chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache temperature of 100.4  temporary nausea (less than 30 minutes); no desire to eat/drink (ate egg, sausage, toast/ drank lemonade, fruit punch, and water) soreness at injection site (long-lasting) as well as noticeable weakness in left arm tiredness (not necessarily sleepiness, though did sleep on-and-off throughout the day); bizarre dreams, difficulty getting comfortable chills; teeth chattering and bodily shaking (uncontrollable); stayed in bed much of the time frequent urination, even with little fluid consumption temporary pain in the region of both kidneys (approx. 4 hours)
Approximately 2 minutes after vaccine was administered the patient had a syncopal episode. At the time of the episode she was sitting in a chair and was transferred by the RN and mother to an exam table. Her vitals signs were taken with a BP of 122/82, and HR of 85 bpm. The Nurse Practitioner was called into the room after a few minutes as it appeared the child was not yet recovering from the episode. Another RN held her legs up as the NP assessed the child. After approximately 10 minutes the child was still unable to respond consistently to commands and questions and her speech was at times incoherent. A decision was made to have her evaluated by emergency personnel due to the protracted length of time to recover from the episode. When the paramedics arrived, the child was sitting up, answering questions and drinking juice. Vital signs were checked and were within normal limits. Her blood sugar was 88. The decision was made by the parent to take her home. The child was escorted from the clinic at 4:50 pm. A follow up call to the parent by the NP was made the following day and her mother reported she was doing fine.
8/18/2021: admitted with COVID breakthrough   Pt reports  fully vaccinated in April 2021. Reports since Sunday having fatigue, diarrhea, mild cough, loss of taste/appetite, and exertional dyspnea.  reported testing positive for COVID-19 on 8/16/21. 1st vaccine 3/8/2021 second 4/15/2021.  Diagnosed with: COVID-19 pneumonia, acute hypoxic respiratory failure, viral enteritis 9/9/21: patient died.
Patient passed away unrelated to covid vaccination Narrative: The patient had diabetes, hypertension and coronary atherosclerosis. Patient received his first dose of Moderna on 1/7/2021. Patient elected to not receive 2nd dose vaccination following clinical discussion with provider. Patient was diagnosed with pancreatic cancer and ws place on hospice care. Patient passed away on 2/21.No indication that death was related to COVID 19 vaccination.
PMH: dx with Grave's disease in 2014, s/p  thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on synthroid 150 mcg).   1/26 ED VISIT: P/w chest pain/SOB went to ED. Patient received the COVID vaccination 3 days prior (1/23). Was in NSH the morning of vaccine, then in the afternoon became tired. Then developed a H/A (frontal and right sided, that has resolved) and chills.  p/w SS chest pain, radiating to the right shoulder and to the back. Worsened with deep inspiration and difficult to take a deep breath. Took tylenol at 8 pm yesterday (1/25) and advil at 1 pm yesterday (1/25). A/w DOE. Denies birth control use, n/v, abd pain, urinary symptoms, tobacco/etoh/drug use, recent travel, cough, le swelling, hx pe/dvt. Patient had imagining completed - no significant findings and discharged on percocet and ibuprofen.  Patient represented to the ED on 2/2/2021: Over the last two days, patient has tender right shoulder pain radiating to neck and chest with ROM and strength limited by pain associated with nausea. Evaluate for rhabdo and myocarditis - negative. Patient seen by ortho (note unable to be obtained).  2/4 Telehealth visit: The patient reports still having a swollen lymph node under her left axillary area. She denies fever. Patient reports pain to her right shoulder. She presented to ortho who said it might be an infected cyst and attempted to drain it unsuccessfully. Patient mentions pain and tingling to her left breast. She notes right shoulder pain to the back of her neck that radiates down to her left arm. She notes a stabbing back pain and rib pain when she takes a deep breath.  Patient given levofloxacin and gabapentin
Redness/swelling at left leg at site of MMR.  Redness/swelling & minimal induration on right leg at site of varicella.
About 30 seconds after administration of Pediarix#2, HIB#2, Prevnar #2 & Tylenol patient developed hive-like rash on face and body. Resolved with Benadryl injection.
Mother states 7/17/17 patient had axillary temp of 103.2 F. Patient stopped breathing, turned blue and may have had a seizure. Mother reported this 7/19/17 after patient had already recovered from the event. Did not call 911. F/U by MD 7/19/17.
Injection site itchy; Injection site hard; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE INDURATION (Injection site hard) and INJECTION SITE SWELLING (Injection site swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE INDURATION (Injection site hard) and INJECTION SITE SWELLING (Injection site swollen). At the time of the report, INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE INDURATION (Injection site hard) and INJECTION SITE SWELLING (Injection site swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provide.
The patient received immunization on 2/11/00.  On or about 4/24/00 the patient discovered a rash on the right shoulder which spread to the torso, front and back.  Follow up on 01/22/2001: "Patient partially recovered from adverse event.  One patch remains on left front thigh, joint pain in fingers and thumbs of both hands."
