test for egg allergy which were negative. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. There were no laboratory diagnostics studies performed. No further information is available.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, doses of PEDVAXHIB (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion, had been administered to unspecified patients. No adverse experienced had been reported. This is one of several reports received from same reporter. Additional information has been requested.
7 Days after vaccine Developed discomfort in lower extremities. Right greater than Left. Then had swelling + increasing pain in Right lower extremity especially behid the knee. Had U/S which revealed DVT involving right peroneal vein Started on eliquis
I have had a headache since October 11th that has not gone away despite taking pain medication. Example tylenol, advil, and my migraine medication. This headache has not subsided. It is a dull ache.
Swelling at injection site beginning about 2 hours after injection. Swelling persisted through to Monday 1/22/2018 and is now developing past the elbow.
At approximately 9:25 am, 23 minutes after the Moderna Vaccine was administered, employee  stated,   "I feel itchy, my lips are numb and my throat feels funny." VS 142/70, HR 75, Respirations-16, O2 sat-99%. Benedryl 1M given. Epinephrine 1M given. 911 called. EMS arrived and transported  employee to outside hospital.
Nausea, diarrhea, abdominal cramping. Started about 40 hours after vaccine administration. Continuing to time of clinic visit.
HYPOXIA 1/12/2022 ADHESIVE CAPSULITIS OF RIGHT SHOULDER  HYPOXIA 1/12/2022 HYPOTHYROIDISM
sore muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient's wife). The consumer reported similar events for two patients, this is the second of two reports. A male patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 MRA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Mar2021 at 08:00, the patient experienced sore muscle and dizziness. The patient's wife knew that sore muscle pain was normal but 3 days after the vaccine and dizziness continued. The outcomes of sore muscle pain and dizziness were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285441 same reporter/drug/event, different patients
Vasovagal syncope. Within a few minutes of receiving the three vaccines the patient fell lightheaded and fell slowly to the floor. Was witnessed by mother who said he was out for a few seconds and body went rigid in that time. He came to within a minute and was back to normal self a few minutes later.
The patient reported that his symptoms started on 11/24 in the form of dizziness and fatigue, that eventually progressed to include chills and shortness of breath and cough with clear sputum.  Denies any chest pain.  Reports nausea and 1 episode of vomiting with no blood.
This spontaneous report as received from a physician refers to one of twin boys of unknown age. The patient received his first dose of GARDASIL (dose, route and lot number not reported) in October of 2011 and his second dose in July 2012 (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. In July 2012, at an unspecified time period post second dose, boy complained of stomach pain. Boy was seen by the physician who diagnosed him with gastritis. The patient was given ZANTAC as treatment. At the time of the report the outcome of gastritis was unknown. The relatedness for gastritis was unknown for GARASIL. This is one of several received from the same source (MARRS # 1207USA006200). Additional information has been requested.
One week after my first dose, I started to feel sick and had a fever. I also slept for 12 hours, felt very fatigued and lethargic for two days.  On 03-27-2021 I went to Urgent Care where they performed lab work and was found I had an UTI. I had not had a UTI for 35 years. I was placed on antibiotics for 10 days which helped fight off my infection.
On 2/23/00, the pt experienced a breakthrough of varicella. No further information is available.
Patient received TDAP, HPV, and MCV-4 in (R) arm on 4-11-12. On afternoon of 4-12-12 noticed pain, swelling and redness of (R) arm. On 4-13-12 reports decreased pain. At O.V. on 4-13-12 area of warmth, red and induration 7" horizontal, 4" vertical lateral arm. 5" posterior arm in mid-upper arm (R). Increased redness from 4-12-12. Tx with KEFLEX 500mg TID x 7 days.