Patient developed large, oval shaped red area around vaccine site 9 days after receiving first dose of Moderna covid vaccine. Low suspicion for allergic or local reaction given time frame. Treated for possible cellulitis with Keflex.
patient was given first dose from a vial that was punctured on 3MAY2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given first dose from a vial that was punctured on 3MAY2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given first dose from a vial that was punctured on 3MAY2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given first dose from a vial that was punctured on 3MAY2021) outcome was unknown. Not Provided      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.   No concomitant medications were provided. No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109639 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109639:
Uveitis/endophthalmitis/vascular following vitrectomy 10 days post-vaccination, resulting in vision loss
pt recv vax; unconsolable crying for 3 hr projectible v; pale; became limp & went to sleep; occasionally restless, question small sz; also had a fever 103;
Patient had a golf ball sized lump form at the injection site. The lump appeared bruised and dark in color. She also noted itching at the injection site. This has occurred since the vaccination 6 days ago. Currently the lump has turned to a pink color and has reduced in some size with itching every now and again.
Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness.  Treated with ibuprofen; tylenol; ice to neck, shoulder and wrist; range of motion exercises; heat for muscle relaxation; rest.  Decreased pain and ache with rest.
A nurse reported the occurrence of a sore throat in a 20-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. The reporting nurse stated that on 11/26/2002, the pt received her 1st Engerix-B injection. On 12/02/2002, the pt's mother called the physician's office to report that the pt was experiencing a sore throat and was "rundown". As of 12/20/2002, the outcomes of the events were unknown.
The vaccine has completely disrupted my menstrual cycle. After getting the second shot in February, I began experiencing negative side effects. First my armpit swelled up to the size of a grapefruit and was tender for a week. My last menstrual cycle I PMSed for 2 weeks, experiencing intense cramps, body aches, extremely tender breasts, irritability, an insatiable appetite, weight gain. Then my period started and lasted for 7 days and was very heavy for much longer than usual. It has only been two weeks since that cycle ended and I already have started PMSing again. My cycle was never this messed up, I used to PMS for one week then bleed for 3-5 days.
pt recv vax; high pitched crying intermittently throughout next 12 hr; staring w/o really seeing;sx subsided w/ med; had fever ;
About 3 days after getting the vaccine, I got chills, body ache, severe headache and my fever spiked to 102.4
Autoinoculation with the following skin reactions: blanching erythroderma on back and chest that is drying and flaking with extension in a lacey fashion to his distal extremities, no mucosal lesions, and his left arm lesion that is a cellulitis extending to the proximal forearm. The lesion over the deltoid and majority of the upper arm is as follows: Superficial bullous with thickly purulent material expressed, the edges have honey crust and thick scale. The area of original vaccination is a bit darker (brown/purple) but macular. Pt has been tachycardic and febrile.  He is currently in an ICU receiving IVF, clindamycin and vancomycin. 9/9/09:  ICD 9 Codes received:  V14.7, E949.0. 1/5/10:  Discharge summary and hospital records received for dates of service 8/1/09 to 8/10/09.  Dx:  Reaction to smallpox vaccine, pyogenic superinfection.  Developed erythema and swelling at injection site followed by fatigue, chills, fever, nausea and headache.  Wound drainage cultured and found to be MRSA.  Admitted to MICU and kept in contact isolation until wound healed.  Found to be sheding vaccinia virus.  Started on IV antibiotics. Discharged on oral antibiotics.
Patient was given the PNEUMOVAX 23 vaccine and experienced significant arm swelling, head pain, chills, and fever.
patient inadvertently received both ActHib and Pentacel/ no adverse event; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional via phone.  This case involves a 12 months old male patient who was inadvertently vaccinated with a 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: UJ084AAAand expiry date: 24-Jul-2020) via intramuscular route in the right thigh and 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot number: UI961AA and expiry date: 27-Jun-2020) via intramuscular route in the left thigh on 10-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) on an unknown date.  It was a case of actual medication error due to extra dose administered.  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 holders compliance with the requirements set out in 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.   Documents held by the sender: none.
Low platelets (3k)  Hospital 3 days, Privigen and Decadon administered.  Platelets 93k, discharged.  Low platelets again 02/01/2021 (89k), Gammaguard administered 02/04/2021 in Dr facility (Onocology).
Patient ran fever (101-102F) and had body aches. Patient also had site reaction (pain, redness and swelling), but since 2 vaccines given in same arm, unable to determine which caused site reaction.
about three hours after my Covid booster, I experienced Diarrheas'  just about every 15 mins lasting about 3 hours. The next day i noticed my R Arm where I received the shot became inflamed & Warm to touch.  2 days post shot my arm became swollen too.  it was painful to reach above my head which meant I needed to take time off from work since physical restrictions  as a  Firefighter don't work.  My arm stayed inflamed, swollen & painful for approximately 7 days before it started to subside.