This spontaneous report was received from a healthcare worker referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of GARDASIL (route of administration, dose and frequency were not reported, lot # K010215 with expiration date: 05-MAY-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
No issues after 1 shot, after 2nd shot chest tightness & shortness of breath
Progress Notes Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 1/29/2021     Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness,  sweating,  and feeling flushed  She denied hives, loss of sensation, SOB.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling.       ALLERGY REVIEW OF SYSTEMS   Previous Reactions: PCN    Objective    Vitals Vitals:   01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99%     Blood Sugar 97 collected at 1500     Physical Exam  No Rashes or Hives noted. No facial swelling , no wheezes.  HEENT  Pharynx is clear without exduate.  No facial or tongue swelling.   Lungs CTA all wheeze   No SOB.  Neck is supple. No swelling is noted.  pt is anxious and nervous.  No sign of anaphalyxis    No stridor, no swelling      Assessment/Plan  Treatment included: antihistamines    Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)  Mild reaction, improving.  Pt refused any further medications or assessment at the ER. Her husband will pick her up.
FATIGUE ON 2/7/2021 LEFT ARM UNDER INJECTION SITE VERY RED HOT AND SWOLLEN VERY PAINFUL
Dose 1- Severe pain at injection site, so much that I couldn?t move my arm.   Dose 2- Woke up at 0300 with severe body aches and fever, lasted for 3 days. My period was due 2/9/2021, and it still has not come.
I felt as if I had a extreme upper respiratory infection. There was congestion and extreme fatigue. It on last about a week.
After 1-2 hr. Became very drowsy. By 8:30PM -so sleepy I went to bed and fell asleep. A ok next day. I never go to bed that early.
Patient reports that she is unable to extend her (L) arm ever since she had her influenza vaccine on 10-26-12. She has a history of torn rotator cuff.
Within a few hours I began to not feel well and had general flu symptoms; muscle aches, headache, achy. I was just feeling miserable. Then I would have the chills and cold sweats and headache and a low grade fever. And then after a few days I went to a drive through testing clinic and they did a COVID test. Two days later I went to see my doctor because I was feeling even worse. I didn't have my results. My doctor said I either had the flu or COVID. Results came back from clinic negative for COVID. I continued to feel flu like symptoms for about two weeks and missed work.   Another condition I get this thing that I am experiencing; its' difficult for me to take a deep breath. I went to the doctor and oxygen level is fine and sleep well at night. My lungs very often just feel like I need another deep breath - and I am unable to get that deep breath.
Information has been received from a physician concerning a 34-year-old female with no pertinent medical history or allergies who on 01-JUN-2007 was vaccinated intramuscularly with 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 656428/0203U). Concomitant vaccines included varicella virus vaccine live (Oka/Merck) (MSD) and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL). On 10-JUL-2007 the patient had a "low" antibody titer for the measles component of the vaccine. The physician reported that the patient did not know her original childhood vaccine status. The patient sought unspecified medical attention. No adverse experience is related to this event. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown deltoid. The pharmacist stated that the patient developed a case of the Shingles 2 months after receiving the a dose of SHINGRIX. The pharmacist consented to follow up.
Tdap given 8/31 and on 9/7/21. Tested positive for COVID.