7 am. 1/13/2021 increased poly arthritis  joint pain  Chills Headache Malaise . Tylenol every 6 hours 1/14/2021.   headache , malaise,  hyper skin sensitivity  on back arms; felt like sunburn  1/15/2021 increased pain on skin especially on back headache  increased malaise ; joint pain subsided,   Malaise and headache has lasted for 3  full days
With each Moderna vaccination experienced throat tightness and transcient difficulty swallowing lasting 30-90 minutes. No stridor or respiratory distress. No adverse reaction to Pfizer vaccines. Had breakthrough  COVID starting  6-28-2022, tested positive on  6-29-2022. Started Paxlovid on 6-28-2022. Had GI upset with nausea and diarrhea while on Paxlovid. Took last dose 7-4-2022, GI symptoms have resolved tonight, 36 hrs after final dose of Paxlovid. I spoke with a representative from VSafe today and I agreed to complete this online survey. She was aware we do not feel that Patient had any severe adverse reaction to the vaccines. I was with Patient during 3rd dose of Moderna vaccine, she took Benedryl 25 MG before vaccination without improvement. No residual effects beyond 90 minute episode.
On 05/06/2022 I began to have pain and difficulty urinating. On 05/08/2022  I went to Urgent Care Facility. I was treated with Septra DS . The bacteria was resistant so on 05/11/2022 the doctor prescribed Macrobid 100mg  for 5 days
Shingles. Diagnosed by my PCP in the T10 dermatome. Prodromal itching followed by large painful vesicles that lasted 2 weeks. Finally vesicles crusted over and scarred. Treated with 7 days of valacyclovir and oxycodone.
Pt. states that after receiving the 2nd dose of Moderna 03/20/2021, started experiencing symptoms 08/2021 (Visit with Primary for Lupus test results Plalets dropped /White Blood Cells dropped) recommendation for retesting through current September (continuing to White Blood Cells count continue dropped) 10/01/2021 White Blood Cells gradually began to rise.
Extremely fatigued, naseua, spasticity, severe stomach pain, diarrhea and joint pain for 2 weeks  , couldn?t move the arm of injection site for a week , and thrush
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. On 24-JUN-2013, the patient presented to the pharmacy with her left arm extremely swollen and red. At the time of the report, the patient had not yet seen a physician. No treatment was provided at this time. No lab diagnostic studies were performed. The patient sought medical attention by visiting the pharmacist. The outcome of left arm extremely swollen and red was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Pt got very pale & head back but woke up right away. Put head down bet. legs & doctor came & assisted pt to exam table & sit pt up reverse Trendelenburg. At the time of event pt also has Hgb 11.3. Pt went home in good spirit, walking fine. 5/15/12 TC to mom & pt doing well. No s/s of reaction after event 5/10/12.
Arm is red; Arm is sore; Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 26th June 2019 refer case, US2019159135). Concomitant products included Herpes zoster (Shingrix).   On 28th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th August 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 29th August 2019, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovering/resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant of Shingrix, as the pharmacist forgotten to reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. After being administered, the patient's arm  was red and sore after receiving only the adjuvant. The patient did not consent to follow-up.
07dec89 pt vax 2nd hepta B. placed on therapy w/ lovastatin for treatment of hypercholesterolemia.  therapy w/ lovastatin discontinued after one week.  see worm...
This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose and route of administration were not provided) (lot # L020015 expiry 16-AUG-2017 and L045711 expiry date 08-MAY-2017). The Certified Medical Assistant (C.M.A) stated that GARDASIL 9 was exposed to the following temperature conditions: -7 degree C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had tremorous type activity during sleep-very hard to wake child; Occurred 6 days p/immun; Father has hx of Epilepsy; No temp at time of sz;
Pain one week after injection, after staying isolated at home with family on Thursday.  Pain flared up three days after injection and impacted mobility in left shoulder/arm.  Went to ER, hysterical crying in pain.  Dx left shoulder calcific tendonitis, neck pain, shoulder pain.
Right side of mouth drooping, unable to close right eye completely. Right eye is watery. Symptoms began 10-31-13. Saw office physician 11-6-13 when e c/o mild pain behind right ear. He was unable to wrinkle his forehead on the right side. Pt c/o dropping things.
The patient started experiencing right arm tingling at her fingertips after she received her vaccination.  She had no other symptoms including no dyspnea, weakness, or symptoms in other parts of her body.   After some time, she started having some numbness of the fingertips.
Passed out briefly-when came around c/o of tightness in throat-lasting approx 5-6 min.
Reports onsent of symptoms 5/26/2021: dry (nearly constant) cough with no specific aggravating factors; SOB  and sore throat.   No congestion or altered sense of taste of smell; no emergency s/s; no GI symptoms reported.   She is 1 week s/p dose #2 of Moderna and denies any past HX of COVID-19 infection.   Pt scheduled with urgent care provider on 5/28/2021 by phone.   She was also advised to dial 911 or go to the nearest ED if any emergency s/s present.
This 72 year old presents with lower abdominal pain x 2-3 days, plus lower rib pain, intermittent. No vomiting, mild diarrhea. Had low grade fever last night. History of ca prostate, controlled. Pre-Operative Diagnosis acute appendicitis Post-Operative Diagnosis acute gangrenous appendix  Operative Summary Procedure Performed  Appendectomy Laparoscopic, Laparoscopic appendectomy  _
One of nine cases: An event of Expired Drug Administered occurred in a six-year-old female. The report was received from a registered nurse . No medical or drug history was reported for this child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.