The patient received her second COVID-19 vaccine (Pfizer) on 5/21/21. She developed itching, itchy throat, cough and shortness of breath two hours after receiving the second vaccine. The itchy throat, cough and shortness of breath resolved within a few days. Pt continues to have itching all over her body as of 7/12/21 provider visit. Pt was seen by allergy clinic on 12/13/21 regarding continued chronic urticaria despite hydroxyzine.  Pt trialed on Allegra. Repeat visit to Allergy 1/4/22. ANA is positive, see below. Referral placed to Rheum clinic. Medical Assistant to call pt to let her know she will need to see Rheum clinic for evaluation of possible autoimmune disorder.     Results as of 1/4/2022 10:42   Ref. Range 12/15/2021 14:31 ANA Pattern Unknown Speckled (A) ANA Titer Unknown 1:160 (A) Antinuclear Antibody (ANA), HEp-2, IgG Latest Ref Range: <1:80  Detected (H) Double-Stranded DNA (dsDNA) Ab IgG ELISA Latest Ref Range: 0 - 24 IU 2 Scleroderma (Scl-70) (ENA) Antibody, IgG Latest Ref Range: 0 - 40 AU/mL 4 Smith (ENA) Antibody, IgG Latest Ref Range: 0 - 40 AU/mL 3 Chromatin Antibody, IgG Latest Ref Range: 0 - 19 Units 4 Ribonucleic Protein (U1) (ENA) Ab, IgG Latest Ref Range: 0 - 19 Units 3 SSA-52 (Ro52) (ENA) Antibody, IgG Latest Ref Range: 0 - 40 AU/mL 2 SSA-60 (Ro60) (ENA) Antibody, IgG Latest Ref Range: 0 - 40 AU/mL 0 SSB (La) (ENA) Antibody, IgG Latest Ref Range: 0 - 40 AU/mL 2   Reviewed allergy labs. + for NUTS and EGG YOLK     Recs; - AVOID all nuts and egg yolk. -Continue meds as discussed LCV. - FU in 1-2 years or sooner prn.   ED 3/28/22 due to nasal congestion, scratchy throat, and cough - received prednisone and albuterol with improvement in sx.  Rheum consult 4/8/22 ANA+: negative subserologies - labs for autoimmune thyroiditis (most common cause of 'false-positive' ANA - also a concern for IBD if the inflammation on CT 7/21 is chronic) - urine pr/cr ratio - labs Chronic urticaria: - query NSAID use - f/u allergy Livedo Reticularis: - labs Joint Pains: query DJD - acetaminophen prn Prediabetes: - f/u PCP - diet/exercise, consider meds Bone health: - calcium/vit D - check vit D Only notable lab was low vitamin D
This case was reported by a pharmacist via call center representative and described the occurrence of local reaction in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction, erythema of extremities and blister. On an unknown date, the outcome of the local reaction, erythema of extremities and blister were unknown. It was unknown if the reporter considered the local reaction, erythema of extremities and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient developed red spot and a blister on arm. No further information was available at the time of report.
Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medication were not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 4/7/21 (lot NA) Pfizer Dose 2 5/5/21 (lot NA) COVID Positive 11/17/21  11/17/21: Patient is a 65 year old female with past history of diabetes mellitus, obesity, and depression who was admitted with respiratory failure secondary to COVID-19 pneumonia.  History is obtained from chart review as well as discussion with the patient and the outside hospitalist. Patient denies any underlying history of heart or lung disease.  She does not using inhalers.  She started feeling poorly approximately 2 weeks ago.  Has had fatigue and weakness and then started developing a cough with chest congestion about 5 days ago.  She then started becoming more short of breath over last few days as well.  She is not having any nausea or vomiting or diarrhea but does admit to a decreased appetite.  She presented to the ER yesterday after her daughter checked her pulse ox and was found to be 67% on room air.  She was placed on 2 L and admitted to that hospital.  She does state that she received 2 doses of the Pfizer COVID-19 vaccine.  Oxygen requirements increased overnight and was transferred to this facility for higher level of care.  Was on 15 L earlier today but currently on 10 L. She states she does have obstructive sleep apnea for which she uses a CPAP at night.  She was given remdesivir as well as Decadron and started on ceftriaxone and azithromycin.  She is currently afebrile.  She denies any chest pain or abdominal pain.  12/19/21: 65-year-old female with obstructive sleep apnea on CPAP, cirrhosis with esophageal varices, type 2 diabetes mellitus, hypertension admitted for acute hypoxemic respiratory failure secondary to COVID-19 and pneumonia. Patient was treated with remdesivir, Decadron, Actemra, broad-spectrum antibiotics.  Patient's oxygen requirement was persistently elevated with progressive worsening hypoxia and ended up intubated on 12/15/2021, developed right-sided pneumothorax pneumomediastinum and subcutaneous emphysema which was treated with chest tube.  Right-sided Pneumothorax has expanded, 2nd chest tube was placed with resolution of pneumothorax.  Patient's condition continued to deteriorate with persistent hypoxia despite being on full ventilator support with 100% FiO2.  Patient's family has decided on comfort care and care had been withdrawn and patient died on 12/19/2021 at 1642. Cause of death COVID 19.